| The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial. | |
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MedLine Citation:
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PMID: 19019730 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: 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 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< or =35%) were included and received 900 mg/day WS 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event. RESULTS: 2681 patients (WS 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS 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 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> or =25%, WS 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 1442 had no significant effect on the primary endpoint. WS 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function. |
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Authors:
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Christian J F Holubarsch; Wilson S Colucci; Thomas Meinertz; Wilhelm Gaus; Michal Tendera; |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-11-18 |
Journal Detail:
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Title: European journal of heart failure Volume: 10 ISSN: 1388-9842 ISO Abbreviation: Eur. J. Heart Fail. Publication Date: 2008 Dec |
Date Detail:
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Created Date: 2008-11-28 Completed Date: 2009-03-11 Revised Date: 2011-06-08 |
Medline Journal Info:
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Nlm Unique ID: 100887595 Medline TA: Eur J Heart Fail Country: Netherlands |
Other Details:
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Languages: eng Pagination: 1255-63 Citation Subset: IM |
Affiliation:
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Median Clinics Bad Krozingen, Bad Krozingen, Germany. c.holubarsch@median-bk.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Cardiac Output
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drug effects Confidence Intervals Crataegus / adverse effects* Death, Sudden, Cardiac / prevention & control Double-Blind Method Exercise Tolerance / drug effects Female Heart Failure / drug therapy*, mortality, physiopathology Heart Rate / drug effects* Humans Male Middle Aged Phytotherapy* Plant Extracts / adverse effects, therapeutic use* Stroke Volume / drug effects Survival Analysis Ventricular Function, Left / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Plant Extracts |
| Investigator | |
Investigator/Affiliation:
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N Dimov / ; R Kermova / ; N Ivanova Konyarova / ; T Manolova / ; B Rangochev / ; P Solakov / ; L Ballek / ; M Brtko / ; J Carda / ; V Drápalík / ; J Drazka / ; P Franc / ; O Hejhal / ; J Toman / ; P Kvásová / ; P Lang / ; K Peterka / ; J Popelová / ; J Rybka / ; V Adelberger / ; A Al-Zoebi / ; S Albrecht / ; K Ammer / ; G Bachour / ; A Barth / ; M Bock / ; G Böhm / ; H Böneke / ; H Bründermann / ; H J Busse / ; H Damaschke / ; K Diehl / ; S Fischer / ; R G Fuchs / ; J Gärtner / ; S Gaydov / ; S Gessner / ; T H Giehrl / ; D Glatzel / ; S Haufe / ; W Heepe / ; P Fries / ; C J Heydenreich / ; R Henke / ; L Hennig / ; M Hilbert / ; U Hofmann / ; H Hohensee / ; M Holzapfel / ; F M Isbruch / ; T Jung / ; N Jung / ; S Kaspari / ; R Kemper / ; K Kleinertz / ; J Krehbiel / ; R Kern / ; R Kuhnen / ; M Leicht / ; S Leszke / ; E Lohr / ; M Maas / ; W Mandlik / ; B Nabel / ; M Orlowski / ; G Overmeyer / ; M Pahl / ; T Peterhansl / ; R Pospiech / ; B Wille / ; P Rapp / ; F Richard / ; G Ringwald / ; B Ritter / ; W D Rudroff / ; T H Scheibner / ; W Schlauch / ; A Schröder / ; D Schwarz / ; W Schwarz / ; W Türk / ; H G Voss / ; W Weiland / ; N Kokott / ; C H Weiler / ; J Weimer / ; M Weingart / ; H W Wozny / ; K Younossi / ; R Zotz / ; I Edes / ; A Gozīte / ; A Pomere / ; J E Marcinkeviciene / ; M R Babarskiene / ; A Baltuskevicius / ; E Berūkstis / ; A Dambrauskaite / ; L Jankauskiene / ; J Misiūra / ; A Simaitis / ; R Steponeniene / ; A Valiulis / ; L Valius / ; L H J van Kempen / ; P Achremczyk / ; M Cholewa / ; J Dubejko / ; M Janion / ; K Jaworska / ; J Kastelik / ; A Kleinrok / ; M Krauze-Wielicka / ; Z Majer / ; M Krzemińska-Pakuła / ; B Kuśnierz / ; J Kuźniar / ; K Łoboz-Grudzień / ; W Musiał / ; E Nartowicz / ; W Pluta / ; A Pluta / ; L Poloński / ; M Tendera / ; T Zaleska / ; J A Coucello / ; S Ilić / ; M Kovac / ; D C Kovacević / ; Z Mijailović / ; M Mirić / ; V Obradović / ; M C Ostojić / ; P M Seferović / ; Z Vasiljević / ; M Zdravković / ; I Gonos / ; P Kmec / ; D Pella / ; P Tóth / ; M Zima / ; M Bombek / ; D Kovac / ; P Rakovec / ; F Skrabl-Mocnik / ; A Zemva / ; A Dyadyk / ; G V Dzyak / ; V M Dzyak / ; M Lutay / ; A Parkhomenko / ; S S Pavlyk / ; S Polivoda / ; L G Voronkov / |
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