[acb-diabetics] new drugs along with statin...

[Patricia LaFrance-Wolf]

and appeared in  

Issue 513

New Drug Reduces Cholesterol without Statin Side Effects

A new drug, eprotirome, has been shown to significantly lower bad
cholesterol, triglycerides and Lp(A), without the side effects that statins
cause in many

people.

Advertisement 

Dr. John Baxter, director of the Genomic Medicine Program at The Methodist
Hospital Research Institute, Houston, TX, and co-author for the study,
stated

that, "Our study has shown a dramatic reduction in the dangerous fats that
cause heart disease, the number one killer of Americans." 

"For patients taking a statin, this drug can further lower LDL cholesterol
by 25 percent -- on top of what the statin is doing. It is also as potent in

lowering triglycerides as any current medication available today," Baxter
added. "It also lowers Lp(a), which is an under recognized factor that also
causes

atherosclerosis and is a common cause of heart attack in young people. Thus,
eprotirome could be a major complement to the only current medication for

this condition, niacin, which causes flushing side effects." 

While statins remain the gold standard for cholesterol reduction today, they
are still limited in helping patients reach strident goals set to reduce a

patient's risk for heart disease and heart attack, and they can have
significant side effects, Baxter added.  

Results from the study show that eprotirome could be used in addition to
statins to help patients who have not been able to reach their cholesterol
goals,

or could be used to reduce the statin dose to decrease statin side effects
including muscle pain and bone loss. 

The phase II clinical trial evaluated eprotirome, a liver selective thyroid
hormone receptor agonist, and its ability to further reduce serum LDL
cholesterol

levels in statin-treated patients.

The study was a randomized, placebo-controlled, double-blind multi-center
trial that lasted three months. It was designed to assess the safety and
efficacy

of eprotirome (KB2115) in lowering the serum concentration of LDL
cholesterol and other atherogenic lipids in patients with high cholesterol
who are already

taking simvastatin or atorvastatin.  

In all, 329 patients were screened for the study, of which 189 were
randomized and included in the trial. In addition to statin treatment, they
received

either eprotirome 25, 50, or 100 mcg per day or placebo. Primary outcome was
LDL cholesterol and secondary outcomes were changes in serum apo B,
triglyceride,

and Lp(a) concentrations. Safety monitoring included assessments of
potential adverse thyroid hormone-like effects on the heart, bone, and
pituitary. 

The addition of eprotirome to statin treatment for 12 weeks resulted in
placebo-adjusted reductions in serum LDL-cholesterol concentrations of -15
percent,

-20 percent, and -26 percent with daily 25 mcg, 50 mcg and 100 mcg
eprotirome, respectively. Similar reductions were seen in serum apo B (-14
percent,

-19 percent, and -24 percent), triglycerides (-20 percent, -20 percent, and
-37 percent), and Lp(a) (-17 percent, -22 percent, and -34 percent). These

effects on atherogenic lipid variables were similar in magnitude to those
found in a previous study where eprotirome was given as monotherapy,
indicating

a full additive effect on top of statins. Eprotirome therapy was clinically
very well tolerated without adverse cardiac or bone or pituitary effects.
The

frequency, pattern and intensity of adverse events were similar in placebo
and eprotirome-treated patients.

NEJM, March 11, 2010   

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://www.acb.org/pipermail/acb-diabetics/attachments/20100322/4e9ed1ab/attachment.htm>