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VALUE TRIAL |
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| Problem | Hypertension with cardiac RFs |
| Format | Multicenter, double-blind, randomized trial |
| Treatment | Valsartan OR amlodipine |
| Control | - |
| Population | 12,570 patients |
| Inclusion criteria | 50 years old Subjects had to have a history of cardiovascular disease or at least 3 risk factors in addition to hypertension Diseases: Verified coronary disease Cerebrovascular disease or peripheral arterial occlusive disease Left ventricular hypertrophy with strain pattern Risk factors: Male sex Age older than 50 years Diabetes Current smoker Hypercholesterolaemia Left ventricular hypertrophy on ECG Proteinuria on dipstick Raised serum creatinine between 150 and 265 µmol/L |
| Exclusion criteria | Renal artery stenosis Pregnancy Acute myocardial infarction Percutaneous transluminal coronary angioplasty or coronary artery bypass graft within the past 3 months Clinically relevant valvular disease Cerebrovascular accident in the past 3 months Severe hepatic disease Severe chronic renal failure Congestive heart failure requiring ACE inhibitor therapy Patients on monotherapy with blockers for both coronary artery disease and hypertension |
| Follow-up | Mean 4.2 years |
| Primary endpoint | Composite measure of cardiac morbidity and mortality, which included: -Sudden cardiac death -Fatal/nonfatal myocardial infarction (MI) -Evidence of recent MI on autopsy -Emergency thrombolytic/fibrinolytic treatment and/or emergency percutaneous transluminal coronary angioplasty (PTCA)/coronary artery bypass graft (CABG) surgery to avoid MI -Death during or after PTCA/CABG -New or chronic congestive heart failure (CHF) requiring hospital management -Heart failure death |
| Secondary endpoint(s) | Fatal and non-fatal myocardial infarction Fatal and non-fatal heart failure Fatal and non-fatal stroke All-cause mortality New-onset diabetes were also prespecified. |
| Details | Subjects were to be randomly assigned to either valsartan or amlodipine 5 mg for 1 month, followed by uptitration to 10 mg of amlodipine or 160 mg of valsartan. By the end of the third month, subjects could be given additional antihypertensive therapy with hydrochlorothiazide, then other agents (sympatholytics and vasodilators), to try to achieve the target blood pressure of 140/90 mm Hg. |
| Brief summary: | Valsartan inferior BP control vs. amlodipine; similar CV event rate |
| PAPER: Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. | |
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| Date | 19 Jun 2004 |
| Journal | Lancet. 2004 Jun 19;363(9426):2022-31. |
| Information | Valsartan vs. Amlodipine in HTN with cardiac RFs -To assess if renin-angiotensin blockade of benefit, above benefits of BP control -Target BP 140/90 mm Hg Significantly lower BPs with amlodipine -Average 2.2 mm Hg at 60 months More rapid control of BP in amlodipine group -Average 4.3 mm Hg lower in early months No difference in composite endpoints -?No benefit from RAS blockade... -...Or just offset by higher BP in ARB group? N.B. Composite endpoint focused on cardiac outcomes, ignoring strokes |