Abstract
Objective: Angiotensin receptor blockers (ARBs) plus calcium channel blockers (CCBs) are a widely used combination therapy for hypertensive patients. This study aimed to determine which combination was better as the next step therapy: a combination with high dose CCBs or a triple combination with diuretics. Design and method: We conducted a prospective, randomized, open-label trial. Hypertensive outpatients who did not achieve their target blood pressure (BP < 140/90mmHg) with usual dosages of ARBs and amlodipine 5 mg were randomly assigned to switch treatment to Irbesartan 100 mg/amlodipine 10 mg (group ARB+C: n = 30, aged 65 ± 14 years) or indapamide 1 mg in addition to ARBs+ amlodipine 5 mg (group ARB+C+D: n = 29, aged 68 ± 9 years). The primary endpoint was any change in the systolic blood pressure (SBP) and diastolic blood pressure (DBP) after the 3-month treatment period, while secondary endpoints were any change in the BP after the 6-month treatment period and laboratory values. We also evaluated the blood pressure variability including the seasonal variation in both groups. Results: At three months, the SBP/DBP significantly (p < 0.01) decreased from 150/80 ± 8/12mmHg to 132/73 ± 13/11mmHg in group ARB+C and 153/81 ± 11/14mmHg to 129/74 ± 16/12mmHg in group ARB+C+D. Similarly, at six months, the SBP/DBP significantly decreased to 132/74 ± 12/10mmHg in the ARB+C group, and to 128/73 ± 12/12mmHg in the ARB+C+D group. The serum potassium tended to decrease and uric acid to increase in the ARB+C+D group. When each treatment group was subdivided into four seasonal groups according to the season in which patients were assessed, there were no significant differences in the BP values between the four treatment groups. On the other hand, the visit-to-visit variability, evaluated by the SD or CV for the systolic BP, was higher in the ARB+C+D group than ARB+C group especially in the summer. Conclusions: High dose CCBs combined with ARBs and a triple combination with diuretics combined with CCB/ARBs produced a similar efficacy in reducing the BP. However, the change in the laboratory data and blood pressure variability were advantageous in the ARB+C group. The results from the ASAHI AI trial will provide new evidence for selecting optimal combination therapies for uncontrolled hypertensive patients.
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