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Antianginal efficacy and tolerability of 50 mg sustained-release isosorbide 5-mononitrate in an open twelve-month
Insights
Elantan Long significantly reduced exercise-induced ST-segment depression and angina attacks in male patients with coronary heart disease over one year. The treatment demonstrated sustained efficacy and good tolerability, with no signs of tolerance development.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Coronary heart disease (CHD) poses a significant health burden.
- Effective long-term management of CHD symptoms like angina is crucial.
Purpose of the Study:
- To evaluate the long-term efficacy and tolerability of Elantan Long (50 mg IS 5-MN) in male patients with CHD.
- To assess the impact of Elantan Long on exercise-induced ischemia and anginal symptoms.
Main Methods:
- A 1-year randomized controlled trial involving 38 male CHD patients.
- Daily administration of Elantan Long (50 mg IS 5-MN) with placebo periods.
- Standardized exercise tests and recording of anginal attacks and nitroglycerin use.
Main Results:
- Significant reduction in mean ST-segment depression during exercise tests (73% decrease, p < 0.001).
- Highly significant decrease in anginal attack frequency (from 8.4 to 2.0 attacks/week, p < 0.001).
- 76% reduction in additional nitroglycerin consumption; sustained efficacy and good tolerability observed.
Conclusions:
- Elantan Long is effective for long-term management of coronary heart disease.
- Sustained therapeutic benefits and good patient tolerability were demonstrated.
- No tolerance development observed, with potential for increasing efficacy over time.
Abstract:
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.