Researchers are raising new questions about the safety of an respiratory inhaler sold by Boehringer Ingelheim and Pfizer. Patients who use the Spiriva Respimat device, which delivers a soluble form of the drug Spiriva, to treat chronic obstructive pulmonary disease could increase their risk of dying by 52 percent, the scientists said.
Pfizer and Boehringer disputed the researchers' new study, which was published in the British Medical Journal. "When analysing the clinical data, Boehringer Ingelheim and Pfizer, unlike the authors of the BMJ publication, have access to detailed patient level data," the companies said in a statement (as quoted by Reuters). "A thorough analysis of these data revealed a statistically non-significant, numerical imbalance in number of fatal events with Spiriva Respimat."
The new study is based on an analysis of data from five clinical trials covering some 6,500 patients. The analysis found that the risk of death in COPD patients using the Respimat inhaler was 52 percent higher than in placebo patients. "What we think is going on is that the mist inhaler is delivering a higher concentration of tiotropium than it should be," lead author Dr. Sonal Singh of Johns Hopkins said in a statement.
The Respimat inhaler device is approved in Europe, but not in the U.S. The FDA cited an increased number of deaths in a 17,000-patient study for its reluctance to clear the inhaler.
As usual with new medical research, the question is now whether the data will affect regulatory attitudes about the product on one hand, and prescription numbers on the other. Panmure Gordon analyst Savvas Neophytou told Reuters that the possible negative impact on Spiriva Respimat sales could benefit GlaxoSmithKline's Advair product, which might offset the growing threat of generic competition in European markets.
- read the Reuters news