| Author/Editor | Pivac, Nediljko; Naranča, Mario; Vujić-Podlipec, Dunja; Bagatin, Jugoslav; Rumboldt, Zvonko | |
| Title | Prospective controlled trial of two nifedipine extended release formulations in the treatment of essential hypertension | |
| Type | članek | |
| Source | Arzneimittelforschung | |
| Vol. and No. | Letnik 52, št. 5 | |
| Publication year | 2002 | |
| Volume | str. 379-84 | |
| Language | eng | |
| Abstract | The aim of this study was to assess the pharmacodynamic equivalence of two different slow-release formulations of nifedipine (CAS-21829-25-4). In a prospective, controlled, double-blind clinical trial, 42 patients with essential hypertension (sitting diastolic blood pressure (DBP) 95-114 mmHg) underwent an initial washout, drug free period of 2 weeks, after which they were randomized to receive either 30 mg of nifedipine in the test preparation "XL" (Nifecard) or 30 mg of nifedipine in a reference formulation, "LA", during six weeks. The response to treatment was assessed by measuring the blood pressure (BP) every two weeks (standard office mercury sphygmomanometry) and by 24-h ambulatory blood pressure monitoring (ABPM). Of the 42 included patients 36 (85.5%) completed the trial: 19 on "XL" and 17 on "LA". After 2 weeks of therapy the DBP decreased by about 11% (-13.4 mmHg) and 10% (-9.5%), respectively, after 4 weeks the mean decrease versus the end of the placebo period reached about 14% (-15.5 mmHg) and 11% (-13 mmHg), and at the end of the trial the DBPs were lower by about 13% (-14.5 mmHg) in both groups. In all these measurements the within group differences were significant (p < 0.001), while the between groups differences were not (p > 0.05). Quite comparable results were obtained with ABPM, e.g. in the "XL" group the systolic blood pressure at the end of the study was lower by 12.3% (-4.6 mm Hg) and in the "LA" group, by 10.6% (-9.0 mm Hg); p = 0.358. The adverse effects were similar in both groups and they required neither particular interventions nor withdrawal from the study. The drugs under study were comparably effective and well tolerated antihypertensives. | |
| Descriptors | CALCIUM CHANNEL BLOCKERS HYPERTENSION NIFEDIPINE PROSPECTIVE STUDIES BLOOD PRESSURE BLOOD PRESSURE MONITORING, AMBULATORY BODY WEIGHT DELAYED-ACTION PREPARATIONS DOUBLE-BLIND METHOD ELECTROCARDIOGRAPHY HEART RATE |