PALM SPRINGS, CA — An analysis of the safety of duloxetine with concomitant nonsteroidal anti-inflammatory drug (NSAID) use found increased bleeding events in patients compared with nonusers of NSAIDs, investigators reported during the American Academy of Pain Medicine 28th Annual Meeting.

Elijah P. Frakes, PhD, of Eli Lilly and Company, Indianapolis, IN, and colleagues examined safety data from 55 placebo-controlled duloxetine trials, enrolling a total of 19,529 patients, for bleeding-related events and stratified patients by NSAID (n=5,937) use vs. nonuse (n=13,529). These four subgroups were compared and differences analyzed using a logistic regression model including therapy, NSAID use, and therapy-by-NSAID subgroup interaction. Tests of hypotheses were based on a two-sided significance of 0.05, excepting 0.1 for therapy-by-NSAID subgroup interaction.

The investigators found at least one bleeding-related event occurred in the treatment group that received an NSAID (P=0.029). In addition, NSAID users were found to experience a significantly greater frequency in bleeding events vs. nonusers (P<0.001), regardless of treatment group.

Bleeding rates were greater between duloxetine/placebo NSAID nonusers (1.51% vs. 0.80%) vs. NSAID users (2.35% vs. 2.13%). Among NSAID users, no significant difference (P=0.598) in bleeding event incidence was observed between placebo and duloxetine. For NSAID users and nonusers, no significant difference in incidence of bleeding events was observed between the duloxetine and placebo groups, including for gastrointestinal bleeding events combined, the researchers concluded (P=0.742).