Spiriva and Atrovent, two drugs widely prescribed in chronic
obstructive pulmonary disease (COPD), were found to increase the risk of heart
attack, stroke, and even death in a study made by researchers at
Spiriva is jointly marketed by Boehringer Ingelheim
Pharmaceuticals Inc. and Pfizer Inc. The drug was approved by the Food and Drug
Administration to relax muscles and open lung airways, symptoms that occur in
COPD. Atrovent is used for the same condition, which kills more than 100,000
Americans annually. The main cause of the disease appears to be smoking.
Analyzing 17 studies involving almost 15,000 patients,
researchers at
The FDA previously noted an increased risk of stroke citing
an analysis of 13,500 patients. However, no specific reason was given for the
risks found with the drug, but researchers believe that damaging proteins
involved in inflammation are also involved in emphysema, chronic bronchitis,
and heart diseases.
Spiriva’s makers were totally dissatisfied with the findings of the analysis
saying their own analysis of 30 studies involving almost 20,000 patients found
no such risk of heart attack, stroke or death among those taking the drug.
“Patients and physicians can be confident that Spiriva is a safe and effective
medication,” the companies’ statement read.
They also cited results from the four-year clinical trial
known as Uplift involving nearly 6,000 patients, which showed no risk of heart
disease or stroke.
“There was no evidence of an increased risk of death during
the study,” lead investigator Marc De Cramer of the University Hospital Leuven,
Belgium said.
Full results of the study will be presented at the annual
meeting of the European Respiratory Society in