An overview of the safety and efficacy of nicardipine in clinical trials.

Nicardipine is currently being evaluated in clinical trials as a treatment for angina and hypertension. Over 2,000 patients have received nicardipine, most at dosages of 20 to 40 mg 3 times daily. In 12 double-blind, parallel-group studies (4 of them placebo-controlled) the efficacy of nicardipine was evaluated in mild to moderate hypertension; supine systolic blood pressure was lowered by 10 to 15 mm Hg and supine diastolic blood pressure by 10 mm Hg. A clear dose response is present at dosages from 10 to 40 mg 3 times daily. Patients with angina were treated in 9 double-blind, crossover design studies: 4 of these were placebo-controlled; 3 were comparison studies with beta blockers; 2 were comparisons with nifedipine. Treadmill exercise tests were the major measure of efficacy. Results of these studies showed consistent, statistically significant improvement in exercise tolerance and time to onset of angina, and clinical improvement in patients with chronic stable angina. The effective dosages of nicardipine were 30 or 40 mg 3 times daily. A placebo-controlled study demonstrated remarkable efficacy in patients with vasospastic angina. No deaths or serious adverse reactions were attributed to nicardipine during clinical trials. The most common side effects reported were flushing, palpitations, headache and pedal edema. These appeared to be due to the drug's pharmacologic property of vasodilatation.