Outcomes in subgroups of hypertensive patients treated with regimens based on valsartan and amlodipine: An analysis of findings from the VALUE trial

BACKGROUND: In the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial the primary outcome (cardiac morbidity and mortality) did not differ between valsartan and amlodipine-based treatment groups, although systolic blood pressure (SBP) and diastolic blood pressure reductions were significantly more pronounced with amlodipine. Stroke incidence was non-significantly, and myocardial infarction was significantly lower in the amlodipine-based regimen, whereas cardiac failure was non-significantly lower on valsartan. OBJECTIVES: The study protocol specified additional analyses of the primary endpoint according to: sex; age; race; geographical region; smoking status; type 2 diabetes; total cholesterol; left ventricular hypertrophy; proteinuria; serum creatinine; a history of coronary heart disease; a history of stroke or transient ischemic attack; and a history of peripheral artery disease. Additional subgroups were isolated systolic hypertension and classes of antihypertensive agents used immediately before randomization. METHODS: The 15 245 hypertensive patients participating in VALUE were divided into subgroups according to baseline characteristics. Treatment by subgroup interaction analyses were carried out by a Cox proportional hazard model. Within each subgroup, treatment effects were assessed by hazard ratios and 95% confidence intervals. RESULTS: For cardiac mortality and morbidity, the only significant subgroup by treatment interaction was of sex (P = 0.016), with the hazard ratio indicating a relative excess of cardiac events with valsartan treatment in women but not in men, but SBP differences in favour of amlodipine were distinctly greater in women. No other subgroup showed a significant difference in the composite cardiac outcome between valsartan and amlodipine-based treatments. For secondary endpoints, a sex-related significant interaction was found for heart failure (P < 0.0001), with men but not women having a lower incidence of heart failure with valsartan. CONCLUSION: As in the whole VALUE cohort, in no subgroup of patients were there differences in the incidence of the composite cardiac endpoint with valsartan and amlodipine-based treatments, despite a greater blood pressure decrease in the amlodipine group. The only exception was sex, in which the amlodipine-based regimen was more effective than valsartan in women, but not in men, whereas the valsartan regimen was more effective in preventing cardiac failure in men than in women. © 2006 Lippincott Williams & Wilkins, Inc.

Zanchetti A.1, 19 , Julius S.2 , Kjeldsen S.2, 3 , McInnes G.T.4 , Hua T.5 , Weber M.6 , Laragh J.H.7 , Plat F.8 , Battegay E.9 , Calvo-Vargas C.10 , Cieśliński A.11 , Degaute J.P.12 , Holwerda N.J.13 , Kobalava J. 14 , Pedersen O.L.15 , Rudyatmoko F.P.16 , Siamopoulos K.C.17 , Störset Ö.18
Номер выпуска
  • 1 Centro Interuniversitario di Fisiologia Clinica e Ipertensione, University of Milan, Ospedale Maggiore, Milan, Italy
  • 2 University of Michigan, Ann Arbor, MI, United States
  • 3 Ullevaal University Hospital, Oslo, Norway
  • 4 University of Glasgow, Glasgow, United Kingdom
  • 5 Novartis Pharma, East Hanover, NJ, United States
  • 6 State University of New York, New York, NY, United States
  • 7 Cornell Medical Center, New York, NY, United States
  • 8 Novartis Pharma AG, Basel, Switzerland
  • 9 University Hospital, Basel, Switzerland
  • 10 Hospital Civil Juan I, Menchaca University of Guadalajara, Guadalajara, Mexico
  • 11 Karol Marcinkowski University, Poznaň, Poland
  • 12 Hôpital Erasme, Brussels, Belgium
  • 13 Sint Elisabeth Ziekenhuis, Tilburg, Netherlands
  • 14 Russian University of People Friendship, Moscow, Russian Federation
  • 15 Viborg Hospital, Viborg, Denmark
  • 16 J.I. Sutorejo-Utara F. 24, Surabaya, Indonesia
  • 17 University of Ioannina, Ioannina, Greece
  • 18 Akershus University Hospital, Nordbyhagen, Norway
  • 19 Centro di Fisiologia Clinica e Ipertensione, Via F. Sforza, 35, 20122 Milano, Italy
Ключевые слова
Amlodipine; Cardiac events; Heart failure; Sex; Valsartan
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