Boehringer Ingelheim/Pfizer position regarding the recent publication by Singh et. al., in British Medical Journal, June 15, 2011
Ingelheim/Germany, New York City/USA, 15 June 2011 — On 15 June 2011, results by Singh et al from a meta-analysis of randomized controlled trials was published in British Medical Journal.
Boehringer Ingelheim and Pfizer disagree with the authors’ conclusion that this meta-analysis proves a risk for tiotropium delivered via the soft mist inhaler Respimat® in COPD patients. Efficacy and safety of Spiriva® Respimat® has been established by a stand alone clinical development program and is fully described in the approved product label.
The authors’ conclusions are not based on new clinical evidence. Data from the five clinical trials used in this meta-analysis are already publicly available, have been submitted to the regulatory agencies and are appropriately reflected in the Spiriva® Respimat® label. When analyzing the clinical data, Boehringer Ingelheim and Pfizer – unlike the authors of the publication – have access to detailed patient level data. A thorough analysis of these data revealed a statistically non-significant, numerical imbalance in number of fatal events with Spiriva® Respimat®. Mortality rates observed in the analyzed studies were within the range of other large COPD trials. These data have been submitted to regulatory authorities worldwide and findings are fully described in the approved product label.
Boehringer Ingelheim is currently conducting the large clinical TIOSPIR trial including approximately 17.000 randomized patients to confirm efficacy and safety of Spiriva® Respimat®. This study has been released by regulatory authorities including the FDA and national ethic committees. An independent Data Safety Monitoring Board reviewed the TIOSPIR study recently as part of a regular procedure and recommended its continuation. Results of the trial are expected in 2014.