ARBs including valsartan were not permitted in the usual care group, but other medications were at the discretion of the investigator. Patients were stratified by presenting syndrome heart failure, ischemic heart disease, or hypertension. Principal Findings: Mean baseline systolic blood pressure was mm Hg. The trial was discontinued early at the recommendation of the Data Safety Monitoring Committee due to evidence of benefit.
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ARBs including valsartan were not permitted in the usual care group, but other medications were at the discretion of the investigator. Patients were stratified by presenting syndrome heart failure, ischemic heart disease, or hypertension. Principal Findings: Mean baseline systolic blood pressure was mm Hg.
The trial was discontinued early at the recommendation of the Data Safety Monitoring Committee due to evidence of benefit. Blood pressure at follow-up was reduced by 8. The primary endpoint of any cardiovascular event was significantly lower in the valsartan group compared with the control group hazard ratio [HR] 0. Among the components of the composite endpoint, stroke was lower in valsartan group HR 0.
There was no difference in mortality all-cause or cardiovascular or in myocardial infarction. Interpretation: Among Japanese patients with heart failure, ischemic heart disease, or hypertension, addition of valsartan to usual care was associated with a reduction in the primary composite endpoint of cardiovascular events compared with usual care alone at a median 3-year follow-up.
The benefit seen with the reduction in cardiovascular events in the valsartan group cannot be fully explained by the blood pressure reduction, which was only minimally larger than in the usual care group 8. The overall results were noteworthy, but several questions remain including what medications were used in the control group and whether the results were similar for each of the three presenting syndromes heart failure, ischemic heart disease, and hypertension.
References: The Lancet Editors. Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study : a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet ; Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study : a randomised, open-label, blinded endpoint morbidity-mortality study.
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Jikei Heart Study - Jikei Heart Study
According to the authors, the addition of the angiotensin receptor blocker ARB valsartan to standard cardiovascular treatment, compared with an increased dose or number of standard non ARB drugs, reduced the incidence of the primary composite endpoint, of heart, brain, and kidney complications 1. The main effect of addition of valsartan was mainly driven by a reduction in stroke, angina pectoris, dissecting aortic aneurysm, and heart failure incidence rate 1. Furthermore, the authors suggested that since patients in both treatment groups showed a similar degree of blood pressure control, the benefit observed with the ARB could not entirely be explained by differences in blood pressure 1,2. Having in mind that Asian patients have often been under-represented in cardiovascular trials, the authors were initially congratulated on their report, mainly because of conducting a randomized trial in Japanese patients with cardiovascular disease 2. However, simultaneously with the Jikei Heart Study publication the accompanying Lancet editorial underscored several major weaknesses of this clinical trial 2. Moreover, it was acknowledged that the primary composite end-point was mainly driven by reductions in new admissions for stable angina and heart failure rather than stroke or myocardial infarction as one would commonly expect 2.
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