In order to evaluate the antihypertensive efficacy and tolerability of a new nicardipine formulation, 26 mild-to-moderate essential hypertensive patients were given slow-release nicardipine, 40 mg, twice daily for 6 weeks. Systolic (SBP) and diastolic (DBP) blood pressure were measured after a 1 week single-blind placebo run-in period and after 1, 2, 4 and 6 weeks of active treatment, just before the morning administration. After 1 week, nicardipine induced a significant blood pressure reduction (p less than 0.01), with a decrease in mean SBP/DBP values of -15/-11 mmHg (from baseline values of 165/104 to 150/93 mmHg) in supine and of -16/-12 mmHg (from 158/110 to 142/98 mmHg) in standing position. After 6 weeks the decrease was of -15/-12 mmHg in supine and of -15/-14 mmHg in standing position. The responder rate (DBP decrease of at least 10 mmHg) was 62% (16/26). Normalization rate (DBP less than 95 mmHg with a concomitant decrease of at least 10 mmHg) was 54% (14/26). Eleven patients reported adverse events (headache, peripheral oedema, palpitations, nausea, constipation, flush, dizziness and asthenia). Due to an improved pharmacokinetic profile, the slow-release formulation prolongs to 12 hours the antihypertensive effect of nicardipine, thus facilitating patient's compliance
[Antihypertensive effect and tolerability of slow-release nicardipine]
FOGARI, ROBERTO;
1989-01-01
Abstract
In order to evaluate the antihypertensive efficacy and tolerability of a new nicardipine formulation, 26 mild-to-moderate essential hypertensive patients were given slow-release nicardipine, 40 mg, twice daily for 6 weeks. Systolic (SBP) and diastolic (DBP) blood pressure were measured after a 1 week single-blind placebo run-in period and after 1, 2, 4 and 6 weeks of active treatment, just before the morning administration. After 1 week, nicardipine induced a significant blood pressure reduction (p less than 0.01), with a decrease in mean SBP/DBP values of -15/-11 mmHg (from baseline values of 165/104 to 150/93 mmHg) in supine and of -16/-12 mmHg (from 158/110 to 142/98 mmHg) in standing position. After 6 weeks the decrease was of -15/-12 mmHg in supine and of -15/-14 mmHg in standing position. The responder rate (DBP decrease of at least 10 mmHg) was 62% (16/26). Normalization rate (DBP less than 95 mmHg with a concomitant decrease of at least 10 mmHg) was 54% (14/26). Eleven patients reported adverse events (headache, peripheral oedema, palpitations, nausea, constipation, flush, dizziness and asthenia). Due to an improved pharmacokinetic profile, the slow-release formulation prolongs to 12 hours the antihypertensive effect of nicardipine, thus facilitating patient's complianceI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
