Prevention of NSAID-associated gastrointestinal lesions: a comparison study pantoprazole versus omeprazole.
OBJECTIVE
To investigate tolerability and efficacy of pantoprazole 20 mg, once daily (o.d.), pantoprazole 40 mg o.d., and omeprazole 20 mg o.d., in patients taking nonsteroidal anti-inflammatory drug(s) (NSAIDs).


METHODS
Included in this randomized, double-blind, multicenter, parallel-group study were rheumatic patients (>55 yr) on continual NSAIDs and with at least one more recognized risk factor that contributes to the development of gastrointestinal (GI) injury. Study duration was 6 months, and the treatment consisted of pantoprazole 20 mg o.d. (N = 196), pantoprazole 40 mg o.d. (N = 199), or omeprazole 20 mg o.d. (N = 200). Patients took NSAID(s) (except COX-2 inhibitors), had no more than five erosions/petechiae in the upper GI tract, no current peptic ulcers or reflux esophagitis, and had at most moderate intensity GI symptoms. Endoscopy was performed at baseline, 3, and 6 months. The primary end points were lack of "therapeutic failure" and lack of "endoscopic failure" at 6 months.


RESULTS
After 6 months, the probabilities to remain in remission were 90% pantoprazole 20 mg o.d., 93% pantoprazole 40 mg o.d., and 89% omeprazole 20 mg o.d. for lack of "therapeutic failure;" 91% pantoprazole 20 mg o.d., 95% pantoprazole 40 mg o.d., and 93% omeprazole 20 mg o.d. for lack of "endoscopic failure."


CONCLUSIONS
For patients taking NSAIDs continually, pantoprazole 20 mg o.d., pantoprazole 40 mg o.d., or omeprazole 20 mg o.d. provide equivalent, effective, and well-tolerated prophylaxis against GI lesions, including peptic ulcers.
Regula
Jaroslaw
J
Institute of Oncology Medical Centre for Postgraduate Education, Warsaw, Poland.
Butruk
Eugeniusz
E
Dekkers
Cornelius P M
CP
de Boer
Sybrand Y
SY
Raps
Dieter
D
Simon
László
L
Terjung
Andreas
A
Thomas
Kathy B
KB
Lühmann
Reinhold
R
Fischer
Renate
R
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077402:Pantoprazole; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012307:Risk Factors; D018709:Statistics, Nonparametric; D013454:Sulfoxides / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole