Good news for Pfizer and Boehringer Ingelheim's Spiriva product. The FDA finished up a safety review of the COPD treatment, finding no increased risk of stroke or heart problems. "[T]he available data do not support an association between the use of Spiriva Handihaler and an increased risk for these serious adverse events," the agency says in a statement.
FDA had been poring over safety data since 2008, after clinical studies suggested Spiriva HandiHaler might boost the risk of stroke. The agency was also looking for evidence that Spiriva might boost the number of heart attacks and the number of cardiovascular-related deaths. But after reviewing data from the so-called "Uplift" study--which compared Spiriva with a placebo in almost 6,000 COPD patients--the agency concluded that evidence didn't support the potential safety concerns.
Interestingly, a study just published in Chest found that Spiriva might actually lower patients' risk of heart problems and death, HealthDay reports. After looking at 30 clinical trials covering more than 19,500 patients, researchers found that patients using Spiriva had a lower risk of dying. Also, the Spiriva patients had fewer respiratory events than placebo patients did. That's good news for the drug's makers; Spiriva accounted for some $3 billion in global sales in 2008.
- see the FDA release
- get more from HealthDay
- read the WSJ article