Cholesterol levels drop by 26%! Complementary therapy achieved 3 positive developments

Cholesterol levels drop by 26%! Complementary therapy achieved 3 positive developments

May 29, 2018 Source: WuXi PharmaTech

Recently, Esperion, based in Ann Arbor, Mich., announced positive top-line data for its low-density lipoprotein cholesterol (LDL-C) study in the key phase 3 clinical trial of study drug bempedoic acid, Study 3 (1002-046). The data presented this time is the third in a key Phase 3 clinical trial of Esperion's five bempedoic acid alone and combination therapies, which performed well in both previously published trials and reached the primary study endpoint.

High levels of LDL-C can lead to accumulation of fat and cholesterol in and around the arterial wall, known as atherosclerosis, which can lead to cardiovascular events including heart disease or stroke. In the United States, there are 78 million people or more than 20% of the population with higher LDL-C. There are 73 million people in Europe, 30 million people in Japan, and elevated LDL-C. There are approximately 13 million patients with atherosclerotic cardiovascular disease (ASCVD) in the United States, and even with the highest tolerated dose of lipid modification therapy (including those who are intolerant to statins), there is still a higher level of LDL-C. , leading to a higher risk of cardiovascular events. The vast majority of these patients (9.5 million) need to reduce LDL-C by nearly 30% to achieve treatment goals.

Esperion is committed to providing patients with daily oral therapy to supplement existing treatments to help these patients achieve additional LDL-C goals. Bempedoic acid is a first-in-class daily, supplemented, orally administered ATP citrate lyase (ACL) inhibitor that lowers cholesterol biosynthesis and lowers LDL-C levels by upregulating LDL receptors. Similar to statins, bempedoic acid also reduces high-sensitivity C-reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease. Currently, Phase 1 and Phase 2 studies on bempedoic acid have been completed, monotherapy has reduced LDL-C by up to 30%, and combined with ezetimibe reduces LDL-C by about 50%, adding stable statins. There is an additional 20% reduction in treatment.

The results of this publication were based on a 24-week globally randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the safety of a daily dose of 180 mg of bempepoic acid versus placebo. Effectiveness. The trial was conducted in a total of 345 patients with hypercholesterolemia who were considered to be statin intolerance and they were already receiving background lipid modification therapy. These patients were treated with bempedoic acid and placebo in a 2:1 ratio.

â–²Esperion company research product line (Source: Esperion official website)

The results showed a total reduction of LDL-C of 26% (absolute reduction of 43 mg/dL) in patients treated with bempedoic acid at weeks 12 and 24, compared with 2% in the placebo group (p<0.001). ). In the intention-to-treat (ITT) analysis, the study achieved a primary endpoint of a 23% reduction in LDL-C (absolute reduction of 39 mg/dL) at week 12, compared with a 1% reduction in the placebo group (p < 0.001). In addition, hsCRP was significantly reduced by 25% in the bempedoic acid group compared with placebo, compared with 3% in the placebo group (p < 0.001). In addition, bempedoic acid was safe and well tolerated and no death was observed in any of the groups.

"The data set obtained in this study is reassuring and highly consistent with our previous bempedoic acid research data. For patients with hypercholesterolemia who are intolerant of statin and have limited treatment options, bempedoic acid is a meaningful LDL-C-lowering drug and can reduce hsCRP levels as well as statins. The medical community needs a New oral therapies provide effective, well-tolerated and easy-to-use treatments for these complex patient populations that have no other treatment options."

Dr. Tim M. Mayleben, President and CEO of Esperion, said: "These results and the extensive evidence that bepedoic acid can be a high-risk group of ASCVD patients or ASCVD requiring additional LDL-C reduction, especially those with statin intolerance Patients are provided with an important new complementary and convenient daily oral regimen. We are eagerly awaiting the results of Phase 3 clinical trials of our major candidate beepedoic acid/ezetimibe combination therapy in late August, and late September. The fourth and final results of the clinical phase 3 study of bempedoic acid. Both studies included ASCVD patients who received the highest tolerated dose of statin therapy. The medical community is looking forward to a new type of once-a-day Oral therapy can complement existing oral medications and provide high-risk patients with the desired LDL-C and hsCRP-lowering effects, as well as the convenience and tolerance that patients need and deserve."

We hope that the follow-up clinical trials of this drug will continue to achieve good results, and provide patients with new and convenient cholesterol-lowering therapies as soon as possible.

Reference materials:

[1] Esperion AnnouncesThird Pivotal Phase 3 Study of bempedoic acid Meets Primary Endpoint

[2] Esperion Therapeutics Official Website

[3] Esperion's LDL drugaces a third pivotal trial

[4] WuXi PharmaTech - 3 new positive progress in cholesterol-lowering drugs

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