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Preventing cardiovascular events in high-risk hypertensive patients: comparing valsartan with amlodipine


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Preventing cardiovascular events in high-risk hypertensive patients: comparing valsartan with amlodipine

  1. 1. Preventing cardiovascular events in high-risk hypertensive patients: comparing valsartan with amlodipine [Excerpt] Copyright © Lorena Tonarelli, M.Sc. 2014 Overview Introduction Antihypertensive treatment with calcium an- Hypertension, defined as blood pressure ≥ tagonists or angiotensin II-lowering agents 140/90 mm Hg, is an important cardiovas- is well established. However, whether cular risk factor. [1] Adequate blood pres- there are advantages of one therapy over sure control is, therefore, essential to re- the other, in terms of cardioprotection, is ducing cardiac morbidity and mortality in unclear. high-risk hypertensive patients. In this This report summarizes the results of the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) study, which compared the angiotensin-receptor blocker valsartan with the calcium antagonist amlodipine in hypertensive patients with high cardiovascular risk. VALUE found that amlodipine and valsartan had similar cardioprotective properties during the study. However, the latter may potentially provide greater cardioprotection long term, due to its superiority in preventing type 2 diabetes–a major risk factor for cardiac morbidity and mortality in hypertension. population, benefits have been reported with angiotensin II-lowering agents, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs), [2] and with calcium antagonists, [3-5] with no evidence of significant difference between the two, in terms of cardioprotective effects. However, studies have shown that increased levels of angiotensin II are an independent risk factor for cardiovascular disease. [6] It is, therefore, reasonable to hypothesize that angiotensin II-lowering agents may provide better cardioprotection than calcium antagonists. This hypothesis has been tested in the VALUE trial [7-9] on hypertensive patients enrolled in 31 countries between September 1997 and November 1999. 2
  2. 2. Methods Findings VALUE was a randomized, double-blind, Efficacy [10] prospective, multicenter, active-controlled, parallel-group trial comparing the longterm cardioprotective effects of regimens based on the angiotensin-receptor blocker valsartan or the calcium antagonist amlodipine, in patients with previously treated or untreated essential hypertension and Blood pressure was reduced to normal levels in both treatment arms. The effect was initially more pronounced in patients on amlodipine. The between-arm difference was 4.0/2.1 mm Hg at 1 month, but decreased to, and stabilized at, 1.5/1.3 mm Hg after high cardiovascular risk. [10] 12 months (p<0.001). A total of 15,245 patients aged 50 years or Table 1 shows the major findings of the older with similar demographics, hypertension severity, cardiovascular risk, and hypertensive therapy used before the study were randomized to once-daily valsartan 80 mg or amlodipine 5 mg. Five step upward titration was performed at one-month intervals to achieve a blood pressure below 140/90 mm Hg. Patients were followed up for a mean of 4.2 years with regular visits. The primary endpoint was a composite of cardiac morbidity and mortality. Secondary endpoints were time to first myocardial infarction, heart failure, stroke, all-cause deaths and new-onset type 2 diabetes. study. No significant difference in the primary composite endpoint of cardiac morbidity and mortality was found between valsartan-based and amlodipine-based regimens (10.6% vs. 10.4%, p=0.49). As for the secondary endpoints, more strokes and myocardial infarctions were reported for patients on valsartan than for those on amlodipine (4.2% vs. 3.7%, p=0.08; 4.8% vs. 4.1%, p=0.02). However, this disparity was most apparent in the early period of the study–when blood pressure differences between the two treatment arms were more pronounced–and decreased thereafter. 3