CONTINUING MEDICAL EDUCATION - Modern Medicine · THE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING...

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THE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING MEDICAL EDUCATION JOURNAL VOLUME 30 | NUMBER 04 | APRIL 2013 MIDDLE EAST M ODERN ME D ICINE 04 | 2013 CONTINUING MEDICAL EDUCATION Delayed ejaculation: a management challenge Delayed ejaculation and anejaculation are probably the least understood of the male sexual dysfunctions. MIDDLE EAST REVIEW Significance of Nutrition Assessment and Nutrition Screening in Determining Nutrition Status and Predicting Complications Among Patients with Liver Cirrhosis IN THE MEDICINE Summary of Antibiotic Treatments in Adults Dose regimens for common bacterial infections. JOURNAL DIGESTS FROM REUTERS HEALTH Whooping cough immunity may wane after vaccination | Women overwhelmed by cancer treatment options | Men with big bellies likely to have weaker bones | Traffic pollution tied to autism risk: study ...and more CME Answers for the month of FEBRUARY 2013

Transcript of CONTINUING MEDICAL EDUCATION - Modern Medicine · THE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING...

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THE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING MEDICAL EDUCATION JOURNAL

VOLUME 30 | NUMBER 04 | APRIL 2013

MIDDLE EAST

MODERNMEDICINE

04 | 2013

CONTINUING MEDICAL EDUCATIONDelayed ejaculation: a management challenge Delayed ejaculation and anejaculation are probably the least understood of the male sexual dysfunctions.

MIDDLE EAST REVIEW Significance of Nutrition Assessment and Nutrition Screeningin Determining Nutrition Status and Predicting Complications Among Patients with Liver Cirrhosis

IN THE MEDICINE Summary of Antibiotic Treatments in AdultsDose regimens for common bacterial infections.

JOURNAL DIGESTS FROM REUTERS HEALTHWhooping cough immunity may wane after vaccination | Women overwhelmed by cancer treatment options | Men with big bellies likely to have weaker bones | Traffic pollution tied to autism risk: study ...and more

CME Answers for the month of FEBRUARY 2013

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MIDDLE EAST BOARD OF CONSULTANTSin Alphabetical Order

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Cardiologist• President, Taibah University, Madinah

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ning and CME Program, Jeddah.• Member of the Saudi Society of Family

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All the Modern Medicine editorial is selected from a pool of international editions. In order to deter-mine the physician’s interest in reading any specific article, we pre-test all available editorial with a revolving random sample of doctors in the Middle East. Only articles rating more than 65% as inter-esting-to-read are cleared for publishing in Modern Medicine. Any article rating above 85% qualifies to become a CME article.

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CME - Continuing Medical EducationManaging scleroderma Challenges in primary careScleroderma is a complex and challenging connective tissue disease that may affect multiple organ systems. Most patients have a slowly progressive course and can be managed with vigilant screening, monitoring and timely intervention.

In the MedicineExcessive scalp hair thinning in a middle-aged womanIs bilateral recession and major hair loss in the central scalp region in a postmenopausal woman a case of female pattern hair loss?

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THE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING MEDICAL EDUCATION JOURNAL

ARTICLESVOLUME 30 | NUMBER 04 | April 2013

Contents

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In collaboration with

Jeddah Primary Care CME unit

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IN THE MEDICINE

MIDDLE EAST REVIEW

CONTINUING MEDICAL EDUCATION

Summary of Antibiotic Treatments in AdultsDose regimens for common bacterial infections. Suspected menin-gococcal disease meningitis with non-blanching rash/meningococcal

septicaemia

Significance of Nutrition Assessment and Nutrition Screening in Determining Nutrition Status and Predicting Complications Among

Patients with Liver CirrhosisIn patients with Protein energy malnutrition (PEM), a common complication among patients with liver cirrhosis, most random-ized studies have shown a significant increase in morbidity and

mortality in relation to the severity of PEM.

Delayed ejaculation: a management challengeDelayed ejaculation and anejaculation are probably the least understood of the male sexual dysfunctions. However, their impact is significant because they may result in a lack of sexual fulfilment

for both the man and his partner.

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CATAFAST® 50 mg powder for oral solu�onImportant note: Before prescribing, please consult full prescribing informa�on. Presentation: Diclofenac potassium: powder for oral solu�on in sachets of 50 mg. Indica�ons: Short-term treatment in the following acute condi�ons: post-trauma�c pain, inamma�on and swelling, e.g. due to sprains, post-opera�ve pain, inamma�on and swelling, e.g. following dental or orthopaedic surgery, painful and/or inammatory condi�ons in gynaecology, e.g. primary dysmenorrhoea or adnexi�s, migraine a�acks, painful syndromes of the vertebral column, non-ar�cular rheuma�sm, as an adjuvant in severe painful inammatory infec�ons of the ear, nose or throat. Dosage: Dose to be individually adjusted, lowest effec�ve dose to be given for the shortest dura�on. Adults: 50 to 150 mg daily in divided doses. For dysmenorrhoea and migraine a�acks: up to 200 mg daily. Adolescents aged 14 and over: 50 to 100 mg daily in divided doses. Not recommended in children and adolescents below 14 years of age. Contraindications: Ac�ve gastric or intes�nal ulcer, bleeding or perfora�on; known hypersensi�vity to diclofenac or to any of the excipients, to aspirin or other non-steroidal an�-inammatory drugs (NSAIDs); last trimester of pregnancy; severe hepa�c, renal or cardiac failure. Warnings/Precautions: Avoid use with other systemic NSAIDs including COX-2 inhibitors. Risk of gastrointes�nal (GI) bleeding, perfora�on or serious allergic reac�ons; to be discon�nued if these condi�ons occur. Risk of allergic reac�ons. May mask signs and symptoms of infec�on. Cau�on recommended in pa�ents with symptoms/history of GI disease, asthma, seasonal allergic rhini�s, chronic pulmonary diseases, elderly or impaired hepa�c func�on (including porphyria), ulcera�ve coli�s or Crohn’s disease. Cau�on when used concomitantly with cor�costeroids, an�coagulants, an�-platelets agents or SSRIs. Cau�on while driving or using machines. Should not be used in the rst and second trimester of pregnancy and by breast-feeding mothers. Not recommended to use in women a�emp�ng to conceive as it may impair female fer�lity. Combined use with protec�ve agents to be considered in pa�ents with history of ulcer, elderly, and those requiring low dose aspirin. Monitoring of liver func�on and blood counts recommended during prolonged period. Monitoring of renal func�on recommended in pa�ents with history of hypertension, impaired cardiac or renal func�on, extracellular volume deple�on, the elderly, pa�ents treated with diure�cs or drugs that impact renal func�on. Monitoring recommended in pa�ents with defect of haemostasis. As Catafast® contains a source of phenylalanine, may be harmful for pa�ents with phenylketonuria. Beware of severe uid reten�on and oedema. Interactions: Cau�on with concomitant use of diure�cs and an�hypertensives (e.g. beta blockers, ACE inhibitors), methotrexate, other NSAIDs and cor�costeroids, SSRIs. Monitoring recommended for pa�ents receiving an�coagulants, an�-platelet agents as well as blood glucose level if used concomitantly with an�diabe�cs. Monitoring of serum lithium and digoxin levels recommended if used concomitantly. Dose of diclofenac to be reduced in pa�ents receiving ciclosporin. Interac�ons with concomitant use of quinolones an�bacterials, CYP2C9 inhibitors (e.g. sulnpyrazone, voriconazole). Monitoring of phenytoin plasma concentra�ons is recommended if used concomitantly. Adverse reactions: Common undesirable effects are: Headache, dizziness, ver�go, nausea, vomi�ng, diarrhoea, dyspepsia, abdominal pain, atulence, anorexia, transaminases increased, rash. Rare undesirable effects are: Hypersensi�vity, anaphylac�c and anaphylactoid reac�ons (including hypotension and shock), somnolence, asthma (including dyspnoea), gastri�s, gastrointes�nal haemorrhage, haematemesis, melaena, diarrhoea haemorrhagic, gastrointes�nal ulcer (with or without bleeding or perfora�on), hepa��s, jaundice, liver disorder, ur�caria, oedema. Very rare undesirable effects are: Thrombocytopenia, leukopenia, anaemia (including haemoly�c anaemia and aplas�c anaemia), agranulocytosis, angioneuro�c oedema (including face oedema), disorienta�on, depression, insomnia, nightmare, irritability, psycho�c disorder, paraesthesia, memory impairment, convulsion, anxiety, tremor, asep�c meningi�s, taste disturbances, cerebrovascular accident, visual disturbance, vision blurred, diplopia, �nnitus, hearing impaired, palpita�ons, chest pain, cardiac failure, myocardial infarc�on, hypertension, vasculi�s, pneumoni�s, coli�s (including haemorrhagic coli�s and exacerba�on of ulcera�ve coli�s or Crohn’s disease), cons�pa�on, stoma��s, glossi�s, oesophageal disorder, diaphragm-like intes�nal strictures, pancrea��s, fulminant hepa��s, hepa�c necrosis/hepa�c failure, bullous erup�ons, eczema, erythema, erythema mul�forme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), derma��s exfolia�ve, loss of hair, photosensi�vity reac�on, purpura, allergic purpura, pruritus, acute renal failure, haematuria, proteinuria, nephro�c syndrome, inters��al nephri�s, renal papillary necrosis. Packs and prices: Country specic. Legal classication: Country specic. (May 2010).

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1. Bussone G, Grazzi L, D’Amico D, et al. Acute Treatment of Migraine Attacks: Efcacy and Safety of a Non-steroidal Anti-Inammatory Drug, Diclofenac-potassium, in Comparison to Oral Sumatriptan and Placebo. The Diclofenac-K/Sumatriptan Migraine Study group. Cephalalgia 1999; 19 (4): 232-240.

2. Marzo A, Dal Bo L, Verga F. Pharmacokinetics of diclofenac after oral administration of its potassium salt in sachet and tablet formulations. Arzneimittelforschung 2000; 50 (1): 43-7.

3. Public Health Service, Food and Drug Administration, Department of Health & Human Services. Approval letter; 2009. Application number: 22-165.

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VOLUME 30 | NUMBER 04 | April 2013

ContentsTHE MULTIDISCIPLINARY PEER-REVIEWED CONTINUING MEDICAL EDUCATION JOURNAL

MEDICAL NEWS

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Liposomal doxorubicin inferior for AIDS-related lymphoma

Version of fetus before birth may lower hip dysplasia risk

No increase in heart disease after food poisoning

Study links obstructive sleep apnea to increased risk of cancer

Caffeine-diabetes link still unresolved: study

Traffic pollution tied to autism risk: study

K-citrate helps maintain bones in older adults

Whooping cough immunity may wane after vaccination

Some women overwhelmed by cancer treatment options

Scientists find immune response to gene in mice

Men with big bellies likely to have weaker bones

Impotence drug may help muscular dystrophy patients

Sumatriptan auto-injector helpful in migraine

Feces transplant may help relieve severe diarrhea

Severe overactive bladder symptoms may need higher solifenacin dose

In collaboration with Reuters, the world’s leading medical news agency, MODERN MEDICINE scans for you over 100 leading medical journals and offers you to read Digests of the most significant articles.

Copyright © 2013 Reuters Limited. All rights reserved. Republication or redistribution of Reuters Limited content, including by framing or similar means, is expressly prohib-ited without the prior written consent of Reuters Limited. Reuters Limited shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

6 | April 2013 | Volume 30 | MODERN MEDICINE

Medical news

LIPOSOMAL DOxORUbICIN INFERIOR FOR AIDS-RELATED LyMPHOMA

NEW YORK (Reuters Health) - Substituting pegylated liposomal doxorubicin into a chemotherapy regimen for AIDS-related lymphoma may be accept-able for some patients who cannot tolerate more intensive standard infusional therapy, but early results show it’s not as effective as previously tested regimens.

By using long-acting pegylated liposomal doxorubicin instead of doxorubicin hydrochloride, the researchers had hoped not just for better lymphoma out-comes but also to obviate the need for multiple-day continuous infusions.

“I think it’s fair to say the regimen was not as effective as we hoped it would be, and it’s probably not as effective as R-EPOCH,” that is, etoposide, prednisone, vincristine, and doxorubicin hydrochloride in combination with rituximab, said Dr. Joseph Sparano, of the Albert Einstein College of Medicine in New York City, in email to Reuters Health. “But it may be an acceptable and poten-tially curative regimen for some patients.”

The single-arm phase II study was led by Dr. Alexandra Levine, of City of Hope National Medical Center in Duarte, California, and conducted by the AIDS Malignancy Consortium, of which Dr. Sparano is vice-chair. Full results were published online Monday in the Journal of Clinical Oncology.

The study regimen, dubbed DR-COP, included pegylated liposomal doxorubicin 40 mg/m2 IV on day 1. On days 1 through 5 of each cycle, patients also received IV rituximab 375 mg/m2, IV cyclophosphamide 750mg/m2, IV vincristine 1.4 mg/m2, and 100 mg of oral prednisone; they also received concomitant antiret-roviral therapy. A median of six cycles was administered to 40 evaluable patients.

All of the patients were previously untreated for B-cell lymphoma. The median CD4 cell count at study entry was 114/uL and the median HIV-1 viral load was 25,000 copies/mL.

Overall, 67.5% of patients responded: 47.5% with a complete response and 20% with a partial response.

During a median follow-up of 25.5 months, one patient who had a complete response relapsed.

Overall survival was 70.3% at one year and 61.6% at two years.

Eleven patients withdrew early from the study because of progressive disease and nine because of adverse events. Infections were common, with 22 infections in 16 patients, but no patient died as a result of infection during treatment.

Medical news

MODERN MEDICINE | Volume 30 | April 2013 | 7

Had the complete response rate been above 60%, the investigators would have initiated a phase III trial comparing DR-COP to R-EPOCH. Still, the less inten-sive regimen may be an option for patients who find more intense regimens intol-erable, they say.

In a Journal of Clinical Oncology podcast published online, Dr. Sonali Smith, a lymphoma expert at the University of Chicago agreed. “When comparing the results of this study to other recent trials,” Dr. Smith said, “it is difficult to make a clear statement regarding relative efficacy since this was as single-arm study, however the overall outcome of a 25-month survival of 62% suggests that this is a reasonable option for patients unable to tolerate R-EPOCH.”By Gabriel MillerJ Clin Oncol 2012.

VERSION OF FETUS bEFORE bIRTH MAy LOWER HIP DySPLASIA RISK

NEW YORK (Reuters Health) - Babies in the breech position at birth have higher risk for hip dysplasia, but turning the fetus before birth may reduce that risk, a new study has found.

After successful external cephalic version (ECV), 2.8% of infants suffered hip dys-plasia, compared to 9.3% of those for whom version attempts were unsuccessful.

“A larger cohort study is needed to establish the definitive nature of this rela-tionship. Until then, we recommend the same screening policy for infants born in cephalic position after successful ECV as for infants born in breech posi-tion,” said a multicenter Dutch team in a paper online November 12th in BJOG.

Dr. Marcella De Hundt at Medical Center Alkmaar and colleagues studied 498 infants who were in the breech position near the time of birth. Forty (8%) were found to have developmental dysplasia of the hip at ultrasound screening three months later, including 35 who required treatment for it.

In177 women (36%), ECV was successful. The success rate was higher in mul-tiparous women, at 52%. Most women with successful ECV --164 (93%) -- gave birth vaginally.

Five of the 177 infants born in cephalic presentation after a successful ECV were later treated for hip dysplasia, as were 30 of the 321 infants born in breech presentation (2.8% vs 9.3%).

After multivariate analysis, successful version was associated with a lower rate of dysplasia at an odds ratio of 0.29.

Besides breech position, other known risk factors for hip dysplasia include female gender and family history of the condition. The researchers had excluded infants who might have had a higher risk through their family history. But, as expected, multivariate analysis found a link to female gender, with an odds ratio of 2.79.

The rate of hip dysplasia in both groups of these infants in the breech position is higher than that of the general population, which is 1.4 to 35 per 1000 births, or about 1%, the researchers write.

Medical news

8 | April 2013 | Volume 30 | MODERN MEDICINE

“Our results confirm the overall agreement that attention should be paid to the referral for ultrasound of all neonates who presented in breech position,” the researchers write in BJOG.

That attention should extend even to those who undergo version because their higher risk is “easily forgotten” after a normal vaginal delivery, the researchers write.BJOG 2012.

NO INCREASE IN HEART DISEASE AFTER FOOD POISONING

NEW YORK (Reuters Health) - Despite earlier evidence tying an outbreak of E. coli infections in Canada to later heart disease, an expanded follow up study finds no link between the two.

“Although we definitely want to avoid anyone getting infected in the first place, this new information is reassuring for those who develop an infection from E. coli O157:H7,” Dr. Amit Garg, one of the authors of the study, said in a press release issued by the Canadian Medical Association Journal (CMAJ), which published the study.

This strain of E. coli bacteria polluted the drinking water supply of Walkerton, Ontario in May of 2000, sickening more than 2,300 people and resulting in seven deaths.

Food-borne E. coli infections - which affect about 265,000 people each year in the U.S., according to the Centers for Disease Control and Prevention - can damage the kidneys and lead to high blood pressure. That has raised concerns that they might also contribute to heart disease and stroke.

“There’s anecdotal evidence that certain infections immediately predate heart attack or stroke,” said Dr. Deepak Bhatt, the chief of Cardiology at VA Boston Healthcare System, who was not involved in the study.

“It’s not been clear whether it’s the infection or inflammation (from the infec-tion) or coincidence,” Bhatt, also a professor at Harvard Medical School, told Reuters Health.

To see whether an E. coli outbreak could increase the risk of heart disease and stroke, Garg, a professor at Western University, Lawson Health Research Institute in London, Ontario, and his colleagues collected data on affected indi-viduals from the 2000 event at a health clinic where they had annual visits.

Initially, the group seemed to have a higher risk for heart disease and stroke compared to people who had not suffered an E. coli infection. The researchers point out, however, that nearly half of the participants dropped out of the study, making those findings difficult to interpret.

In the current study, the group included 153 people who experienced severe illness during the outbreak, 414 people with mild illness, 331 people from Walkerton who did not get sick and more than 11,000 people who lived in neighboring towns that were spared from the E. coli outbreak.

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Medical news

10 | April 2013 | Volume 30 | MODERN MEDICINE

In the decade following the outbreak, people who became severely sick were no more likely to later suffer a heart attack or stroke than people who lived outside of Walkerton.

In contrast, people who suffered a mild illness were actually 36 percent less likely to die from heart disease or stroke than residents of the surrounding communities.

Among people with a mild reaction to the infection, about 6 percent died dur-ing the study period, compared to about 10 percent of people who lived outside of the outbreak.

The reason is not totally clear. The authors write in their study that perhaps peo-ple in the mild-illness group didn’t get that sick from the infection - and also had a lower risk of cardiovascular death - because they were healthier than average.

(Garg would not agree to an interview with Reuters Health unless he was able to review major portions of this article in advance, a practice that violates Reuters’ policy to protect journalistic independence.)

still unClear?

The results from the study don’t necessarily mean infections don’t increase the risk of cardiovascular disease, said Dr. Liam Smeeth, a professor at the London School of Hygiene and Tropical Medicine, who was not part of the study.

Smeeth told Reuters Health that research has shown that any impact on the coronary arteries from infection and subsequent inflammation is short-lived, and perhaps the numbers in the Walkerton study were not big enough, or the increased risk not large enough, to be detected.

“It’s not crystal clear because it was a relatively small study,” he said.

Bhatt agreed that the findings don’t prove or disprove the idea that infections could be involved in heart disease, and it’s also possible that the type of infec-tion might matter.

He said that it’s important to rule out the types that don’t contribute.

“I think the study’s important because it makes it very, very much less likely that gastrointestinal infections in some way are linked to atherosclerosis, and I think that finding is useful because probably investigators in the future shouldn’t focus on this area as far as causes of atherosclerosis and heart attack and stroke,” he said.By Kerry Grens

STUDy LINKS ObSTRUCTIVE SLEEP APNEA TO INCREASED RISK OF CANCER

NEW YORK (Reuters Health) - A large Spanish study suggests an association between obstructive sleep apnea (OSA) and the development of cancer in men younger than age 65.

But the researchers say the age and gender findings should be interpreted cautiously since the smaller number of individuals in each age and gender subgroup may have decreased the power to detect relevant associations. Nonetheless, they say, the associations found deserve further study.

Medical news

MODERN MEDICINE | Volume 30 | April 2013 | 11

Intermittent hypoxia, one of the most specific hallmarks of OSA, report-edly plays an important role in tumor formation and progression, Dr. Francisco Campos-Rodríguez, of the Sleep-Disordered Breathing Unit at Hospital de Valme, Sevilla, Spain, noted in an email to Reuters Health.

“However, despite sharing this pathophysiological pathway, a possible associa-tion between OSA and the risk of cancer occurrence had not been previously assessed in human cohorts,” he said.

He also noted that a recent study by the Spanish Sleep Network showed that when mice were subjected to an intermittent hypoxia pattern mimicking OSA, the growth rate of melanoma tumors was twice that in control animals who were not subjected to hypoxia. The mice subjected to intermittent hypoxia also showed more pulmonary metastases than the control group.

These findings prompted the researchers to perform a multicenter study in a large sleep cohort to investigate whether OSA is associated with increased can-cer incidence in humans.

According to a November 15 online paper in the American Journal of Respiratory and Critical Care Medicine, they analyzed 4,910 individuals who were assessed for OSA suspicion in seven Spanish teaching hospitals, and who were followed for 4.5 years.

“We found an increased cancer incidence (that is, occurrence of a new cancer) in OSA patients exhibiting nocturnal hypoxia as compared with those who did not experience nocturnal hypoxia, independently of several potential con-founders such as age, gender, obesity, smoking habit and alcohol intake,” Dr. Campos-Rodríguez said.

It appears that the longer a patient with OSA spends with low night time oxy-gen levels, the greater the risk of developing a cancer.

“For example,” Dr. Campos-Rodríguez told Reuters Health, “compared with patients who spent <1.2% of the night time with low oxygen levels (defined as an oxygen saturation <90%), those who spent >12% of the time with low oxy-gen levels (oxygen saturation <90%) had more than twice the risk of having a cancer during the follow-up period.”

The fact that the oximetric parameters were better predictors of cancer inci-dence than the apnea-hypopnea index, “underscores the hypothesis that hypoxia could be the most likely pathological link between OSA and cancer,” Dr. Campos-Rodríguez noted.

The association between OSA and cancer incidence seemed to be limited to men younger than 65 years; the association wasn’t seen in women or elderly patients (>65 years), but again, this finding needs to be interpreted cautiously. It can’t be ruled out that the lack of association between OSA and cancer incidence in women and those over 65 may be due to lack of power, the researchers say.

More work, they say, is needed to investigate whether a specific cancer location or subtype is more likely to be associated with OSA and the potential role of continuous positive airway treatment (CPAP) in this relationship.

“CPAP is the treatment of choice for OSA patients. This treatment avoids upper airway collapse and its consequences, including intermittent hypoxia. Unfortunately, we did not assess the effect of CPAP treatment in our cohort,” Dr. Campos-Rodríguez said. “Therefore, although one may speculate that if

Medical news

12 | April 2013 | Volume 30 | MODERN MEDICINE

CPAP avoids intermittent hypoxia associated with OSA, it would possibly have a protective effect against this outcome, whether CPAP reduces cancer inci-dence in OSA patients needs to be investigated.”By Megan BrooksAm J Resp Crit Care Med 2012.

CAFFEINE-DIAbETES LINK STILL UNRESOLVED: STUDy

NEW YORK (Reuters Health) - Results of a large new U.S. study confirm that sugary drinks are linked to a heightened risk of developing Type 2 diabetes, but shed little light on whether caffeine helps or hinders the process.

Among more than 100,000 men and women followed for 22 years, those who drank sugar-sweetened drinks were as much as 23 percent more likely to devel-op diabetes than those who didn’t, but the risk was about the same whether the drinks contained caffeine or not. And drinkers of both caffeinated coffee and decaf had slightly lowered diabetes risk.

“We found that caffeine doesn’t make a difference at all,” said the study’s lead author Dr. Frank Hu of Harvard University. “Coffee can be beneficial and the caffeine doesn’t appear to have a positive or negative effect on diabetes risk,” Hu told Reuters Health.

Numerous past studies have linked regular consumption of soft drinks - both sugar- and artificially-sweetened - to an increased risk of diabetes. Research over the past decade has also suggested that caffeine temporarily prevents the body from processing sugar efficiently. Those who live with diabetes deal with this problem all the time.

That at least suggests that caffeine in conjunction with sweetened drinks might raise diabetes risk even further. However, other research has found a protective effect from coffee and tea, suggesting caffeine does the opposite.

Hu and his coauthors wanted to know if people who regularly drink sugary and caffeinated beverages might only be exaggerating their risk of developing a dis-ease that affects nearly 26 million adults and children, or about eight percent of the U.S. population, according to the American Diabetes Association.

They examined the health habits of 75,000 women and 39,000 men involved in long-term health studies that began in the mid-1980s.

Compared to people who didn’t consume sugary drinks, the likelihood of developing diabetes over the years for those who did was higher by 13 percent (caffeinated) or 11 percent (decaffeinated) among women, and by 16 percent (caffeinated) or 23 percent (decaffeinated) among men.

Caffeine-free artificially sweetened drinks were also linked to a slight (six per-cent) increase in risk among women.

However, coffee drinkers showed slightly lower risk compared to non-drinkers. The chances of developing diabetes were eight percent lower among women, whether they drank decaf or regular coffee, and for men, four percent lower with caffeinated coffee and seven percent lower with decaf.

Hu and his team have used this same dataset, which contains the health habits of mostly white health professionals, to suggest that regular coffee drinking in general is tied to lower diabetes risk.

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Broad indication: • 1 dose for individuals 2-55 years of age• 2 doses at least 3 months apart for infants/toddlers 9-23 months

Easy-to-use, fully liquid vaccine

1. Sanofi Pasteur. Data on fi le.2. MacNeil J, Cohn A, Zell E. et al. Early estimate of the effectiveness of quadrivalent meningococcal conjugate vaccine. Ped Infect Dis J. 2011;30(6);1-5.3. Sanofi Pasteur. Menactra Package Insert (Standard Expert Package). Sept 2011.

For further information, please refer to the local prescribing information.

The only US FDA-approved quadrivalent meningococcal conjugate vaccine with over 8 years of real-world experience

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Broad indication: • 1 dose for individuals 2-55 years of age• 2 doses at least 3 months apart for infants/toddlers 9-23 months

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1. Sanofi Pasteur. Data on fi le.2. MacNeil J, Cohn A, Zell E. et al. Early estimate of the effectiveness of quadrivalent meningococcal conjugate vaccine. Ped Infect Dis J. 2011;30(6);1-5.3. Sanofi Pasteur. Menactra Package Insert (Standard Expert Package). Sept 2011.

For further information, please refer to the local prescribing information.

Medical news

14 | April 2013 | Volume 30 | MODERN MEDICINE

But past studies, like the current one, have also found that the risk falls even lower if adults drink decaffeinated coffee.

“Our understanding of the body’s tolerance to caffeine is not complete,” said James Lane of Duke University. Lane has done short-term studies that linked caffeine to a disruption of the body’s ability to process glucose, or “blood sugar.”

This latest study suggests that people who currently drink sugary beverages could substitute unsweetened coffee or tea - though tea was associated with fewer benefits - instead.

Such advice could be important, since the number of Americans who develop diabetes has steadily increased, according to a study released earlier this month by the U.S. Centers for Disease Control and Prevention.

Diabetes can only be managed, not cured and its side effects range from high blood pressure to debilitating blindness.

“I’m disappointed that they are essentially repeating something they published several years ago. The bit about including sugar sweetened beverages and caf-feine’s possible interaction with sugar and diabetes does not add something of great value,” Lane told Reuters Health.

Others agree more research is necessary to untangle caffeinated coffee’s compli-cated relationship with diabetes risk.

At least one small, randomized two-month-long trial led last year by Rob Martinus van Dam of the National University of Singapore, also a co-author of the current study, found that caffeinated coffee did not seem to affect glucose levels in the blood.

Van Dam told Reuters Health that the next step toward establishing a direct link between caffeinated coffee and reduced diabetes risk would require a much larger study.

“We still don’t advise people to start drinking coffee if they do not already,” van Dam said.

People who want to lower their risk of developing diabetes could follow advice that has been better substantiated, such as eating large amounts of fruits and vegetables and exercising regularly.By Kathleen Raven

TRAFFIC POLLUTION TIED TO AUTISM RISK: STUDy

NEW YORK (Reuters Health) - Babies who are exposed to lots of traffic-related air pollution in the womb and during their first year of life are more likely to become autistic, suggests a new study.

The findings support previous research linking how close children live to free-ways with their risk of autism, according to the study’s lead author.

“We’re not saying traffic pollution causes autism, but it may be a risk factor for it,” said Heather Volk, an assistant professor at the Keck School of Medicine of the University of Southern California in Los Angeles.

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MODERN MEDICINE | Volume 30 | April 2013 | 15

Autism is a spectrum of disorders ranging from a profound inability to commu-nicate and mental retardation to milder symptoms seen in Asperger’s syndrome.

The prevalence of autism has grown over the past few years. It’s now estimated that the disorder affects one in every 88 children born in the United States, which is a 25 percent increase from a 2006 estimate.

The increase in autism diagnoses has also been accompanied by a growing body of research on the disorder.

Including Volk’s new study, there are three articles on autism in Monday’s issue of the Archives of General Psychiatry.

“A decade ago, the journal published about the same number of autism articles per year,” wrote Geraldine Dawson of the University of North Carolina at Chapel Hill, in an editorial accompanying the studies.

The two other reports in the current issue deal with ways to image a person’s brain to look for physical differences between an autistic and non-autistic brain.

According to Dawson, who is also chief science officer of the advocacy group Autism Speaks, the number of studies on autism began to grow around 2000. Most studies, she says, deal with the biology of the disease.

ENVIRONMENTAL FACTORSVolk’s new study, however, is one of a series of looks into how environmental fac-tors may be linked to a child’s risk of being autistic, done over the past few years.

“I think it’s definitely an area that’s been understudied until recently,” Volk told Reuters Health.

Unlike their last study, which used how close a child lived to a freeway as a substitute for pollution exposure, for the new analysis Volk and her colleagues looked at measures of air quality around kids’ homes.

Compared to 245 California children who were not autistic, the research-ers found that 279 autistic children were almost twice as likely to have been exposed to the highest levels of pollution while in the womb, and about three times as likely to have been exposed to that level during their first year of life.

They found that children exposed to the highest amount of “particulate matter” - a mixture of acids, metals, soil and dust - had about a two-fold increase in autism risk. That type of regional pollution is tracked by the Environmental Protection Agency.

Volk and her colleagues also saw a similar link between autism and nitrogen dioxide, which is in car, truck and other vehicle emissions.

“This is a risk factor that we can modify and potentially reduce the risk for autism,” wrote Dawson in an email to Reuters Health.

The researchers said certain pollutants could play a role in brain development - but that doesn’t prove being exposed to air pollution makes kids autistic. They warned that there may be other factors that explain the association, including indoor pollution and second-hand smoke exposure.

“There are some potential pathways that we’re examining in our current research that will be coming up next,” said Volk.By Andrew M. Seaman

Medical news

16 | April 2013 | Volume 30 | MODERN MEDICINE

K-CITRATE HELPS MAINTAIN bONES IN OLDER ADULTS

NEW YORK (Reuters Health) - Elderly, osteoporosis-free men and women who take potassium citrate daily have significant increases in areal and volu-metric bone mineral density (BMD) after two years, new findings show.

“By neutralizing the acid we generate by our diet it is possible to slow or pos-sibly reverse the age related decline in bone density and bone mass,” Dr. Reto Krapf of the University of Basel in Switzerland, one of the study’s authors, told Reuters Health.

Eating a diet heavy in proteins from meat and grains can increase the acid load in the body, leaching calcium from the bone and resulting in other bone-weak-ening effects, Dr. Krapf and his team noted in a paper online November 15th in the Journal of Clinical Endocrinology and Metabolism.

The researchers note that a study in osteopenic women found those who took potassium citrate for a year to neutralize diet-induced acidosis showed an increase in areal BMD.

To investigate whether this approach could also prevent the decline in bone mass and quality that occurs with aging, Dr. Krapf and his colleagues enrolled 201 men and women over 65, none of whom had osteoporosis at baseline. Subjects took 60 mEq of potassium citrate daily or placebo, along with calcium and vitamin D. The primary outcome was areal BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DEXA) at 24 months.

Twenty-four-hour urinary acid excretion showed complete neutralization of endogenous acid production in the patients taking potassium citrate, while these patients also showed lower calcium excretion at six and 12 months.

After two years, lumbar spine density had increased by 1.7%, on average, in patients taking potassium citrate. All parameters measured showed increases, with no signs of a plateau.

High-resolution peripheral quantitative computed tomography, used to mea-sure volumetric bone density, showed trabecular density increases in the non-dominant tibia and radius of 1.3% and 2.0%, respectively. Both men and women taking potassium citrate had significant decreases in fracture risk as measured by FRAX.

The participants in the current study were at very low risk of fracture, Dr. Krapf noted, and conducting a study that would yield fracture data would require enroll-ing thousands of patients and following them for several years. However, he noted, the current findings probably provide enough evidence to make claims for the bone-strengthening benefits of potassium citrate as a nutritional supplement

He and his colleagues conclude: “K-citrate administered in a background of vita-min D and calcium supplements is well-tolerated and constitutes an inexpensive intervention to increase bone aBMD and trabecular vBMD and to improve bone micro architecture in healthy elderly people with normal bone mass.”By Anne HardingJ Clin Endocrinol Metab 2012.

Medical news

18 | April 2013 | Volume 30 | MODERN MEDICINE

WHOOPING COUGH IMMUNITy MAy WANE AFTER VACCINATION

NEW YORK (Reuters Health) - During a recent whooping cough outbreak in California, kids who hadn’t been vaccinated against the disease were nine times more likely to get it than those who had received the entire five-shot series, researchers found.

But even among children who were fully vaccinated, the longer it had been since their final dose of DTaP vaccine, the higher their risk of pertussis.

The lead researcher on the study from the Centers for Disease Control and Prevention (CDC) said the effectiveness of many childhood vaccines is known to decrease over the years after vaccination.

Because of such waning immunity, a DTaP booster was recently added to the vaccine schedule for 11- to 12-year-olds, on top of the five doses traditionally given between age 2 months and 6 years. The combination vaccine also protects against diphtheria and tetanus.

“Pertussis vaccines are still our best tool to prevent pertussis,” said Dr. Lara Misegades, from the National Center for Immunization and Respiratory Diseases at the CDC.

“The first couple of years after children complete their vaccine series, vaccine effectiveness is still high,” she said.

Her team’s study, she told Reuters Health, “Reinforces the importance of getting the adolescent DTaP booster.”

During the 2010 whooping cough outbreak in California, more than 9,000 cases were reported and 10 infants died, the researchers wrote Tuesday in the Journal of the American Medical Association.

The new study included 682 kids aged 4 to 10 with whooping cough across the state and another 2,016 comparison children who never got the disease.

According to their medical records and immunization registries, 7.8% of the kids who got whooping cough hadn’t received any DTaP vaccines, compared to 0.9% of their pertussis-free peers.

Children who’d finished their vaccine series recently were the least likely to become infected. For example, just 2.8% of kids who got sick had received their fifth DTaP dose in the past year, compared to 17.6% of those who didn’t come down with whooping cough.

And with each year that passed since children’s last vaccine dose, their odds of getting pertussis rose.

“The message should clearly not be, ‘Don’t get the vaccine because it doesn’t work,’” said Dr. Eugene Shapiro, a pediatrician and infectious diseases research-er from the Yale School of Medicine in New Haven, Connecticut.

“It works, but we need to continue to work to improve it,” Dr. Shapiro, who wrote an editorial accompanying the new study, told Reuters Health. “The problem is we don’t really know what should be done.”

He said one strategy might be to give an earlier DTaP booster dose, or to con-

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MODERN MEDICINE | Volume 30 | April 2013 | 19

sider a different type of pertussis vaccine - but each of those ideas will require more research.

To prevent the most serious whooping cough cases including deaths, both research-ers emphasized the importance of vaccinating pregnant women and anyone living with an infant. Babies are the most likely to get seriously ill in a whooping cough outbreak, and “cocooning” could prevent them from being exposed in the first place.

Dr. Misegades said the CDC also recommends catch-up vaccination for every-one who hasn’t gotten their entire DTaP series. Whooping cough cases for this year have already topped 36,000 in the U.S., she added.

“This is still an ongoing pertussis epidemic that we’re seeing in many areas, and not just California,” she said.By Genevra PittmanJAMA 2012.

SOME WOMEN OVERWHELMED by CANCER TREATMENT OPTIONS

NEW YORK (Reuters Health) - More than one in five women with early-stage breast cancer in a new study said they were given too much responsibility for treatment-related decisions - and those patients were more likely to end up regretting the choices they made.

The findings don’t mean women should not be fully informed about their treat-ment options, researchers said, but rather that doctors may need to find new strategies to communicate with patients, especially those who are less educated.

“Some women may feel overwhelmed or burdened by treatment choices, par-ticularly if they are not also given the tools to understand and weigh the ben-efits and harms of these choices,” researchers led by Jennifer Livaudais wrote in the Journal of General Internal Medicine.

Her team from the Mount Sinai School of Medicine in New York surveyed 368 women who had just had surgery for early-stage breast cancer at one of eight New York City hospitals, and again six months later.

The majority said they typically had trouble understanding medical informa-tion and less than one-third knew the possible benefits of surgery, radiation and chemotherapy, Livaudais and her colleagues found.

Lack of both “health literacy” and knowledge about treatment benefits was common among the 21 percent of women who said they had too much respon-sibility for decision-making - as well as among the seven percent who felt they didn’t have enough responsibility.

Women who were poor, non-white or didn’t finish high school were also more likely to feel that they had either too much or too little say in their treatment.

Close to two-thirds of women on both ends of the spectrum had some regret about their original treatment decisions six months down the line. That compared to one-third of women who originally said they had a “reasonable amount” of decision-making responsibility.

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20 | April 2013 | Volume 30 | MODERN MEDICINE

One in eight women will be diagnosed with breast cancer at some point in her life, according to the National Cancer Institute, with a higher risk among those with certain genetic mutations.

Dr. Steven Katz, who has studied cancer-related decision-making at the University of Michigan in Ann Arbor, said that compared to past years, doctors now have better ways to tailor treatment to individual patients. But that also means treatment options are based on more convoluted information.

“The treatments are linked in complicated ways, and the information that doc-tors draw on to make recommendations has increasingly become more and more complex,” Katz, who wasn’t involved in the new research, told Reuters Health.

He said that for patients trying to make the best treatment choices, the smartest thing they can do is have a team of doctors - an experienced surgeon, a medical oncologist, a radiation oncologist and a plastic surgeon - all working on their case and sharing ideas.

“Of course if they have strong preferences for retaining a breast and having radiation yes (or) no, those are really important decisions for a patient to think about,” Katz said.

“There are very strong reasons to engage women at the very highest level regarding those values and preferences.”

“The purpose (of the study) was not to say women shouldn’t be provided with these treatment options, but that the information really needs to be tailored better,” Livaudais, who is now at the University of California, San Francisco, told Reuters Health.

She recommended doctors ask each patient how much responsibility she feels comfortable taking going into treatment.

“Some patients prefer... for the information to be presented in simpler terms, or for the physician to recommend something to them,” Livaudais said.

By Genevra Pittman

Continued on page 44

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Medical news

44 | April 2013 | Volume 30 | MODERN MEDICINE

SCIENTISTS FIND IMMUNE RESPONSE TO GENE IN MICE

HONG KONG (Reuters) - A gene that keeps embryos alive appears to control the immune system and determine how it fights chronic diseases like hepatitis and HIV, and autoimmune diseases like rheumatoid arthritis, scientists said on Monday.

Although the experts have only conducted studies on the gene Arih2 using mice, they hope it can be used as a target for drugs eventually to fight a spec-trum of incurable diseases.

Lead author Marc Pellegrini at the Walter and Eliza Hall Institute of Medical Research in Australia said the gene appears to act like a switch, flipping the immune system on and off.

“If the gene is on, it dampens ... the immune response. And if you switch it off, it greatly enhances immune responses,” Pellegrini said in a telephone interview.

Arih2 was first identified by another group of scientists in the fruit fly but it drew the interest of Pellegrini’s team because of its suspected links to the immune system.

In a paper published in Nature Immunology, Pellegrini and his team described how mice embryos died when the gene was removed.

Next, they removed the gene from adult mice and noticed how their immune systems were boosted for a short period of time. But it quickly went into an overdrive and started attacking the rodents’ own healthy cells, skin and organs.

“The mice survived for six weeks quite well. Then they started developing this very hyperactive immune responses and if you leave it for too long, it starts reacting against the body itself,” Pellegrini said.

Pellegrini and his colleagues hope that scientists can study the gene further and use it as a drug target to fight a large spectrum of diseases.

“It’s like an accelerator. In infectious diseases, you want to slam on the brakes on this gene, and for autoimmune diseases, you want to push the accelerator to make it work much harder to stop the whole immune response,” said Pellegrini.

“The more the gene works, the less of an immune response there is. And the less active the gene is, the more the immune response is.”By Tan Ee Lyn

MEN WITH bIG bELLIES LIKELy TO HAVE WEAKER bONES

CHICAGO (Reuters) - Men with excessive fat around their abdomen, commonly known as a “beer belly,” are at an elevated risk for heart disease and Type 2 diabe-tes, and now researchers are adding osteoporosis to the list of potential hazards.

More than 37 million American men over age 20 are obese, according to the National Center for Health Statistics. While obesity is associated with a host of other health problems - hypertension, high cholesterol, asthma, sleep apnea and joint diseases - it has been widely accepted that overweight men were at a lower risk for bone loss.

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MODERN MEDICINE | Volume 30 | April 2013 | 45

“Not true,” said Dr. Miriam Bredella, a radiologist at Massachusetts General Hospital and an associate professor of radiology at Harvard Medical School. “Everyone thinks of osteoporosis as a disease of women. Studies all focused on women, and men were always thought to be fine. We specifically wanted to look at young men.”

Bredella and her team of researchers evaluated 35 obese men with a mean age of 34 and a mean body mass index, a measure of body fat, of 36.5.

The men were divided into two groups: one with mainly subcutaneous fat, which lies just beneath the skin and is spread all over the body, and the other with mostly visceral or intra-abdominal fat, located deep under the muscle tis-sue in the abdominal cavity.

DEEP FAT MORE DANGEROUSVisceral fat, which is what causes a pot belly even in thin people, is far more menacing because the fat is packed in-between the inner organs and is strongly linked to heart disease. Genetics, a high-fat diet and a sedentary lifestyle all contribute to visceral fat.

“What surprised us most was that men with visceral fat had significantly weaker bones than (the subcutaneous fat) group. These are men with the same degree of obesity and who were about the same age,” Bredella said in a tele-phone interview.

For the study, she put the men through a computed tomography, or CT scan, of the abdomen and thigh to measure fat and muscle mass, as well as very high resolution CT of the forearm.

She assessed bone strength to predict fracture risk using a technique called finite element analysis, which is used in mechanical engineering to determine the strength of materials for the design of bridges and airplanes.

What she found was that the bones of the group with more visceral fat were near-ly twice as weak as those with subcutaneous fat, or fat spread all over the body.

The results also showed that muscle mass was positively associated with bone strength.

She said the size of her study was limited by the sophistication and expense of the imaging tools that were used to predict risk. Since the results of this study, she has evaluated an additional 30 men in the same fashion, rendering the same results.

There appears to be two main reasons that visceral fat leads to osteoporosis, Bredella said. One is that all people with visceral fat secrete less human growth hormone, which plays an important role in maintaining healthy bones. The second reason is that visceral fat secretes certain molecules that cause inflam-mation, which in turn, weakens bones.

The secretion of these molecules and their effect on the body will be the focus of her future research.By Debra Sherman

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46 | April 2013 | Volume 30 | MODERN MEDICINE

IMPOTENCE DRUG MAy HELP MUSCULAR DySTROPHy PATIENTS

LONDON (Reuters) - The erectile dysfunction drug tadalafil (Cialis, Eli Lilly) can correct abnormal blood flow in patients with Becker muscular dystrophy and could in the future be used to slow progression of the disorder, researchers said on Wednesday.

The findings suggest that tadalafil could be used as a treatment to slow or pre-vent muscle weakening and help patients retain more function for longer.

Becker muscular dystrophy is an inherited disorder that involves slowly wors-ening muscle weakness of the legs and pelvis. It occurs in about 3 to 6 out of every 100,000 births.

Patients with Becker muscular dystrophy often have difficulties with walking that get worse over time. There is no cure for the condition, and by the age of 25 to 30 many patients are unable to walk.

In a small study involving men with the disorder, researchers from the Cedars-Sinai Medical Center in Los Angeles took measurements when volunteers’ fore-arm muscles were either rested or lightly exercised with a handgrip.

They found that almost all the patients had defective blood flow when they exercised. This lack of blood flow may contribute to muscle fatigue and weak-ness, the researchers wrote in a paper in the journal Science Translational Medicine this week.

But after giving some of the patients a single oral dose of tadalafil and compar-ing them to others given a placebo, the scientists found that normal blood flow was restored to the muscles of 8 out of 9 patients who got the drug.

Like other erectile dysfunction drugs, tadalafil dilates blood vessels and is designed to increase blood flow. In the impotence drug market, it is a longer-acting alternative to sildenafil (Viagra, Pfizer).

The researchers cautioned that more, larger studies are needed to show whether the improved blood flow has a meaningful effect on dystrophic muscles.Sci Transl Med 2012.

SUMATRIPTAN AUTO-INjECTOR HELPFUL IN MIGRAINE

NEW YORK (Reuters Health) - Patients with migraine in a recent study found Pfizer’s Alsuma sumatriptan auto-injector easy to use and effective, and most said they preferred the device over earlier auto-injectors, according to a new paper.

Dr. Elodie Ramos of Pfizer, New York and colleagues say their subcutaneous (SC) formulation of sumatriptan is more effective than any oral migraine treat-ment on the market. Yet the oral formulation continues to be more commonly prescribed; the researchers suspect anxiety about injections and dexterity prob-lems may be among the barriers to use of the subcutaneous form.

Although sumatriptan injectors have been available for use in the US since 1992, the devices vary in portability and convenience and many need assembly immediately prior to use.

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Medical news

48 | April 2013 | Volume 30 | MODERN MEDICINE

One possible solution may be the now widely-available Alsuma device, which offers rapid single use and provides a 6 mg SC dose of sumatriptan. The injec-tor was approved by the US Food and Drug Administration in 2010.

As Dr. Ramos told Reuters Health by email, “The Alsuma auto-injector... has no FDA-approved therapeutic equivalent, which means there is no substitut-able generic product with which pharmacists can fill an Alsuma prescription. The Alsuma auto-injector, which is prefilled and ready to use, offers patients an additional treatment option for acute migraine attacks or cluster headache episodes.”

In a November 13th online paper in Headache, the researchers report on an open-label trial conducted to assess the ability of patients to employ the device successfully during attacks.

All 63 subjects were having at least two migraine attacks with or without aura per month, and all had used SC sumatriptan at least twice within the previous two months.

Sixty-one study subjects used the Alsuma auto-injector on the thigh, and the other two patients reported injection in the arm.

Questionnaire responses showed that all believed that the instructions were easy to follow. Almost all (95.2%) thought that the device was easy to use and 65.1% felt it was easier to use than the traditional auto-injector they were using prior to study entry.

The headache response rate at two hours was 93.7%; at that point, 60.3% were pain-free overall. In the subgroup of patients reporting severe baseline head-ache pain, 58.3% were pain-free at two hours.

Mild injection site bruising, seen in 15.9% was the most common adverse event. The next most common was injection site pain, reported by 6.3% of patients; all but one patient reported this as being mild.

Success was high but the researchers point out that the results “must be inter-preted with caution because this was an open-label trial that was not designed with appropriate methodology to formally test efficacy.” In addition, the sub-jects were familiar with sumatriptan SC self-injection “and thus were likely responders.”

Nevertheless, the researchers conclude that as well as being preferred, “the new auto-injector (was) safe and well tolerated, with levels of injection site reactions that were mild and infrequent.”

The study was sponsored by King Pharmaceuticals, which was acquired by Pfizer in 2011.By David DouglasHeadache 2012.

FECES TRANSPLANT MAy HELP RELIEVE SEVERE DIARRHEA

NEW YORK (Reuters Health) - It may sound like the most unappealing treat-ment available, but a small new study has concluded that inserting fecal mate-

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MODERN MEDICINE | Volume 30 | April 2013 | 49

rial from a healthy person into the gut of someone with severe diarrhea may cure their problem more effectively than antibiotics.

The study, which appears in the New England Journal of Medicine, involved patients who had repeated bouts of diarrhea caused by a bacterium known as Clostridium difficile. So-called C. diff can take over the intestines after antibi-otic treatment has killed off the beneficial bacteria found in the gut.

One transplant of fecal material from a volunteer - with its mix of healthy bac-teria - resolved severe diarrhea in 13 out of 16 volunteers. Standard treatment with an antibiotic, in comparison, worked in four of 13 patients.

“This is the first hard evidence that has been provided for the treatment,” senior author Dr. Josbert Keller of the University of Amsterdam told Reuters Health.

“Those of us who do it know how effective it is,” said Dr. Colleen Kelly of Brown University’s Alpert Medical School in Providence, Rhode Island, who was not connected with the study but uses fecal transplant in her practice.

About 3 million people in the U.S. are infected annually with C. diff, which spreads mainly through hospitals, nursing homes and doctors’ offices.

The bacterium underlying the problem is called “difficile” for a reason. When it controls the gut, it can be difficult to eradicate. Antibiotics typically only work in 15 to 26 percent of patients with C. diff. - and after repeated rounds of treat-ment, the drugs become less effective.

“I’ve done 90 of these now in the last four and a half years. In patient after patient who has failed multiple courses of antibiotic, if you give them a dose of stool, they get better,” she told Reuters Health.

Stool transplants have been proposed as one alternative (see Reuters story of November 30, 2012: http://reut.rs/QRaAIy).

Keller and his colleagues compared three treatments in a small trial.

Thirteen volunteers with C. diff received a standard antibiotic, vancomycin, four times a day for 14 days. After 10 weeks, four were free of bacteria-related diarrhea.

Another 13 patients had the same drug therapy after drinking a solution to clean out the bowel, a process known as bowel lavage that is similar to what people go through if they are getting a colonoscopy. That worked in three cases.

The remaining 16 volunteers had a brief treatment with vancomycin, combined with bowel lavage, followed by the infusion of 500 milliliters of diluted donor feces through a tube that went into the nose, down the throat, past the stomach and into the small intestine.

In the three cases where that treatment failed, the doctors re-treated patients with fecal material from a different donor. That worked in all but one case.

Among the volunteers in the non-transplant groups who had a relapse of C. diff, 18 were later given a fecal transplant. It cured 15 of them, although four of the 15 needed two treatments.

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All of the donors - people who worked in the hospital who were not involved with patient care - were periodically screened for a variety of diseases.

When side effects were tallied in the transplant group, 94 percent of patients reported diarrhea, 31 percent had cramping and 19 percent had belching, but all of those symptoms disappeared within three hours. Nineteen percent ulti-mately reported constipation after treatment.

Feces transplants may sound extremely distasteful, but “the patients were desperate because they had had several episodes. There was nothing else they could do. There was no psychological hurdle for them,” said Keller.

“I think the ‘yuck’ thing is overplayed,” Kelly said. “There’s a desperation when you’re this sick this long.”

Only eight of the 43 patients in the study were willing to try the treatment after their first relapse of C. diff, Keller and his colleagues reported.

“The efficacy of antibiotic therapy decreases with subsequent recurrences, and it seems reasonable to initiate treatment with donor-feces infusion after the sec-ond or third relapse,” they wrote.By Gene Emery

SEVERE OVERACTIVE bLADDER SyMPTOMS MAy NEED HIGHER SOLIFENACIN DOSE

NEW YORK (Reuters Health) - Patients with overactive bladder (OAB) symp-toms not controlled by 5 mg of the antimuscarinic solifenacin may benefit from a doubling of the dose, according to new results from the SUNRISE study.

“If patients are unresponsive or poorly responsive to a low dose of an antimus-carinic, it is well worth trying them on a higher dose before changing their therapy,” Dr. Linda Cardozo from King’s College Hospital, London, UK told Reuters Health. “Dose flexibility is useful, as one dose does not suit everyone.”

Everyone in the SUNRISE trial started out on either 5 mg of solifenacin, or pla-cebo, for eight weeks. At eight weeks, everyone could request a dose increase. Placebo patients requesting a dose increase would still receive a placebo, but patients in the solifenacin group who requested a higher dose were randomly assigned to continue at 5 mg or go up to 10 mg.

In 2008, the SUNRISE research team reported that solifenacin at either 5 or 10 mg was significantly more effective than placebo in reducing the mean number of urgency episodes, as well as all secondary measures, in patients with OAB.

In this study, reported January 7 online in BJU International, Dr. Cardozo and colleagues investigated whether requests for dose increases at week eight in the SUNRISE study were related to the severity of OAB symptoms at baseline. Also, in the solifenacin patients who requested dose increases, the researchers com-pared those who got them to those who didn’t.

Dose increases were requested by 275 patients in the solifenacin group (46.5%) and 131 patients in the placebo group (65.8%). Patients who requested dose increases had worse OAB symptoms, including more severe urgency episodes, higher total urgency scores, greater micturition frequencies, more incontinence

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and urgency incontinence episodes per 24 hours, and worse perceived bladder condition, urgency bother, and treatment satisfaction, compared with patients not requesting a dose increase.

Patients who requested a dose increase and were randomized to receive the increased dose of 10 mg experienced greater improvements in the number of severe urgency episodes (the primary endpoint), compared with those who requested a dose increase but were randomized to continue on the dose of 5 mg.

All other OAB efficacy variables improved after the requests for dose increases, but the improvements were significantly greater among patients who were ran-domized to the increased dose.

Although treatment-emergent adverse events after randomization to the increased or same dose of solifenacin were more frequent among patients in the 10-mg group (especially dry mouth), the absolute numbers were low and simi-lar to or lower than previously reported rates with solifenacin, the authors say.

“The findings of the study suggest that patients with more severe symptoms are likely to benefit more from a higher dose of an antimuscarinic than those who have milder symptoms,” Dr. Cardozo said.

“It is not necessary to wait eight weeks before considering a dose increase in patients who have not experienced significant relief with antimuscarinic therapy,” Dr. Cardozo said. “Two weeks is probably sufficient based on other historical data.”

She added, “Other drugs have also been investigated in this way and, similarly, with fesoterodine, patients with worse symptoms at baseline require a higher dose for similar symptom benefit to those patients with lesser symptoms who require less antimuscarinic.”

“The drug is well tolerated and effective at 5 mg but nearly 50% of patients would benefit from up titration of the dose in this randomized controlled trial to 10 mg,” Dr. Christopher R. Chapple from The Royal Hallamshire Hospital’s Department of Urology, Sheffield, UK, told Reuters Health. “Often the patients with more severe baseline symptoms will elect to do this.”

Dr. Chapple, who wasn’t involved with this new study but who has also writ-ten about flexible dosing of antimuscarinics, added, “This study supports the importance of being able to titrate drug therapy as previously demonstrated in the field of OAB therapy and in particular with solifenacin in the ‘STAR’ study.”

He continued, “In particular this study comprehensively evaluated the symp-tom of urgency and demonstrated the efficacy of solifenacin on this symptom as well as on the other symptoms of the overactive bladder symptom complex.”

Three of the authors were employed by Astellas Pharma, which markets solife-nacin as Vesicare and which funded the study. Dr. Cardozo carries out research, consultancy, and/or advisory work for Astellas, as does Dr. Chapple.

In 2010, the U.S. Food and Drug Administration complained to Astellas that the company’s web site was overstating the benefits of Vesicare.By Will Boggs, MDBJU Int 2013.

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