Antianginal efficacy and tolerability of 50 mg sustained-release isosorbide 5-mononitrate in an open twelve-month observation study.

Thirty-eight male patients with coronary heart disease were treated with 1 capsule Elantan Long (50 mg IS 5-MN) daily over a period of 1 year. Both before and after the 12-month therapy, a placebo phase of 1 week each was carried out. Two hours after drug administration (Elantan Long and placebo, respectively) a standardized exercise test was carried out at the end of each placebo period and every 3 months during the treatment with Elantan Long. Furthermore, anginal attacks and nitroglycerin consumption were recorded throughout the whole study. Under individually maximum comparable load of 81 +/- 20 W, mean ST-segment depression decreased from 0.19 mV (baseline value) to 0.05 mV respectively, after 12 months of therapy, a decrease of 73% (p less than 0.001). The measurement during the last placebo phase with an increase of ST-segment depression up to 0.18 mV still remained slightly below the baseline value. The incidence of anginal attacks highly significantly decreased from 8.4 +/- 2.0 to 2.0 +/- 1.2 attacks/week after 12 months' treatment (p less than 0.001). Correspondingly, additional nitroglycerin consumption also diminished by 76%. Both values increased to 7.1 +/- 1.9 after the following placebo phase. With the exception of 2 cases the tolerability was judged to be 'very good' and 'good'. During long-term therapy with Elantan Long, no sign of tolerance development was found; on the contrary, a further increase in efficacy was seen in the course of therapy.

RCT Entities:   Population Interventions Outcomes