caa a22 4500 477071937 CHVBK 20180405111428.0 cr unu---uuuuu 170330e19960301xx s 000 0 eng 10.1007/BF00051131 doi (NATIONALLICENCE)springer-10.1007/BF00051131 Pranidipine, a novel calcium antagonist, once daily, for the treatment of hypertension: A multicenter, double-blind, placebo-controlled dose-finding study [Elektronische Daten] [Julian Rosenthal, Norbert Hittel, Karl Stumpe] Summary: The antihypertensive effects and tolerance of once-daily (od), pranidipine, a novel dihydopyridine derivative with a long duration of action, were evaluated in a double-blind, placebo-controlled, parallel-group dose-finding study. A total of 199 patients, with a diastolic blood pressure (BP) of 95-115 mmHg, were included in the trial. After 4 weeks on placebo, patients were randomly assigned to either placebo or pranidipine at 1, 2, 4, or 8 mg od for a further 4 weeks. A dose response was seen in the reduction (Δ) of diastolic BP: placebo, Δ1.7 mm Hg; 1 mg, Δ6.4 mmHg; 2 mg, Δ7.5 mmHg, p<0.01; 4 mg, Δ11.5 mmHg, p<0.01; and 8 mg, Δ10.6 mmHg, p<0.01. There were no meaningful changes in heart rate. The number of responders (decrease of diastolic blood pressure to <90 mmHg and by 10 mmHg or more from baseline value) in each group also revealed a dose-response relationship: placebo=9%; 1 mg=25%, n.s.; 2 mg=27%, n.s.; 4 mg=41.5%, p<0.01; and 8 mg=41%, p<0.01 (compared with placebo). Plasma concentrations of pranidipine also demonstrated linear dose-response relationships. An increase in adverse events was observed within the 8 mg group. The degree of reduction in BP and the number of responders were not greater in the 8 mg group compared with the 4 mg group, although the plasma concentration (mean values, ng/dl) of pranidine in the 8 mg group was higher (2.2 on day 42; 2.3 on day 56) compared with the 4 mg group (1.4 on day 42; 1.6 on day 56). In conclusion, pranidipine is a well-tolerated and 24-hour effective novel calcium antagonist that reduces BP in a dose-related manner up to 4 mg od. Kluwer Academic Publishers, 1996 calcium antagonists nationallicence dihydropyridine derivative nationallicence dose-finding study nationallicence antihypertensives nationallicence placebo controlled nationallicence Rosenthal Julian Ulm University Medical Center, Ulm, Germany aut Hittel Norbert Ulm University Medical Center, Ulm, Germany aut Stumpe Karl University Medical Center, Bonn, Germany aut Cardiovascular Drugs and Therapy Kluwer Academic Publishers 10/1(1996-03-01), 59-66 0920-3206 10:1<59 1996 10 10557 https://doi.org/10.1007/BF00051131 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00051131 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Rosenthal Julian Ulm University Medical Center, Ulm, Germany aut NATIONALLICENCE 700 1- Hittel Norbert Ulm University Medical Center, Ulm, Germany aut NATIONALLICENCE 700 1- Stumpe Karl University Medical Center, Bonn, Germany aut NATIONALLICENCE 773 0- Cardiovascular Drugs and Therapy Kluwer Academic Publishers 10/1(1996-03-01), 59-66 0920-3206 10:1<59 1996 10 10557 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer