Navigation Links
Study Raises New Questions About Cholesterol Drug Zetia
Date:11/16/2009

It was found less effective than extended-release niacin, or Niaspan

SUNDAY, Nov. 15 (HealthDay News) -- A new study raises more questions about ezetimibe (Zetia), a drug used by millions of Americans in tandem with statins to lower LDL, or "bad," cholesterol.

The trial, known as ARBITER-6 HALTS, was stopped early in June after it was discovered that LDL-cholesterol-lowering Zetia was less effective than extended-release niacin (Niaspan), which raises HDL, or "good," cholesterol levels, in reducing plaque build-up in the arteries.

Clinical trials are generally terminated early if a safety issue arises, less so when a measure of success is achieved.

The niacin combination also reduced the number of heart attacks and deaths.

"This trial provides a clear and undeniable statement on the superior clinical effectiveness of niacin over ezetimibe," study principal investigator Dr. Allen Taylor, director of Advanced Cardiovascular Imaging and the Lipid/Prevention Clinic at Washington Hospital Center in Washington, D.C., said at a Sunday afternoon news conference.

The study was funded by the pharmaceutical company Abbott Laboratories, which makes Niaspan, and Taylor and other study authors have received consulting fees from the company. Merck & Co. makes Zetia.

Taylor presented the findings at the American Heart Association's annual meeting in Orlando, Fla. The report was also released early online Nov. 16 in the New England Journal of Medicine.

"This trial showed the clear superiority of niacin over ezetimibe. I would say that the combination of LDL-lowering and HDL-increasing with niacin was associated with a greater regression of atherosclerosis," added Dr. John J.P. Kastelein, author of one of two editorials accompanying the paper. Kastelein is with the department of vascular medicine, Academic Medical Center, Meibergdreef, the Netherlands.

The current evidence on Zetia and a related drug, Vytorin, both made by Merck, have not been overwhelmingly positive. One study found that the combination of Vytorin and a statin was no better than the statin on its own.

Although statins -- drugs such as Crestor, Lipitor and Zocor -- reduce LDL cholesterol levels in a great many patients, some people need additional therapy. The ARBITER-6 HALTS study looked at either raising HDL levels (Niaspan) or further lowering LDL levels (Zetia).

The study enrolled 363 patients with or at high risk for heart disease, but was stopped after only 208 participants had finished the full 14 months.

Patients taking extended-release niacin, to boost HDL levels, in addition to a statin had less plaque build-up and fewer cardiovascular "events," such as heart attacks, compared to patients taking the combination drug Zetia, which delivers both a statin and ezetimibe, both of them dampening LDL levels.

Participants taking Zetia had more plaque build-up in their carotid artery.

In an accompanying editorial in the journal, researchers at Johns Hopkins University said the study findings were too preliminary to warrant any changes in how doctors treat high-risk patients.

Merck stood by its product. "The results of the small ARBITER 6 study do not, in any way, change our view of Zetia and Vytorin as effective medicines for fighting LDL cholesterol," said Peter S. Kim, president of Merck Research Laboratories. "Nothing from this study ... changes the well-established understanding that lowering LDL cholesterol is the primary target of therapy according to the guidelines. Zetia and Vytorin, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol."

And American Heart Association spokesman Dr. Robert Eckel recommended waiting for safety results from a larger ongoing trial involving Zetia, while emphasizing that there is no clear reason to stop using Zetia.

"I would caution the public and prescribing community about reaching conclusions too early," he said. "At this point, there is no evidence that the drug does harm. I see no reason at this point to be concerned about using ezetimibe as an LDL-lowering therapy as an option for patients who need a further decision made about their treatment."

Taylor said over-the-counter niacin, a B vitamin, "is not considered a useful alternative to prescription niacin. Its safety and efficacy are unknown."

More information

The American Heart Association has more on cholesterol.



SOURCES: Nov. 15, 2009, press conference with Allen Taylor, M.D., director, Advanced Cardiovascular Imaging and the Lipid/Prevention Clinic, Washington Hospital Center, Washington, D.C.; John J.P. Kastelein, M.D., Ph.D., department of vascular medicine, Academic Medical Center, Meibergdreef, the Netherlands; and Robert Eckel, M.D., American Heart Association spokesman; Nov. 15, 2009, news statement, Merck & Co.; Nov. 16, 2009, New England Journal of Medicine, online; Nov. 15, 2009, presentation, American Heart Association annual meeting, Orlando, Fla.


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... (PRWEB) , ... February 09, 2016 , ... On January ... family scheduled an appointment after they noticed their furnace not producing any heat. Shortly ... heat exchanger. The cracked heat exchanger was leaking dangerous levels of carbon monoxide into ...
(Date:2/9/2016)... ... ... METTLER TOLEDO has published a new guide entitled “Essential ... the techniques they use so they can more easily spot potential error sources ... to create a leaner overall lab experience. , The new guide offers ...
(Date:2/9/2016)... ... ... i2i Systems, an early innovator and developer of population health management technology, ... report, Population Health Management 2015: How Far Can Your Vendor Take You? , ... The latest KLAS Report, leveraging over 200 user interviews, shines a light on ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... Nutrition into the Food & Beverage and Dietary Supplement ... partner throughout Canada and USA geographies east of the Rocky Mountains since 2012. ...
(Date:2/8/2016)... ... February 08, 2016 , ... Brenton ... for pouches, bags, and flow wrapped products at WestPack 2015, February 9-11, in ... manufacturers step up to semi-automatic or fully-automatic case packing with a small footprint, ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... N.J. , Feb. 9, 2016  Bluestar Silicones ... (LSR) product line for long-term implant applications and ... Medical Design & Manufacturing (MD&M) West Conference (Booth ... --> --> ... Silbione® Biomedical LSRs offer outstanding physical properties enabling ...
(Date:2/8/2016)... , Feb.8, 2016 Respiratory Devices - ... GlobalData,s Medical Devices sector report, " Respiratory Devices ... an overview of Respiratory Devices currently in pipeline ... the pipeline products with comparative analysis of the ... reviews major players involved in the pipeline product ...
(Date:2/8/2016)... , Feb. 8, 2016 CBG Technologies, ... PW Series Solvent Recycling Systems, specifically designed for ... integration with new and existing vapor degreasers, parts ... consistently-fresh solvent through continuous recycling and recovers 100% ... --> --> Precision parts manufacturers ...
Breaking Medicine Technology: