A study of the long-term efficacy and tolerability of oral nicardipine in hypertensive patients.

This study was designed to evaluate the efficacy of oral nicardipine in 91 patients with uncomplicated essential hypertension over a period of 12 months. All patients started on a fixed nicardipine dose of 30 mg three times daily which was adjusted in the range 10-40 mg three times daily, where necessary to achieve a target diastolic blood pressure less than 95 mm Hg. At 6 weeks, blood pressure (mean +/- s.e. mean) was reduced from an average of 190 +/- 22/112 +/- 8 to 167 +/- 23/96 +/- 11 mm Hg supine and from 180 +/- 21/113 +/- 7 to 154 +/- 17/95 +/- 11 mm Hg standing and remained controlled in all patients throughout the study. A total of 96 unwanted experiences were reported by 49 patients (54%); 17 (19%) reported a single symptom once and two (2%) reported a single symptom more than once. The most frequently reported adverse experiences were peripheral oedema in 27 (28%) and headaches in 15 patients (16%). The majority of the adverse experiences occurred in the first 3 months of treatment. Ten patients (11%) withdrew from the study during this time and eight (9%) in the subsequent 9 months because of drug-related side effects; five others (5%) withdrew for unrelated reasons. The incidence of adverse experiences was dose-related. Three patients reported unwanted effects on 10 mg three times daily, eight on 20 mg three times daily, 36 on 30 mg three times daily, and 12 on 40 mg three times daily oral nicardipine.(ABSTRACT TRUNCATED AT 250 WORDS)