Long-term Risk of Ischemic Stroke Associated with Rofecoxib

Abstract

Based on extended follow-up data, APPROVe is the first trial to report an increase in ischemic stroke risk with rofecoxib compared to placebo. The finding of ischemic strokes after rofecoxib use had been discontinued should be further studied to determine whether patients previously exposed to rofecoxib remain at an increased risk.

Adaptation of Bayesian Data Mining Algorithms to Longitudinal Claims Data

“…Our observation that celecoxib was associated with an approximately two-fold increased risk of AMI has been observed in some (11-13) but not all (14, 15) studies. Although we observed a significant association between rofecoxib and stroke events, as has been found previously (16, 17), we did not observe a significantly increased risk of AMI. This study was likely underpowered to establish a significant relationship.…”

Nonaspirin NSAIDs, Cyclooxygenase 2 Inhibitors, and the Risk for Stroke

“…Because extended follow-up data from the APPROVe trial indicate that patients who stopped rofecoxib remain at an increased risk of stroke, we also examined former use of rofecoxib and valdecoxib. 17 Because new users are less susceptible to bias introduced by events that might arise shortly after the onset of therapy or by modification of disease risk factors, such as hypertension, by the exposure of interest, we conducted a similar analysis confined to new users. 18 New users were defined as persons who started an NSAID and had no prescription for any NSAID in the prior 365 days.…”