The Clinical study for Efficacy and Safety of Amezinium methylsulfate

ABSTRACT

BACKGROUND: Amezinium methylsulfate(Risumic) is the useful drug in the treatment of essential hypotension. This drug elevate blood pressure by stimulating sympathetic nervous system and improve symptoms related hypotension. This study was designed to evaluate efficacy and safety of Risumic for patients with essential hypotension. METHODS: This study was performed in patients with systolic blood pressure less than 100mmHg from June, 1999 to December, 1999. Risumic blood pressure response, improvement of symptom and side effect were examined in a double-blind, placebo-controlled, crossover trial. RESULTS: Total of 54 patients participated in this study and only 55.6% of them were finished and the rest of them(44.4%) was stopped. 6 patients of this patients were stopped because of side effects. But there was no difference in side effects in Risumic and placebo periods. In diastolic BP, Risumic group is 5mmHg higher than placebo group. And then there was significant difference in statistics. CONCLUSIONS: In essential hypotensive patients, Risumic is elevater DBP than SBP, side effects frequency was no significance difference in Risumic and placebo group.