The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.

Abstract

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.

• Authors: Christian J F Holubarsch, Wilson S Colucci, Thomas Meinertz, Wilhelm Gaus, Michal Tendera, Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in CHF (SPICE) trial study group
• Journal: European journal of heart failure (Eur J Heart Fail) Vol. 10 Issue 12 Pg. 1255-63 (Dec 2008) ISSN: 1388-9842 [Print] England
• PMID: 19019730 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Plant Extracts

Topics

• Cardiac Output (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)