The use of Spiriva administered in mist form was associated with a 52 percent increase in the risk of mortality, compared with patients given only a placebo, according to the review published today in the British Medical Journal. The analysis included five clinical trials involving more than 6,500 patients.
“The findings add weight to recent safety concerns by regulatory agencies regarding the risk of an increased mortality risk associated with this device,” the BMJ said in a statement.
The U.S. Food and Drug Administration last year said a two-year review didn’t indicate Spiriva increased the risk of heart attack and stroke. Earlier studies had suggested a potential risk. Spiriva is a long-acting treatment for chronic obstructive pulmonary disease, a breathing difficulty that affects as many as 24 million Americans, according to the National Heart, Lung and Blood Institute, a U.S. agency. The medicine is co-marketed by New York-based Pfizer and closely held Boehringer, of Ingelheim, Germany.
Physicians should inform patients of the elevated risk of the therapy and should be careful in prescribing it to those with possible underlying heart problems, the U.K. and U.S. researchers concluded in the BMJ study. Spiriva is produced both as a mist, delivered with the Respimat inhaler, and as a powder, delivered with a Handihaler device. The mist inhaler is available in 55 countries including the U.K., though isn’t approved yet in the U.S., according to the study.
“We do not agree with the authors’ conclusion that there is an increased mortality risk for Spiriva Respimat in COPD,” Boehringer said in an e-mailed statement. The treatment’s risks and benefits have been documented in clinical trials and are described in the product’s label, the drugmaker said. Boehringer and Pfizer have access to detailed patient data from the trials which the authors of the BMJ study didn’t have, the company said.
Boehringer said it’s conducting a study of more than 17,000 patients comparing Spiriva Respimat and Spiriva Handihaler to confirm efficacy and safety, and results are due in early 2014.
Until the results of that study, dubbed TioSpir, become available, “the indirect evidence that is currently available suggests that the Handihaler is a safer bet than the Respimat,” Christopher Cates, a senior clinical research fellow at St. George’s University of London, wrote in an accompanying editorial.
The mist inhaler’s increased risk may stem from higher plasma concentrations of Spiriva resulting from the device’s improved delivery, Cates said.
Also known as emphysema, chronic bronchitis or smoker’s cough, chronic obstructive pulmonary disease kills more than 120,000 Americans a year as blockages in the lungs lead to shortness of breath and disability.
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