Ambulatory blood pressure assessment of once-daily candesartan cilexetil versus enalapril in patients with hypertension

Abstract

Blood pressure reduction, effect duration and tolerability of the AT1-receptor blocker candesartan and the ACE inhibitor enalapril, once daily, was studied in a multicenter, double-blind, randomised, parallel group study. A total of 395 patients, aged 20–80 years, with mean sitting diastolic blood pressure 95–114 mmHg and mean awake diastolic ambulatory blood pressure (ABP) >85 mmHg after a 4-week placebo run-in period were randomised to 8 weeks treatment. The starting doses were candesartan cilexetil 8 mg or enalapril 10 mg. After 4 weeks the doses were doubled to 16 mg and 20 mg respectively, for all patients. At the end of the study, ABP was measured 0–36 hours after dose. Trough blood pressure was calculated as ABP 22–24 hours post dose. The mean adjusted reduction from baseline to after 8 weeks of trough diastolic ABP was 8.7 mmHg (95% CI 7.0–10.5) in the candesartan group vs 5.8 mmHg (95% CI 4.0–7.6) in the enalapril group (p = 0.008). For trough systolic ABP 22–24 hours post dose, the mean adjusted reduction in the candesartan group was 13.5 mmHg (95% CI 10.9–16.1) vs 9.9 mmHg (95% CI 7.3–12.6) in the enalapril group (p = 0.032). Mean adjusted reduction of diastolic ABP on the day of a missed dose (6 a.m.–6 p.m.) was 8.0 mmHg (95% CI 6.7–9.3) in the candesartan group vs 4.5 mmHg (95% CI 3.2–5.9) in the enalapril group (p < 0.001). The corresponding reductions in systolic ABP were 11.4 mmHg (95% CI 9.3–13.5) with candesartan and 7.2 mmHg (95% CI 5.1–9.4) with enalapril (p = 0.002). The proportion of patients who discontinued due to adverse events was 2.0% and 3.6% in the candesartan and enalapril groups, respectively. Once-daily candesartan cilexetil, 16 mg, was superior to enalapril, 20 mg, in reducing blood pressure at trough. At least 12 hours after a missed dose there was a persistent reduction of blood pressure during treatment with candesartan. Both treatments were well tolerated.