COPD Medicines: Risky or Safe?
Study Links 2 COPD Drugs to Risks of Heart Attack, Stroke, Death
COPD Medicines: Industry's View
Both medications are safe, according to spokespeople from pharmaceutical companies that market Spiriva and Atrovent.
"Extensive research provides strong support for the safety of these medications and is contrary to the conclusion expressed in the recently released articles by Dr. Lee and colleagues [the Annals of Internal Medicine study] and Dr. Singh and colleagues," says Lara Crissey, a spokeswoman for Boehringer Ingelheim, which markets Atrovent and jointly markets Spiriva with Pfizer Inc.
In a statement jointly issued by the companies, officials elaborate on Spiriva, saying its safety profile is confirmed by 30 clinical trials recently analyzed by both companies but not yet published.
The statement reads, in part: "The new and expanded safety data contradicts the conclusions about [Spiriva]" in Singh's review.
Citing "data on file" at Boehringer Ingelheim, the statement says the analysis of 30 trials involving nearly 20,000 COPD patients, some on Spiriva, some on placebo, found no increased risk of death from all causes or from cardiac events nor an increased risk of stroke or heart attack.
The data reviewed, according to the statement, includes information from findings of a trial called UPLIFT, to be presented in October at a respiratory society meeting overseas.
Most evidence in the Singh report, the statement also points out, comes from a single study, the Lung Health Study, which involved Atrovent, not Spiriva, and that most deaths from cardiovascular disease occurred among patients who didn't take their medicine.
Singh counters that even after excluding information from the Lung Health Study, the risks remained.
COPD Medicines: Ask Your Doctor
The results of Singh's review are "troublesome," says Norman Edelman, MD, chief medical officer of the American Lung Association and professor of medicine and preventive medicine at Stony Brook University in Long Island, N.Y. "We use anticholinergics a lot," he says of physicians who treat the more than 12 million U.S. adults with COPD.
Until recently, he says, research looked good on both COPD medicines. "Clinical data show people have better lung function on these drugs, especially Spiriva."
Still, he says, "the study doesn't necessarily mean everyone should go off these drugs."