They were split into 2 groups. The average age of the people involved was 66. THURSDAY, March 14, 2019 (HealthDay News) -- People whose high cholesterol is resistant to treatment with statin drugs may soon have a new treatment option. Professor Kausik Ray, from Imperial College London's School of Public Health, who led the study, said: "We know that reducing your cholesterol levels is key to cutting the risk of heart attack and stroke, particularly if you already have established heart disease. However, the number of people experiencing side effects that led to them stopping the drug was slightly higher in the bempedoic acid group (10.9% compared with 7.1% in the placebo group). The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The research, published today in the New England Journal of Medicine, reports on findings from more than 2,200 patients and is the first to measure the safety and effectiveness of the new treatment against placebo in patients with increased risk of heart attack and stroke. We do not guarantee individual replies due to extremely high volume of correspondence. It could be an option for patients who are unable to tolerate statins at higher doses, or at all. Citation: New cholesterol-lowering drug could help patients unable to take statins (2019, March 13) retrieved 24 November 2020 This document is subject to copyright. After 3 months, those who took bempedoic acid had lowered their bad cholesterol by around 17% compared to those on the placebo. At 12 weeks, the drug treatment had reduced the mean LDL cholesterol level by 19.2mg per decilitre, representing a drop of 16.5% from the baseline (95%. This RCT was also double blind, which means that the people receiving the treatment and the doctors administering the treatment are unaware of which treatment is being given. A new class of oral cholesterol-lowering drug could help patients unable to take statins due to side effects. The drug hasn't been shown to be better than statins and is unlikely to replace them – if licensed it would probably be used alongside. The content is provided for information purposes only. There was also no significant difference in the rate of major cardiovascular events like heart attack or stroke (4.6% in the bempedoic acid group and 5.7% in the placebo group). In addition, they found that the treatment was effective irrespective of the intensity of the patient's existing cholesterol-lowering treatment. People were randomly assigned to take bempedoic acid (1,488 people) or matching placebo (742), in addition to their statin, for 52 weeks. Close menu. Most people in this trial were white, so we can't be sure how people of other ethnicities respond to this treatment. Bempedoic acid has been shown to lower LDL cholesterol and appears safe over the course of 1 year. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. Secondly, they wanted to see if the level of LDL cholesterol changed from the beginning of the trial to week 12. The drug is offered in two FDA-approved formulations to lower LDL cholesterol levels in patients who are intolerant of statins. The trial has strengths in its large size and relatively long follow-up for safety. Our genetic studies suggest that the benefit on prevention of heart disease and strokes in ongoing trials should be identical to that achieved through statins. This was a randomised controlled trial (RCT) looking at a new treatment to lower LDL cholesterol. Patients were drawn from the UK, Germany, Poland, Canada and the US, and were on varying intensities of cholesterol-lowering treatment regimens. The new drug, Repatha (evolocumab), is approved for patients with hereditary forms of high cholesterol and those with cardiovascular disease This document is subject to copyright. The ongoing trial, called 'CLEAR OUTCOMES', is specially testing even longer-term safety and whether this approach reduces cardiovascular disease in addition to lowering cholesterol.". The FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol. Doctors recruited 2,230 people with cardiovascular disease, hereditary high cholesterol or both, who had high LDL cholesterol (at least 70mg per decilitre) despite taking the maximum-tolerated dose of statin therapy for at least 1 year.