This randomised, double-blind study compared the anti-hypertensive efficacy and tolerability of Candesartan cilexetil (CC 8–16 mg) and Amlodipine (AML 5–10 mg) on home blood pressure (HBP) measurements in mild-to-moderate hypertensive patients. After a 2-week wash-out, patients aged 18–74 years, with a sitting diastolic blood pressure (sDBP) = 95–115 mmHg, untreated or intolerant to therapy or uncontrolled were randomised to CC 8 mg or AML 5 mg O.D. for 12 weeks (W12). Patients not normalised or not responders at W12 had their dose doubled for the remaining 6 weeks.
HBP was measured before each visit, during 5 days (three measurements in the morning, 24 h after last dose and before drug intake and three measurements before bedtime).
The primary criterion was the comparison of mean morning sDBP at baseline and post-treatment.
A total of 638 patients were enrolled, 540 of whom were randomised to CC or AML. The intent-to-treat and safety analyses were performed in 532 patients while 321 constituted the per protocol population.
Baseline characteristics and BP values of the two groups were similar. Morning sDBP did not differ between groups at W12, but AML patients had significantly more adverse events (AEs) than those treated by CC (28 vs. 20%, p = 0.03); 6% of AML patients vs. 1% of CC patients were withdrawn due to AEs (p = 0.009).
CC demonstrates a better tolerability over AML and an equivalent anti-hypertensive efficacy in terms of morning home DBP after 12 weeks of treatment.