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Novel therapy lowered LDL in patients with diabetes, hypercholesterolemia
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ETC-1002, a novel agent in development by Esperion Therapeutics, lowered LDL levels by nearly 43% in patients with type 2 diabetes and hypercholesterolemia, according to phase 2 study results.
The compound works by activating adenosine monophosphate-activated protein kinase and inhibiting adenosine triphosphate-citrate lyase, according to the study background.
Researchers conducted a single-center, double blind, placebo-controlled trial to evaluate 60 patients with type 2 diabetes and elevated LDL. All participants discontinued antidiabetes and lipid-lowering drugs before the study. Half was randomly assigned ETC-1002 80 mg once daily for 2 weeks followed by ETC-1002 120 mg once daily for 2 weeks. The other half was assigned placebo for 4 weeks.
The primary efficacy endpoint was percent change from baseline to day 29 in calculated LDL.
At day 29, the ETC-1002 group had mean lowered LDL levels by 42.9% compared with 4% for the placebo group (P<.0001), Maria J. Gutierrez, MD, FACR, CPI, of Comprehensive Clinical Development in Miramar, Fla., and colleagues found.
The ETC-1002 group had a mean reduction in non-HDL of 32% compared with 0.5% for the placebo group (P<.0001) and a mean reduction in total cholesterol of 25.1% compared with 0.5% for the placebo group (P<.0001). The researchers found no difference between the groups in change in HDL levels.
High-sensitivity C-reactive protein was reduced by a median of 41% in the ETC-1002 group compared with 11% in the placebo group (P=.0011).
The researchers found no clinically meaningful safety issues. There were 45 adverse events in 14 patients from the ETC-1002 group compared with 52 adverse events in 21 patients in the placebo group. The most common adverse event was hyperglycemia, which occurred more frequently in the placebo group.
“This degree of LDL reduction is impressive, approaching the effect of high-intensity statin therapy,” Ronald Goldberg, MD, of the University of Miami School of Medicine, wrote in a related editorial.
The present findings, besides previous data, “provide a basis for anticipating that this agent, in contrast to statins, does not aggravate glucose intolerance and, like metformin, may reduce hepatic glucose production and improve insulin sensitivity,” Goldberg wrote.
For more information:
Goldberg R. Arteriorscler Thromb Vasc Biol. 2014;34:477-478.
Gutierrez MJ. Arteriorscler Thromb Vasc Biol. 2014;34:676-683.
Disclosure: The study was funded by Esperion Therapeutics. Gutierrez and Goldberg report no relevant financial disclosures. The other researchers are employees of or consultants for Esperion Therapeutics.