Spiriva, Serevent COPD Drugs Could Increase Heart Problem Risk: Study

The findings of a new study resurrects concerns that some long-acting inhalers used to treat chronic pulmonary obstructive disease (COPD), such as Spiriva and Serevent, could increase the risk of serious heart problems.  

In a study published this week in the the medical journal JAMA Internal Medicine, Canadian researchers say that patients who use long-acting bronchodilators, either anticholinergics like Spiriva or long-acting beta-agonists (LABAs) like Serevent, could face an increased risk of cardiovascular complications.

The study looked at data on patients over 65 from healthcare databases in Ontario, with information on about 13 million people in the province. Researchers found that patients who used long-actiong COPD inhalers were at significantly increased risk of heart problems.

Link Between Spiriva and Heart Problems

Spiriva (tiotropium) is a medication used for the long-term maintenance treatment of bronchospasm linked to chronic pulmonary obstructive disease (COPD). Since the Handihaler was approved by the FDA in 2004, it has grown to dominate the market for COPD inhalers and has been used by millions of Americans.

Concerns about heart problems with Spiriva were first raised following a combined analysis of 29 clinical trials, which found that users may face a slight increase in the risk of stroke when compared to the use of a placebo. In October 2008, a subsequent study showed that users of Spiriva Handihaler may face an increased risk of heart attack, stroke and death.

The FDA conducted a Spiriva safety investigation in 2010, but did not find a link between the inhaler and an increased risk of heart attack, stroke or death.

In February 2010  the FDA indicated that LABAs, including Advair, Symbicort, Foradil and Serevent should never be used alone in the treatment of asthma in children and adults. The decision came after studies raised concerns that long-term use of LABAs could cause a worsening of asthma symptoms and death in some users. Foradil, Severent, Symbicort and Advair side effects can mask worsening inflammation in the airways, the FDA determined, and worsening asthma symptoms may not be recognized in a timely manner, potentially leading to severe health risks and death.

The researchers in this latest study recommended regular monitoring for older patients using COPD long-term inhalers regardless of the drug class.