[Randomized, double-blind comparison of isosorbide-5-mononitrate and delayed-action nifedipine in patients with stable exertional angina. Multicenter Study Group].
The therapeutic effects of IS-5-MN and s.r. nifedipine were investigated in this double-blind, randomized, group-comparative, multicenter study over 2 weeks, in 251 patients with stable reproducible exercise-induced angina. After 2 weeks' treatment with IS-5-MN 20 mg b.i.d. or t.i.d., 61% of the patients were responders who showed an increase in total exercise time (to moderately severe angina) of greater than or equal to 20% in comparison with placebo in the run-in phase. The corresponding responder rate after s.r. nifedipine 20 mg b.i.d. or 40 mg b.i.d. was 53%. Both IS-5-MN and s.r. nifedipine significantly increased the total exercise time, the time to angina onset and to greater than or equal to 1 mm ST-depression, and significantly reduced the rate pressure product and the ST-segment depression at peak exercise in comparison with placebo in the run-in phase. The improvement in quality of life as indicated by the reduction in anginal episodes and intake of short-acting nitrates was comparable with both drugs. The pattern and incidence of all AEs were as expected in the two active treatment groups. The daily treatment costs for a 20 mg b.i.d. dosing regimen for both drugs in the Federal Republic of Germany was 64% higher for s.r. nifedipine than with IS-5-MN.
Ueberbacher
H J
HJ
Boehringer Mannheim (Schweiz) AG, Rotkreuz.
Patyna
W D
WD
Krepp
P
P
Puespoek
J
J
Neuhaus
R
R
Hilbich
K
K
Bulitta
M
M
Rittinghausen
R
R
D000787:Angina Pectoris / Q000188:drug therapy* / Q000191:economics / Q000209:etiology; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D016527:Drug Costs; D005080:Exercise Test; D006801:Humans; D007548:Isosorbide Dinitrate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000627:therapeutic use*; D005082:Physical Exertion; D011788:Quality of Life
D003692:Delayed-Action Preparations; D009543:Nifedipine; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate
Randomisierter, doppelblinder Vergleich von Isosorbid-5-Mononitrat und retardiertem Nifedipin bei Patienten mit stabiler Belastungsangina. Multicenter Studien-Gruppe.