Copyright © 1994 by the European Society of Cardiology.
© 1994 The European Society of Cardiology
Once- versus twice-daily administration of controlled-release isosorbide-5-mononitrate 60 mg in the treatment of stable angina pectoris
A randomized, double-blind, cross-over study
*Department of Cardiology Karolinska Hospital, Stockholm, Sweden
Astra Hässle AB, Cardiovascular Medicine Mölndal, Sweden
Received 7 May 1993; revised 24 August 1993; .
Correspondence: Marcin Walter, MD. PhD. Cardiovascular Medicine, Clinical Research & Development, Astra Hassle AB. S-431 83 Mölndal, Sweden
Abstract
Thirty-seven patients with chronic, stable angina pectoris were included in a randomized, double-blind cross-over study to assess the efficacy of once- and twice-daily dosage regimens of 60 mg isosorbide-5-mononitrate, in a controlied release formulation (5-ISMN Durules® Astra). After 2 weeks of treatment, during a symptom-limited bicycle ergometer exercise test performed 3 h after the dose, the time to 1 mm ST segment depression was observed to be longer by once-daily than by a twice-daily dosage regimen (614 ± 165 vs 561 ± 148 s, P<0·01). The time to the end of exercise was also significantly prolonged by once-daily dosage, as compared with placebo (693 ± 158 and 645 ± 173 s, respectively; P<0·05), which was not observed with the twice-daily regimen. Both dosage regimens still had a significant effect on the prolongation of the time to onset of angina 9 h after the dose: 420 ± 164 s by placebo, 492 ± 161 s by once-daily dosage; P<0·01 and 466 ± 154 s by twice-daily dosage; P<0·05. Anginal attack rate and nitroglycerin consumption was significantly lower during the once-daily dosage period as compared with placebo; this difference was not evident during the twice-daily administration of the drug.
Controlled-release 5-ISMN 60 mg given once daily was effective in angina pectoris patients for at least 9 h after the dose and showed no clinical signs of tolerance after 2 weeks of the treatment. Attenuation of the clinical effect was observed with the twice-daily (in 12 h intervals) dosage regimen, presumably caused by constantly high 5-ISMN plasma concentration.
Key Words: lsosorbide-5-mononitrate • angina pectoris • efficacy • nitrate tolerance • rebound phenomenon
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