A Clinical Study of Amosulalol Hydrochloride(YM-09538) on the Antihypertensive Effects in Essential Hypertension

ABSTRACT

BACKGROUND: Newly developed alpha-, beta-receptor blocker, Amosulalol HCI(YM-09538) was evaluated for its hypotensive efficacy, safety and usefulness in patients with mild to moderate essential hypertension. METHODS: Thirty patients of essential hypertension(male 8, female 22), mean age 55 years were included for the study. Amosulalol HCI was administered 20-60mg daily for 10 weeks and initial starting dose was 10mg twice daily and dose was increased 40mg and 60mg daily in cases of insatisfactory hypotensive effect ever 2 weeks interval. Patients were evaluated every two weeks on blood pressure, pulse rate, improvement of subjective symptoms and side effects. Laboratory examinations were carried out routinely in principle two times before trial and after completion of study. RESULTS: Blood pressure began to fall significantly after tow weeks of administration and changed from initial 172.4mmHg of systolic pressure to final 149.3mmHg and from 104.7mmHg of diastolic pressure to final 92.5mmHg. The response rates were marked fall in 30%, satisfactory fall in 40%, thus overall hypotensive effect was observed in 70%. Pulse rate decreased slightiy but significantly from 4 weeks of administration. Improvement of subjective symptoms were observed in 7 cases out of 12 cases and no significant side effects were observedd except of two mild transitory cases of polyuria and indigestion. Laboratory examination also did not show any significant changes before and after medication. CONCLUSION: The daily administration fo 20-60mg of Amosulalol HCI to moderate essectial hypertension seems to be effective and safe with clinical usefulness.