|
An experimental drug more than doubles the level of good cholesterol and cuts the bad kind nearly in half without the blood pressureincrease linked to another agent in its class, according tolate-breaking clinical trial results presented at the AmericanHeart Association's Scientific Sessions 2010. Determining the EFficacy and Tolerability of CETP INhibition withAnacEtrapib (DEFINE) is a randomized, double-blind trial of 1,623patients who took either 100 milligrams (mg) of thecholesterylester transfer protein (CETP) inhibitor anacetrapib, ora placebo for 18 months at 153 centers in 20 countries. Thepatients were already being treated with a statin and/or otherlipid-lowering medicine and had achieved their goal level oflow-density lipoprotein (LDL) cholesterol. The study's primary endpoints were the percent change in LDL, knownas the "bad" cholesterol associated with the development of cloggedarteries, and safety as measured by a number of clinical andlaboratory measures as well as cardiovascular (CV) events. Anacetrapib reduced LDL by 40 percent - from 81 milligrams perdeciliter (mg/dL) to 49 mg/dL. It also more than doubled the levelof high-density lipoprotein cholesterol (HDL) that helps clearlipids from the bloodstream - from 40 mg/dL to 101 mg/dL - withoutraising blood pressure. "Anacetrapib has a knock-your-socks-off effect on HDL and ajaw-dropping effect on LDL," said Christopher P. Cannon, M.D.,senior investigator of the TIMI Study Group in the cardiovasculardivision of Brigham and Women's Hospital in Boston, Mass. "Thesechanges are striking because virtually all the patients in thestudy were already taking cholesterol-lowering drugs and achievedpreviously unattainable levels of good and bad cholesterol." The experimental drug is one of a new class that blocks the abilityof the CETP enzyme to transfer cholesterol particles from the goodHDL to the bad LDL. Elevated LDL and low levels of HDL are both risk factors forcardiovascular disease. Statins reduce LDL and lessencardiovascular risk. Despite statin therapy, many patients stillhave a high risk of cardiovascular disease. High natural levels of HDL are associated with lower cardiovascularrisk, which is why researchers have been looking for ways toincrease HDL levels, said Cannon, an associate professor ofmedicine at Harvard Medical School. "No treatments raise HDL levels as substantially as seen here (morethan doubling of the levels)," said Cannon. Patients in DEFINE were 62.5 years old on average; 23 percent werewomen; 17 percent were Asian, black or multiracial and 15 percentwere Hispanic. The study included interim safety analyses at sixand 12 months, and researchers found no change in blood pressure orelectrolytes among participants. Levels of aldosterone, a hormone produced in the adrenal gland thataffects kidney function and blood pressure, didn't change. Theresearchers also found no increase in muscle problems or liverfunction abnormalities between groups - a side effect occasionallyassociated with statins. Although the study was not designed or powered to assess theeffects of anacetrapib on cardiovascular events, fewercardiovascular events occurred in the anacetrapib group than in thestatin-only group. The full efficacy and safety of anacetrapib willbe evaluated in a larger Phase III trial, Cannon said. "This agent provides us a very strong add-on treatment to statinsthat dramatically increases the good cholesterol and dramaticallyfurther decreases the bad cholesterol," he said. "If thecardiovascular effects are borne out by future research, it wouldbe a very promising approach to reducing cardiovascular events inpatients with or prone to atherosclerosis." Co-authors are Sukrut Shah, R.Ph., Ph.D.; Hayes M. Dansky, M.D.;Michael Davidson, M.D.; Eliot A. Brinton, M.D.; Antonio M. GottoJr., M.D., D.Phil.; Michael Stepanavage, M.S.; Sherry Xueyu Liu,M.S.; Patrice Gibbons, M.S.; Tanya B. Ashraf, B.A.; JenniferZafarino, M.S.; Yale Mitchel, M.D. and Philip Barter, M.D., Ph.D.Author disclosures are on the abstract. Merck Research Laboratories, Rahway, N.J., funded the study. Source: American Heart Association Additional References Citations. We are high quality suppliers, our products such as S Type Turbine , Pelton Turbine Runner for oversee buyer. To know more, please visits Bulb Hydro Turbine.
Related Articles -
S Type Turbine, Pelton Turbine Runner,
|
