How I Manage Refractory GERD Joel E Richter, MD, FACP, MACG Hugh - - PowerPoint PPT Presentation

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How I Manage Refractory GERD Joel E Richter, MD, FACP, MACG Hugh - - PowerPoint PPT Presentation

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Gastroenterology at USF: An Update December 8, 2012 How I Manage Refractory GERD Joel E Richter, MD, FACP, MACG Hugh Culverhouse Chair and Director Division of Digestive Diseases and Nutrition Joy McCann Center for Swallowing Disorders

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SLIDE 1

How I Manage Refractory GERD

Joel E Richter, MD, FACP, MACG Hugh Culverhouse Chair and Director Division of Digestive Diseases and Nutrition Joy McCann Center for Swallowing Disorders University of South Florida Tampa, Florida Gastroenterology at USF: An Update December 8, 2012

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SLIDE 2

Failure of PPI Therapy

  • 10 ‐ 40% of GERD patients fail to respond symptomatically

to standard once daily dose of PPIs

Fass R. Aliment Pharmacol Ther 2005

  • Over 7 years (1997‐2004), Manitoba province had 50%

increase in use of BID PPIs (9.7% to 15.2%)

Targownik LE. Am J Gastroenterol 2007

  • Only 58% of GERD patients receiving PPIs report a high

level of satisfaction with their therapy

Bytzer P. Clinical Gastroenterol and Hepatol 2009

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SLIDE 3

Is There a Clinical or pH Profile for PPI Non‐Responders?

  • 100 patient: 43 responders, 57 non‐responders
  • Clinical predictors:

BMI<25 kg/m2 Normal endoscopy IBS or functional dyspepsia

  • No 24 hr pH‐impedance parameters off PPIs

were predictive of response to PPIs

Zerbid F et al. Gut 2012

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SLIDE 4

Failure to Respond to Once a Day PPI

  • What to do next??

Check compliance Dose appropriately Switch PPI Increase to BID PPI (up to 25% improve)

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SLIDE 5

Sub‐Optimal Proton Pump Inhibitor Dosing

Gunaratnam NT, et al. Alimentary Pharmacol Ther 2006

100 pts Referred by PCPs 46% dosed

  • ptimally
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SLIDE 6

Failure to Respond to Once a Day PPI

  • What to do next??

Check compliance Dose appropriately Switch PPI Increase to BID PPI (up to 25% improve)

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SLIDE 7

FAILURE TO RESPOND TO ONCE DAILY PPI: SWITCH PPI OR DOUBLE DOSE?

  • Multicenter randomized double blind, double dummy trial
  • 328 pts with persistent heartburn on lansoprazole 30 mg
  • Randomly assigned to esomeprazole 40 mg

lansoprazole 30 mg BID

  • Both equally effective for:

‐ heartburn free days: 55% eso vs 58% lansoprazole ‐ symptom score improvement for heartburn, acid regurgitation and epigastric pain ‐rescue antacid use Fass R et al Clin Gastroenterol and Hepatology 2006

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SLIDE 8

Persistent Heartburn Symptoms Switch or Double Dose PPIs?

None Mild Moderate Severe

Lansoprazole 30 mg twice daily (n=44) Esomeprazole 40 mg once daily (n=138) Lansoprazole 30 mg twice daily (n=144) Esomeprazole 40 mg once daily (n=138)

Week 4 P=.25 Week 8 P=.35 Patients (%)

100 70 60 50 40 30 20 10 80 90

Fass R, et al. Clin Gastroenterol Hepatol. 2006;4:50‐56.

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SLIDE 9

GERD Symptoms Presence of esophagitis is unknown Single dose PPI Failure to improve

  • Dose appropriately
  • Switch to newer PPI
  • BID PPI

Initial Treatment and Diagnostic Approach

Failure to improve – Refractory GERD

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SLIDE 10

UGI Findings in Refractory GERD

PPI failures No Treatment N=105 N=91

  • Normal 54% p=.04 41%
  • Esophagitis

7% p<.001 31% LA A/B 7% 29% LA C/D 0% 2%

  • Barretts

4% 3%

  • Eosinophilic E 1% 0%
  • Ulcer Disease 1% 4%
  • Cancer 0% 1%

Poh CH et al GIE 2010

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SLIDE 11

Upper Endoscopy Esophagitis—10% Non‐esophagitis—90%

  • 1. Pill esophagitis
  • 2. Skin disease with esophagitis
  • 3. Hypersecretor – ZE syndrome
  • 4. CYP2C19 Genotype differences
  • 5. Eosinophilic esophagitis

Failure to improve – Refractory GERD

Initial Treatment and Diagnostic Approach

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SLIDE 12

Fosamax Pill Esophagitis

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SLIDE 13

PILL INDUCED ESOPHAGEAL INJURY

  • 92 patients in 5 years—6% EGDs

59 women, mean age 59, 25‐87

  • Common symptoms:
  • dynophagia 75% chest pain 60% heartburn 55%

vomiting 58% dysphagia 33% hematemesis 15%

  • Causative pills:

NSAIDs/ASA 41% tetracyclines 22% KCL tablets 10% alendronates 9% Other 16%‐‐ascorbic acid, quinidine, antibiotics S Abid et al Endscopy 2005

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SLIDE 14

Lichen planus

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SLIDE 15
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SLIDE 16

Eosinophilic Esophagitis Demographics and Presenting Symptoms

  • Presenting symptoms:

Dysphagia: >90% Food impaction: 50% Heartburn: 33% Chest pain/ vomiting: 20% Most carry a diagnosis of GERD

Potter JW GIE 2004, Desai TK GIE 2005, Remedios M GIE 2005

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SLIDE 17

Prevalence of Eosinophilic Esophagitis in Patients with Dysphagia A Prospective Study

  • 376 patients with dysphagia undergoing endoscopy
  • Findings:

Total # Biopsied #EoE(%) Normal 180 102 10(10%) Reflux esophagitis 84 48 7(14%) Schatzki ring 28 18 1( 5%) Stricture 17 8 4(50%) Suggestive EoE 21 21 8(38%) Other* 46 30 3(10%) *achalasia, Barretts, ulcer, cancer

Prasad G Am J Gastro 2007

Overall rate: 14.5%

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SLIDE 18

Failure to improve – Refractory GERD

Upper Endoscopy Esophagitis—10% Non‐esophagitis—90%

  • 1. Pill esophagitis
  • 2. Skin disease with esophagitis
  • 3. Hypersecretor – ZE syndrome
  • 4. Genotype differences
  • 5. Eosinophilic esophagitis
  • Persistent acid reflux
  • Weak or non‐acid GER
  • Sensitive esophagus
  • Missed GER
  • Wrong diagnosis
  • Achalasia
  • Gastroparesis
  • “Functional” heartburn

Failure to improve – Refractory GERD

Initial Treatment and Diagnostic Approach

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SLIDE 19

PPI Resistant Patients—What is the Clinical Question??

  • Insufficent PPIs to control acid reflux??
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SLIDE 20

% Distal Total Time pH < 4

5 10 15 20 25 30

Upper limit of normal

QD

ATYPICAL GERD

(n = 145) )

BID QD BID

TYPICAL GERD

(n = 175) )

ROLE OF PH MONITORING IN SYMPTOMATIC PATIENTS ON THERAPY

Samer and Vaezi, A m J Gastroenterol 2005

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SLIDE 21

Symptom Analysis

SI>50% SSI>10%

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SLIDE 22

Calculation of the SAP

Weusten BLAM et al. Gastroenterology 1994

= [1 – p value] X 100% Symptom Reflux event ‐ + + ‐ S‐R+ S+R+ S+R‐ S‐R‐

Fisher’s exact test

SAP two‐tailed

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SLIDE 23

Concordance of Symptom Assessments with Omeprazole Test

Taghavi SA et al. Gut 2005

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SLIDE 24

Sensitive Esophagus (SI+/SI‐) Response to Omeprazole 20 mg BID for 4 Weeks

Watson, et al. Gut 1997

Reflux symptom score Days per week of reflux symptoms All had normal % total time pH<4

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SLIDE 25

PPI Resistant Patients—What is the Clinical Question??

  • Insufficent PPIs to control acid reflux??
  • Uncontrolled Weak or Non‐Acid Reflux??
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SLIDE 26

Impedance pH Monitoring

  • Resistance to the flow
  • f alternating current

Air Esophageal Lining Saliva Food Refluxate

Impedance

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SLIDE 27
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SLIDE 28

Number of Reflux Episodes Off and On PPIs

Hemmink GJM, et al Am J Gastro 2008

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SLIDE 29

Symptom Episodes Off and On PPIs

Hemmink GJM, et al Am J Gastro 2008

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SLIDE 30

Etiology of Refractory GERD

Persistent Acid Reflux

1% ‐ 15% Refractory “GERD” Symptoms on PPIs Non‐ Acid GERD Not GERD 30% ‐ 40% 50% ‐ 60% GER Controlled on PPIs Another Diagnosis Mainie et al Gut 2006 Zerbid et al Am J Gastro 2006

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SLIDE 31

Symptom Relief in Patients With and Without Pathological Findings of Imp‐pH Testing

Becker V, et al. Aliment Pharmacol Ther 2007

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SLIDE 32

PPI Resistant Patients—What is the Clinical Question??

  • Insufficent PPIs to control acid reflux??
  • Uncontrolled Non‐Acid Reflux??
  • Patient does not have acid reflux??

Look for other diagnoses Refer patients with extraesopheal complaints back to ENT, Lung, and Cardiac specialists Stop unnecessary and expensive PPIs

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SLIDE 33

Transoral during endoscopy Transoral without endoscopy Transnasal after manometry Placement methods

Catheter‐Free pH Monitoring

  • Capsule device with pH sensor
  • Attachment to distal esophageal mucosa
  • Radiotransmission of pH data
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SLIDE 34

Extended Recording Time Identifies More Abnormal GER

Prakash C et al Clin Gastro Hepatology 2005

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SLIDE 35

Normal Bravo pH Test

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SLIDE 36

It’s Like a Baseball Game

  • Strike 1

atypical symptoms, normal endoscopy

  • Strike 2

no response to BID‐QID PPIs for months/yrs

  • Strike 3

normal 24‐48 hrs ph test off PPIs for 2 weeks YOU’RE OUT—NO GERD

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SLIDE 37

PPIs and Esophageal pH Testing

High Probability GERD

  • Classic Symptoms
  • Suggestive EGD
  • Hx of Previous PPI Response

PPBID PPIs

Improved No or Partial Response

  • R/O Non‐acid Reflux

Impedance pH on BID PPIsPPIs

  • Diagnosis Made

↑Non-Acid ↑Acid Normal

  • Baclofen
  • ? Surgery
  • Switch PPIs
  • ? Surgery
  • GER or no

GER??

Low Probability GERD

  • Atypical Symptoms
  • Extraesophageal Sx
  • Normal endoscopy
  • Previous Failure on PPI

Off PPI

pH Testing Bravo Capsule

  • Transnasal pH
  • Impedance pH

Normal Abnormal pH

  • St
  • p

PPI s

  • BID PPI Trial
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SLIDE 38

PPI Use after Negative Reflux Tests

  • Chart review and telephone survey
  • 90 patients with negative Bravo/impedance

pH off PPIs

  • 38 (42%) still using PPIs 2 yrs later

17 patients recalled being told to stop PPIs 15 patient’s chart documented instruction 13 on BID PPIs

  • No predictors of continued PPI use

Gawron AJ et al. Clinical GI and Hepatology 2012

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SLIDE 39

Confirming GERD as Cause

Misc Asthma ENT Chest Pain Non‐erosive Reflux Disease Erosive Esophagitis

0% 100% Yes No Prevalence of GERD Need to investigate role of acid (pH test)

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SLIDE 40

Stepping Down from Twice Daily PPIs

  • Two VA studies have addressed this issue
  • Inadomi JM et al: Am J Gastroenterol 2003

117 patients—80% success of 6 months Cost savings--$33,708 for entire group

  • Cote GA et al: Aliment Pharmacol Ther 2007

223 pts switched from lansoprazole 30 mg BID to rabeprazole 20 mg AM 50%--maintained on once day PPIs 10%--off all meds 40%--failed shift

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SLIDE 41

Weekly Dyspepsia Scores Placebo vs Pantoprazole

Niklasson, et al. Am J Gastroenterol 2010

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SLIDE 42

Rebound Dyspepsia Symptoms Pantoprazole vs Placebo

Niklasson, et al. Am J Gastroenterol 2010

Pantoprazole Placebo

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SLIDE 43

WRONG DIAGNOSIS

  • Achalasia

esophagus minimally dilated diagnosis made by manometry

  • Delayed gastric emptying

usually postprandial pain and regurgitation are major symptoms‐not heartburn

  • “Functional “ heartburn—up to 58%
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SLIDE 44

Failure to improve – Refractory GERD

Upper Endoscopy

Esophagitis—10% Non‐esophagitis—90%

  • 1. Pill esophagitis
  • 2. Skin disease with esophagitis
  • 3. Hypersecretor – ZE syndrome
  • 4. Genotype differences
  • 5. Eosinophilic esophagitis
  • Persistent acid reflux
  • Weak or non‐acid GER
  • Sensitive esophagus
  • Missed GER
  • Wrong diagnosis
  • Achalasia
  • Gastroparesis
  • “Functional” heartburn

Failure to improve – Refractory GERD

Initial Treatment and Diagnostic Approach

Bravo 48 hr pH Low probability Impedance pH High probability