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Antihypertensive effect of slow-release nicardipine. A placebo-controlled cross-over study
A Salvetti1, G Cardellino, M Pesenti
1Cattedra di Terapia Medica Sistematica, Clinica Medica I, Pisa, Italy.
Insights
Slow-release nicardipine (SR-Nicardipine) effectively lowers blood pressure for up to 12 hours in patients with essential hypertension. This study confirms its sustained antihypertensive effect compared to placebo.
Area of Science:
- Pharmacology
- Cardiovascular Medicine
Background:
- Essential hypertension is a prevalent cardiovascular condition requiring effective long-term management.
- Slow-release formulations aim to provide sustained therapeutic drug levels and reduce dosing frequency.
Purpose of the Study:
- To evaluate the magnitude and duration of the antihypertensive effect of slow-release nicardipine (SR-Nicardipine) compared to placebo.
- To assess the sustained efficacy of SR-Nicardipine in patients with uncomplicated essential hypertension.
Main Methods:
- A double-blind, randomized, cross-over study involving 36 patients with essential hypertension.
- Patients received SR-Nicardipine 40 mg twice daily (b.d.) and placebo for one month each.
- Blood pressure and heart rate were measured at multiple time points up to 12 hours post-dose.
Main Results:
- SR-Nicardipine significantly reduced both systolic (SBP) and diastolic (DBP) blood pressure at all measured time points.
- Peak antihypertensive effect was observed 4 hours post-dose, with over 90% of this effect persisting at 12 hours.
- A slight increase in heart rate was noted with SR-Nicardipine; adverse events were comparable between SR-Nicardipine and placebo groups.
Conclusions:
- SR-Nicardipine 40 mg b.d. demonstrates a maintained and significant antihypertensive effect in essential hypertension.
- The efficacy of SR-Nicardipine extends for up to 12 hours, supporting its use for sustained blood pressure control.
Abstract:
The magnitude and duration of the antihypertensive effect of slow-release nicardipine (SR-Nicardipine) have been compared with placebo in 36 uncomplicated essential hypertensives (diastolic BP 95 to 115 mm Hg after 1-month placebo washout). According to a double-blind, randomized, cross-over design they received SR-Nicardipine 40 mg b.d. and placebo for 1 month. At the end of each treatment period, blood pressure and heart rate were measured 12 h after the evening dose and 1, 2, 3 and 4 h after the morning dose. SR-Nicardipine significantly reduced systolic (SBP) and diastolic (DBP) blood pressure at each time after dosing. The absolute decrements peaked 4 h after dosing (-18.3 and -11.7 mm Hg, respectively) and more than 90% of the peak effect persisted 12 h after dosing, both for SBP and DBP. The heart rate was slightly increased by SR-Ni-cardipine. Adverse effects monitored with a check-list occurred in 31% of patients during SR-Nicardipine treatment and in 28% on placebo. Thus, SR-Nicardipine 40 mg b.d. has a maintained and significant antihypertensive effect lasting up to 12 h in essential hypertension.