COPD Medicines: Risky or Safe?
Study Links 2 COPD Drugs to Risks of Heart Attack, Stroke, Death
COPD Medicines: Industry's View continued...
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
Still, he says, "the study doesn't necessarily mean everyone should go off
Physicians who care for COPD patients, he says, should read the report
carefully and then use their clinical judgment to decide the best
Other options for treating COPD include inhaled steroids and
long-acting bronchodilators, he says, or a combination of
treatments. If the COPD is severe, he says, "it is common to take all
For COPD patients, he has this advice: "COPD patients should sit with their
doctors and say, 'Look, I read this [study], I am concerned about this." Ask
the doctor what medicines are best and why, he says.