CHICAGO (AP) - Inhaler drugs used by millions of people with emphysema and
bronchitis may slightly raise the risk for heart attacks and even death, a study
suggests.
The results aren't conclusive and inhalers provide significant relief for
these patients struggling to breathe. But the study authors urged doctors to
closely monitor patients who use the inhalers.
Most affected patients have both emphysema and chronic bronchitis. The
condition's formal name, chronic obstructive pulmonary disease, COPD, is the
nation's fourth leading cause of death.
The study's increased risks were small, and the drugs' marketer said both
medicines are safe. Outside experts called the study compelling but said it has
limitations that make it hard to know if the drugs or something else was at
fault.
The drugs are tiotropium, sold as Spiriva Handihaler by Boehringer Ingelheim
Pharmaceuticals Inc., and ipratropium, available generically and also sold by
Boehringer under the brand name Atrovent.
Spiriva, approved in 2004, and the decade-old Atrovent are used once or more
daily to relax muscles and open lung airways. They've been used by 8 million
patients worldwide.
A Veterans Affairs study published last week linked ipratropium with an
increased risk for heart-related deaths in men.
The new study appears in Wednesday's Journal of the American Medical
Association.
The company told the Food and Drug Administration earlier this year that its
own data had linked Spiriva with a possible increased risk for strokes. But
Boehringer and Pfizer Inc., which jointly market Spiriva, said Tuesday that they
had recently given the FDA a new analysis of that data plus new long-term data,
which they said shows initial concerns about strokes were unfounded.
"We strongly disagree with the conclusion" in the new study, the companies
said in a statement.
COPD affects as many as 24 million Americans and kills more than 100,000
each year. It involves thickened and narrowed lung airways and excess mucous.
Symptoms include persistent coughing and severe shortness of breath; smoking is
a leading cause.
Patients describe COPD breathing problems as feeling like they're "living
the entire day under water, unable to come to the surface," said Dr. Aaron
Milstone of Vanderbilt University medical school.
The new study pooled results from 17 randomized studies comparing mostly
older patients on either of the drugs with those on different medicine or dummy
drugs. Randomized studies are the most rigorous kind of medical research, but
Milstone said drawing conclusions from a pooled analysis can be problematic
because of differences in patients' characteristics.
It found that using either drug for more than one month appeared to increase
chances for fatal and nonfatal heart problems including heart attacks by more
than 50 percent.
Among about 7,400 patients on either inhaled drug, 1.8 percent or 135 people
developed fatal or nonfatal heart problems over a period of several weeks to
several years. By contrast, among about 7,300 patients on other drugs or dummy
medicine, 1.2 percent or 86 had those problems.
In absolute terms, out of 40 patients using either drug for one year, there
would be one extra drug-linked death, said study author Dr. Sonal Singh of Wake
Forest University's medical school.
Other drugs are used for COPD, but they also can have serious side effects,
Singh said. This puts patients in "a very tough spot," he acknowledged.
He said before starting drugs, patients should try to reduce heart risks by
quitting smoking, keeping blood pressure and cholesterol under control, and
using oxygen.
Dr. Mark Rosen, former president of the American College of Chest Physicians
and a lung specialist on New York's Long Island, said the data "are very
compelling but they're not conclusive."
He said it's unclear what caused the apparent increased risks since the
drugs aren't known to affect the heart. The authors said that damaging proteins
involved in inflammation are thought to play a role in both COPD and heart
disease.
Rosen noted that the analyzed studies weren't designed to look for heart
problems, and said it's possible patients on the drugs had more heart problems
to begin with.
Still, Rosen said the study "is an excellent reason to do more research to
figure out why this is true, if it is true and not a statistical fluke."
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