The FDA, in reviewing preliminary data from UPLIFT, a four-year, placebo-controlled clinical trial with Spiriva HandiHaler in approximately 6,000 patients with chronic obstructive pulmonary disease (COPD), has found no increased risk of stroke with tiotropium bromide compared to placebo.
Two recent clinical studies reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics, according to the FDA. Both studies examined cardiovascular outcomes.
On March 18, Boehringer Ingelheim, the Ingelheim am Rhein, Germany-based maker of Spiriva HandiHaler (tiotropium bromide), informed the agency that it had conducted a pooled analysis of 29 trials that suggested a small excess risk of stroke (two cases per 1,000) with tiotropium bromide over placebo. Yet, the agency said that the preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) shows no increased risk of stroke with Spiriva, compared to placebo.
The FDA expects to receive the complete report for UPLIFT in November.
Results from this trial will also help to address some issues raised about tiotropium in the two recent publications, the agency said. 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.