Monotherapy of stable angina with nicardipine hydrochloride: double-blind, placebo-controlled, randomized study
M Gheorghiade1, D A Weiner, S Chakko
1Veterans Administration Medical Center, Salem, Virginia.
Insights
Nicardipine hydrochloride, a calcium-channel blocker, improved exercise duration in stable angina patients. However, higher doses showed no significant benefit in angina onset time and some patients experienced adverse events.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Stable angina pectoris is a common cardiovascular condition.
- Calcium-channel blockers are frequently used in angina management.
Purpose of the Study:
- To evaluate the efficacy and safety of nicardipine hydrochloride in patients with stable angina.
Main Methods:
- Double-blind, placebo-controlled, randomized, repeated cross-over study.
- 46 patients with stable angina received nicardipine hydrochloride (30 or 40 mg) or placebo three times daily.
- Treadmill exercise testing was used to assess exercise duration and time to angina onset.
Main Results:
- Nicardipine hydrochloride (30 and 40 mg) significantly increased exercise duration.
- A 40 mg dose significantly decreased systolic and diastolic blood pressure.
- Time to angina onset improved with 30 mg but not 40 mg nicardipine.
- Anginal frequency and nitroglycerin use did not change significantly.
- Adverse events included unstable angina and myocardial infarction in a few patients.
Conclusions:
- Nicardipine hydrochloride demonstrates efficacy in improving exercise tolerance in stable angina.
- The 40 mg dose impacts blood pressure significantly.
- Careful monitoring is advised due to potential adverse events, particularly in patients with a history of cardiovascular issues.
Abstract:
The effect of nicardipine hydrochloride, a calcium-channel blocking agent, was studied in 46 patients with stable angina in a double-blind, placebo-controlled, randomized, repeated cross-over protocol, using a 30 or 40 mg dose of nicardipine or placebo three times a day. Mean resting heart rate and blood pressure did not change significantly with 30 mg nicardipine; heart rate increased from 81 +/- 10 to 88 +/- 13 beats min-1, systolic blood pressure decreased from 129 +/- 18 to 119 +/- 16 mmHg, and diastolic blood pressure from 81 +/- 12 to 74 +/- 11 mmHg (P less than 0.01 for all three variables) with a 40 mg dose. Using a treadmill exercise protocol, mean exercise duration increased from 5.4 +/- 1.8 to 6.0 +/- 1.8 min (P less than 0.01) with 30 mg nicardipine, and from 5.8 +/- 1.7 to 6.6 +/- 1.9 min (P less than 0.01) with 40 mg. Time to onset of angina increased from 4.6 +/- 1.9 to 5.2 +/- 1.7 min (P less than 0.05) with 30 mg and from 5.1 +/- 1.8 to 5.7 +/- 1.8 min (P = NS) with 40 mg. Mean anginal frequency and sublingual nitroglycerin consumption were low during the cross-over placebo period and did not change significantly during therapy with nicardipine. Non-cardiac side-effects were mild and required the withdrawal of only one patient from the study. However, during nicardipine therapy four patients had unstable angina and two developed a non-Q wave myocardial infarction. Of these patients, five were receiving a beta-adrenergic blocker that was discontinued prior to the study.(ABSTRACT TRUNCATED AT 250 WORDS)
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