No Link Between Ibandronate and Atrial Fibrillation in Postmenopausal Osteoporosis Patients: Presented at EULAR

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Title: No Link Between Ibandronate and Atrial Fibrillation in Postmenopausal Osteoporosis Patients: Presented at EULAR
URL: http://www.pslgroup.com/dg/223ADA.htm
Doctor's Guide
June 16, 2008

By Jill Stein

PARIS -- June 16, 2008 -- A large body of data on the effects of ibandronate shows no association between its use and atrial fibrillation (AF) in patients with postmenopausal osteoporosis, researchers reported here at EULAR 2008, the Annual Congress of the European Union League Against Rheumatism.

Socrates Papapoulous, MD, Leiden University Medical Centre, Leiden, Netherlands, and associates conducted an analysis to assess whether the incidence of AF is increased among patients with postmenopausal osteoporosis receiving ibandronate treatment.

The study was prompted by a prior report of an increased frequency of serious cases of AF in a study of zoledronic acid in patients with postmenopausal osteoporosis. That report led to a review of all reports of AF in the pivotal clinical trials of ibandronate in postmenopausal osteoporosis.

Ibandronate is unique among bisphosphonates because of the broad range of dosing regimens that have been studied, the investigators said in their poster presentation on June 14.

They conducted their analysis in the safety populations of the 4 pivotal ibandronate studies; 6,830 patients received ibandronate for a cumulative exposure exceeding 15,000 patient-years and 1,924 patients received placebo for a cumulative exposure of approximately 4,800 patient-years.

Ibandronate doses were classified according to low, medium, and high annual cumulative exposure (ACE) groups.

Results showed that the overall incidence of AF was 0.9% for placebo, while the incidence of serious AF was 0.4%. The respective rates were 0.9% and 0.3% for low-dose ibandronate (2.0-4.0 mg), 0.8% and 0.5% for medium-dose ibandronate (5.5-7.2 mg), 0.8% and 0.2% for high-dose ibandronate (>=10.8 mg), and 0.8% and 0.4% for all ibandronate doses.

Overall, the data showed that none of the regimens tested in the ibandronate pivotal trials is associated with an increased risk of AF, the researchers noted.

Funding for the study was provided by Hoffmann-La Roche Ltd.

[Presentation title: Ibandronate Is Not Associated With an Increased Risk of Atrial Fibrillation; An Assessment of Annual Cumulative Exposure. Abstract SAT0333.]

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