Single daily administration of spirapril in the treatment of essential hypertension. A multicentre double-blind comparison of 1, 6, 12 and 24 mg of spirapril once daily.

A total of 171 male and female patients with mild-to-moderate hypertension [diastolic blood pressure (DBP) 100-115 mmHg] entered this randomized, double-blind, multicentre study. A 3-week placebo run-in period was followed by a 5-week active-treatment period during which patients received either 1, 6, 12 or 24 mg of spirpril once daily. Predose sitting blood pressure was taken in the morning by sphygmomanometer as well as by an automatic device (Tonoprint). Spirapril in doses of 6, 12 or 24 mg once daily significantly and similarly lowered systolic blood pressure (SBP) and DBP compared with 1 mg once daily. The rates of blood pressure normalization (DBP < or = 90 mmHg) were 12.5%, 37.5%, 30.8% and 28.9% with 1, 6, 12 and 24 mg, respectively. The percentage of patients experiencing a DBP reduction of at least 10 mmHg was 25.0%, 56.3%, 48.7% and 52.6% and 1, 6, 12 and 24 mg of spirapril, respectively. No serious or severe adverse events related or uncertain if related to the study medication were observed. The effective 6-mg dose was as well tolerated as the inefficacious 1-mg dose. In conclusion, in patients with mild-to-moderate essential hypertension, 6 mg of spirapril once daily is an efficacious and safe antihypertensive therapy with a favourable benefit-risk profile.