Treatment of coronary heart disease with isosorbide mononitrate ('Elantan' 20).

An open, multi-centre trial was carried out to investigate the efficacy and tolerance of isosorbide mononitrate used as anti-anginal therapy in a large group of patients under normal general practice conditions. A total of 10,229 patients with coronary heart disease of average duration of 4 years entered the trial, of whom 8769 had sufficiently severe symptoms to be included in the analysis of results. Most of the patients (92.3%) had previously been treated with cardiovascular drugs. In the trial, all patients were treated with oral isosorbide mononitrate, 20 mg 3-times daily, for a period of 14 days. Treatment resulted in an improvement of angina (compared with the situation during previous therapy) in 79.9% of the assessed patients, complete abolition of angina attacks being achieved in 52.1% and a reduction in frequency of attacks in a further 28.7%. This reduction in angina was associated with a reduced acute consumption of nitrates used for the treatment of attacks. In the smaller sub-group of patients who had received no previous anti-anginal therapy, isosorbide mononitrate treatment resulted in improvement in 91% of patients, complete abolition being achieved in 77.5%. Nocturnal angina was almost totally eliminated by isosorbide mononitrate treatment and this can probably be explained in terms of the favourable pharmacokinetic profile of the drug. 'Nitrate headache', observed in 20.5% of the patients, was the only common side-effect of treatment. The absence of hypotension or tachycardia in significant numbers of patients indicates that isosorbide mononitrate should be well tolerated, as well as efficacious, in all patients with coronary heart disease.