Efficacy and tolerability between an olmesartan/amlodipine fixed-dose combination and an amlodipine double dose in mild to moderate hypertension

Fixed-dose combinations (FDCs) are one of the options for improving blood pressure (BP) goal attainment. We enrolled 141 patients and evaluated the efficacy and safety between a fixed dose of olmesartan/amlodipine (OA) and a double dose of amlodipine (DA) for treating mild to moderate hypertension after amlodipine monotherapy failure. After at least 2 weeks of monotherapy failure, the patients were randomized to receive either OA or DA for 8 weeks. We compared the systolic blood pressure (SBP)-lowering efficacy of the OA and DA using both an office BP and an ambulatory blood pressure monitoring (ABPM) device. The intent-to-treat analysis found that the early (2nd week) and final visit (8th week) SBP reductions were significantly greater in those patients receiving OA (n = 70) than DA (n = 71) (17.57 ± 15.49 vs. 10.46 ± 13.36 and 24.89 ± 14.09 vs. 17.03 ± 13.27 mmHg, p = 0.002 and 0.001, respectively). Among those using ABPM, the patients with 8-week OA had a greater SBP-lowering effect in comparison with those on DA (14.08 ± 10.74 vs. 6.32 ± 10.21, p = 0.018). Both treatment strategies were well tolerated. This study showed that an OA FDC is more effective than DA in reducing SBP for mild to moderate hypertension after the failure of amlodipine monotherapy.