Comparative effects of once-daily molsidomine in coronary patients from two distinct European ethnicities.

INTRODUCTION

Molsidomine, a direct nitric oxide donor, is frequently used in several European countries for the treatment of stable angina. The aim of this study was to compare the effects of a new once-daily 16-mg dose formulation, Coruno (Therabel Pharmaceuticals, Loughrea, Ireland), in patients with stable angina belonging to two distinct European ethnicities.

METHODS

A total of 261 Hungarian and 267 Polish patients took part in this multicenter, randomized, double-blind, placebo-controlled clinical trial. Exercise testing was performed after the first administration of molsidomine and repeated after a 2-week treatment. Frequency of anginal attacks, short-acting nitroderivative tablet consumption, and incidence of adverse events were also evaluated.

RESULTS

Demographic and clinical characteristics were significantly different in Hungarian compared with Polish patients. Hungarian patients had a lower proportion of males, were shorter in stature, had less previous smoking experience, consumed more alcohol, had less severe coronary disease (electrocardiographic evidence, rate of anginal crises, and nitroderivative consumption), and higher exercise capacity. However, molsidomine-related improvement in exercise capacity at start of the study was similar in both cohorts. After a 2-week treatment, improvement was fully maintained in Polish and only minimally reduced in Hungarian patients. Furthermore, molsidomine reduced significantly more anginal episodes and nitroderivative consumption in the more severely affected Polish cohort. Proportions of patients reporting drug-related adverse events were similar on placebo and molsidomine in both cohorts. Most of the adverse events were not severe and resolved spontaneously. Less myocardial ischemia and gender (including height, a confounding covariate) acted positively and negatively, respectively, on the higher exercise capacity of Hungarian versus Polish patients.

CONCLUSION

The once-daily 16-mg molsidomine formulation is effective and has good tolerability in both patient cohorts. Molsidomine does not induce any meaningful tolerance issues in Hungarian or Polish patients with stable angina, despite significant demographic and clinical disparities.