In the placebo-controlled ICARE study, more than 3,000 patients were tested for Haptoglobin phenotype, and the 801 patients who had the Hp2-2 phenotype who were also taking statins were randomized to receive either natural source Vitamin E (400 IU daily) or placebo. Results demonstrated a dramatic reduction in the event rate of those taking combination therapy of Vitamin E and statins compared with statin treatment alone (1.3 percent compared with 4.1 percent, respectively, p=0.017) after 600 days.
About the ICARE Study
The ICARE (Israel Cardiovascular events Reduction with Vitamin E) study is a prospective, randomized placebo controlled trial of Vitamin E therapy in individuals with diabetes mellitus and the Haptoglobin 2-2 genotype. The study was conducted in conjunction with the Clalit Health Service in Israel by Andrew Levy, M.D., Shany Blum, M.D., Uzi Milman, M.D., et. al. of the Technion Faculty of Medicine, Technion Institute of Technology, Haifa, Israel. The population-based study of more than 3,000 individuals age 55 and older with diabetes were tested for Hp type and followed for two years in a registry. The study was halted in 2007 based on a 50 percent decrease in cardiovascular events in patients with Hp 2-2 taking Vitamin E, as the primary endpoints had been met.
About Haptoglobin 2-2
The Hp protein is polymorphic in humans, occurring with two alleles, 1
and 2, existing at the Hp genetic locus. Three phenotypes linked to the
three genotypes, Hp 1-1, Hp 1-2 and Hp 2-2, can be identified using an
ELISA assay. In multiple independent prospective longitudinal studies of
more than 20,000 individuals, it has been established that the Haptoglobin
genotype is an independent risk factor for cardiovascular disease, with a
specific relationship to patients with diabetes mellitus. After accounting
for conventional cardiovascular risk factors and diabetes characteristics
|SOURCE Synvista Therapeutics, Inc.|
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