new drugs along with statin...

[Guest guest]

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. 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