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:10/13/2017)... ... 2017 , ... As health professionals work to improve their approach to healthcare, ... doing more than filling out a survey; in many cases health professionals and patients ... health care and research on the importance of active engagement with patients and members ...
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has ... today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula ... the highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., ... analytics, today announced that it has been ranked #1 by ... Black Book™ Rankings 2017 User Survey. ZirMed was recognized ... for large hospitals and medical centers over 200 beds and ... Book,s healthcare technology user survey history. ...
(Date:9/12/2017)... -- Consumer reviews on the independent review site Consumer Affairs ... for hearing aids, ranking it higher than Miracle Ear ™, ... ... Hearing Aids ... store that provides high performance, state-of-the-art, German-engineered hearing aids directly to ...
Breaking Medicine Technology: