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001-es BibID:	BIBFORM008217
Első szerző:	Holubarsch, Christian J. F.
Cím:	The efficacy and safety of Crataegus extract WS R 1442 in patients with heart failure : the SPICE trial / Holubarsch, C. J. F., Colucci, W. S., Meinertz, T., Gaus, W., Tendera, M., Investigation of Crataegus Extract WS R 1442 in CHF (SPICE) trial study group
Dátum:	2008
Megjegyzések:	Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed. Aim: To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS R 1442 in patients with congestive heart failure. Methods: In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF?35%) were included and received 900 mg/day WS R 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event. Results: 2681 patients (WS R 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS R 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS R 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF?25%, WS R 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups. Conclusions: In this study, WS R 1442 had no significant effect on the primary endpoint. WS R 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS R 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	European Journal of Heart Failure. - 10 : 12 (2008), p. 1255-1263. -
További szerzők:	Colucci, Wilson S. Meinertz, Thomas Gaus, Wilhelm Tendera, Michal Édes István (1952-) (kardiológus) Investigation of Crataegus Extract WS R 1442 in CHF (SPICE) trial study group
Internet cím:	DOI elektronikus változat
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