NEW YORK (Reuters Health) – Patients requiring chronic nonsteroidal anti-inflammatory drug (NSAID) treatment develop fewer gastric or duodenal ulcers if they take ibuprofen with high-dose famotidine in a single tablet rather than ibuprofen alone, investigators report in the American Journal of Gastroenterology online December 20.
“Use of a combination tablet theoretically should improve adherence to antisecretory therapy as compared with use of separate individual NSAID and antisecretory agents,” the authors comment.
Building on a prior study showing a significant benefit of double-dose histamine-2-receptor antagonists in reducing ulcers in NSAID users, Dr. Loren Laine, at Yale University School of Medicine in New Haven, Connecticut studied the effects a combination pill, HTZ-501,containing 800 mg ibuprofen and 26.6 mg famotidine.
The team conducted two trials, in which a total of 1533 patients who were expected to need NSAID therapy for at least 6 months were randomized 2:1 to either HZT-501 TID or 800 mg ibuprofen TID for 24 weeks. They were negative for H pylori and baseline endoscopy established that they were initially free of gastric or duodenal ulcers.
Study endoscopies were performed at 8, 16 and 24 weeks. Pooled analyses of the data showed that crude rates of upper GI (i.e., gastric or duodenal) ulcers were 10.5% in the HZT-501 group compared to 20.1% in the group given ibuprofen alone.
After adjustment for factors such as age and use of low-dose aspirin, the risk ratio for upper GI ulcer was 0.46 with HZT-501 relative to ibuprofen alone, the authors report.
Rates of dyspepsia for HZT-501 compared with ibuprofen were 4.7% vs 8.0%, and corresponding rates of nausea were 5.8% vs 4.7%, the report indicates. No other adverse effects occurred at a rate of 5% or more.
“In summary,” Dr. Laine and colleagues conclude, “the combined results of two studies indicate that double-dose famotidine plus ibuprofen, given as a combination tablet, decreases endoscopic upper GI ulcers as compared with ibuprofen alone.”
They add, “Future studies will be necessary to prospectively study adherence and the effect on endoscopic or clinical outcomes.”
SOURCE:
Am J Gastroenterol 2011
