October 8, 2008 – FDA informed healthcare professionals this week it reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) reported by Boehringer Ingelheim, which showed no increased risk of stroke with tiotropium bromide compared to placebo.
Tiotropium is marketed as Spiriva HandiHaler. UPLIFT is a large, four-year, placebo controlled clinical trial with Spiriva HandiHaler in about 6,000 patients with chronic obstructive pulmonary disease. 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.
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 make an update with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.
For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium