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[Intraindividual dose-response relationship of sustained-release Elantan]
Abstract:
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 one week periods. On the 7th day of each treatment period, 8 h after medication, 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 work loads: 28.6%, 46% and 63.5% decreases occurred with the 25, 50 and 100 mg isosorbide-5-mononitrate doses, respectively. Compared to placebo, the frequency of anginal attacks and the consumption of nitroglycerin also 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.