© 2008 European Society of Cardiology
The efficacy and safety of Crataegus extract WS® 1442 in patients with heart failure: The SPICE trial
a Median Clinics Bad Krozingen Bad Krozingen, Germany
b Cardiology Department, Boston Medical Center Boston, USA
c Department of Cardiology/Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
d Department of Biometrics and Medical Documentation, University of Ulm Ulm, Germany
e 3rd Division of Cardiology, Medical University of Silesia Katowice, Poland
* Corresponding author. Median Kliniken Bad Krozingen, Herbert-Hellmann-Allee 38, 79189 Bad Krozingen, Germany. Tel.: +49 7633 936871; fax: +49 7633 936872. E-mail address: c.holubarsch{at}median-bk.de (C.J.F. Holubarsch).
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Abstract |
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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
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 
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.
Key Words: Crataegus extract WS® 1442 • Congestive heart failure • Survival • Efficacy • Safety • Controlled randomised trial
Received February 27, 2008; Revised July 7, 2008; Accepted October 9, 2008
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