OR-29: The value trial: long-term blood pressure trends in 13,449 patients with hypertension and high cardiovascular risk

Purpose: The VALUE Trial compares cardiovascular outcomes in 15,314 eligible patients from 31 countries randomized to valsartan or amlodipine-based treatment. Methods: The blood pressure (BP) trends are analyzed in 13,449 patients with baseline and 24 months data, and in 12,570 patients with baseline and 30 months data. Results: Ninety two % received antihypertensive therapy prior to enrollment. The (entry) BP in treated patients was 153.5/ 86.9 mmHg compared to 168.1.8/95.3 mmHg in untreated patients. After sixth months both groups had indistinguishable BP values. At 12 months the BP fell to 141.2/ 82.9 mmHg, at 24 month to 139.1/79.8 mmHg (p <0.0001 vs 12 months), and to 138.1/79.0 mmHg at 30 months (p< 0.0001 vs 24 months). Compared to baseline (21.7%) the systolic control BP (<140 mmHg) increased to 59.5% at 24 months and 62.2% at 30 months. Similarly, the diastolic control BP (<90 mmHg) increased from 53.7% at baseline to 88.6% at 24 months and 90.0% at 30 months, and combined control (<140 and <90 mmHg) increased from 18.9% at baseline to 57.6% at 24 months and 60.5% at 30 months. All proportions at 24 and 30 months vs baseline for diastolic, systolic and combined control BP are highly significant (p<0.0001). At 24 months 87.7% of all patients received randomized therapy: monotherapy = 39.7%, added hydrochlorothiazide= 46.0%, additional drugs permitted by the protocol= 15.9%. Conclusion: The VALUE Trial is executed in regular clinical settings. The achieved BP control in this study is better than in any published large-scale trial. Our results demonstrate that when explicit BP goal is set and a treatment algorithm is provided, the physicians achieve much better control rates than in their regular practic

Valsartan in acute myocardial infarction trial (VALIANT): rationale and design

Background Survivors of acute myocardial infarction (MI) complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete pharmacologic mode to inhibit the adverse influence of angiotensin II. Methods Valsartan in Acute Myocardial Infarction (VALIANT) is a multicenter, double-blind, randomized, active controlled parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designed with 3 arms, giving equal statistical consideration to survival comparisons of captopril versus the angiotensin II receptor blocker valsartan, as well as the combination of captopril plus valsartan, compared with a proven effective dose of captopril. This 14,500-patient trial is designed with an 86% power to detect a 15% reduction in mortality rate with either use of valsartan compared with captopril. The trial encourages optimal individualization of other proven therapies in acute and chronic infarction, and the international patient body ensures good representation of multiple practice patterns. Conclusion VALIANT is a large international investigative effort that will evaluate the role of valsartan in the management of patients with MI associated with heart failure and/or left ventricular dysfunction. The use of a proven dose of captopril and the comparator arms with valsartan alone or in combination with captopril provides a unique test of whether the angiotensin II receptor blocker can make an additional improvement in clinical outcomes beyond angiotensin-converting enzyme inhibitors