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USPharma Esperion, a cholesterol-lowering drug that can be used when statins do not work in high-risk patients, is moving closer to the market after a successful Phase III trial.
The trial showed that bempedic acid significantly reduced the "bad" LDL cholesterol and highly sensitive C-reactive protein of biomarkers of inflammation in high-risk patients with elevated LDL cholesterol levels, despite drugs like statins.
Esperion's international study 1 tested the drug versus placebo in 2,230 patients at high risk for atherosclerotic cardiovascular disease (ASCVD), inadequately controlled by lipid-modifying therapies, including maximal doses of statins.
The company has already deposited bempedic acid and a combined pill with ezetimibe from the FDA and the European Medicines Agency.
If approved, the drug could be a serious competitor to Sanofi and Amgen, whose injected PCSK9 inhibitor drugs, Praluent and Repatha, are used in patients with high cholesterol levels despite treatment by the statin.
The study included patients with ASCVD or heterozygous familial hypercholesterolemia with high levels of LDL-C, insufficiently controlled by lipid-modifying therapies, including maximal-dose statins.
They were randomly selected in a ratio of 2: 1 to receive bapeboic acid or placebo, the main objective being the safety and tolerability after one year of treatment.
The secondary objective was to evaluate the efficacy of bempedic acid to lower cholesterol after 12 weeks compared to placebo.
Tertiary objectives were to evaluate the effect of bempedic acid on other lipid parameters and on risk markers, including hsCRP.
The results published in the New England Journal of Medicine showed that after 12 weeks of bempedic acid significantly reduced LDL-cholesterol by 18% compared to statin-tolerated background therapy maximally.
It has reduced the C-reactive protein of high sensitivity by 22%, which is an important marker of the underlying inflammation badociated with cardiovascular diseases.
The drug did not result in higher overall adverse events compared to placebo (78.5% vs. 78.7% with placebo) and the proportion of patients with serious adverse events was similar (14.5% vs. 14%).
There were fewer major adverse cardiac events judged (4.6% vs. placebo 5.7%) and lower rates of onset or worsening of diabetes (3.3% versus 5.4% of a placebo).
Esperion also expects CLEAR OUTCOMES test results, which tests the long-term safety and determines whether the treatment reduces the risk of cardiovascular disease in addition to lowering cholesterol.
Professor Kausik Ray, of the Imperial Center for Prevention of Cardiovascular Disease at the School of Public Health at Imperial College London, said: "This latest study shows that boredoid acid could be another addition to the arsenal of cholesterol-lowering treatments administered once a day. to patients.
"Overall, these recent studies show that the treatment is not only generally well tolerated, that it is comparable to a placebo and that it is potentially safe over longer periods, but that, combined with treatment with high intensity with statins, it can help further lower LDL-cholesterol levels. "
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