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    CARE Initiative on

    ot ty sor ersin Primary Care:

    ERD

    11

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    FACP, FAACHEmeritus Chief, Division of Gastroenterology

    on e ore e ca en er anAlbert Einstein College of MedicineProfessor of Medicine and Sur erAlbert Einstein College of Medicine

    New York, New York

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    Faculty

    John Allen, MD, MBA, AGAFMedical Director for QualityMinnesota GastroenterologyChair, AGAI Clinical Practice and Quality Management CommitteeClinical Councillor, AGA Governing Board

    Peter J. Kahrilas, MD, AGAFGilbert H. Marquardt Professor of Medicine

    Lead author of AGA guidelines

    Stuart S echler MD AGAFChief, Division of Gastroenterology, Dallas VA Medical CenterProfessor of Medicine, Berta M. and Cecil O. Patterson Chair inGastroenterolo

    33University of Texas Southwestern Medical Center at Dallas

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    Accreditation and Funding

    This activity has been planned and implemented in

    accordance with the Essential Areas and Policies ofthe Accreditation Council for Continuing MedicalEducation (ACCME) through joint sponsorship of

    ,Associates LLC, Medikly, and PeerView AcademicNetwork. Albert Einstein College of Medicine isaccredited by the ACCME to provide continuing

    medical education for physicians.

    This activity is funded through an educational grantfrom Takeda Pharmaceuticals North America, Inc.

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    S onsorshi

    Co-sponsored by: Albert Einstein College of,Association, DIME, and PeerPoint MedicalEducation Institute, LLC

    Jointly sponsored by: Albert Einstein College ofMedicine, Montefiore Medical Center, Gullapalli& Associates, LLC, Medikly, and PeerView

    Academic Network

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    Conflict of Interest Statement

    The Conflict of Interest Disclosure Policy of Albert Einstein

    College of Medicine requires that faculty participating in anyCME activity disclose to the audience any relationship(s) witha pharmaceutical, product, or device company. Anypresenter whose disclosed relationships prove to create a

    conflict of interest with regard to their contribution to theactivity will not be permitted to present.

    faculty participating in any CME activity disclose to the

    audience when discussing any unlabeled or investigationaluse of an commercial roduct or device not et a roved foruse in the United States. The Albert Einstein College ofMedicine CCME staff has no conflicts of interest withcommercial interests related directl or indirectl to this

    66educational activity.

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    Facult DisclosuresJohn Allen, MD, MBA, AGAF

    Sources of Funding for Research:NoneConsulting Agreements:Medtronic, Inc.

    Speakers Bureau/Honorarium Agreements:None

    Financial Interests/Stock Ownership:None

    Discussion of Off-Label, Investigational, or Experimental Drug Use:None

    Lawrence J. Brandt, MD, MACG, AGAF, FASGE, FACP, FAACH

    Sources of Funding for Research:None

    Consulting Agreements:NoneS eakers Bureau/Honorarium A reements:None

    Financial Interests/Stock Ownership:None

    Discussion of Off-Label, Investigational, or Experimental Drug Use:None

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    Facult Disclosures contPeter J. Kahrilas, MD, AGAF

    Sources of Funding for Research:National Institutes of HealthConsulting Agreements:AstraZeneca Pharmaceuticals LP; RevalesioCorporation; XenoPort, Inc.

    Speakers Bureau/Honorarium Agreements:None

    Financial Interests/Stock Ownership:NoneDiscussion of Off-Label, Investigational, or Experimental Drug Use:None

    Stuart Spechler, MD, AGAF

    Sources of Funding for Research:AstraZeneca Pharmaceuticals LP;Takeda Pharmaceuticals; BARRX Medical, Inc.

    Consulting Agreements:Procter & Gamble

    Speakers Bureau/Honorarium Agreements:None

    Financial Interests/Stock Ownership:None

    88Discussion of Off-Label, Investigational, or Experimental Drug Use:None

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    Plannin CommitteeRosalee Blumer, MA

    DIME EditorConsulting Agreements:NoneSpeakers Bureau/Honorarium Agreements:None

    Discussion of Off-Label, Investigational, or Experimental Drug Use:None

    CCME of Albert Einstein College of Medicine

    Sources of Funding for Research:NoneConsultin A reements:Procter & GambleSpeakers Bureau/Honorarium Agreements:NoneFinancial Interests/Stock Ownership:Bioheart, Inc.; Chelsea Therapeutics, Inc.;Pharmacopeia, Inc.

    Discussion of Off-Label, Investigational, or Experimental Drug Use:None

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    Plannin Committee contBonny McClain, MS, DC

    Gullapalli & Associates EditorConsulting Agreements:NoneSpeakers Bureau/Honorarium Agreements:None

    Discussion of Off-Label, Investigational, or Experimental Drug Use:None

    . ,The AGA Institute

    Sources of Funding for Research:NoneConsultin A reements:Procter & GambleSpeakers Bureau/Honorarium Agreements:NoneFinancial Interests/Stock Ownership:NoneDiscussion of Off-Label, Investigational, or Experimental Drug Use:None

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    The staff of CCME of Albert Einstein College of Medicine,The American Gastroenterological Association,

    Gullapalli & Associates, and DIME have no conflictsof interests to report with commercial interests related

    rec y or n rec y o s e uca ona ac v y.

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    Continuing Education Credit

    Albert Einstein College of Medicine designates this

    educational activity for a maximum of 4.0 AMA PRACategory 1 Credits. Physicians should only claimcredit commensurate with the extent of their participationin the activit .

    Participants must complete and return the evaluationform at the conclusion of this activit to receive credit.

    Certificates will be available online. Please visit. .receive your certificate.

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    Primary Care Management of

    OverviewMultidisciplinary, multi-interventional educational

    program that provides relevant and concise,

    validate, and address the gaps and barriersrelated to gastroesophageal reflux disease(GERD) care in the primary care setting

    Multi le educational activitiesEducational outreach program; 3 regional

    workshops; Performance Improvement activity;

    1313e-monograp ; anwebsitewww.medikly.com/gerd

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    On completion of this activity, participants should beable to:

    Identif risk factors for GERD

    Demonstrate multidisciplinary management of

    referral and surgical options

    management of patients at risk for or diagnosedwith GERD

    1414

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    GERD Case Study 1: Carol

    American Gastroenterological Association Institute (AGAI)2008 Guideline Recommendations

    GERD Case Study 2: JimQuestion and Answer Session

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    Audience Response System (ARS)

    When instructed, press the number

    button s that corres ond with our selectedanswer (you do not need to press Enter)

    Individual res onses will be dis la ed in the

    screen at the top of the keypad

    If ou want to chan e our answer ressthe C keyto clear; you may enter a new

    answer as long as voting is open Audience results will be displayed on your

    main screen immediately after voting is

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    GERD

    17

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    The Need for Performance Improvement

    Performance Improvement (PI) is designed to measure

    and demonstrate ractice rocess chan es that arelinked by evidence to improved patient outcomes

    Selected activities will inte rate a continuous rocess b

    which a provider or a practice environment participatesin the following:

    ses e a es gu e nes or mprove pa en care

    Improves providerpatient communication

    Assesses baseline knowledge regarding the GERD guidelines

    Learns about specific performance measures

    Retrospectively assesses their clinical practice

    useful interval and re-evaluates performance

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    CARE Initiative on GI Motility Disorders in

    a en -re a e arr ers

    From the atients ers ective there are

    challenges and barriers to meeting GERDdiagnosis and treatment needs:Lack of awareness about GERD

    The psychological impact of GERDPolypharmacy

    Poor adherence

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    CARE Initiative on GI Motility Disorders

    Provider-related barriers in the primary care of GERD Although many providers are involved in the management of

    GERD, they experience barriers to optimal care for their

    GERD patients, including: Burden of care assigned to PCPs

    primary care

    Patients psychological resistance to long-term treatment with

    Difficulties in referral to gastroenterologists

    Financial challenges

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    How Can I Im rove Patient Outcomes?

    To begin evaluating and potentially improvingpatient care:

    1. Go to www.medikly.com/gerd

    2. Fill out a brief baseline self-assessment survey3. Gather appropriate patient-level data (based on identified

    per ormance measures re rospec ve y or prospec ve yon 10 GERD patients

    .

    HIPAA = Health Insurance Portability and Accountability Act

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    Live support will be available throughout the initiative

    All communication will be confidential

    - ,

    a quantitative report of the data you submitted

    an article that will be submitted to a peer-reviewed

    journal that focuses on improving patient carenat ona y

    You will receive up to 20.0 AMA PRA Category 1

    Credits for successful completion of the program*RegistrantsmustcompletetheentireprogramtoreceivethemaximumavailableCME/CNEcredit

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    How interested would you be to participate in a

    you to do the following for your practice?:

    Assess your practice performance against nationally recognized measures.

    Compare your practice performance to your peers on a local, regional and.

    Compare your performance to other healthcare providers and specialists.(Receive up to 20 CME/CE credits)

    Veryinterested

    Interested,tell me more

    Not at allinterested

    1 2 3 4 5 6 7

    0 / 100Cross-Tab Label

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    Do you have additional questions?

    Please speak to personnel on site

    or call a PeerPointPerformance Im rovement

    site coordinator:

    800.777.5790

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    Please turn off

    cellphones and pagers whileparticipating in todays activity.

    Please refrain from photography.

    25

    .

    25

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    Your Presenters for Today

    Peter J. Kahrilas, MD, AGAF

    .Northwestern University Feinberg School of MedicineLead author of AGA guidelines

    Stuart Spechler, MD, AGAFChief Division of Gastroenterolo Dallas VA Medical CenterProfessor of Medicine, Berta M. and Cecil O. Patterson Chair

    in Gastroenterology

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    What is your specialty?1. Internal medicine

    2. Family practice

    3. General practitioner4. Physician assistant

    5. Physical medicine

    6. Gastroenterolo ist

    7. Other

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    Which of the following best describes your

    1. Private (individual)

    . r va e par ners p or group3. Hospital-based

    4. HMO

    5. VA6. Other

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    ase u y : aro

    2929

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    Case Study: Carol

    Carol, a 37-year-old African American

    ,of heartburn and occasional regurgitationof food or fluids into her mouth

    Ht 52, W 148 lbs, BMI 27 Cor: Re ular rh thm and normal rate

    Labs: Normal, including hemoglobin 13/dL hemocrit 42%

    Current meds: inhaler

    3030

    x s ng con ons: as ma, a a ern a

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    On a scale of 1 to 5, with 1 being notconfident at all, and 5 being extremelyconfident, how would you rate your

    con ence n rea ng aro1. Not at all confident

    2. Somewhat confident

    4. Very confident

    3131

    .

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    Wh n ini i ll r in i n wi h m mof heartburn and regurgitation, which approach

    i ll k ?

    1. Recommend lifestyle modifications

    -. , ,antagonists [H2RAs] and move up to proton pump

    inhibitors (PPIs) if symptoms persist3. Step-down approach, ie, start with PPI therapy

    4. None of the above

    3232

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    Clinical Practice Key Points

    practice environment

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    American Gastroenterological Associationnst tute

    2008 Guideline Recommendations For patients with esophageal GERD syndromes, treatment

    with antisecretor dru s is recommended for healin

    esophagitis, symptomatic relief, and maintenance ofesophageal healing. In this setting, PPIs are moreeffective than H2RAs, which, in turn, are more effectivethan placebo

    Grade A: strongly recommended based on goodevidence

    3434

    Kahrilas P et al. Gastroenterology. 2008; 135:1392-1413.

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    Association Institute (AGAI)

    3535

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    AGAI 2008 Guidelines

    3636Kahrilas P, Shaheen N, Vaezi M. American Gastroenterological Association Institute Technical Review on theManagement of Gastroesophageal Reflux Disease. Gastroenterology. 2008;135:1392-1413.

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    Standards of Care for Assessing Evidenceu e nes or

    . .guidelines, ie, the US does not put a priority on whichguidelines to use

    This process is being refined and may be part ofhealthcare reform, but we are not there yet

    AGAI guidelines use US Preventive Services

    Task Force (USPSTF) grades to assign strength ofev ence

    3737

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    USPSTF Grades Usedin AGAI Guidelines

    Grade A: strongly recommended based on good evidence that itimproves important health outcomes

    important outcomesGrade C: balance of benefits and harm is too close to justify a

    Grade D: recommend against; fair evidence that it is ineffective

    or that harms outweigh benefits

    Grade Insufficient: no recommendation; insufficient evidence torecommend for or against

    3838

    Kahrilas P, Shaheen N, Vaezi M. Gastroenterology. 2008;135:1392-1413.

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    The Difficulty of Defining GERD

    3939

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    Symptoms of Gastroesophageale ux sease

    ass c symp omsHeartburn

    egurg a on

    Common symptomsChest pain (noncardiac)

    Dysphagia

    Source: US National Library of Medicine,National Institutes of Health

    4040

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    GERD: The Montreal DefinitionGERD is a condition that develops when the reflux of stomach content

    causes troublesome symptoms and/or complications

    Esophageal syndromes Extra-esophageal syndromes

    SymptomaticSyndromes Typical reflux

    ProposedAssociation Sinusitis

    Syndromes WithEsophageal Injury Reflux esophagitis

    EstablishedAssociation Reflux cough

    Reflux chestpain syndrome

    Pulmonaryfibrosis

    Pharyngitis

    Recurrent otitis

    Reflux stricture

    Barrettsesophagus

    Adenocarcinoma

    Refluxlaryngitis

    Reflux asthma

    Reflux dentalmediaerosions

    4141

    Adapted from Vakil N et al. Am J Gastroenterol. 2006;101:1900-1920.

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    What is the Distinction BetweenGERD and Episodic Heartburn?

    In the absence of esophageal injury,heartburn of sufficient intensit to be

    perceived as troublesome by the patient(after assurance of its benign nature)meets t e ontrea e n t on o a

    symptomatic esophageal GERD syndrome

    4242Kahrilas P et al. Gastroenterology. 2008; 135:1392-1413.Vakil N et al. Am J Gastroenterol. 2006;101:1900-1920.

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    PCP Review of the Pathophsysiology of GERD

    External factors

    Diet

    Tissue resistance Stratified squamous epithelium

    Smoking Obesity

    Esophageal clearance

    Gastric emptying

    Body position (gravity)

    Antireflux barriers Crural diaphragm Hiatal hernia

    Gastric refluxate Acid Pepsin

    43434343

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    u

    What is/are your goal(s) whentreating a patient such as Carolwho has typical symptoms of

    1. Relieve the symptoms

    2. Prevent relapse and complications

    3. Heal the eso ha us

    4. All of the above

    4444

    .

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    Goals of Treatment: AGAI Guidelines

    Relieve s m toms Prevent relapse and complications

    erosive esophagitis

    4545

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    diagnosing Carol?

    . nce- a y r a

    2. Endoscopy

    3. Manometry

    4. H monitorin5. Refer to gastroenterologist

    4646

    .

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    Diagnosis of Uncomplicated GERD:u e nes

    PPI therapy is appropriate foratients with uncom licated

    heartburn such as Carols,

    need exists for endoscopy or

    require immediate referral toa specialist)

    4747

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    Diagnosis of Uncomplicated GERD:AGAI Guidelines (cont)

    Although Carol hascoexistin conditions her

    case qualifies asuncomplicated GERDbecause she has no

    warning signs

    4848

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    Which of the following would be a warningsign(s) that would warrant endoscopyand/or immediate referral to a specialist?

    1. Weight loss2. GI bleedin

    3. Loss of appetite

    .

    5. Dysphagia

    49496. All of the above

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    Carols Risk Factors for GERD

    ARS Question

    ? Which of the following is/arerisk factor s for GERD?

    1. Overweight

    2. st ma

    3. Hiatal hernia4. None of the above

    5. 1 2 and 3

    5050

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    Participants perspectives on individual practice

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    AR i n: ?Extraesophageal Syndromes

    ,classified as an extraesophageal syndrome, aswell as laryngitis. If Carol did present with adult-onset asthma or laryngitis concomitant with anycommon or uncommon symptoms of GERD,

    1. Yes

    . o

    3. Depends on physical examination

    52524. Not sure

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    Treatment of Extraesophageal RefluxSyndromes: AGAI Guideline

    Recommendations

    Acute or maintenance thera with once- or twice-dailPPIs (or H2RAs) for patients with a suspectedextraesophageal GERD syndrome (laryngitis, asthma)with a concomitant esophageal GERD syndrome

    Grade B: recommended with fair evidence that itimproves important outcomes

    5353

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    Treatment of Extraesophageal Refluxyn romes: u e ne

    Recommendations (cont)

    Once- or twice-daily PPIs (or H2RAs) for acuterea men o pa en s w po en a ex raesop agea

    GERD syndromes (laryngitis, asthma) in the absenceof a concomitant esophageal GERD syndrome

    Grade D: recommend against; fair evidence that itis ineffective or that harm outweighs benefits

    5454

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    Treatment of Extraesophageal Refluxyn romes: u e ne

    Recommendations (cont)

    Once- or twice-daily PPIs for patients with suspectedre ux coug syn rome

    Grade Insufficient: no recommendation; insufficientevidence to recommend for or against

    5555

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    ues on

    Carols GERD symptoms?

    .

    2. OTC antihistamines

    3. Change in diet

    4. All of the above5. None of the above

    5656

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    Nonpharmacologic Approaches

    5757

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    Weight loss is advised for patients who are overweight

    have esophageal GERD syndromes Grade B: recommended with fair evidence that it

    5858

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    BMI Associated With Symptoms of GERD in Normal

    Association Between BMI and GERD Symptoms in Women

    3

    .

    2.92 2.353.62

    2.93 (2.243.85)

    P

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    GERD in both normal weight andoverwei ht women

    Even moderate weight gain among

    exacerbate symptoms of reflux

    6060

    Jacobson BC et al. N Engl J Med. 2006;354:2340-2348.

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    precipitate refluxCoffee alcohol chocolate

    fatty foods

    precipitate heartburn

    Red sauce tomatoes citruscarbonated drinks, spicy foods

    6161

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    esophageal exposureAvoid late-ni ht meals and bedtime snacks

    Raise the head of the bedSto smokin

    Weight loss

    6262

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    Except for weight loss, evidence for lifestylemo cat ons nc u ng smo ng s genera yweak

    owever, mo ca ons a ore o eac pa en s

    individual circumstances may sometimes beeffective

    Elevating the head of the bed for selected patients whoare troubled with heartburn or regurgitation when

    Other lifestyle modifications including, but not limited to,avoiding late meals, specific foods, or specific activities

    6363

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    Contributing Conditions:

    6464

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    What is the Role of Hiatal Hernia in GERD?

    Promotes reflux of stomach contents (via its direct

    and thus is associated with GERD

    ,

    potential consequences of GERD: heartburn,esophagitis, Barretts esophagitis, and esophagealcancer

    However, the role attributed to hiatal hernia isvariable and difficult to quantify

    6565

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    Axial Hiatus Hernia is Commonly Associated, spec a y en evere

    Type I hiatal hernia.In this example, the

    evident at rest, aftercompletion of esophageal

    6666Kahrilas, PJ, Pandolfino JE. Hiatus hernia. In: Castell DO, Richter JE, eds. The Esophagus. 4th ed.Philadel hia: Li incott Williams & Wilkins, 2004:389-407.

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    Two-Sphincter Model of the

    LES relaxation Squamocolumnar junction

    CD relaxation

    CD incompetence?

    Right

    a a ern a

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    Muscular Anatom of the EGJ

    Slin

    Spiral m.

    Longitudinal m.

    fibers

    Claspfibers

    6868PJ Kahrilas 2004.

    The Flap Valve Concept of EGJ Disruption

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    The Flap Valve Concept of EGJ DisruptionGrade IGrade I Grade IIGrade II Grade IIIGrade III Grade IVGrade IV

    Normal ridge oftissue closely

    Ridge is slightlyless well defined

    Ridge is effacedand the hiatus is

    Hiatus is wide open atall times and displaced

    6969

    Adapted from Hill LD et al. Gastrointest Endosc1996;44:541-547.

    scopean opens w

    respiration

    pa u ous axially

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    Radiographic Appearance of a Small SlidingHiatal Hernia Durin Swallowin

    TubularEsophagus

    EsophagealVestibule

    Phrenic Ampulla

    Sliding HiatalHernia

    A ring

    B ring

    DiaphragmaticRugal Folds

    Traversing Hiatus

    7070

    impression

    Kahrilas PJ and Pandolfino JE. GI Motility Online. 2006;doi:10.1038/gimo48.

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    Type I (Sliding) and Type II (Paraesophageal)Hiatus Hernia

    EsophagusEsophagus

    SquamocolumnarSquamocolumnarjunctionjunction

    EsophagusEsophagus

    HerniatedHerniatedstomachstomach

    PhrenoPhreno--esophagealesophagealmembranemembrane

    HerniatedHerniatedgastric fundusgastric fundus

    HerniatedHerniatedparietalparietaleritoneumeritoneum

    DiaphragmDiaphragm DiaphragmDiaphragmSquamocolumnarSquamocolumnar

    junction (normal position)junction (normal position)

    7171Modified from Jaffee BM, Surgery of the esophagus. In Orlando RC Ed. Atlas of EsophagealDiseases, Second Edition. 223242.

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    Pharmacologic Treatments

    7272

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    u According to AGAI guidelines, which one

    of the following agents is never appropriatein the treatment of GERD?

    1. OTC PPIs

    2. Metoclo ramide

    3. H2RAs

    .

    5. None of the above, they are all appropriate

    7373

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    Available Treatments for GERD Promotility agents

    Bethanechol

    e oc opram e ac ox warn ng; see o ow ng s e orrecommendation)

    Histamine2 receptor antagonists (H2RAs) me ne

    Famotidine Nizatidine

    Proton pump inhibitors (PPIs) Dexlansoprazole

    someprazo e

    Lansoprazole

    Omeprazole

    7474

    Rabeprazole

    Source: www.fda.gov. Accessed on August 20, 2009.

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    Metoclopramide:AGAI Guideline Recommendation

    Metoclopramide as monotherapy or adjunctive therapyin patients with esophageal or suspected

    Grade D: recommend against; fair evidence that it isineffective or harms outweigh benefits

    7575

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    Participants perspectives on individual practice

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    PPIs and H2RAs:

    7777

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    AGAI 2008Guideline Recommendation

    Antisecretory drugs for the treatment of patients withesophageal GERD syndromes (healing esophagitis

    In these uses, PPIs are more effective than H2RAs,which are more effective than placebo

    Grade A: strongly recommended based on goodevidence

    7979

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    ARS Question

    c o e o ow ng agen s as emost rapid speed of healing?

    1. H2RAs.

    3. PPIs

    . nset o act on s a out t e same or eac

    8080

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    Speed of Healing GERD: PPIs vs H2RAsSpeed of healing GERD expressed as the mean percentage ofhealing per week for each drug class at evaluation time points

    Placebo

    PPI

    35

    30Healed/week

    225

    20

    (%)

    10

    5

    02 4 6 8 12

    Weeks

    8181

    , 2 ,

    but the speed of healing falls off as fewer patients are left to be healedAdapted from Chiba N et al. Gastroenterology. 1997;112:1798-1810.

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    ARS Question

    ccor ng o e gu e nes, w cof the following agents heal(s) more

    1. PPIs

    2. H2RAs

    3. Promotility agents

    4. A and B are equal

    8282

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    Healing-time Curve: PPIs vs H2RAs vs Placebo100

    80PPI

    (3)(26)

    (2)

    60

    H2RAlhealed

    (4)(27)

    (25)

    (22)

    40

    20Placebo%

    Tota

    (2)

    (23) (25)

    (8)

    (5)

    (9)

    0

    2 4 6 8 12

    By week 4, PPIs heal more atients than H RAs and continue to do so

    Time in weeks

    8383

    even after 12 weeks of treatment (number of studies is shown in

    parentheses)Adapted from Chiba N et al. Gastroenterology. 1997;112:1798-1810.

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    Percentage of Symptom-Free Patientsfor PPIs and H2RAs

    Heartburn-PPI

    40

    30(%)

    20

    12 34 68

    10

    Time in Weeks

    With longer therapy, PPIs continue to relieve heartburn faster thanH RAs but the s eed of s m tom relief falls off as fewer atients

    8484

    Adapted from Chiba N et al. Gastroenterology. 1997;112:1798-1810.

    remain symptom-free

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    Proton Pump Inhibitors-GERD Omeprazole Esomeprazole Lansoprazole Rabeprazole DexlansoprazolePantoprazole

    Symptomaticrelief 20 mg daily

    X 4 weeks

    20 mg daily

    X 4 weeks

    15 mg daily

    X 8 weeks

    20 mg daily

    X 48

    20 mg daily

    X 48 weeks

    40 mg daily

    X 48

    Healing of

    wee swee s

    ulcerativeesophagitis

    X 48 weeks

    daily X 48weeks

    X 816weeks

    X 48weeks

    daily X 48weeks

    X 816weeks

    Maintenanceof healing orerosive or

    20 mg daily 20 mg daily 15 mg daily 20 mg daily 30 mg daily40 mg daily

    8585

    Source: www.fda.gov. Accessed on August 22, 2009.

    esophagitis

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    H2RAs- pprove n cat ons or t e reatment o

    Cimetidine Famotidine Nizatidine Ranitidine

    Treatment of

    GERD

    800 mg at night,

    or in divideddoses, for up to12 weeks

    20 mg bid for up

    to 6 weeks

    150 mg bid for

    up to 12 weeks150 mg bid

    Maintenanceof healing or

    erosive or

    800 mg at night,or in divided

    doses for u to

    20 or 40 mg bidfor up to 12

    150 mg bid forup to 12 weeks

    150 mg up to 4xper day

    ulcerativeesophagitis

    12 weeks

    8686

    Source: www.fda.gov. Accessed on September 2, 2009.

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    Nocturnal Breakthrough Symptoms

    8787

    C S d 1 C l

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    Case Stud 1: Carol

    After 4 weeks of once-daily

    PPI therapy, Carol returnsto your office

    Her symptoms haveimproved somewhat,especially during the day;however, she wakes upa ou n g s a wee wheartburn and regurgitation

    8888

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    u How would you proceed with your

    management of Carols symptoms?

    1. Endosco

    2. pH monitoring. -

    4. Increase PPI to twice a day

    5. Refer for surgical consultation

    6. None of the above

    8989

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    Participants perspectives on individual practice

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    AGAI guidelines recommend endoscopy to evaluatepatients with a suspected esophageal GERD syndrome

    -daily PPI therapy

    Grade B: recommended with fair evidence that itmproves mpor an ou comes

    9191

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    level

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    Nocturnal Breakthrou h S m toms: AGAI2008 Guideline Recommendation

    There is no evidence of improved long-term efficacy byadding a nocturnal dose of an H2RAs to twice-daily PPI

    Grade Insufficient: no recommendation; insufficientevidence to recommend for or against

    9393

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

    ARS Question ?

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    ARS Question ? Carols symptoms are successfully

    managed after 3 weeks on twice-daily

    PPI therapy. How would you approachmaintenance therapy?

    . on nue ong- erm erapy a e same

    dosage2. Continue lon -term thera and titrate down

    to the lowest effective dose on the basis ofsymptom control

    . discontinue until symptoms reappear

    4. All of the above

    94945. None of the above

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    u t sc p nary anagement

    Appropriate Referrals

    9595

    Case Stud : Jim

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    Case Stud : Jim 63 years old

    stent, arthritis, GERD

    , ,

    Meds: clopidogrel, low-dose,

    Smoker, drinks a 6-pack of beer

    Presenting symptoms: on twice-dail PPI but re orts ersistent

    9696heartburn

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    Because Jims presenting symptom is

    ,proceed?

    .

    2. Perform diagnostic tests to rule out cardiac-

    3. Prescribe an antacid trial to see if it relieves

    4. Refer him to a cardiologist

    97

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    Which of the following

    closely monitored if Jim isrescribed PPI thera ?

    1. Clopidogrel. e a oc ers

    3. Low-dose aspirin

    4. All of the above

    9898

    Clinical Practice Key Points

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    Clinical Practice Key Points

    Participants perspectives on individual practice

    Are PPIs Contraindicated in Patients

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    Are PPIs Contraindicated in Patientsa ng op ogre

    Retrospective cohort study of 8205 patients with

    acute coronary syndrome (ACS) taking clopidogrelafter discharge from 127 Veterans Affairs hospitals

    , ,

    Conclusion: Concomitant use of clopidogrel and PPI

    a higher risk of adverse outcomes than use ofclopidogrel without PPI, suggesting that use of PPI

    may e assoc a e w a enua on o ene s oclopidogrel after ACS

    100100

    Ho PM et al. JAMA. 2009;301:937-944.

    Cumulative Hazard for Death or ACS

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    Cumulative Hazard for Death or ACS0.6

    0

    eathsor

    ACS

    .40

    rtion

    of

    ecurrent

    Prop

    0.2

    0

    None

    Clop

    0.0

    0Clop+PPI

    DaysSinceDischargeAdapted from Ho PM et al. JAMA. 2009;301:937-944.

    PPIs Clo ido rel and Cardiovascular

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    PPIs, Clo ido rel, and CardiovascularEvents: Expert Consensus Statement

    In 2008, the American College of CardiologyFoundation, the American College of

    ,Association recommended that all patients who arereceiving NSAIDs, aspirin, dual antiplatelet therapy,or concom an an coagu an erapy an w o areat risk for gastrointestinal injury should receive

    ro h lactic treatment with a PPI to reduce the riskof ulcer complications and GI bleeding

    Bhatt D et al. J Am Coll Cardiol. 2008;52:1502-1517.

    Conflicting Results

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    Conflicting Results Several recent publications have reported

    outcomes of patients concurrently takingclo ido rel and a PPI vs clo ido rel alone

    Also, it is unclear if an interaction between

    clinically meaningful adverse outcomes

    Rude MK, Chey WD. Gastroenterology. 2009;137:1168-1171.

    : im n ?

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    : im n ? How would you proceed with

    Jims treatment?1. Consider surgery

    2. Recommend endoscopy

    3. Order impedance pH monitoring

    4. Switch to a different PPI

    5. First ensure that he is taking his

    twice-daily PPI therapy at theappropriate time

    104104

    AGAI 2008

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    AGAI 2008u e ne ecommen a on

    patients with a suspected esophageal GERD syndromewho have not responded to an empirical trial of twice-

    Biopsies should target any area of suspectedmetaplasia, dysplasia, or malignancy

    Grade B: recommended with fair evidence that itimproves important outcomes

    105105

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

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    Jim reports that he is taking his PPI

    medication one-half hour before

    breakfast and one-half hour beforedinner

    How would you proceed?

    1. Endoscopy with or without biopsy

    2. Upper GI series

    3. Esophageal manometry

    4. Ambulatory pH monitoring

    5. Impedance-pH monitoring

    106106

    6. Other

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    Which of the following

    characteristics put Jim athigh risk for Barrettsesop agus

    1. Over 50 years of age

    2. White man

    .4. All of the above

    107107

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    Participants perspectives on individual practice

    Barretts Eso ha us: Risk Factors

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    Barrett s Eso ha us: Risk FactorsGroup at Highest Risk

    Age >50 years

    ObeseGERD symptoms Early age of onset

    Longer duration ( >510 years)

    109109

    Adapted from Katz PO et al. Curbside Consultation: 49 Clinical Questions. Thorofare, NJ: SLACK Inc., 2008.

    m s agnos s

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    m s agnos s

    Jim is sent for anendoscopy

    Results show Barrettseso ha us with hi h-grade dysplasia

    110110

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    What are the treatment options for patients

    '1. Do nothing

    2. Surveillance

    3. Antireflux sur er

    4. Mucosal ablation

    . epen s on ex s ence an eve o ysp as a

    6. I do not know

    111111

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    Participants perspectives on individual practice

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    What are the next steps

    1. Referral to agas roen ero og s e

    isnt seeing one already.

    3. Antireflux surgery

    4. Mucosal ablation

    5. De ends on existence

    113113

    and level of dysplasia

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    Barretts Eso ha us

    114114

    Barretts Esophagus

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    p g

    115115

    Shaheen NJ. Gastroenterology. 2000;119:333..

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    Barretts Esophagus andAdenocarcinoma

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    Adenocarcinoma

    Patients with Barrett's esophagus have anincreased risk of developing esophageala enocarc noma

    The incidence of esophagealadenocarcinoma is 0.3%0.5% per patientyear

    However, lifetime incidence in anindividual atient ma be 10%11%

    117117Reid BL et al. Annu Rev Med. 1987;38:477-492.Eisen GM. Gastrointest Endosc. 2003;58:760-769.

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    Pr v l n f B rr E h

    in the General Population of Sweden

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    in the General Population of Sweden

    1000 persons had endoscopy

    .

    9 (56%) had symptoms of GERD

    119119

    Ronkainen J. Gastroenterology. 2005;129:1825.

    Metaplasia: Response to Chronic InflammationOne adult cell type replaces another

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    One adult cell type replaces another

    Stratified SquamousEpithelium

    Specialized IntestinalMeta lasia

    120120

    (Normal Esophagus) (Barretts Esophagus)

    Histological Features of Dysplasia

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    Nuclei showenlargement,

    pleomorphism,hyperchromatism,stratification,

    Villiform surfacesand tubules showcrowding

    121121

    No Dysplasia Dysplasia

    Estimates of Annual Cancer Incidence for

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    . Shaheen. Gastroenterology. 2000;119:333.

    Low-Grade Dysplasia: 0.6% Sharma. Clin Gastroenterol Hepatol. 2006;4:566.

    - Spechler. Am J Gastroenterol. 2005;100:927. Rastogi. Gastrointest Endosc. 2008;67:399.

