PMID- 11759645
OWN - NLM
STAT- MEDLINE
DCOM- 20011228
LR  - 20220408
IS  - 0028-4793 (Print)
IS  - 0028-4793 (Linking)
VI  - 345
IP  - 23
DP  - 2001 Dec 6
TI  - A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart 
      failure.
PG  - 1667-75
AB  - BACKGROUND: Actions of angiotensin II may contribute to the progression of heart 
      failure despite treatment with currently recommended drugs. We therefore 
      evaluated the long-term effects of the addition of the angiotensin-receptor 
      blocker valsartan to standard therapy for heart failure. METHODS: A total of 5010 
      patients with heart failure of New York Heart Association (NYHA) class II, III, 
      or IV were randomly assigned to receive 160 mg of valsartan or placebo twice 
      daily. The primary outcomes were mortality and the combined end point of 
      mortality and morbidity, defined as the incidence of cardiac arrest with 
      resuscitation, hospitalization for heart failure, or receipt of intravenous 
      inotropic or vasodilator therapy for at least four hours. RESULTS: Overall 
      mortality was similar in the two groups. The incidence of the combined end point, 
      however, was 13.2 percent lower with valsartan than with placebo (relative risk, 
      0.87; 97.5 percent confidence interval, 0.77 to 0.97; P=0.009), predominantly 
      because of a lower number of patients hospitalized for heart failure; 455 (18.2 
      percent) in the placebo group and 346 (13.8 percent) in the valsartan group 
      (P<0.001). Treatment with valsartan also resulted in significant improvements in 
      NYHA class, ejection fraction, signs and symptoms of heart failure, and quality 
      of life as compared with placebo (P<0.01). In a post hoc analysis of the combined 
      end point and mortality in subgroups defined according to base-line treatment 
      with angiotensin-converting-enzyme (ACE) inhibitors or beta-blockers, valsartan 
      had a favorable effect in patients receiving neither or one of these types of 
      drugs but an adverse effect in patients receiving both types of drugs. 
      CONCLUSIONS: Valsartan significantly reduces the combined end point of mortality 
      and morbidity and improves clinical signs and symptoms in patients with heart 
      failure, when added to prescribed therapy. However, the post hoc observation of 
      an adverse effect on mortality and morbidity in the subgroup receiving valsartan, 
      an ACE inhibitor, and a beta-blocker raises concern about the potential safety of 
      this specific combination.
FAU - Cohn, J N
AU  - Cohn JN
AD  - Department of Medicine, University of Minnesota Medical School, Minneapolis, 
      55455, USA.
FAU - Tognoni, G
AU  - Tognoni G
CN  - Valsartan Heart Failure Trial Investigators
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 0 (Tetrazoles)
RN  - 80M03YXJ7I (Valsartan)
RN  - HG18B9YRS7 (Valine)
SB  - IM
CIN - N Engl J Med. 2002 Apr 11;346(15):1173-4. PMID: 11948282
CIN - N Engl J Med. 2002 Apr 11;346(15):1173-4. PMID: 11951861
CIN - N Engl J Med. 2002 Apr 11;346(15):1173-4. PMID: 11951862
CIN - N Engl J Med. 2002 Apr 11;346(15):1173-4. PMID: 11951863
SPIN- J Card Fail. 2002 Apr;8(2):56-8. PMID: 12016625
CIN - Rev Cardiovasc Med. 2002 Summer;3(3):162-3. PMID: 12439444
MH  - Adrenergic beta-Antagonists/therapeutic use
MH  - *Angiotensin Receptor Antagonists
MH  - Angiotensin-Converting Enzyme Inhibitors/therapeutic use
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Heart Failure/*drug therapy/mortality/physiopathology
MH  - Hospitalization
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Probability
MH  - Quality of Life
MH  - Stroke Volume/drug effects
MH  - Survival Analysis
MH  - Tetrazoles/*therapeutic use
MH  - Valine/*analogs & derivatives/*therapeutic use
MH  - Valsartan
EDAT- 2002/01/05 10:00
MHDA- 2002/01/05 10:01
CRDT- 2002/01/05 10:00
PHST- 2002/01/05 10:00 [pubmed]
PHST- 2002/01/05 10:01 [medline]
PHST- 2002/01/05 10:00 [entrez]
AID - 10.1056/NEJMoa010713 [doi]
PST - ppublish
SO  - N Engl J Med. 2001 Dec 6;345(23):1667-75. doi: 10.1056/NEJMoa010713.