Nebenwirkungen · Zoledronic acid Mylan
Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10
HOS-126261 · Präparat HOS-096231
Atrial fibrillation In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively. The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively. The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients. The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
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Version 2026-09-10T10:44:00Z · SHA-256 92cd88ed3642055fedbd569341cc36203efa8391140080f6b77e94d7a284838d · Passage 1c9ed4e3cec08c9d74421eee84912c110576123dd4d386f6d642925578247ace · Zeichen 7842–8695 im Abschnitt