Effects of valsartan and amlodipine on cardiorenal protection in Japanese hypertensive patients: the Valsartan Amlodipine Randomized Trial

Abstract

on behalf of the VART InvestigatorsThe Valsartan Amlodipine Randomized Trial, a multicenter, prospective, randomized, open-labeled, blinded-end point trial, was designed to compare the beneficial effects of the angiotensin II receptor blocker valsartan and the calcium channel blocker amlodipine on cardiovascular events in Japanese essential hypertensive patients. The primary end point was a composite of all-cause death, sudden death, cerebrovascular death, cardiac events, vascular events and renal events. The secondary endpoints were effects on left ventricular hypertrophy, cardiac sympathetic nerve activity and renal function. A total of 1021 patients were enrolled in the present trial. The mean follow-up period was 3.4 years. There were no significant differences in blood pressure (BP) levels between the valsartan group and the amlodipine group throughout the trial. There was no significant difference in the primary endpoint between the two groups (hazard ratio: 1.0, P¼0.843). No difference in any event category of the primary endpoint was noted for either group. However, we observed a significant reduction of left ventricular mass index, as determined by echocardiography, in the valsartan group compared with the amlodipine group. We also observed a significant decrease in cardiac sympathetic nerve activity in the valsartan group but not in the amlodipine group. Moreover, there was a significant reduction in the urinary albumin to creatinine ratio in the valsartan group but not in the amlodipine group. Therefore, although BP levels were well controlled and remained equal in the two groups, valsartan had more protective effects on the heart and kidney than amlodipine in Japanese hypertensive patients.

Effects of valsartan and amlodipine on home blood pressure and cardiovascular events in Japanese hypertensive patients: a subanalysis of the VART

“…However, in the valsartan group, significant improvements in left ventricular hypertrophy (LVH) and microalbuminuria were observed. 7 It has been shown that home BP (HBP) is superior to office BP in the prediction of HT-related cardiovascular complications. [8][9][10][11][12] Especially, high morning HBP is closely correlated with organ damage and future cardiovascular events.…”

“…In the Valsartan Amlodipine Randomized Trial (VART), 7 we compared the beneficial effects of ARB valsartan and calcium channel blocker amlodipine on cardiovascular events in Japanese patients with mild-to-moderate hypertension. Office BP levels were well controlled and remained similar in the valsartan group and the amlodipine group.…”

Long-term effects of candesartan and amlodipine on cardiovascular morbidity and mortality in Japanese high-risk hypertensive patients: the Candesartan Antihypertensive Survival Evaluation in Japan Extension Study (CASE-J Ex)

“…Achieved BP level in the CASE-J Ex was lower than values achieved in other clinical trials directly comparing the effect of ARB with that of amlodipine on the incidence of CV morbidity and mortality in hypertensive patients. 3,13,14 No significant difference was noted between the two groups in the incidence of the primary CV events, all-cause death, or CV death under strict BP control in the CASE-J Ex.…”

How to evaluate real-world medicine in a Japanese population: important lessons from the JIKEI, CASE-J, KYOTO and VART studies

“…Because the VART patient population is relatively low risk when compared with those of previous trials, statistically evaluating the hard end points is insufficient to confirm the initial hypothesis. 7 However, the researchers showed a significant reduction in the H/M ratio using 123I-MIBG imaging. Advanced healthcare systems that enable patients to visit hospitals often and that widely distribute expensive medical devices (for example, MRI) enable researchers to track the performance of these treatments with highly accurate evaluations in large trials.…”

“…In this issue, the Valsartan Amlodipine Randomized Trial (VART) study is also added to this list. 7 One of the important features of these large clinical trials held in Japan is that they achieve the same level of BP control from the beginning to the end of the trial (except CASE-J). A direct comparison between CCBs and ARBs carried out in the CASE-J and VART studies revealed no significant difference in the primary end point, but overall cardiac mortality and morbidity are lower in Japan than in other countries.…”