Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL)
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). / Mann, Douglas L; McMurray, John J V; Packer, Milton; Swedberg, Karl; Borer, Jeffrey S; Colucci, Wilson S; Djian, Jacques; Drexler, Helmut; Feldman, Arthur; Køber, Lars Valeur; Krum, Henry; Liu, Peter; Nieminen, Markku; Tavazzi, Luigi; van Veldhuisen, Dirk Jan; Waldenstrom, Anders; Warren, Marshelle; Westheim, Arne; Zannad, Faiez; Fleming, Thomas.
I: Circulation, Bind 109, Nr. 13, 2004, s. 1594-602.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL)
AU - Mann, Douglas L
AU - McMurray, John J V
AU - Packer, Milton
AU - Swedberg, Karl
AU - Borer, Jeffrey S
AU - Colucci, Wilson S
AU - Djian, Jacques
AU - Drexler, Helmut
AU - Feldman, Arthur
AU - Køber, Lars Valeur
AU - Krum, Henry
AU - Liu, Peter
AU - Nieminen, Markku
AU - Tavazzi, Luigi
AU - van Veldhuisen, Dirk Jan
AU - Waldenstrom, Anders
AU - Warren, Marshelle
AU - Westheim, Arne
AU - Zannad, Faiez
AU - Fleming, Thomas
N1 - Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Disease Susceptibility; Double-Blind Method; Female; Heart Failure; Hospitalization; Humans; Immunoglobulin G; Infection; Life Tables; Male; Middle Aged; Receptors, Tumor Necrosis Factor; Survival Analysis; Treatment Failure; Tumor Necrosis Factor-alpha
PY - 2004
Y1 - 2004
N2 - BACKGROUND: Studies in experimental models and preliminary clinical experience suggested a possible therapeutic role for the soluble tumor necrosis factor antagonist etanercept in heart failure. METHODS AND RESULTS: Patients with New York Heart Association class II to IV chronic heart failure and a left ventricular ejection fraction < or =0.30 were enrolled in 2 clinical trials that differed only in the doses of etanercept used. In RECOVER, patients received placebo (n=373) or subcutaneous etanercept in doses of 25 mg every week (n=375) or 25 mg twice per week (n=375). In RENAISSANCE, patients received placebo (n=309), etanercept 25 mg twice per week (n=308), or etanercept 25 mg 3 times per week (n=308). The primary end point of each individual trial was clinical status at 24 weeks. Analysis of the effect of the 2 higher doses of etanercept on the combined outcome of death or hospitalization due to chronic heart failure from the 2 studies was also planned (RENEWAL). On the basis of prespecified stopping rules, both trials were terminated prematurely owing to lack of benefit. Etanercept had no effect on clinical status in RENAISSANCE (P=0.17) or RECOVER (P=0.34) and had no effect on the death or chronic heart failure hospitalization end point in RENEWAL (etanercept to placebo relative risk=1.1, 95% CI 0.91 to 1.33, P=0.33). CONCLUSIONS: The results of RENEWAL rule out a clinically relevant benefit of etanercept on the rate of death or hospitalization due to chronic heart failure.
AB - BACKGROUND: Studies in experimental models and preliminary clinical experience suggested a possible therapeutic role for the soluble tumor necrosis factor antagonist etanercept in heart failure. METHODS AND RESULTS: Patients with New York Heart Association class II to IV chronic heart failure and a left ventricular ejection fraction < or =0.30 were enrolled in 2 clinical trials that differed only in the doses of etanercept used. In RECOVER, patients received placebo (n=373) or subcutaneous etanercept in doses of 25 mg every week (n=375) or 25 mg twice per week (n=375). In RENAISSANCE, patients received placebo (n=309), etanercept 25 mg twice per week (n=308), or etanercept 25 mg 3 times per week (n=308). The primary end point of each individual trial was clinical status at 24 weeks. Analysis of the effect of the 2 higher doses of etanercept on the combined outcome of death or hospitalization due to chronic heart failure from the 2 studies was also planned (RENEWAL). On the basis of prespecified stopping rules, both trials were terminated prematurely owing to lack of benefit. Etanercept had no effect on clinical status in RENAISSANCE (P=0.17) or RECOVER (P=0.34) and had no effect on the death or chronic heart failure hospitalization end point in RENEWAL (etanercept to placebo relative risk=1.1, 95% CI 0.91 to 1.33, P=0.33). CONCLUSIONS: The results of RENEWAL rule out a clinically relevant benefit of etanercept on the rate of death or hospitalization due to chronic heart failure.
U2 - 10.1161/01.CIR.0000124490.27666.B2
DO - 10.1161/01.CIR.0000124490.27666.B2
M3 - Journal article
C2 - 15023878
VL - 109
SP - 1594
EP - 1602
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 13
ER -
ID: 17397177