Abstract

OBJECTIVE:

To determine the incidence of adverse events or serious adverse events of atrial fibrillation in the pivotal trials of ibandronate and to assess whether increasing dose or duration of exposure had any effect on the incidence of atrial fibrillation.

PATIENTS AND METHODS:

Pooled data from all four pivotal ibandronate clinical trials were analysed to assess the incidence of atrial fibrillation as an adverse event and serious adverse event with ibandronate vs. placebo. The incidence of atrial fibrillation with ibandronate was also assessed by dose, by annual cumulative exposure (ACE) and by patient age.

RESULTS:

This analysis included 6830 patients treated with ibandronate and 1924 treated with placebo. The incidence of atrial fibrillation as an adverse event (ibandronate, 0.8% and placebo, 0.9%) and serious adverse event (0.4% for both ibandronate and placebo) was comparable between the ibandronate and placebo groups. There was no increase in the incidence of atrial fibrillation as an adverse event or serious adverse event with increasing oral or intravenous (i.v.) ibandronate dose. No correlation between the incidence of atrial fibrillation as a serious adverse event and ibandronate duration of exposure was observed. Based on various ACE categories, none of the ibandronate regimens evaluated in these trials was associated with an increased incidence of atrial fibrillation.

CONCLUSIONS:

In this pooled analysis of all four ibandronate pivotal trials, including analysis by ACE, all studied ibandronate regimens, including the licensed doses of 150 mg monthly oral and 3 mg quarterly i.v., were not associated with an increased incidence of atrial fibrillation.