Tuesday, Nov. 15, 2011, Cleveland, OH: Researchers at Cleveland Clinic reported today that administration of a new drug- evacetrapib - can dramatically increase HDL (good) cholesterol, while significantly lowering LDL (bad) cholesterol). At the highest tested dosage, the levels of HDL more than doubled.
The study was presented today by lead investigator Stephen Nicholls MD PhD, Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research (C5), at the American Heart Association's Scientific Sessions in Orlando, Fla. The results of this Phase II clinical trial were simultaneously published in the Journal of the American Medical Association.
There were initially 1154 patients screened at 70 site locations, with 398 patients randomized for the trial. Evacetrapib (500 mg) produced an HDL increase that ranged from 53.6 percent to 128.8 percent, while decreasing LDL by 13.6 percent to 35.9 percent. When combined with statin therapy, evacetrapib (100mg) increased HDL by 79.9 percent to 94 percent and further decreased LDL.
"In this study, evacetrapib was able to show striking increases in HDL while significantly lowering LDL," said Dr. Nicholls. "The next step will be a large cardiovascular outcome trial to determine if this drug can reduce cardiovascular morbidity and mortality."
Evacetrapib belongs to a new class of drugs under development known as cholesteryl ester transfer protein (CETP) inhibitors. The first drug in the class, torcetrapib, failed due to unexpected toxicity, but many researchers believe that newer compounds such as evacetrapib may avoid this toxicity. In the current trial, evacetrapib showed none of the adverse effects noted with torcetrapib. Specifically, evacetrapib resulted in no increase in blood pressure or adrenal synthesis of aldosterone or cortisol.
Despite the benefits of statins, cardiovascular disease remains the No. 1 cause of death in both men and women in developed countries. Accordingly, considerable efforts have focused on development of new therapeutic agents designed to address residual cardiovascular risk.
Dr.Nicholls served as Principal Investigator for the trial and Steven Nissen, M.D. served as Study Chairman. Both Cleveland Clinic physicians.
About Cleveland Clinic
Celebrating its 90th anniversary, Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. It was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, eight community hospitals and 16 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 155,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at http://www.