JIKEI Heart

Presenter Björn Dahlöf, MD, at the 2006 World College of Cardiology Background Inhibitors of the renin–angiotensin aldosterone system, such as angiotensin receptor blockers (ARBs), have demonstrated clinical benefits among patients with existing cardiovascular disease or at risk for the same. Evidence for such benefits among the Asian populations has been largely absent. Study Design In JIKEI Heart, patients with hypertension were randomized 1 : 1 to either an ARB‐containing arm, with valsartan started at 80 mg and titrated up or down to 40–160 mg over 16 weeks, or to the non‐ARB arm, in which the patients received conventional antihypertensive agents over the same period. The primary endpoint was a composite of cardiovascular mortality and morbidity including the following: stroke or TIA, myocardial infarction (MI), hospitalization for congestive heart failure (CHF) or angina pectoris, dissecting aneurysm of the aorta, lower limb arterial obstruction, doubling of serum creatinine or transition to dialysis. Study Population The JIKEI Heart study enrolled 3,081 Japanese patients (mean age 65 years, 66% male) with high blood pressure, coronary heart disease and/or heart failure that was being conventionally treated. Their hypertension was well‐treated at study entry, with a mean systolic and diastolic blood pressure of ∼139/81 mmHg in both groups. Results On recommendation from the Data Safety Monitoring Board after just over 3 years, the trial was terminated prematurely because of clear benefits in the valsartan group, with 92 events in the valsartan group and 149 in the non‐ARB group. The 39% reduction in events was highly significant (p = 0.00021). The blood pressure target achieved, 130/80 mmHg, was similar in both groups (131/77 mmHg for the valsartan group and 132/78 mmHg for the non‐ARB group). New or recurrent stroke reduced by 40% in the two groups, with 29 and 48 events occurring (p = 0.028). Hospitalization for heart failure reduced by 46%, with 19 and 36 events, respectively (p = 0.029). Furthermore, hospitalization for angina pectoris reduced by 65% in the valsartan group, with 19 events vs. 53 events (p = 0.00007). There were no differences between the two groups for MI, cardiovascular mortality or all‐cause mortality. Conclusions In JIKEI Heart, there was quite a substantial benefit in a short‐term trial by just adding a specific blocker of the renin–angiotensin system on top of the other therapy. Comment (Xavier Girerd, MD, Paris) These effects demonstrated in an Asian population should be confirmed in a European population. Copyright © 2006 Wiley Periodicals, Inc.