    122122

    Endoscopic Screening and Surveillancefor Barretts Esophagus: Pros

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    p g

    arre s w cancer s ncreas ng nfrequency

    Computer models suggest benefit

    No study shows physical harm

    123123

    for Barretts Esophagus: Cons

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    for Barrett s Esophagus: Cons

    Endoscopy is expensive

    No proof that these procedures improvesurvival

    No roof likel in the near future

    124124

    ARS Question ? As previously noted, Jim has beendi d i h B h d

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    ?diagnosed with Barretts esophagus and

    - . , ,dysplasia is found on 2 endoscopies within1 year, which would be the appropriate nextstep

    1. Surveillance endoscopy every year

    2. Surveillance endoscopy every 6 months

    every 3 years

    4. No future surveillance endosco

    125125

    Wang KK et al. ACG Practice Parameters Committee. Am J Gastroenterol. 2008;103:788.

    needed

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    If Jim had low-grade dysplasia, how

    1. When dysplasia is first noted,

    within 6 months

    . expert pathologist

    . dysplasia is seen on 2consecutive endoscopies

    1261264. All of the above

    Wang KK et al. ACG Practice Parameters Committee. Am J Gastroenterol. 2008;103:788.

    ARS Question ? Which of the following would bei t t ( ) i th

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    ?an appropriate step(s) in the

    -dysplasia?

    . an expert pathologist

    . months

    surveillance (Q 3 months),EMR, endoscopic ablation,

    127127

    esop agec omy

    4. All of the above

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    Participants perspectives on individual practice

    Appropriate Management of High-Grade

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    Have diagnosis confirmed by an expert pathologist

    Repeat endoscopy within 3 months;4- uadrant bio sies at 1-cm intervalsmucosal irregularity should have EMR

    ons er op ons o n ens ve surve ance mon s ;EMR; endoscopic ablation; esophagectomy

    Individualize treatment

    129129

    Wang KK. ACG Practice Parameters Committee. Am J Gastroenterol. 2008;103:788.

    Jim experiences hoarseness which may

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    Jim experiences hoarseness, which may

    GERD. Which of the following is nota

    GERD?

    .

    2. Neck pain

    3. Chronic cough

    4. Halitosis

    130130

    Extraeso ha eal S m toms of GERD

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    Hoarseness

    Chronic cough

    Laryngitis

    Sinusitis

    Dental erosions

    Halitosis

    131131

    Maintenance Thera

    f

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    Typical esophageal reflux syndrome

    (with or without esophagitis)

    (asthma, laryngitis, cough)

    decreased or discontinued?

    132132

    Under what condition(s) should antisecretory

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    Under what condition(s) should antisecretory

    1. Patient reports likely adverse effect (headache,

    2. Patient has been taking PPIs for a prolonged-

    3. It is unclear why the patient is taking PPIs

    4. The patient was started on twice-daily PPI beforeonce-daily dosage was tried

    133133

    5. All of the above

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    Once PPIs have proven to be clinically effective for thetreatment of patients with esophagitis, therapy should be

    -effective dose on the basis of symptom control

    Grade A: strongly recommended based on good evidence

    134134

    Kahrilas P et al. Gastroenterology. 2008;135:1392-1413.

    Clinical Conse uencesof Long-term Acid Inhibition

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    Screening for potential adverse effects

    Calcium supplementation?H. pyloriscreening?

    135135

    Clinical Conse uencesof Long-term Acid Inhibition (cont)

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    Dependency?

    with PPIs for 8 weeks may induce rebound

    acid-related symptoms upon discontinuanceo e

    136136

    Reimer C et al. Gastroenterology. 2009;137:80-87.

    ARS Question ?Role of Endoscopy in the Long-termM t f GERD

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    Mana ement of GERD

    When should endoscopy be used as a tool forevaluating treatment failure or risk management?

    1. Every 5 years

    2. When a patient reports occasional breakthrough,

    3. When the patient reports the new sensation of foodsticking in his esophagus

    4. Every 10 years

    5. When the patient was begun on empiric PPI therapy and

    137137

    has 80% resolution of heartburn after 2 weeks of therapy

    Case Study: JimAntireflux Surgery

    ARS Question ?

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    ARS Question ? Under what conditions should

    antireflux surgery be recommended

    1. Never2. If Jim has worsening symptoms

    3. After 2 years of PPI therapy,

    because it is safer4. If Jim cannot tolerate acid

    138138

    suppress ve t erapy, even t s

    effective

    Clinical Practice Key Points

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    Participants perspectives on individual practice

    Surgery vs Acid-Suppressive Therapy:u e nes

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    patient with esophageal GERD syndrome cannottolerate acid-suppressive therapy, even if pharmacology

    When treatment with antireflux surgery or PPIs isthought to be similarly effective in a patient withesophageal GERD syndrome, PPI therapy is consideredsafer and is therefore preferred as initial treatment

    Grade A: stron l recommended based on ood

    evidence

    140140

    Kahrilas P et al. Gastroenterology. 2008; 135:1392-1413.

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    Question and Answeress on

    141141