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Eprotirome responses signal potential as add-on CV therapy

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American College of Cardiology’s 58th Annual Scientific Sessions

Patients with primary hypercholesterolemia assigned to daily eprotirome experienced LDL reductions ranging from 21% to 32% after 12 weeks, according to data presented at the American College of Cardiology’s 58th Annual Scientific Sessions.

Eprotirome, a selective thyromimetic designed to act on the liver, mimics the beneficial effects of thyroid hormone on lipid levels.

Results demonstrate that “eprotirome is an attractive add-on to current lipid-lowering therapy, and particularly for patients with mixed dyslipidemia,” said Bo Angelin, MD, PhD, professor of clinical metabolism at Karolinska Institute and head of the Center for Metabolism and Endocrinology at Huddinge University Hospital in Sweden.

The phase-2 study included 189 patients with LDL >116 mg/dL already taking statins. Patients were randomly assigned to one of four daily doses: placebo; 25 mcg; 50 mcg; or 100 mcg.

Twelve weeks of treatment revealed a dose-related LDL reduction compared with baseline. Patients assigned to 100 mcg had a 32% reduction, followed by 26% with the 50 mcg dose and 21% with the 25 mcg dose.

Eprotirome reduced triglycerides up to 44% compared with placebo — 33% with the highest dose and 15% for the 50 mcg and 25 mcg doses.

Other CV risk factors were also improved with eprotirome, including apolipoprotein (reduction range, 20% to 30%), lipoprotein(a) (27% to 41%) and non-HDL (20% to 32%).

Safety analyses support that the function of eprotirome is restricted to the liver. Researchers observed no adverse changes in heart rate, cardiac rhythm, hypothalamic-pituitary-thyroid axis or markers of bone and skeletal muscle. Further, eprotirome was well tolerated by the patient population. – by Katie Kalvaitis

This was a very nice and interesting presentation of a new mechanism that could be of clinical benefit in the future. It was remarkable that we saw the drop in key markers of risk, and all of these off-target effects look very good.

– Robert M. Califf, MD

Vice Chancellor for Clinical Research and Professor of Medicine
Division of Cardiology, Duke University

For more information:

• Kristensen J. #404. Presented at: American College of Cardiology’s 58th Annual Scientific Sessions; March 29-31, 2009; Orlando, Fla.