REDUCE-1 trial

Combined Ibuprofen/Famotidine Tablet Might Reduce Ulcers.

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Patients receiving the combination tablet developed fewer upper gastrointestinal ulcers than those receiving ibuprofen alone.

Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) have an increased risk for upper gastrointestinal (GI) ulcers (gastric and duodenal ulcers). Acid reduction with a proton-pump inhibitor (PPI) has been shown to decrease this risk. However, many patients taking NSAIDs either do not receive a prescription for PPIs or do not take them.

To investigate the efficacy of a combination tablet of 800 mg ibuprofen and 26.6 mg famotidine to reduce development of upper GI ulcers in patients requiring NSAID therapy, researchers conducted two industry-sponsored, randomized, double-blinded trials (REDUCE-1 and REDUCE-2) in which patients received the combination tablet or an 800-mg ibuprofen tablet three times daily for 24 weeks. The endpoint for the studies was upper GI ulcers identified by endoscopy during the 24-week study period.

In the REDUCE-1 trial, incidence of gastric ulcers was lower in the combination-tablet group than in the ibuprofen group (12.7% vs. 22.9%; P=0.004). In REDUCE-2, results showed a nonsignificant trend toward lower incidence of upper GI ulcers with the combination-tablet group versus ibuprofen (13.0% and 20.5%; P=0.059). In a pooled analysis of results from both trials, the combination-tablet group had lower incidence of both gastric ulcers (12.5% vs. 20.7%) and duodenal ulcers (1.6% vs. 6.9%) than the ibuprofen group. After adjustment for other potential risk factors, the risk ratio for upper gastrointestinal ulcers with the combination therapy versus ibuprofen alone was 0.46 (95% confidence interval, 0.34–0.61).

Comment: Our ability to compare these findings with data on efficacy of acid reduction with proton-pump inhibitor cotherapy is limited because this study was based on endoscopic ulcers. There were not enough complicated ulcers in the study to allow for comparison of this outcome between the two treatment groups. While some studies suggest that endoscopic ulcers are a reasonable surrogate for clinically significant events, it is impossible for us to determine how combination therapy — with its improved acid-reduction compliance — compares with standard PPI cotherapy without a head-to-head trial based on clinical events.

Source: Journal Watch Gastroenterology