CRITERIA FOR USE:HIGH DOSE ORAL PROTON PUMP INHIBITOR

ANTONIO C. COMIA, MD

GOOD EVENING!

CRITERIA FOR USE:HIGH DOSE ORAL PROTON PUMP INHIBITOR

(THE PROMISE OF OMEPRON 40)

ANTONIO C. COMIA, MD

DOSING ISSUES

STANDARD DOSE: OMEPRAZOLE 20 MG

HIGH DOSE DOUBLE OR QUADRUPLE DOSE: 20 BID, 40 OD, 40 BID

AS INITIAL THERAPY?

IF INADEQUATE IMPROVEMENT WITH INITIAL STANDARD THERAPY?

WHEN TO GIVE HIGH DOSE PPI (OMEPRON 40) AS INITIAL THERAPY

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS: DIAGNOSIS

Diagnostic trial (PPI test)

Uncomplicated GERD: no alarm symptoms

An 8-week therapeutic or empiric trial of double-dose PPI may be considered

Treatment plan should be re-evaluated if there is no response after 8 weeks.

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS: GERD-RELATED COUGH

GERD-related chronic nonspecific cough

dry and non-productive cough of ≥ 3 weeks’ duration without any other respiratory symptom, sign, or systemic illness)

CHRONIC COUGH AND GERD

When GERD is the cause of chronic cough there may be no GI symptoms – silent GERD

24 hour esophageal pH monitoring provides a sensitive and specific test for the presence of GERD

GERD related cough may take 2 – 3 months to resolve with therapy

Definitive diagnosis of cough resulting from GERD can only be made if the cough resolves with anti-GERD therapy

CHRONIC COUGH AND GERD

Accurate diagnosis and therapy of chronic cough due to GERD is difficult

Therapeutic, empiric trial with PPI is reasonable initial diagnostic approach

Non-response does not rule out GERD as cause of chronic cough

Objective investigations for GERD are suggested (esophageal pH monitoring)

Laryngopharyngeal reflux (LPR)

Hoarseness, throat pain, dysphagia, throat clearing, dyspnea, chronic cough

May not have the classic symptoms of GERD

Also called silent reflux.

Cause: LES dysfunction, acid reflux upwards to throat

PPI TEST: useful in diagnosis and treatment Double dose, given at east 8 weeks

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS AS INITIAL THERAPY Gastric Ulcers – may give Omeprazole 40 mg as initial

dose, specially in high risk NSAID patients

Pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome) – up to 240 mg/day

Helicobacter pylori eradication to reduce recurrence of duodenal ulcers, as part of dual or triple antibiotic-based therapy – given together with antibiotics Double-dose PPI therapy, typically for 1–2 weeks

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS:

Endoscopic evidence of severe erosive esophagitis presence of ulceration, stricture, perforation, or bleeding Presence of Barrett’s

Double-dose PPI as initial therapy

May continue with double dose as maintenance therapy.

Treatment and maintenance doses for severe reflux esophagitis

Relapse rates during maintenance of severe reflux esophagitis

17.5% for healing doses (high dose PPI)

29.1% for half-healing doses (standard dose PPI)

Double dose (OMEPRON 40 MG) for healing and maintenance

HIGH DOSE PPI IN ULCER REBLEEDING

Acid suppression with PPI use significantly reduces the risk of re-bleeding in bleeding peptic ulcers.

The mechanism of action is thought to be related to clot stabilization by increasing gastric pH.

Both oral and intravenous PPIs have been demonstrated to decrease hospital stay, re-bleeding rate and the need for blood transfusion in patients treated with endoscopic therapy.

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS:

Prevention of acute rebleeding of peptic ulcers after endoscopic hemostasis

IV PPI initially for 72 hours: 80 MG LD, 8 MG PER HOUR

Quadruple-dose oral PPI may be given in 2 divided doses for 5 days

Standard doses should be used thereafter.

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS:

Reduction of risk of upper gastrointestinal bleeding in critically ill patients (STRESS BLEEDING)

who have documented intolerance, contraindication, or insufficient response to intravenous H2RA therapy

Double-dose PPI for up to 2 weeks

WHEN TO GIVE HIGH DOSE PPI:

INADEQUATE IMPROVEMENT WITH STANDARD THERAPY

REASONS FOR LACK OF RESPONSE WRONG DIAGNOSIS – MALIGNANCY, NOT ACID-

RELATED (GALLSTONES, PANCREATIC DISEASE, COLONIC) – PPI WILL NOT WORK

PATIENT COMPLIANCE, TIMING OF MEDICATIONS

GERD NOCTURNAL ACID BREAKTHROUGH ESOPHAGEAL AND GASTRIC MOTILITY DISORDERS LES DYSFUNCTION

REASONS FOR LACK OF RESPONSE

BARRETT’S AND LPR – INADEQUATE RESPONSE

PEPTIC ULCERS – CONTINUED ASPIRIN/NSAID USE

RESISTANCE? TOLERANCE?

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS Insufficient improvement in OR recurrence of symptoms

of GERD or other acid-related disorders (such as high-risk NSAID-related gastric ulcers)

after an adequate trial (≥ 4 to 8 weeks) of standard-dose PPI

Double-dose PPI (for ≥ 4 weeks) may be started empirically without further diagnostic testing

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS:

Insufficient improvement in or recurrence of symptoms of GERD or other acid-related disorders (such as high-risk NSAID-related gastric ulcers) after an adequate trial (≥ 4 to 8 weeks) of double-dose PPI therapy

Higher than double-dose PPI therapy may be started while awaiting further consultation and testing, and continued as maintenance therapy

INDICATIONS FOR HIGH DOSE PROTON PUMP INHIBITORS:

Step-down: titrate according to symptom control.

If test results suggest possible relative “resistance” to that particular PPI, then consider switching to another PPI at double the standard dose.

SUMMARY:Selected Indications for High-Dose PPI (OMEPRON 40)

Diagnostic PPI Test for Uncomplicated GERD, and Non-cardiac Chest Pain

GERD-related chronic cough

Empiric diagnosis and treatment of LPR

Selected Indications for High-Dose PPI (OMEPRON 40)

Treatment and maintenance of severe reflux esophagitis

Prevention of rebleeding of peptic ulcers

THANK YOU!