Boehringer finds no increased risk of death with Spiriva Respimat

Boehringer Ingelheim GmbH (Ingelheim, Germany) said once-daily Spiriva Respimat tiotropium met the co-primary endpoint of non-inferiority to the company's once-daily Spiriva HandiHaler tiotropium in the risk of death in the Phase III TIOSPIR trial to treat chronic obstructive pulmonary disease (COPD). The 5 ug dose of Spiriva Respimat did miss the co-primary endpoint of superiority to once-daily Spiriva HandiHaler in the risk of first COPD exacerbation. The double-blind trial, which enrolled 17,135 COPD patients, did not evaluate the 2.5 ug dose of Spiriva Respimat on the exacerbation co-primary endpoint. Data were published in the New England Journal of Medicine and are slated to be presented next week at the European Respiratory Society meeting in Barcelona.

In 2011, researchers at Johns Hopkins University and colleagues reported data from a meta-analysis of 6,522 COPD patients in five trials showing Spiriva Respimat was associated with a 52% increased risk of all-cause mortality compared to placebo (p=0.02). The researchers said the increased risk of death may have been due to the Respimat Soft Mist Inhaler delivering higher concentrations of tiotropium than it should. Boehringer started the TIOSPIR trial to evaluate the numerical imbalance of mortality (see BioCentury Extra, June 14, 2011). ...