Hoffmann A, Kraul H, Burkardt I
Department of Clinical Pharmacology, Friedrich Schiller University Jena, Germany.
Int J Clin Pharmacol Ther. 1997 May;35(5):195-203.
To investigate the 24-hour efficacy of nilvadipine (8 and 16 mg)in patients with mild to moderate essential hypertension, a double-blind, randomized, placebo-controlled, multicenter study with 3 parallel medication groups (placebo, 8, and 16 mg nilvadipine) was performed. Included in the study were 172 outpatients of both sexes with a mean age of 56 years. The primary target variable for the evaluation of efficacy was the difference in sitting diastolic blood pressure 24 hours after administration of the trial medication, in mmHg, achieved by the different doses after 8 weeks of therapy compared to baseline. This difference was -6.8 in the placebo group (n = 59), -10.4 in the nilvadipine 8 mg group (n = 60), and -11.0 in the nilvadipine 16 mg group (n = 49). Paired comparison showed a significant and clinically relevant difference between placebo and both nilvadipine doses. There were no serious adverse events reported. Nonserious adverse events were reported in 40.1% of all patients. Most frequently reported adverse drug reactions were flushing, headache, edema, and tachycardia. The adverse events occurred dose-dependently. As the dose-response relationship shows clinical saturation at a daily dose of 16 mg, the recommended dose is 8 mg taken once daily.
