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Potential treatment for high cholesterol reaches goals in phase 3 trial

NEW ORLEANS — Bempedoic acid significant lowered LDL cholesterol after 12 weeks in patients at high risk for CV events who also received maximally tolerated statin and other lipid-lowering therapies, according to a presenter at the American College of Cardiology Scientific Session.

Bempedoic acid (Esperion Therapeutics) is an investigational oral, once-daily therapy designed that when activated, “acts in the same cholesterol synthesis pathway as statins,” Anne C. Goldberg, MD, FACP, FAHA, FNLA, professor of medicine at Washington University School of Medicine in St. Louis, said.

Other results from the phase 3 placebo-controlled trial include:

• The lower LDL levels observed at 12 weeks were maintained through 1 year.
• There was no worsening of 12-week glycemic measurements in patients with a history of diabetes;
• The most common adverse events were nasopharyngitis and urinary tract infection.
• There was no significant difference regarding adverse events, serious adverse events, study drug discontinuation due to adverse events and fatal adverse events between study groups.

“All fatal adverse events and serious adverse events were assessed as unrelated to the study medication,” Goldberg added.

 

An investigational oral, once-daily therapy significantly lowered patients' cholesterol, according to a presentation at the ACC Scientific Session.

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New drug applications for bempedoic acid and a bempedoic acid/ezetimibe combination have been submitted to the FDA, according to Esperion.

For more Healio coverage of this study, please click here. - by Janel Miller

References:

Goldberg AC, et al. “Late-breaking clinical trials IV.” Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.

Ray KK, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1803917.

Disclosure: Goldberg reports receiving grants/research support from Amgen, Amarin, Ionis, Pfizer, Regeneron and Sanofi and honoraria from Akcea, Esperion, Merck, the National Lipid Association, Novartis, Regeneron/Sanofi and 23andMe.