Delapril Monotherapy in the Treatment of Essential Hypertension

ABSTRACT

BACKGROUND: Delapril, a recently developed nonsulfhydry(SH) angiotensin converting enzyme inhibitor, was known to have more prolonged duration of action. In order to investigate the efficacy and safety of delapril, patients with essential hypertension were studied. METHODS: The study subject consisted of 37 patients(mean age 50.4 years, 15 male, 22 female). Because 4 of 37 patients dropped out due to side effects of delapril, the antihypertensive efficacy was evaluated in the remaining 33 patients. Delapril was administered orally in a daily dose of 30-120mg in two divided doses for 10 weeks after the administration of a placebo for 2 weeks. RESULTS: Delapril decreased systolic blood pressure significantly from a baseline value of 162.4+/-18.8mmHg to 142.9+/-20.9mmHg(p<0.01) and diastolic blood pressure from 103.2+/-5.0mmHg to 92.8+/-10.4mmHg(p<0.01) after 2 weeks of therapy, and maintained this effect throughout the study period. The efficacy rates were 72% for systolic pressure, 75% for diastolic pressure. The cumulative efficacy rate was 48% at 30mg/day, 66% at 60mg/day, and 73% at 120mg/day. Heart rate did not change until after 8 weeks, when they modestly decreased(p<0.05), through the 10th week(NS). Side effects were noticed in 12 out of 37 cases(32.4%). The main symptoms included dry cough(7 cases, 18.9%), headache(2 cases, 5.4%), dizziness(1 case, 2.7%), dry mouth(1 case, 2.7%) and angioedema(1 case, 2.7%). Six of the 7cases of dry cough were in women, and 3 caes discontinued the drug due to intractable cough. Angioedema in the oropharynx occurred in 1 patient and caused severe dyspnea which was relieved by the discontinuation of the medication. There was no significant change in CBC and biochemical variables. CONCLUSIONS: A daily dose of delapril in two divided doses is effective in decreasing blood pressure in patients with essential hypertension, and safe when an awareness of possible side effects is taken into account.