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FDA Says No Increased Risk of Stroke Associated With Tiotropium Compared to Placebo
Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes. Singh et al.1 performed a systematic review and meta-analysis of 17 clinical trials enrolling 14,783 patients treated with inhaled anticholinergic drugs used for the treatment of chronic obstructive lung disease. Lee et al. performed a case-control study of 32,130 patients (320,501 controls) treated with inhaled medications, including an anticholinergic, for the treatment of chronic obstructive lung disease.
FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.
Source: Food and Drug Administration