Boehringer Ingelheim releases new Spiriva trial data

Boehringer Ingelheim and Pfizer have release the results of a new analysis of 30 controlled trials which confirm the long-term safety profile of Spiriva (tiotropium).

The companies said this new and expanded safety data for the compound contradicts the conclusion made regarding the drug in the recent issue of the Journal of the American Medical Association.

Boehringer Ingelheim added the firms have released the details of this new analysis in order to provide healthcare professionals with the most up-to-date and comprehensive safety information for Spiriva to facilitate the best treatment decisions.

The company noted chronic obstructive pulmonary disease (COPD) patients have a higher cardiovascular risk than the general population, making cardiovascular safety in its treatment of vital importance.

Dr Andreas Barner, vice-chairman of the board of managing directors at Boehringer Ingelheim responsible for research, development and medicine, said: “We strongly disagree with the conclusion reached by Singh et al.”

He added the company has disclosed the data from the landmark Uplift trial to support the safety profile of Spiriva, while patients and doctors should be confident it is a safe and effective treatment.

In July 2007, Boehringer Ingelheim and Pfizer said they had completed the approval process for the application of Spiriva Respimat in the EU as a treatment for COPD.