The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial: Outcomes in Patients Receiving Monotherapy

• Published in: Hypertension (Dallas, Tex. 1979) Vol. 48; no. 3; pp. 385 - 391
• Main Authors: Julius, Stevo, Weber, Michael A., Kjeldsen, Sverre E., McInnes, Gordon T., Zanchetti, Alberto, Brunner, Hans R., Laragh, John, Schork, M Anthony, Hua, Tsushung A., Amerena, John, Balazovjech, Ivan, Cassel, Graham, Herczeg, Bela, Koylan, Nevres, Magometschnigg, Dieter, Majahalme, Silja, Martinez, Felipe, Oigman, Willie, Gomes, Ricardo Seabra, Zhu, Jun-ren
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.09.2006
• Subjects: Aged; Amlodipine - therapeutic use; Angiotensin II Type 1 Receptor Blockers - administration & dosage; Angiotensin II Type 1 Receptor Blockers - adverse effects; Angiotensin II Type 1 Receptor Blockers - therapeutic use; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Blood Pressure - drug effects; Calcium Channel Blockers - therapeutic use; Cardiac Output, Low - epidemiology; Cardiac Output, Low - etiology; Diabetes Mellitus - epidemiology; Diabetes Mellitus - prevention & control; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hypertension - complications; Hypertension - drug therapy; Hypertension - physiopathology; Incidence; Male; Middle Aged; Risk; Tetrazoles - administration & dosage; Tetrazoles - adverse effects; Tetrazoles - therapeutic use; Valine - administration & dosage; Valine - adverse effects; Valine - analogs & derivatives; Valine - therapeutic use; Valsartan
• ISSN: 0194-911X; 1524-4563; 1524-4563
• DOI: 10.1161/01.HYP.0000236119.96301.f2

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 ratios0.63, 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 ratios0.78, 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.