April 02, 2012
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Famotidine ibuprofen combination reduced upper GI ulcers

A double dose of famotidine combined with ibuprofen decreased the occurrence of upper gastrointestinal ulcers compared with ibuprofen alone in a recent study.

In two, 24-week double blind trials conducted at 68 medical centers throughout the US from March 2007 to September 2008, researchers evaluated the effects of famotidine and ibuprofen on gastric (trial REDUCE-1) and duodenal ulcers (trial REDUCE-2). Patients were aged 40 to 80 years and required daily NSAID treatments for more than 6 months.

For the REDUCE-1 trial, 607 patients received 800 mg famotidine/ibuprofen combination and 301 received 800 mg ibuprofen; in REDUCE-2, 415 received 800 mg famotidine/ibuprofen and 212 received 800 mg ibuprofen. After 8, 16 and 24 weeks, endoscopies were performed to determine the presence of gastric ulcers in the REDUCE-1 group and upper gastrointestinal ulcers in the REDUCE-2 group, as well as other complications, including bleeding or ulcer perforation.

Among patients in REDUCE-1, 12.7% assigned the combination experienced gastric ulcers compared with 22.9% in the ibuprofen group (P=.0044).

In REDUCE-2, 13.0% in the combination group had upper GI ulcers compared with 20.5% in the ibuprofen group (P=.0587).

A pooled analysis of the studies also determined that 12.5% of patients in the combination group experienced gastric ulcers compared with 20.7% in the ibuprofen group, and 1.6% of combination patients experienced duodenal ulcers compared with 6.9 % in the ibuprofen group. Investigators associated the combination treatment with a lower risk ratio for ulcer formation (RR=0.46; CI 95%, 0.34-0.61).

“Use of a combination tablet theoretically should improve adherence to antisecretory therapy as compared with use of separate individual NSAID and antisecretory agents,” researchers wrote,” but future studies will be necessary to prospectively study adherence and the effect on endoscopic or clinical outcomes.”