Characteristics of 15314 Hypertensive Patients at High Coronary Risk. The VALUE Trial

Sverre E. Kjeldsen From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Stevo Julius From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Hans Brunner From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Lennart Hansson From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Marc Henis From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Steffan Ekman From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

John Laragh From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Gordon McInnes From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Beverly Smith From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Michael Weber From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

Alberto Zanchetti From the Department of Cardiology, Ullevaal University Hospital, Oslo, Norway; Division of Hypertension , University of Michigan Hospital, Ann Arbor, MI, USA; University of Lausanne, Lausanne, Switzerland; Department of Geriatrics, University of Uppsala, Uppsala, Sweden; Novartis Pharma, East Hanover, NJ, USA and Novartis Pharma, Basel, Switzerland; New York Hospital, Cornell Medical Center, New York, NY, USA; Department of Medicine and Therapeutics , Gardiner Institute, Western In. rmary, University of Glasgow, Glasgow, UK; State University of New York, Brooklyn, NY, USA; and Centro di Fisiologia Clinica e Ipertensione , University of Milan, Ospedale Maggiore and Instituto Auxologico Italiano, Milan, Italy

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Abstract

Valsartan is an orally active, selective antagonist of the angiotensin II-1 (AT1) receptor developed for the treatment of hypertension. The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) Trial of Cardiovascular Events in Hypertension is a double-blind, randomized prospective, parallel group study designed to compare the effects of valsartan with those of the calcium-antagonist amlodipine on the reduction of cardiac morbidity and mortality. Patients with essential hypertension, aged 50 years and older, and at particularly high risk of coronary events were enrolled. 18119 patients were screened and 15314 patients in 31 countries were randomized mainly between January 1998 and December 1999. These hypertensives had a mean blood pressure of 154.7/87.5 mmHg at the time of their randomization to blinded medication. The population comprises both genders (men 57.6%), Caucasians (89.1%), mean age 67.2 years, mean body mass index 28.6 kg/m², coronary heart disease (45.8%), high cholesterol (33.0%), type 2 diabetes mellitus (31.7%) and smokers (24.0%). More than 92% of the randomized participants had been treated for high blood pressure for at least 6 months when screened for the study. The randomized population is now being treated (goal blood pressure < 140/90 mmHg) in adherence with the protocol until at least 1450 patients experience primary cardiac endpoint defined as clinically evident or aborted myocardial infarction, hospitalization for heart failure or death caused by coronary heart disease.

Keywords

Amlodipine Angiotensin Ii Antagonist Angiotensin Receptor Blocker Calcium Antagonist Cardiovascular Risk Hypertension Mortality-MORBIDITY Valsartan

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Characteristics of 15314 Hypertensive Patients at High Coronary Risk. The VALUE Trial

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