The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial: Outcomes in patients receiving monotherapy

Stevo Julius, Michael A. Weber, Sverre E. Kjeldsen, Gordon T. McInnes, Alberto Zanchetti, Hans R. Brunner, John Laragh, M. Anthony Schork, Tsushung A. Hua, John Amerena, Ivan Balazovjech, Graham Cassel, Bela Herczeg, Nevres Koylan, Dieter Magometschnigg, Silja Majahalme, Felipe Martinez, Willie Oigman, Ricardo Seabra Gomes, Jun Ren Zhu

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)385-391
Number of pages7
JournalHypertension
Volume48
Issue number3
DOIs
Publication statusPublished - Sep 2006

Keywords

  • Clinical trials
  • Diabetes mellitus
  • Heart failure

ASJC Scopus subject areas

  • Internal Medicine

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    Julius, S., Weber, M. A., Kjeldsen, S. E., McInnes, G. T., Zanchetti, A., Brunner, H. R., Laragh, J., Schork, M. A., Hua, T. A., Amerena, J., Balazovjech, I., Cassel, G., Herczeg, B., Koylan, N., Magometschnigg, D., Majahalme, S., Martinez, F., Oigman, W., Gomes, R. S., & Zhu, J. R. (2006). The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial: Outcomes in patients receiving monotherapy. Hypertension, 48(3), 385-391. https://doi.org/10.1161/01.HYP.0000236119.96301.f2