Survival and Prognosis: Investigation of Crataegus Extract WS 1442 in CHF - SPICE – Presented at ACC 2007

Description:

The goal of the trial was to evaluate use of Crataegus Extract WS 1442, an herbal Hawthorn extract, on clinical events among patients with congestive heart failure (CHF).

Study Design

Study Design:

Patients Enrolled: 2,681
Mean Follow Up: 24 months
Mean Patient Age: Mean age, 60 years
Female: 16

Patient Populations:

CHF with NYHA class II or III and LVEF ≤35%

Primary Endpoints:

Composite of cardiac death, MI, or hospitalization due to progression of heart failure

Secondary Endpoints:

Cardiac death; sudden cardiac death

Drug/Procedures Used:

Patients were randomized in a double-blind manner to Crataegus Extract WS 1442 (450 mg twice daily; n = 1,338) or placebo (n = 1,343). Patients were treated with the study drug for 24 months. All patients were also treated with conventional standard therapy for CHF.

Concomitant Medications:

Diuretics (85%), angiotensin-converting enzyme inhibitors (83%), beta-blockers (64%), and nitrates (56%)

Principal Findings:

Mean left ventricular ejection fraction (LVEF) at baseline was 23.8% and 56% were in New York Heart Association (NYHA) class II; 70% of patients had ischemic heart failure.

The primary endpoint of cardiac death, myocardial infarction (MI), or hospitalization due to progression did not differ for the WS 1442 group compared with placebo (27.9% vs. 28.9, hazard ratio [HR] 0.95, p = NS). Cardiac death was lower at 6 months (2.9% vs. 4.9%, p = 0.009), but did not differ at study end (13.5% vs. 14.9%, p = 0.269). Adverse events occurred with a similar frequency in the WS 1442 group and placebo group (67.0% vs. 68.3%), as did serious adverse events (39.2% vs. 41.1%, respectively).

Interpretation:

Among patients with CHF and impaired left ventricular function, treatment with the herbal Hawthorn extract Crataegus Extract WS 1442 was not associated with a significant difference in the primary endpoint of cardiac death, MI, or hospitalization for worsening heart failure through 2 years compared with placebo.

Hawthorn extracts have been used for the treatment of heart disease, but the present study is the first large-scale trial of the effect of an herbal extract on clinical events in heart failure patients also treated with conventional medical therapy. The mechanism of action of WS 1442 is not known, but has been speculated to have a positive inotropic effect as well as anti-ischemic and anti-arrhythmic effects. While some early benefit on cardiac death was observed, there was no difference in cardiac death at study end, nor was there a difference in the primary endpoint.

References:

Presented by Dr. Christian J.F. Holubarsch at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Myocardial Infarction, Ventricular Function, Left, Heart Failure, Stroke Volume, Crataegus, Flavonoids


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