Link between widely used osteoporosis drugs and heart problems inconclusive

New research conducted at Wake Forest University School of Medicine evaluated the link between a common class of drugs used to prevent bone fractures in patients with osteoporosis and the development of an irregular heartbeat.

“Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn’t conclusive,” Sonal Singh, MD, MPH, an assistant professor of internal medicine and lead investigator for the study, said in a press release. “We urge that additional investigations be conducted.”

The study findings appear in the April issue of Drug Safety, a publication of the International Society of Pharmacovigilance.

For the study, researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heartbeat.

Researchers found that bisphosphonate use was associated with a significant increase in the incidence of “serious” heart rhythm disturbances, classified by hospitalization, disability or death resulting from the condition. However, when they included “non-serious” cases in their analysis, they found no overall increased risk of atrial fibrillation, according to the press release.

The investigators reviewed the medical records of more than 13,000 patients who had osteoporosis or fractures and were given bisphosphonates and compared them to the records of more than 13,000 patients who received a placebo during study participation.

Researchers looked for the incidence of irregular heartbeat first, then death caused by stroke or heart attack as a secondary outcome. The patient files reviewed were primarily of women who were treated with bisphosphonates and were generally in their early 70s, according to the study.

“We found no risk of stroke and cardiovascular mortality in the trials,” Singh said in the press release. “That was very reassuring.”

The observational studies evaluated the risk of irregular heartbeat in patients treated with bisphosphonates and compared it to the risk of those who had not received the drug. A review of these studies found different results. One study showed an increased risk of irregular heartbeat in patients taking the drugs and others showed no associated risk.

“The amount of data on the outcome of bisphosphonate use is insufficient to make a definitive conclusion,” co-investigator Vinodh Jeevanantham, MD, an instructor of internal medicine, said in the press release.

Given these results, physicians should not change they way they prescribe the drugs for the majority of patients with osteoporosis, Singh added, and patients should not stop taking them.

He cautioned, however, that patients with pre-existing heart conditions and those with risk factors for rhythm disturbance should be especially vigilant for the development of atrial fibrillation, and doctors should continue to closely monitor patients at risk for atrial fibrillation who are taking bisphosphonates, Singh said in the press release.

Reference:
Loke YK, Jeevanantham V, Singh S. Bisphosphonates and atrial fibrillation: Systematic review and meta-analysis. Drug Safety. 32(3):219-228.