The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial
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The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial. / Holubarsch, Christian J F; Colucci, Wilson S; Meinertz, Thomas; Gaus, Wilhelm; Tendera, Michal; Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in CHF (SPICE) trial study group.
in: EUR J HEART FAIL, Jahrgang 10, Nr. 12, 12.2008, S. 1255-1263.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -