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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Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study : a randomised, open-label, blinded endpoint morbidity-mortality study. Retraction in Lancet. Comment in Lancet. J Clin Hypertens Greenwich. However, evidence for this effect in Asian populations is scarce. We aimed to investigate whether addition of an angiotensin receptor blocker, valsartan, to conventional cardiovascular treatment was effective in Japanese patients with cardiovascular disease.
METHODS: We initiated a multicentre, prospective, randomised controlled trial of Japanese patients, aged years, mean 65 [SD 10] years who were undergoing conventional treatment for hypertension, coronary heart disease, heart failure, or a combination of these disorders. In addition to conventional treatment, patients were assigned either to valsartan mg per day or to other treatment without angiotensin receptor blockers. Our primary endpoint was a composite of cardiovascular morbidity and mortality.
Analysis was by intention to treat. The study was registered at clintrials. This difference was mainly attributable to fewer incidences of stroke and transient ischaemic attack 29 vs 48; 0.
Mortality or tolerability did not differ between groups. These benefits cannot be entirely explained by a difference in blood pressure control.
Retraction of the Jikei Heart Study
Jikei Heart Study - Jikei Heart Study
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.
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