Open-Label Study Assessing the Long-term Efficacy and Safety of Triple Olmesartan/Amlodipine/Hydrochlorothiazide Combination Therapy for Hypertension

To reduce cardiovascular risk associated with hypertension, the majority of patients require at least two drugs to control their blood pressure (BP), and many require three or more. An open-label extension of a 10-week double-blind study assessed the long-term efficacy and safety of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) triple combination treatment in 2,509 patients with Grade 2-3 hypertension. After 8 weeks of single-blind OLM/AML/HCTZ 20/5/12.5 mg treatment, patients at BP goal [seated systolic/diastolic BP (SeSBP/SeDBP) < 140/90 mmHg, or < 130/80 mmHg for patients with diabetes, or chronic kidney or cardiovascular disease] entered open-label treatment for 36 weeks. Patients not at goal received 8 weeks of randomized, double-blind treatment before entering open-label treatment. During open-label treatment, patients received OLM/AML/HCTZ 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5 or 40/10/25 mg with up- or down-titration as needed to achieve BP goals. During open-label treatment, mean SeSBP/SeDBP levels remained within the ranges 120-140 and 75-85 mmHg, respectively. At study end, significant reductions from baseline were seen in each group for SeSBP (37-43 mmHg) and SeDBP (22-27 mmHg), and 78.1% of patients overall achieved BP goal. Categorical analysis of patients by baseline SeSBP (150-159, 160-169, 170-179, 180-189, 190 to < 200 mmHg) correlated with changes in SeSBP. Patients in the lowest baseline category (150-159 mmHg) showed a reduction of 34.3 mmHg, and those in the highest category (190 to < 200 mmHg) showed a 59.4 mmHg reduction. At baseline, 90.8% of patients had Grade 2 or 3 hypertension, but at study end 91.9% had normal/high-normal BP. The incidence of adverse events was similar across the treatment groups. In patients with Grade 2-3 hypertension, long-term treatment with OLM/AML/HCTZ triple combination therapy was well tolerated and effective. A high level of BP control and a substantial reduction in the level of hypertension severity were achieved.