番茄社区

A bempedoic acid/ezetimibe combination pill packed an extra punch for low-density lipoprotein (LDL) cholesterol reduction in patients already on maximally-tolerated statins, according to .

Individuals who were randomized to the combo pill -- with 180 mg bempedoic acid and 10 mg ezetimibe -- showed LDL reduction of 32% at 12 weeks in the 382-patient phase III trial, compared with the following:

• Placebo (3%, P<0.001)
• Ezetimibe 10 mg alone (24%, P<0.001)
• Bempedoic acid 180 mg alone (20%, P<0.001)

In those considered statin-intolerant, a post hoc analysis suggested that the combination pill reduced LDL cholesterol by 43%, versus 1% with placebo, Esperion said.

"Combination ezetimibe/bempedoic acid will be most useful in high-risk, statin-intolerant patients who will get the largest reduction in LDL cholesterol, which is what drives cardiovascular disease event reduction, not titration to an LDL cholesterol goal <70 mg/dl," predicted Jennifer Robinson, MD, MPH, of the University of Iowa in Iowa City, who was not involved in the trial.

"We anticipate the with bempedoic acid [without ezetimibe] will have a similar reduction in the relative reduction in the risk of nonfatal and fatal cardiovascular events proportional to LDL cholesterol lowering as observed in the statin trials," Robinson told 番茄社区.

When it came to serious adverse events and drug discontinuations due to adverse events, the combination pill ran in the middle of the pack.

Besides a decrease in LDL, bempedoic acid/ezetimibe was associated with a 34% drop in high-sensitivity C-reactive protein.

Esperion said it expects top-line results from a with the bempedoic acid/ezetimibe combo in October, with marketing applications filed in early 2019. Esperion was careful to note that it had negotiated a "regulatory pathway" for the combination product with the FDA -- which had not been the case when the company submitted bempedoic acid monotherapy for approval, leading to the FDA's 11th-hour demand in 2016 for the cardiovascular outcomes trial. That is not expected to finish until 2022.

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