Study Shows Statin and Antioxidant Therapy to be Superior to Statins Alone in Decreasing Cardiovascular Events in Diabetics with Haptoglobin 2-2
MONTVALE, N.J., March 5 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (Amex: SYI) announces the publication of a pre-planned sub-analysis from the ICARE study demonstrating that the addition of vitamin E to statin therapy prevented more cardiovascular events (heart attack, stroke and cardiovascular death) than statin therapy alone in patients with Diabetes Mellitus (DM) who tested positive for a genetic marker called Haptoglobin 2-2 (Hp2-2). This sub-analysis was published in the March issue of Arteriosclerosis, Thrombosis and Vascular Biology, a journal of the American Heart Association.
"These data are significant because they demonstrate that Haptoglobin testing may help physicians tailor optimal therapy for patients with diabetes who may be at risk for cardiovascular events. Physicians can better describe to their patients whether they are at high risk for a heart attack and whether they may anticipate a lower risk for heart attack if they take vitamin E. The knowledge of who would benefit from this nutriceutical is valuable for patients and physicians and may be cost saving for payers," said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, Inc., which is developing a diagnostic product to identify Haptoglobin types. "This study demonstrates that positive clinical outcomes may be achieved with the application of patient selection. Thus, the 6,000,000 patients in the United States with diabetes and Hp2-2, who are at elevated risk for heart attack, could see that risk reduced by adding an inexpensive therapy, Vitamin E, to their statin therapy."
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 in these studies, research has demonstrated that there is a 2-5 fold increased risk of cardiovascular disease in people with both diabetes and the Hp 2-2 genotype (approximately 40 percent of all diabetes patients).
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing drugs to treat and prevent cardiovascular disease and nephropathy in people with diabetes. The Company believes it has identified several product candidates that represent novel approaches to some of the largest pharmaceutical markets. The Company's portfolio includes orally bioavailable, organoselenium mimics of glutathione peroxidase. These compounds metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. The Company is developing a clinical diagnostic test, based on cardiovascular risk assessment, using Haptoglobin characterization, to identify patients at high risk for cardiovascular complications of diabetes.
Synvista Therapeutics also is developing alagebrium, a proposed breaker of AGEs for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to assemble a sizeable human safety database. For more information, please visit the Company's website at http://www.synvista.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics' product candidates, and other risks identified in Synvista Therapeutics' filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption "Risk Factors" in Synvista Therapeutics' Annual Report on Form 10-K for the year ended December 31, 2006. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics undertakes no obligation to publicly release the result of any revision to these forward- looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
|SOURCE Synvista Therapeutics, Inc.|
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