Published online before print July 24, 2006, doi: 10.1161/01.HYP.0000236119.96301.f2
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(Hypertension. 2006;48:385.)
© 2006 American Heart Association, Inc.
Original Articles |
The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial
Outcomes in Patients Receiving Monotherapy
From the University of Michigan (S.J., S.E.K., M.A.S.), Ann Arbor, Mich; Ullevaal Hospital (S.E.K.), Oslo, Norway; University of Glasgow (G.M.), Glasgow, United Kingdom; Istitito Auxologico Italiano (A.Z.), Ospedale Maggiore and University of Milan, Milan, Italy; New York Hospital (J.L.), Cornell Medical Center, New York, NY; State University of New York (M.A.W.), Brooklyn, NY; University of Lausanne (H.R.B.), Lausanne, Switzerland; Novartis Pharmaceutical (T.A.H.), East Hanover, NJ; Geelong Hospital (J.A.), Geelong, Australia; Faculty Hospital (I.B.), Bratislava, Slovak Republic; Milpark Hospital (G.C.), Johannesburg, South Africa; Megyei Hetényi Géza Kórház (B.H.), Szolnok, Hungary; Istanbul University (N.K.), Istanbul, Turkey; Institut für Hypertoniker (D.M.), Vienna, Austria; Appleton Heart Institute (S.M.), Appleton, Wis; National University of Cordoba (F.M.), Cordoba, Argentina; Hospital Universitário Pedro Ernesto (W.O.), Rio de Janeiro, Brazil; Hospital Santa Cruz Instituto do Coração (R.S.G.), Carnaxide, Portugal; and Zhong Shan Hospital (J.R.Z.), Shanghai, China.
Correspondence to Stevo Julius, University of Michigan, Department of Internal Medicine, Division of Cardiovascular Medicine, 24 Frank Lloyd Wright Dr, PO Box 322, Lobby M, Ann Arbor, MI 48106. E-mail sjulius{at}umich.edu
In the main Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) report, we investigated outcomes in 15 245 high-risk hypertensive subjects treated with valsartan- or amlodipine-based regimens. In this report, we analyzed outcomes in 7080 patients (46.4%) who, at the end of the initial drug adjustment period (6 months), remained on monotherapy. Baseline characteristics were similar in the valsartan (N=3263) and amlodipine (N=3817) groups. Time on monotherapy was 3.2 years (78% of treatment exposure time). The average in-trial blood pressure was similar in both groups. Event rates in the monotherapy group were 16% to 39% lower than in the main VALUE trial. In the first analysis, we censored patients when they discontinued monotherapy ("censored"); in the second, we counted events regardless of subsequent therapy (intention-to-treat principle). We also assessed the impact of duration of monotherapy on outcomes. No difference was found in primary composite cardiac end points, strokes, myocardial infarctions, and all-cause deaths with both analyses. Heart failure in the valsartan group was lower both in the censored and intention-to-treat analyses (hazard ratios: 0.63, P=0.004 and 0.78, P=0.045, respectively). Longer duration of monotherapy amplified between-group differences in heart failure. New-onset diabetes was lower in the valsartan group with both analyses (odds ratios: 0.78, P=0.012 and 0.82, P=0.034). Thus, despite lower absolute event rates in monotherapy patients, the relative risks of heart failure and new-onset diabetes favored valsartan. Moreover, these findings support the feasibility of comparative prospective trials in lower-risk hypertensive patients.
Key Words: clinical trials • heart failure • diabetes mellitus
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