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

TY - JOUR

T1 - The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial

AU - Holubarsch, Christian J F

AU - Colucci, Wilson S

AU - Meinertz, Thomas

AU - Gaus, Wilhelm

AU - Tendera, Michal

AU - Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in CHF (SPICE) trial study group

PY - 2008/12

Y1 - 2008/12

N2 - 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.

AB - 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.

KW - Cardiac Output/drug effects

KW - Confidence Intervals

KW - Crataegus/adverse effects

KW - Death, Sudden, Cardiac/prevention & control

KW - Double-Blind Method

KW - Exercise Tolerance/drug effects

KW - Female

KW - Heart Failure/drug therapy

KW - Heart Rate/drug effects

KW - Humans

KW - Male

KW - Middle Aged

KW - Phytotherapy

KW - Plant Extracts/adverse effects

KW - Stroke Volume/drug effects

KW - Survival Analysis

KW - Ventricular Function, Left/drug effects

U2 - 10.1016/j.ejheart.2008.10.004

DO - 10.1016/j.ejheart.2008.10.004

M3 - SCORING: Journal article

C2 - 19019730

VL - 10

SP - 1255

EP - 1263

JO - EUR J HEART FAIL

JF - EUR J HEART FAIL

SN - 1388-9842

IS - 12

ER -