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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.
Furthermore, robust evidence has been published describing the safety profile of tiotropium HandiHaler® from a large series of randomized controlled trials including
These studies, separately and together, further corroborate the safety profile of Spiriva® delivered via HandiHaler® and demonstrate that its usage as maintenance treatment was associated with a reduced risk for an adverse event, serious adverse event and a fatal event. A reduced risk was also present for adverse events that were cardiac, lower respiratory and for a composite endpoint of major adverse cardiovascular events.
Spiriva® is a long-term maintenance therapy that patients with COPD can use on a daily basis to improve lung function and reduce the risk of developing exacerbations that can result in hospitalization and death.
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This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive yet treatable disease that restricts patients’ lives over time and is a major cause of death and disability throughout the world. Symptoms include cough, sputum (mucus or phlegm) production, and breathlessness on exertion. Acute worsening of these symptoms, i.e. exacerbations (sometimes referred to as COPD lung attacks due to their severe impact on patients’ health) often occur and can restrict a patient’s ability to perform normal daily activities. The latest World Health Organization (WHO) figures estimate that 210 million people are currently living with COPD and more than 3 million people died from the disease in 2005 – more than breast cancer and diabetes combined. Dyspnoea (breathlessness), the main symptom of COPD, is characteristically persistent and progressive and has a serious impact on patients’ quality of life. At its most severe, it even limits a patient from performing simple tasks such as washing and dressing.
About Spiriva® (tiotropium)
Spiriva®, a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva® positively impacts the clinical course of COPD, helping to change the way patients live with their disease. It is the most prescribed maintenance therapy for COPD worldwide. Spiriva® helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. Spiriva® works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.
Spiriva® is currently available for inhalation via HandiHaler® and Respimat®.
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