Efficacy and safety of nicardipine in 29,104 patients with hypertension.

The efficacy and safety of nicardipine were assessed in 29,104 hypertensive patients (mean age, 64 years) during a 90-day multicenter clinical trial. By treatment day 90, blood pressure was controlled in 60% of the patients taking nicardipine alone. The efficacy of nicardipine combined with another antihypertensive agent was examined in 6,479 of the patients. When nicardipine was added to their treatment regimen, blood pressure was controlled by day 90 in 63% of the patients taking beta-blockers, in 58% of those on diuretics, in 50% of those on angiotensin converting enzyme inhibitors, and in 49% of those taking centrally acting antihypertensive agents. Nicardipine was well tolerated; only 11% of the 29,104 patients discontinued treatment because of side effects. Most adverse reactions were transient and were related to vasodilation, and included peripheral edema in 7% of the patients, flushing in 7%, and headache in 4%. The results indicate that nicardipine is suitable as initial therapy in arterial hypertension.