Abstract
A pilot placebo-controlled, double-blind, randomised trial was carried out to ascertain whether patients with cardiac failure due to coronary artery disease would benefit further from an additional application of isosorbide-5-mononitrate (IS-5-MN) along with basic Captopril treatment. 21 patients were randomised in this study. Complete haemodynamic data sets of 11 patients in the placebo group and 7 patients in the IS-5-MN group were available for efficacy evaluation. The main target parameter was the mean pulmonary artery pressure (MPAP) during ergometric exercise. After 28 days of treatment with either IS-5-MN or placebo, patients’ MPAP decreased from 43.3 to 35.6mm Hg with IS-5-MN and from 44.2 to 43.8mm Hg in the placebo group under comparable load. Under resting conditions, there was a similar decrease from 27.4 to 22.4mm Hg in the IS-5-MN group and from 26.4 to 25.3mm Hg in the placebo group. The global evaluation of efficacy was judged by the physician as being good in 7 cases in the IS-5-MN group compared with only 1 patient in the placebo group. Two patients in the IS-5-MN group dropped out because of continuous, nonsevere headaches, which were attributed to the use of the test drug.
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