Valsartan beats amlodipine for CHF risk, but not CV events, in hypertensive diabetics
MedWire News: The angiotensin II receptor blocker (ARB) valsartan was comparable to the calcium channel blocker (CCB) amlodipine at reducing blood pressure (BP) in Japanese patients with hypertension and diabetes or impaired glucose tolerance (IGT), according to results of the NAGOYA HEART study.
There were no significant differences in a composite cardiovascular (CV) endpoint, but valsartan was associated with a significantly lower risk for congestive heart failure (CHF), the researchers reported at the American College of Cardiology Annual Scientific Sessions in New Orleans, Louisiana, USA.
The trial compared the effects of valsartan with amlodipine on CV morbidity and mortality in Japanese hypertensive patients with Type 2 diabetes or IGT. Patients were randomly assigned to receive amlodipine 5-10 mg per day or valsartan 80-160 mg per day, plus other antihypertensives as needed, except for angiotensin enzyme converting (ACE) inhibitors, and other ARBs or CCBs. Analysis was by intent-to-treat.
The primary composite endpoint of major CV events occurred at a rate of 9.4% in the valsartan group and 9.7% in the amlodipine group (hazard ratio [HR]=0.97; 95% confidence interval [CI], 0.66-1.40; p=0.85).
The rate of the secondary endpoint of all-cause mortality was 3.8% in the valsartan group and 2.8% in the amlodipine group (HR=1.37; nonsignificant).
"Our results will highlight the safety and efficacy of an ARB, valsartan, in preventing heart failure, and support the current therapeutic guidelines recommendations for diabetic hypertensive patients," said lead investigator, Toyoaki Murohara (Nagoya University Graduate School of Medicine, Japan).
Several international clinical guidelines issued by cardiology and diabetes groups recommend ACE inhibitors and/or ARBs as first-line agents for the control of hypertension in patients with diabetes. CCBs are either considered as alternative agents or, in the case of the American Diabetes Association (ADA) guidelines, not recommended for diabetic patients.
The NAGOYA HEART study investigators looked at the comparative efficacy and safety of the ARB valsartan versus the CCB amlodipine in 1150 Japanese patients with diabetes or IGT and hypertension. A computer program randomly assigned patients to either of the two drugs, and it controlled for the risk factors of age, gender, statin use, smoking, and diabetes or IGT.
The BP target was <130/80 mm Hg. Median follow-up was 3.2 years, ranging from 2.6 to 4.7 years. The primary outcome was a composite of CV events, including acute myocardial infarction, stroke, requirement for coronary revascularization, admission for worsening heart failure, or sudden cardiac death. The secondary outcome was all-cause mortality.
The drugs were identical in their ability to control systolic and diastolic BP, did not differ with respect to the primary endpoint, and there were no significant changes in hemoglobin A1c levels up to 5 years.
Valsartan was, however, significantly better than amlodipine at preventing CHF, with only three (0.5%) patients on valsartan developing it, compared with 15 (2.6%) of those on amlodipine (HR=0.20; 95% CI, 0.06-0.69; p=0.01).
The findings suggest that valsartan or another ARB in combination with other agents is a preferred first-line agent in patients with diabetes and hypertension, concluded Murohara.
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By Neil Osterweil