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The efficacy of angiotensin receptor blockers (ARBs) for treating hypertension has been demonstrated in several studies, but clinical practice in Japan has remained unaffected in the absence of conclusive population-specific data. In this manufacturer-funded study, 3081 Japanese patients with hypertension, coronary heart disease, heart failure, or any combination of the three were randomized to receive, in addition to their conventional treatments, either valsartan (40–160 mg/day) or non-ARB therapy, with the goal in both groups of achieving a target blood pressure of <130/80 mm Hg. One third of the participants were women. Baseline characteristics were similar in the two groups (mean age, 65; mean body-mass index, 24; mean blood pressure, 139/81 mm Hg).
Median follow-up was 3.1 years. Blood pressure levels and heart rates were similar in the two groups throughout the trial. The average number of antihypertensive drugs taken during the study was slightly higher in the valsartan than in the non-ARB group. The primary endpoint (a composite of cardiovascular morbidity and mortality) was significantly lower in patients taking valsartan than in those on non-ARB regimens (hazard ratio, 0.61). This difference was attributable mainly to reduced incidences of stroke and transient ischemic attack (29 vs. 48), angina pectoris (19 vs. 53), and heart failure (19 vs. 36) in the valsartan group compared with the non-ARB group. Overall mortality and drug tolerability did not differ between the groups. Only 2.5% of all participants reported adverse effects.
Mochizuki S et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): A randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 2007 Apr 28; 369:1431-9.
Comment
The addition of valsartan to conventional treatment seemed to confer an outcome benefit on Japanese individuals with cardiovascular disease. This benefit was not explained by a difference in blood pressure control and was seen for several secondary endpoints. These findings provide further evidence of ARBs’ value in treating a range of cardiovascular diseases in a broad spectrum of patients.