The pharmacokinetics of molsidomine 16 mg in patients with stable angina pectoris is compatible with a o.a.d. dosage regimen. This o.a.d. formulation is effective and well-tolerated, providing a 24-h therapeutic control of myocardial ischemia. A positive and significant linear relationship between molsidomine plasma concentration and the increase in exercise tolerance was observed.
Background: A once-daily 16-mg-dose formulation of molsidomine (Coruno® tablets) was recently developed for the chronic treatment of angina pectoris. It required efficacy and safety testing. Objective: The objective of the present study was to compare the efficacy and tolerability of Coruno with that of the currently prescribed twice-daily 8-mg dose of molsidomine (Corvatard® tablets), using them as add-on therapies in patients with stable angina pectoris aged either less or more than 75 years. Methods: 133 patients (including 55 elderly patients of at least 75 years) received molsidomine 8 mg twice daily (M8) for at least 1 month as add-on therapy before enrollment. The study itself consisted of a 1-week period during which patients went on with M8, followed by a 4-week period during which M8 was replaced by molsidomine 16 mg once daily (M16). The frequency of anginal attacks and short-acting nitroderivative consumption for symptomatic relief were measured, and the quality of life was assessed by validated questionnaires. Results: M16 significantly reduced the incidence of anginal attacks in elderly patients compared with M8. The same significant benefit was not observed in younger patients. A nonsignificant decrease in the consumption of nitroderivatives for pain relief was recorded in both age groups. From 3 weeks of treatment, M16 did not induce more drug-related adverse events than M8. It had no significant effect on blood pressure, heart rate or ECG. Conclusions: M16 was as safe and effective as M8 in controlling angina, reducing the frequency of anginal attacks even more in the elderly compared with the younger patient group.
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