Navigation Links
Statin Alternative Looks Promising in Early Trials
Date:3/21/2012

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, March 21 (HealthDay News) -- A new anti-cholesterol drug appears safe and effective in people already taking statins such as Lipitor, making it a potential addition to statin therapy or an alternative, a preliminary new study suggests.

Two single-dose trials in healthy volunteers and a multiple-dose trial in a group with high cholesterol showed that the drug, known as a monoclonal antibody, reduced low-density lipoprotein (LDL, or "bad") cholesterol levels an average of 40 percent. The injectable drug was also well-tolerated by all participants, with headache the most commonly reported side effect.

The drug works by attacking a destructive enzyme in the liver, keeping LDL cholesterol from spilling into the bloodstream, according to the report published in the March 22 issue of the New England Journal of Medicine.

"It was entirely safe, as best they could tell, and LDL levels plummeted within a matter of a few days and remained low for three months," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, who was not involved in the study. "If this antibody turns out to be as safe and effective as it appears, this may very well be a very important method for controlling LDL cholesterol, particularly in patients with [drug-resistant] cases."

The study, by Dr. Evan Stein, of the Metabolic and Atherosclerosis Research Center in Cincinnati, and colleagues, was funded by Sanofi and Regeneron Pharmaceuticals -- makers of the antibody.

About one in four Americans aged 45 and older takes statins, which interfere with the production of cholesterol in the liver, to control their high cholesterol levels and improve their odds against heart disease, according to the U.S. Centers for Disease Control and Prevention. While widely effective, some patients experience intolerable side effects -- which include liver damage or muscle pain -- and others don't achieve the recommended LDL blood levels of 70 milligrams (mg) per deciliter or lower for those at risk of heart disease.

Two randomized, single-dose studies of the antibody, known as REGN727, were administered either intravenously (in 40 participants) or by injection (in 32 participants) and compared with a group given an inactive placebo. These trials were followed by a randomized study of multiple doses in 51 adults with high cholesterol who were taking atorvastatin (brand name Lipitor) and whose baseline LDL levels were more than 100 mg per deciliter.

Higher doses of REGN727 lowered LDL cholesterol levels by up to 64 percent, and the effect was similar across the board whether or not participants were also taking a statin, which works by a different mechanism.

Commenting on the study, Christine Metz, head of the Laboratory of Medicinal Biochemistry at the Feinstein Institute for Medical Research in Manhasset, N.Y., said, "The next step would be to test a much larger group of people for a much longer time. But this is very promising, apparently safe under the conditions used, and worth very quickly going forward."

Garratt noted that the new drug, which could take at least several years to reach the market, would need to be injected, since antibodies typically can't be formulated into pills. Such a compound would likely be extremely expensive, especially when compared to statins, which are now available as generic drugs. Also, like statins, such a drug would probably need to be taken for life, he said.

Metz pointed out that the trials were very small and consisted heavily of men, making it hard to generalize results for a broader population.

However, "I thought the study was very beautifully conceived and well done," she added. "It did everything it set out to do."

More information

The U.S. National Library of Medicine has more information about statins.

SOURCES: Kirk Garratt, M.D., clinical director, interventional cardiovascular research, Lenox Hill Hospital, New York City; Christine Metz, Ph.D., head of the Laboratory of Medicinal Biochemistry, Feinstein Institute for Medical Research, Manhasset, N.Y.; March 22, 2012, New England Journal of Medicine


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Small Increase in Diabetes Risk Noted in Statin Patients
2. Statins May Benefit Prostate Cancer Patients
3. Alternative to Statins Shows Promise
4. Statins may slow progression of multiple sclerosis, new study finds
5. Statins May Slow Progression of Multiple Sclerosis, New Study Finds
6. Do Statins Lower Male Sex Drive?
7. Statins Wont Lower Colon Cancer Risk
8. Statins decrease risk of clot-related diseases
9. Statin Use Tied to Eye, Kidney, Liver Troubles
10. Some statins have unintended effects and warrant closer monitoring, study finds
11. Too Many Stroke Patients Go Without Statins
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Statin Alternative Looks Promising in Early Trials
(Date:2/8/2016)... D.C. (PRWEB) , ... February 08, 2016 , ... ... officially launched its newly redesigned website, federallabs.org . The site houses a ... or license available federal technologies through the process called technology transfer (T2). As ...
(Date:2/8/2016)... ... 2016 , ... A man who has struggled to quit smoking, a man who has struggled ... to find solutions to his problems – and he did. Now Nabat, a serial entrepreneur ... introduce his breakthrough inventions to the world and better people's lives. His own experience with ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Bell Agency, ... the latest beneficiary of their ongoing community enrichment program. The current campaign fundraises ... schools. Donations are now being accepted at: http://www.angelsanddoves.com/donate.html . , Angels & ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... that co-occur frequently. While a significant number of women and men with eating ... the trauma itself, that best predicts the development of an eating disorder. ...
(Date:2/8/2016)... ... 08, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to a ... derived from a cluster of melanin when exposed to sunlight. Although most moles are ... lifetime of embarrassment. Historically, mole removal has involved a painful, often expensive ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... -- Avista Pharma Solutions ("Avista Pharma") announced today that it ... (CFO). Mr. Setzer is a finance and operations executive ... within growing technology and life science companies. Prior to ... of Finance at INC Research, a publicly traded clinical ... Previously, Mr. Setzer served as CFO of Expression Analysis, ...
(Date:2/8/2016)... DUBLIN , Feb. 8, 2016 /PRNewswire/ ... announced the addition of the "Label-Free ... Global Forecasts to 2020" report to ... has announced the addition of the ... - Global Forecasts to 2020" report ...
(Date:2/8/2016)... YORK, Pa. , Feb. 8, 2016  Unilife Corporation ... developer and supplier of injectable drug delivery systems, today announced ... and six months ended December 31, 2015 after market close ... not scheduled a conference call to discuss these financial results.  ... About Unilife Corporation --> About Unilife ...
Breaking Medicine Technology: