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Transcript of Inflammatory Bowel Disease: Why Should I Take My Medications? Sunanda V. Kane, MD, MSPH Associate...
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Inflammatory Bowel Disease: Why Should I Take My
Medications?
Sunanda V. Kane, MD, MSPH
Associate Professor of Medicine
Mayo Clinic College of Medicine
Rochester, Minnesota
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Indeterminate colitis10%–15%
The Spectrum of IBD
CROHN’S DISEASE– Patchy inflammation– Mouth to anus
involvement– Full-thickness
inflammation– Variable involvement– Fistulas– Strictures – Extraintestinal
manifestations
ULCERATIVE COLITIS– Continuous
inflammation– Colon only– Superficial
inflammation– Variable involvement– Risk of cancer– Strictures (cancer)– Extraintestinal
manifestations
1–2 Million Americans
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Potential Causes of IBD
GeneticPredisposition
ImmuneSystem
Abnormalities
Environmental Factors
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Environmental Triggers
IBD
Antibiotics
Diet
Smoking
Infections
NSAIDs
Stress
NSAIDs=nonsteroidal anti-inflammatory drugs.
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Diagnosing IBD
• Clinical history
• Physical examination
• Laboratory tests
• Endoscopy (gastroscopy/colonoscopy)
• Findings on X-ray films
• Tissue biopsy (pathology)
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Questions Frequently MissedDuring History-Taking
• Family history for second-degree relatives
• NSAID use
• Antibiotic use
• Recent/previous infections
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Clues in the Physical Examination
• Clues are present from head to toe– Aphthous oral ulcers
– Pale conjunctiva, red eyes
– Skin rashes
– Abdominal mass
– Perianal abnormalities
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Ulcerative Colitis
Left-sided colitisProctitis Pancolitis
• The small intestine is not involved
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Symptoms of Ulcerative Colitis
• Symptoms depend on extent and severity of inflammation– Rectal bleeding and urgency to evacuate
– Diarrhea
– Abdominal cramping
– Extraintestinal (systemic) symptomsJoint pain/swellingEye inflammationSkin lesions
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Common Symptoms of Crohn’s Disease
• Diarrhea
• Abdominal pain and tenderness
• Loss of appetite and weight loss
• Fever
• Fatigue
• Rectal bleeding and anal ulcers
• Stunted growth in children
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Laboratory Tests
• Routine laboratory tests are ordered first– Complete blood count to rule out infection and
anemia– C-reactive protein to assess for active inflammation– Chemistry panel for electrolytes and proteins– Thyroid-stimulating hormone for weight loss– Celiac testing of the physician’s choice
• Stool studies– Ova and parasite examinations, but yield may be low– Clostridium difficile toxin– White blood cell count, lactoferrin, and calprotectin
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• A long stricture in the terminal ileum (Kantor’s string sign)
Diagnostic Studies:Small Bowel Series
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Endoscopy
Ulcerative colitis Crohn’s disease
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Endoscopy
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Management Goals for IBD
Relievesymptoms
Treat inflammation
Treatcomplications
Address psychosocial
issues
Identify dysplasiaand detect
cancerImprove daily
functioning
Replenish nutritional
deficits
Minimize treatment toxicity
Maintain remission
EstablishDiagnosisEstablishDiagnosis
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Medical Therapies for IBD
• 5-aminosalicylic acid (5-ASA) agents– Mesalamine
Delayed release tablets, Lialda®
Delayed release tablets, Asacol®
Controlled-release capsules, Pentasa®
Rectal suspension (Rowasa® enema)Rectal suppository (Canasa®)
– Sulfasalazine (Azulfidine®)
– Balsalazide (Colazal®)
– Olsalazine (Dipentum®)
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Medical Therapies for IBD
• Antibiotics– Ciprofloxacin (Cipro®)– Metronidazole (Flagyl®)
• Steroids– Adrenocorticotropic hormone– Budesonide– Methylprednisolone (Medrol®)– Prednisone– Hydrocortisone (Cortenema®, Cortifoam®)
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Medical Therapies for IBD
• Immunologic agents– Azathioprine (Imuran®, Azasan®)
– 6-Mercaptopurine (Purinethol®)
– Cyclosporine (Neoral®)
– Methotrexate
• Biologic agents– Infliximab (Remicade®)
– Adalimumab (Humira®)
– Natalizumab (Tysabri®)
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Drugs don’t work in patients who don’t take them.
― C. Everett Koop, MD Former US Surgeon General
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Factors that Affect Adherence
• Adherence is taking medications over a long period of time
• Extent, duration, and severity of disease affect adherence
• People who are more likely to adhere to therapy
– Have more disease flare-ups
– Are more knowledgeable about their treatment
• Clear instructions and educational materials provided by healthcare professionals increases knowledge about
– Importance of treatment
– Risks of non-adherence
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006;24(Suppl 3):45-49.Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
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Risk Factors for Non-Adherence
Risk Factor Odds Ratio (95% CI)
Married 0.46 (0.39-0.57)
Recent procedure 0.96 (0.93-0.99)
Greater extent of disease 0.55 (0.22-1.3)
Male gender 2.1 (1.2-4.8)
Taking more than 4 medications 2.5 (1.4-5.7)
Kane SV, et al. Am J Gastroenterol. 2001;96:2929-2932.
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National Quality Forum Report
• Goals– Improve medication adherence by creating standards to
change the way healthcare professionals interact with patients
– Develop standard performance measures that could be implemented in patient care settings to improve adherence
• Recommendations– Adherence needs to be evaluated as a vital sign, every time
a patient is seen by a physician or nurse
– Ask the questions: Are you taking the medication, how are you taking it, and what is the dose?
Traynor K. Am J Health-Syst Pharm. 2005;62:2440-2442.
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Significant Factors Associated with Risk of Not Refilling 5-ASA at
3 Months
3,574 UC patients with 5-ASA prescriptions; 1,530 (42.8%) patients did not refill at 3 months.* 12 months prior to index date.
Kane S, et al. Gastroenterology. 2007;132(4 Suppl 2):M1033.
Rectal 5-ASA*Glucocorticoid use*
Copay (per $1 increase)Lower daily pill load (per 1 pill decrease)Male genderMail orderPsychiatric history*
Patients More Likely to be Adherent
Patients Less Likely to be Adherent
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Adherence Decreases Risk of Relapse
0
25
50
75
100P
atie
nts
Rem
ain
ing
in
R
emis
sio
n,
%
40 36 32Adherent n =Non-adherent n = 59 32 28
0 12 24Time (months) 36
From Kane S, et al. Am J Med. 2003;114:39-43; with permission.
Adherent
Non-adherent
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Adherence Decreases Risk of Relapse
Kane S, et al. Am J Med. 2003;114:39-43.
• Prospective study in patients with UC in remission and taking mesalamine found chance of remission was – 89% in adherent patients– 39% in non-adherent patients
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Non-Adherence is Associated with Recurrence
Follow-up
Med
icat
ion
Ref
ille
d i
n
Pre
vio
us
6 M
on
ths,
%No Recurrence
Recurrence
From Kane S, et al. Am J Med. 2003;114:39-43; with permission.
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Non-Adherence is Associated with Recurrence
Kane S, et al. Am J Med. 2003;114:39-43.
• 82% of patients with recurrence had not taken their medication
• 34% of patients remaining in remission had not taken their medication
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Other Factors that Affect Adherence
• Adverse reactions to medications
• Need for many medications
• Effectiveness of treatment
• Convenience of treatment
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006; 24(Suppl 3):45-49.Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
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To Increase Treatment Adherence
• Simplify the treatment regimen
• Continue taking the medications
• Find support for emotional and social issues
Hall A, et al. Gastrointestinal Nurs. 2006;4:31-40.Lopez-Sanroman A, Bermejo F. Aliment Pharmacol Ther. 2006;24(Suppl 3):45-49.Kane SV. Aliment Pharmacol Ther. 2006;23:577-585.
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Patient-Centered Self-Management Training
Robinson A, et al. Lancet. 2001;358:976-981.
Self-Guided Group
Control Group P-Value
Time to treat relapses 14.8 h 49.6 h <0.0001
Outpatient visits 0.9 2.9 <0.0001
Time spent visiting a doctor 1 h 6.2 h <0.0001
• Patients preferred guided self-management over traditional outpatient care
• Patient-centered self-management resulted in– Earlier treatment of relapses– Fewer hospital and primary care visits– Less time spent during a visit with a doctor
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Why Take Your Medications?
• Possible decreased risk of colorectal cancer
• Decreased risk of disease progression
• Increased chance of disease regression
Velayos FS, et al. Am J Gastroenterol. 2005;100:1345-1353. Pica R, et al. Inflamm Bowel Dis. 2004;10:731-736. Picco MF, et al. Inflamm Bowel Dis. 2006;12:537-542.