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Amlodipine More Effective for Blood Pressure Reduction but Confers Similar Cardiac Outcomes to Valsartan Therapy

Amlodipine-based therapy resulted in better initial blood pressure reduction than did valsartan-based therapy, but long term blood pressure and cardiac mortality and morbidity were similar between treatments in hypertensive patients at high cardiovascular risk who participated in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE).

"VALUE was designed to compare the effects of treatment regimens based on the angiotensin-receptor blocker valsartan or on the calcium antagonist amlodipine on cardiac morbidity and mortality in patients with essential hypertension and at high risk for cardiac disease," writes Professor Stevo Julius, MD, Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, United States, and colleagues.

The researchers assessed composite cardiac outcomes over a mean follow up of 4.2 years in 7649 patients randomised to valsartan and 7596 randomised to amlodipine. Median daily doses were 151.7 mg for valsartan and 8.5 mg for amlodipine. To achieve blood pressure control, patients could take further antihypertensive medications, except for angiotensin-receptor blockers.

Overall, 10.6% of the valsartan group and 10.4% of the amlodipine group reached the primary composite outcome of cardiac mortality and cardiac morbidity. Secondary endpoints of fatal or non-fatal myocardial infarction, heart failure, or stroke were reported in 4.8% and 4.1%, 4.6% and 5.3%, and in 4.2% and 3.7%, respectively, in the valsartan and amlodipine groups. All-cause mortality was 11.0% in the valsartan group compared with 10.8% in the amlodipine group, and new-onset diabetes occurred in 13.1% compared with 16.4%, respectively.

Blood pressure, after 1 month, of therapy was 4.0/2.1 mm Hg lower in the amlodipine patients versus those taking valsartan. At 6 months the difference decreased to 2.1/1.6 mm Hg. From month 6 to the end of the study blood pressure decreased by 3.0/2.5 mm Hg in the amlodipine group and by 3.3/2.6 mm Hg in the valsartan group.

In the amlodipine group 62% reached the target blood pressure of less than 140 mm Hg systolic and less than 90 mm Hg diastolic compared with 56% of the valsartan patients.

Both treatment strategies were well tolerated with few adverse events, the authors note.

"The amlodipine group had a significantly lower incidence of myocardial infarction and a higher rate of new-onset diabetes than in the valsartan group," the authors write, however "amlodipine-based therapy was significantly more efficacious in reducing BP [blood pressure], especially during the early phases of treatment."

"The findings suggest that recommended BP goals need to be reached within a relatively short time (weeks rather than months), at least in patients with hypertension who are at high cardiovascular risk," the authors conclude.

Lancet 2004;363:2022-31

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