CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Effect of Valsartan on hospitalization: results from Val-HeFT.

BACKGROUND: Although current therapies have improved heart failure (HF) outcome, hospitalizations continue at high rates. The Valsartan Heart Failure Trial (Val-HeFT) showed that valsartan reduced the risk of first worsening HF hospitalization by 27.5% versus placebo (P <.001). This article analyzes all-cause and investigator-assessed HF hospitalization in Val-HeFT overall and in subgroups defined by preexisting HF therapy.

METHODS: Val-HeFT was a randomized, double-blind parallel-arm study in which HF patients (New York Heart Association class II-IV) received either valsartan (n = 2511, force-titrated to 160 mg twice daily) or placebo (n = 2499) in addition to prescribed HF therapy. Total and per patient-year investigator-assessed hospitalizations (all-cause or HF) were analyzed according to prescribed therapy at baseline (angiotensin-converting enzyme inhibitors [ACEI] and beta-blockers [BB]).

RESULTS: Hospitalization for worsening HF accounted for 35% of all hospitalizations. There were 2856 and 3106 total all-cause hospitalizations in the valsartan and placebo groups, respectively, an 8% reduction (P =.145). Valsartan significantly reduced the overall number of investigator-assessed HF hospitalizations (-22.4%, P =.002) and reduced HF hospitalizations in the combination therapy subgroups (significant for ACEI+/BB- P =.003 and ACEI-/BB- P =.028) except those receiving both ACEI and BB. The benefit of valsartan versus placebo was more pronounced in reducing the number of patients with recurrent HF hospitalization (-20.6%) than single hospitalizations (-8.7%).

CONCLUSIONS: Addition of valsartan to prescribed HF therapy demonstrated significant reductions in HF hospitalizations and was particularly beneficial in reducing recurrent HF hospitalization.

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