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Spiriva, Atrovent Up Heart Attack and Stroke Risks

Sep 24, 2008 | Parker Waichman LLP

Spiriva and Atrovent, inhaled anticholinergic drugs used to treat the lung condition chronic obstructive pulmonary disease (COPD), have been linked to an increased risk of heart attack and stroke.  A new study conducted by researchers at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. found that using one of these drugs for a month increased a patient's risk of cardiovascular death, heart attack or stroke by a whopping 58 percent.

COPD affects as many as 24 million Americans and kills more than 100,000 each year.  COPD is a progressive lung disease, often caused by smoking, for which there's no known cure. Symptoms include restricted breathing, secretion of mucus, oxidative stress and inflammation of the airway.

Spiriva is the most widely prescribed drug for COPD, used by more than 8 million patients globally since it was approved by the Food and Drug Administration (FDA)  in 2002. Atrovent is the second most commonly prescribed drug in this class.

Inhaled anticholinergic drugs like  Atrovent and Spiriva are usually taken once a day by people with COPD.  They ease breathing by preventing the airways from constricting.  Earlier this year, the FDA issued an "early communication" warning of a possible increased risk of stroke with use of Spiriva. A Veterans Affairs study published last week linked Atrovent with an increased risk for heart-related deaths in men.

This latest study involved a meta-analysis of 17 randomized studies comparing a total of 15,000 mostly older patients who had taken either of the drugs with those on different medicine or a placebo.  All of the patients in the study were treated for at least 30 days.

The researchers found that the use of inhaled anticholinergic drugs increased the risk of a heart attack by 53 percent, cardiovascular death by 80 percent and stroke by 46 percent. An increased risk of all-cause death was not clinically significant, but just barely so.

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, what it means is that if you were to use these drugs for a year, your absolute risk of developing an additional cardiac death would be one in 40," Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest and author of an article detailing the study that appeared in the Sept. 24 issue of the "Journal of the American Medical Association", told "US News and World Report".

Dr. Singh said before starting drugs, patients should try to reduce heart risks by quitting smoking, keeping blood pressure and cholesterol under control, and using oxygen. The study authors also urged doctors to closely monitor patients who use the inhalers.


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