Dose-effect relationship amongst three different sustained-release forms of isosorbide 5-mononitrate in patients with coronary artery disease.
Fifteen patients with coronary artery disease and stable angina pectoris were included in a double-blind, randomized, cross-over study. The patients received 25, 50 and 100 mg isosorbide 5-mononitrate, as well as a placebo, for subsequent 1-week periods. On the 7th day of each treatment period, 8 h after medication application, an exercise test was performed. A highly significant (p less than 0.001) and dose-dependent reduction of the sum of the ST-segment depression was observed at similar workloads: 28.6, 46 and 63.5% decreases occurred at the 25, 50 and 100 mg isosorbide 5-mononitrate doses, respectively. Compared to placebo, the frequency of anginal attacks and the consumption of nitroglycerin likewise decreased highly significantly (p less than 0.001) with all three doses. Isosorbide 5-mononitrate plasma levels (8 h post-application) increased linearly with the dose; amounting to 228 +/- 53, 485 +/- 93 and 991 +/- 177 ng/ml at the 25, 50 and 100 mg doses of the sustained release medication forms, respectively.
Kenedi
P
P
Gathmann-Lewik
U
U
D000368:Aged; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000097:blood / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged
D003692:Delayed-Action Preparations; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate