Proton-pump inhibitor therapy for acetylsalicylic acid associated upper gastrointestinal symptoms: a randomized placebo-controlled trial.
OBJECTIVE
Patients using acetylsalicylic acid (aspirin) have an increased risk of upper gastrointestinal discomfort. The aim of this study was to assess whether gastric acid suppression improves upper gastrointestinal symptoms in patients using low-dose aspirin for cardiovascular disease.


METHODS
In a double-blind, placebo-controlled randomised trial, 150 patients using low-dose (80 mg) acetylsalicylic acid with upper gastrointestinal symptoms who had been admitted at the Coronary Care Unit of the University Medical Center Nijmegen were assigned to treatment with rabeprazole (20 mg once daily) or placebo for 4 weeks. Treatment success, defined as complete upper gastrointestinal symptom relief, could be evaluated in 143 patients.


RESULTS
At 4 weeks after randomization, 34 of the 73 patients assigned to rabeprazole therapy (47%) as compared with 30 of the 70 patients given placebo (43%) reported complete upper gastrointestinal symptom relief (P = 0.54). Rabeprazole therapy did lead to a 52% improvement of heartburn symptoms [25% vs. 16%; odds ratio (OR) 0.48, 95% confidence interval (CI): 0.24-0.97]. Epigastric pain, regurgitation, bloating and nausea symptoms did not statistically change after treatment. Patients with a history of dyspepsia more often reported treatment success in comparison to those without (75% vs. 40%; OR 0.25, 95% CI: 0.09-0.70).


CONCLUSIONS
Proton-pump inhibitor therapy significantly reduced heartburn, but not other acetylsalicylic acid associated symptoms.
Laheij
R J F
RJ
Department of Gastroenterology, Heart Center, University Medical Center Nijmegen, The Netherlands. R.Laheij@mdl.umcn.nl
Van Rossum
L G M
LG
Jansen
J B M J
JB
Verheugt
F W A
FW
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000139:chemically induced; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000188:drug therapy; D006356:Heartburn / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009853:Omeprazole / Q000031:analogs & derivatives; D010146:Pain / Q000139:chemically induced; D054328:Proton Pump Inhibitors; D064750:Rabeprazole
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D009853:Omeprazole; D001241:Aspirin