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Norman K. Hollenberg, P-73: Observations on the safety of lercanidipine: adverse event data from placebo-controlled trials, American Journal of Hypertension, Volume 15, Issue S3, April 2002, Pages 58A–59A, https://doi.org/10.1016/S0895-7061(02)02424-X
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Abstract
Lercanidipine HCl is a 1,4-dihydropyridine derivative with potent, long-lasting, and vascular-selective calcium channel blocking activity. It is approved for the treatment of hypertension in 27 countries worldwide. A new drug application (NDA) for lercanidipine in the treatment of hypertension is currently under review by the US Food and Drug Administration. The safety of lercanidipine was evaluated in 14 short-term, placebo-controlled, double-blind clinical trials in patients with hypertension or stable effort angina. A total of 1850 patients were randomized and received at least 1 dose of study medication, 1393 of whom received at least 1 dose of lercanidipine. Most patients were treated with 10-20 mg lercanidipine qd, which is the clinically effective dose range. The average duration of exposure to lercanidipine was 46.6 days, and the average duration of exposure to placebo was 40.7 days. Dosing with lercanidipine in these studies ranged up to 129 days. Treatment-emergent adverse events (TEAEs) were reported in 26.8% of the lercanidipine-treated patients overall and in 20.3% of the placebo-treated patients. At the 10 mg/d dose, 15.7% of the lercanidipine-treated patients reported at least 1 TEAE, and at the 20 mg/d dose, 23.1% of the lercanidipine-treated patients reported at least 1 TEAE. TEAEs that occurred in ≥1% of all lercanidipine-treated patients were headache (5.6%), edema (2.4%), tachycardia (2.1%), flushing (2.0%), palpitations (1.7%), rhinitis (1.3%), and hypokalemia (1.2%). The most common TEAEs among patients treated with placebo were headache (3.8%), hypokalemia (1.3%), and hyperuricemia (1.1%). There were no obvious dose-related effects on the incidence of any individual TEAE in the 10-20 mg/d dose range. Approximately 90% of all TEAEs among the lercanidipine-treated patients were mild or moderate in severity, and the majority of these were considered to be not drug-related. These data demonstrate that lercanidipine, at doses of 10-20 mg/d, can be used safely in patients with hypertension or stable effort angina.
