Researchers find increased risk of death with Spiriva Respimat

Researchers at Johns Hopkins University and colleagues reported meta-analysis data showing that Spiriva Respimat tiotropium from Boehringer Ingelheim GmbH (Ingelheim, Germany) was associated with a 52% increased risk of all-cause mortality compared to placebo in patients with chronic obstructive pulmonary disease (p=0.02). The researchers said the increased risk of death may be caused by the Respimat Soft Mist Inhaler delivering higher concentrations of tiotropium than it should. The analysis included 6,522 patients from five clinical trials. Data were published in the British Medical Journal.

The product, which delivers a propellant-free mist of tiotropium, is approved in 55 countries outside of the U.S. to treat COPD. Boehringer also markets Spiriva HandiHaler tiotropium, a propellant-free breath actuated dry powder inhaler that delivers tiotropium powder to the lungs, in the U.S. and EU. In 2010, FDA said current data do not support an increased risk of stroke, heart attack or death in patients using Spiriva HandiHaler tiotropium. Pfizer Inc. (NYSE:PFE) has co-marketing rights to both products. ...