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Nicardipine versus nifedipine: multicentre controlled trial in essential hypertension
Z Rumboldt1, D Stojanova, J Drinovec
1Clinical Pharmacology Unit, Clinical Centre, Split, Yugoslavia.
Insights
Nicardipine and nifedipine sustained-release are equally effective first-line treatments for mild to moderate hypertension. Both drugs demonstrated comparable blood pressure reduction and good tolerability in hypertensive outpatients.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Hypertension is a prevalent cardiovascular risk factor requiring effective management.
- Calcium channel blockers are widely used for hypertension treatment.
Purpose of the Study:
- To compare the efficacy and tolerability of nicardipine and nifedipine sustained-release in hypertensive patients.
- To evaluate these drugs as potential first-line agents for hypertension management.
Main Methods:
- A randomized controlled trial involving 95 hypertensive outpatients.
- Patients received either nicardipine (40 mg/day) or nifedipine sustained-release (20 mg/day) for six weeks after a placebo run-in.
- Blood pressure was monitored throughout the study, including an acute oral test.
Main Results:
- Both nicardipine and nifedipine significantly reduced blood pressure (mean decrease of 20%, p < 0.01).
- Acute oral tests showed similar hypotensive effects for both drugs (mean arterial pressure decrease of 11%, p < 0.05).
- No significant changes in pulse rate were observed, and laboratory data remained stable. Adverse events like headache and flushing were mild and infrequent.
Conclusions:
- Nicardipine and nifedipine sustained-release exhibit comparable efficacy and tolerability.
- These drugs are suitable as first-line agents for managing mild to moderate hypertension.
Abstract:
Ninety-five hypertensive outpatients of both sexes, aged 23 to 65 years with diastolic blood pressures above 105 but below 120 mmHg (greater than 14.0 but less than 16.0 kPa), after one week on a placebo were randomly assigned either to nicardipine plus a placebo (40 mg/day - 48 patients) or nifedipine sustained-release plus a placebo (20 mg/day - 47 patients) for an additional six weeks. The study groups were homogeneous and comparable. After the run-in period the average blood pressure was 181 +/- 17/116 +/- 9 mmHg (24.1 +/- 2.3/15.5 +/- 1.2 kPa) in the nicardipine and 177 +/- 22/116 +/- 9 mmHg (23.6 +/- 2.9/15.5 +/- 1.2 kPa) in the nifedipine group (p greater than 0.10). In the acute oral test (nicardipine 40 mg to all the subjects; blood pressure measured at 30 min intervals during two hours) almost identical hypotensive effects within and between groups were observed (mean arterial pressure decrease of 11%, after 120 min; p less than 0.05). At the end of this trial blood pressure decreased further to 152 +/- 12/94 +/- 11 mgHg (20.3 +/- 1.6/12.5 +/- 1.5 kPa) (mean decrease of 20%; p less than 0.01) on nicardipine and to 145 +/- 12/94 +/- 11 mmHg (19.3 +/- 1.6/12.5 +/- 1.5 kPa) (mean decrease of 20%; p less than 0.01) on nifedipine. There were no significant changes in pulse rate. The observed between-group differences were trivial (p greater than 0.10). The laboratory data did not alter appreciably during this study. Three patients on nicardipine and four on nifedipine reported headache, palpitations and flushing: one patient on nicardipine and two on nifedipine were as a result excluded from the trial. It was concluded that nicardipine and nifedipine sustained-release were comparably effective and well-tolerated drugs suitable as the first-line agents for the management of mild to moderate hypertension.