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Herbal extract extends life for heart failure patients

March 28, 2007

Compound is shown to be safe; adds 4 months to patient survival

An herbal medicinal substance, Crataegus Extract WS®1442, safely extends the lives of congestive heart failure patients already receiving pharmacological treatment for the disease, according to a study presented today at the American College of Cardiology's 56th Annual Scientific Session. Crataegus Extract WS®1442 is an extract of leaves of the Crataegus tree, and is a natural antioxidant. The herb is currently approved for use in some European countries to treat early congestive heart failure, a condition in which the heart cannot pump enough blood to the body's other organs. ACC.07 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further breakthroughs in cardiovascular medicine.

The randomized, double-blind trial, known as the SPICE study, was conducted at 156 centers in Europe. The majority of the patients were male (84 percent) and nearly half the group (44 percent) were classified as NYHA III, meaning they were significantly impaired by their heart condition. The primary endpoint of the study was time to first cardiac event, including sudden cardiac death, death due to progressive heart failure, fatal heart attack, non-fatal heart attack or hospitalization due to heart failure.

A total of 2,681 patients with markedly impaired left ventricular function - indicating advanced congestive heart failure - were randomized to WS®1442 or placebo for a duration of two years. All patients were already receiving pharmacological therapy with ACE-inhibitors (83 %), beta-blockers (64 %), glycosides (57 %), spironolactone (39 %) and diuretics (85 %).

Dr. Christian J. F. Holubarsch and his team saw a 20 percent reduction in cardiac-related deaths among patients on WS®1442, extending patients' lives by four months during the first 18 months of the study. The safety of the compound was confirmed by a lower number of adverse events among the study group than those on placebo.

"WS 1442 is safe in patients with more severe congestive heart failure and left ventricular ejection fraction lower than 35 percent," said Dr. Holubarsch of Median Kliniken Hospitals in Bad Krozingen, Germany, and lead study author. "It postpones death of cardiac cause after 18 months and sudden cardiac death in an important subgroup of patients."

Dr. Holubarsch wil present "Crateagus Extract WS 1442 Postpones Cardiac Death in Patients With Congestive Heart Failure Class NYHA II-III: A Randomized, Placebo-Controlled, Double-Blind Trial in 2,681 Patients" on Tuesday, March 27 at 8:30 a.m. in Hall A.

American College of Cardiology