Heartburn & Gastroesophageal Reflux Disease (GERD)

Question 1

Gastroesophageal Reflux Disease

defintion

Answer 1

– “A condition in which the reflux of gastric contents into the esophagus results in symptoms
and/or complications”
– GERD is objectively defined by the presence of characteristic mucosal injury seen at endoscopy
and/or abnormal esophageal acid exposure demonstrated on reflux monitoring study.
-Occurs in people of all ages but more common if > 40 yo

Question 2

Gastroesophageal Reflux Disease

presentations

Answer 2

– Presumptive GERD based on typical symptoms “ treated empirically
– Erosive Esophagitis seen on endoscopy
• Develops in patients with GERD when acid & inflammation injure the esophagus
– Endoscopy Negative Reflux Disease (ENRD)
• Normal esophagus on endoscopy (i.e., non-erosive reflux disease, NERD)

Question 3

red flags

Answer 3

• Heartburn Symptoms:
• >3m, severe, nocturnal
• Continue after 2 wks of Tx with OTC H2RA or
PPI
• Occur when taking Rx H2RA or PPI
• New onset >age 50 to 55 yrs
• Dysphagia or odynophagia
• GI bleeding (Hematemesis, black stool, anemia)
• Sx of laryngitis: Hoarseness, wheeze, cough,
choking
• Unexplained weight loss
• Continuous nausea, vomiting, diarrhea
• Sx suggestive of cardiac chest pain
• Pregnant women or nursing mothers
• Children <12 for antacids/H2RA; <18 for PPI
• Family History of GI Cancer

Question 4

goals of tx

Answer 4

Goals of Therapy: dec Pain & symptoms;
freq. & duration of reflux; healing of the
esophageal mucosa; Avoid complications; Prevent recurrence

Further History Taking:
• No family history of GI cancer, No alarm symptoms, Age <60
• Typical Symptoms: Heartburn & Regurgitation; Frequency: 2-3x/wk
Assessment: Presumptive Diagnosis of GERD, Empiric treatment appropriate
Plan: Lifestyle modification plus, OTC Esomeprazole daily x 2 wks

Question 5

what classifies as severe GERD

Answer 5

frequent, severe pain
nocturnal
complications

PPI for 8 wks
if no response, twice daily PPI
if response, stop PPI but if recur, long term PPI

ex: severe GERD Lifestyle modification plus Pantoprazole 40 mg po
daily x 8 weeks. RTC clinic in 8 wks.

Question 6

more info on management of GERD severe

Answer 6

For suspected GERD & those with noncardiac
chest pain, an empiric trial of a PPI twice daily
for 8 wk also can be diagnostic.
[b] Severe GERD or endoscopic-proven erosive
esophagitis warrants 8 wk of PPI treatment.
After 8 wk, patients with severe erosive
esophagitis or Barrett esophagus (BE) should
remain on maintenance PPI therapy.
[c] Do not maintain long-term PPI therapy in
patients with nonerosive GERD without an
attempt to D/C or $ the dose at least once/yr. It
may be possible to gradually lower the dose and
step down to H2RAs.
[d] Endoscopic screening for BE is
recommended in men with chronic (>5 y) and/or
frequent (≥once/wk) Sx of GERD & ≥2 of the
following risk factors: >50 yo, Caucasian,
presence of central obesity, current or past Hx
of smoking, & a confirmed family history of BE
or esophageal adenocarcinoma in a first-degree
relative.[4]

Question 7

Erosive Esophagitis Management

Answer 7

• “An 8 wk course of PPI is the therapy of choice for symptom relief &
healing of erosive esophagitis.” (GRADE: Strong, High)2

• Why? “PPI are more effective than H2RA for treating patients with erosive esophagitis.”

• PPI do not reverse Barrett’s esophagus
• Indefinite maintenance therapy recommended for severe EE
• Step down therapy to H2RA is not appropriate

Question 8

Lifestyle Management

Answer 8

Weight loss in overweight/obese patients (GRADE: Strong, Moderate)
– Elevation of head of the bed for HS symptoms (GRADE: Conditional, Low)

Inconsistent evidence for:
– Diet: Suggest avoidance of trigger foods
(GRADE: Conditional, Low)
– Avoiding meals 2-3 hours prior to bedtime
(GRADE: Conditional, Low)
– Smoking cessation (GRADE: Conditional, Low)2
– Reducing alcohol and coffee intake
– Smaller meals

Question 9

Efficacy of Drugs for GERD1

compare classes

Answer 9

antacids, alginates, prokinetic not useful for esophagitis healing or prevention of recurrence

all help with symtpoms (prokinetic unsure)

only H2RA and PPI help esophagitis healing and prevnetion of recurrence (H2RA unsure)
PPI greatest effects

“We recommend Tx with PPIs over Tx with H2RA for healing and maintenance of healing from EE.”

Question 10

Antacids

Answer 10

– “On demand” use for mild GERD symptoms occurring < 1x/wk1
• Fast relief – more prompt than H2RA or PPI
• Onset: 5 min; Duration: 30-60 min
– Do not promote healing of the esophagus
– Dosing: Take PRN q30-60 minutes
– Drug Interactions: Iron, sulfonylurea, quinolones, levothyroxine etc.

Question 11

Alginate combo with Antacid

Answer 11

– Effective symptom relief in mild GERD vs. placebo or antacids
– Add on in GERD with inadequate response to PPI
– Directions for Use
• Best taken 1/2 hr after meals to produce raft effect
• Taking before or with meals dec the ability of the alginate to form the raft

Question 12

Histamine H2 Receptor Antagonists

Answer 12

Mild GERD à OTC Formulations
– Effective in episodic & mild GERD
– Half dose of prescription formulation; All are equally effective
– Rapid onset of action makes them attractive for “on-demand” use Onset: 3 hrs; Duration: 4-10 hrs
• H2RA less effective than PPI in erosive esophagitis3
• H2RA effective in empiric treatment & non-erosive reflux disease (ENRD)

Question 13

Proton Pump Inhibitor - Clinical Pearls

Answer 13

There are no major differences in efficacy between different PPIs.
Maximum
Allowable Cost Pricing (Oct 2016)
– Cover only the lowest cost, generic versions of R & P
– Plan members may receive other PPIs, but have to pay the price difference.
– Special authorization may be considered in certain circumstances.
Recommend PPI be administered 30-60 min before a meal rather than at bedtime for
GERD symptom control.

Once daily 30-60 min before breakfast; BID: 30-60 min before breakfast & dinner

Question 14

Prokinetic Agents

Cisapride

Answer 14

• Only prokinetic agent with evidence of efficacy in GERD1
– Improved healing rates vs. placebo in patients with mild-mod esophagitis
• Withdrawn from the market
– Life threatening cardiac arrhythmias, ++ DI (CYP 3A4)
– Limited access program from the manufacturer

Question 15

Prokinetic Agents

Metoclopramide & Domperidone

Answer 15

• Not recommended as monotherapy or adjunctive therapy for GERD1
• Recommend against prokinetic for any kind of GERD unless there is objective evidence of delayed gastric emptying
• Metoclopramide: 5-10 mg QID before meals and at bedtime
• Domperidone: 10 mg TID before meals (max dose to dec QT risk)

Question 16

Maintenance, On Demand, & PRN PPI

what is thedifference

Answer 16

Maintenance therapy with PPI is appropriate in pts with GERD complications:
– Symptomatic relapse after lower dose or discontinuation
– Severe erosive esophagitis
– Barrett’s esophagus
– Chronic NSAID users with bleeding risk
– Documented history of bleeding peptic ulcer

On Demand PPI: Daily PPI use for a period of time sufficient to eliminate symptoms. Upon remission PPI stopped until symptoms recur.
- appears to be effective in long-term management of pts with ENRD or mild/uninvestigated forms of GERD, but not in patients with severe EE

PPIs “As Needed” Sporadic use for very short periods of time
“PPI might provide benefit from the first day, but most will not have symptom relief within 1 or 2 days.”
OTC PPI should not be taken symptomatically

Question 17

Refractory GERD

defintion

Answer 17

Definition: Persistent symptoms despite 8-12 weeks of double dose PPI
• Failure may relate to:

– Inadequate acid suppression Non compliance; Rapid metabolism of PPI (e.g., CYP 2C19)
– Reflux hypersensitivity (acidic or non acidic reflux evokes symptoms
– Incorrect diagnosis (i.e., eosinophilic esophagitis, achalasia, gastroparesis, rumination, or heart disease)
– Symptoms are functional

Question 18

Refractory GERD

management
see slide 20

Answer 18

Management (PPI Optimization= compliance, timing, Double dose PPI, Switch)
– What about switching PPI in “incomplete responders?”
• There is variation in individual intragastric pH b/w PPIs
• Genetic differences in CYP2C19 may affect PPI response, but PGx testing has no established role in practice
• Might consider a switch to PPI that does not rely on CYP2C19 for 1°metabolism (i.e., rabeprazole)

Question 19

Summary

Answer 19

• GERD is a condition that develops when reflux of stomach contents causes troublesome symptoms or complications
• Typical symptoms are heartburn and acid regurgitation as primary presentation
• Presumptive diagnosis can be based on clinical symptoms alone
• Treat mild symptoms with a step up approach
• Treat frequent symptoms with a step down approach starting with PPI
• No clinically important differences between PPIs: choose on availability & cost
• Don’t maintain long term PPI therapy without an attempt to reduce/stop treatment once yearly in appropriate patients