Navigation Links
American Heart Association Late Breaking Clinical Trial Report: In Patients on Statins, Raising Good Cholesterol with Niacin, but not Reducing Bad Cholesterol with Ezetimibe, Decreases Plaque Build-Up
Date:11/15/2009

Study highlights:

In patients with or at high-risk for coronary artery disease and LDL (bad cholesterol) treated with statins to < 100mg/dL but low HDL (good cholesterol), adding medication to raise HDL was compared with lowering LDL further.

Patients were randomized to the addition of niacin (primarily to raise HDL), or ezetimibe (to further lower LDL cholesterol). Plaque buildup in the lining of the neck arteries was significantly reduced only in the niacin group.

DUE TO AN EMBARGO BREAK, THE EMBARGO ON THIS STUDY IS RELEASED

ORLANDO, Fla., Nov. 15 /PRNewswire-USNewswire/ -- In combination with statins, adding a medication that raises high-density lipoprotein (HDL) cholesterol was more effective in reversing artery wall plaque buildup and in reducing heart disease risk than adding a drug that lowers low-density lipoprotein (LDL) cholesterol, researchers reported today at the American Heart Association Scientific Sessions 2009.

In the study titled The Effect of Extended-release Niacin or Ezetimibe Added to Chronic Statin Therapy On Carotid Intima Media Thickness (ARBITER 6-HALTS), researchers found:

  • Adding the cholesterol drug niacin to a statin improved HDL ("good") cholesterol levels and significantly reduced arterial plaque buildup within 8 months, with further improvement seen at the end of the study (14 months).
  • A second approach, adding ezetimibe to a statin, lowered LDL ("bad") cholesterol to a greater extent, but did not raise HDL. With it, there was no overall effect on arterial build up in the neck arteries.
  • With ezetimibe, greater reductions in LDL cholesterol paradoxically were associated with more arterial buildup, a result opposite to that expected.
  • The incidence of major cardiovascular events such as fatal and non-fatal heart attack was higher in the ezetimibe group as compared to the niacin group (5 percent vs. 1 percent).

HDL And LDL Treatment Strategies (HALTS) was a prospective, randomized, parallel group, open-label, blinded endpoint study conducted at Walter Reed Army Medical Center in Washington, D.C., and Washington Adventist Hospital in Tacoma Park, Md. It included 363 adults (80 percent male, average age 68 years) with or at high risk for atherosclerotic cardiovascular disease.

All participants were on cholesterol-lowering statin drugs, and their LDL cholesterol was at the treatment goal of under 100 milligrams per deciliter (mg/dL) of blood. Their HDL cholesterol was lower than 50 mg/dL for men and 55 mg/dL for women.

The researchers randomly assigned the subjects to receive either niacin or ezetimibe in addition to their usual statin. The primary endpoint was the change in the wall thickness of the carotid artery in the neck between the two groups of patients. In June, researchers halted the trial early because the primary endpoint was met. Specifically, 14-month follow-up data on 208 patients showed that in the niacin group, average HDL cholesterol rose from 42 mg/dL to 50 mg/dL and there was a significant regression in artery wall thickness. In the ezetimibe group, average LDL cholesterol levels dropped from 83 mg/dL to 66 mg/dL; however no overall change was found in average artery wall thickness.

LDL cholesterol is generally linked to the buildup of plaque in the arteries, which makes them more likely to become narrowed, and can lead to heart attack or stroke. HDL cholesterol helps clear LDL cholesterol from the blood in a process called reverse cholesterol transport.

"These findings for ezetimibe are counter to the prevailing understanding of LDL cholesterol -- that lowering LDL cholesterol results in slowing of the atherosclerotic process as has been convincingly shown for other classes of lipid modifying drugs, such as statins and bile acid resins," said Allen J. Taylor, M.D. FAHA, principal investigator of the study and director of Advanced Cardiovascular Imaging and the Lipid/Prevention Clinic in the Department of Medicine (Cardiology) at Washington Hospital Center in Washington, D.C.

In earlier studies demonstrating the protective effects of statins, researchers found strong associations between LDL cholesterol reduction and the prevention of cardiovascular disease. Consequently, many people now view LDL cholesterol reduction as a way to measure whether a treatment will be useful.

But HALTS researchers' findings "challenge the use of LDL reduction as a guaranteed surrogate for clinical performance, particularly for new clinical compounds, and in this particular case, ezetimibe," Taylor said. Patients should know their HDL numbers and, if they are low, ask their doctors if adding a treatment such as niacin is right for them once their LDL is treated to goal with a statin drug, he said.

Co-authors are: Todd C. Villines, M.D.; Patrick J. Devine, M.D.; Mark Turco, M.D.; Len Griffen, M.D.; Michael Miller, M.D.; Eric J Stanek, Pharm. D.; and Neil J Weissman, M.D.

Study sponsor: Abbott Inc. (initially Kos Pharmaceuticals, Inc., Cranbury, N.J.) provided an unrestricted, investigator-initiated research grant administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine in Rockville, Md. The investigators were solely responsible for all aspects of the study and the final decisions on manuscript content.

Disclosures: Dr. Taylor reports receiving lecture fees from Abbott. Dr. Turco reports receiving consulting and lecture fees from Abbott Cardiovascular. Dr. Miller reports receiving lecture fees and grant support from Merck-Schering Plough. Dr. Villines reports receiving lecture fees from Novartis Pharmaceuticals. Dr. Devine reports receiving consulting fees from Medacorp, MDLinx, and Guidpoint Global, equity ownership in Evergreen solar, Openwave, Unifi, Novavax, Genaera Pharm, and Generex Biotech. Dr. Stanek is senior director of research in Personalized Medicine Research and Development at Medco Health Solutions, Inc. (Franklin Lakes, N.J.), but all work performed on this trial was independent of this relationship. No other potential conflict of interest was reported.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

NR09 - 1164 (SS09/ARBITER 6-HALTS Taylor)

SOURCE American Heart Association


'/>"/>
SOURCE American Heart Association
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. American Heart Associations Scientific Sessions Media Alert
2. American Heart Association Late Breaking Clinical Trial Report: Tests Predict Which Patients Are Resistant to Anti-Clotting Therapy During Angioplasty, Stenting
3. LTC Awareness Month Finds Americans Still in Dark about Long-Term Care
4. New Poll Finds 71 Percent of Americans Favor Investing More in Disease Prevention as Central to Health Reform
5. Regence Recognized as an American Heart Association Start! Fit-Friendly Company
6. African-Americans with colorectal cancer have poorer outcomes, lower survival rates
7. American Red Cross Auctions Historical Artifacts Through OLS Trading, Inc
8. American Academy of Physician Assistants Applauds U.S. House of Representatives for Passing Health Care Reform Bill
9. Give an Hour(TM) Partners with American Red Cross and Calls All Mental Health Professionals in Texas to Volunteer Their Services
10. Statement by American Heart Association CEO Nancy Brown on Passage of the Affordable Health Care for America Act in the U.S. House of Representatives
11. Americans United for Life Action Comments on Passage of Pro-Life Amendment: Bipartisan Pro-life Majority Reflects the Will of the American People
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
Breaking Medicine Technology: