For the intolerant at statins a new up-and-comer is on the way molecule to fight the cholesterolimportant risk factor for cardiovascular disease. This is bempedoic acid – which will be available in Italy from the end of March – the efficacy of which was demonstrated by the Clear Outcomes study, presented in New Orleans at the annual congress of the American College of Cardiology (ACC), organized in collaboration with the World Heart Federation. The study results are published simultaneously in the New England Journal of Medicine. In patients intolerant to statins, widely used against hypercholesterolemia which affects about 3 million people in Italy alone, treatment with bempedoic acid has been shown to reduce the rate of cardiovascular events compared to placebo.
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I study
Between December 2016 and August 2019, the study enrolled more than 14,000 statin-intolerant patients from more than 1,200 centers in 32 countries. All participants had LDL cholesterol levels of 100 mg/dL or higher, a previous event, or other cardiovascular risk factors. Those who received bempedoic acid experienced an average reduction of about 20-25% in cholesterol levels, compared with about 10% reduction in participants receiving placebo. Heart attack or stroke events occurred in 11.7% of subjects taking bempedoic acid and 13.3% of those taking a placebo. No significant difference emerged between the two groups in terms of mortality. The mechanism of action of the new molecule is similar to that of statins.
The main difference concerns its activation which, unlike the standard treatment for hypercholesterolemia, occurs only once the drug has reached the liver. This causes bempedoic acid to be associated with minor side effects in the muscles, brain and other tissues. “Statins are the cornerstone of risk reduction in patients with elevated LDL cholesterol,” said study leader Steven E. Nissen of the Heart Vascular & Thoracic Institute at Cleveland Clinic. Most people can take statins, but some cannot. This is the first study that has directly addressed the problem of statin-intolerant people,” who are estimated to account for approximately 10% of treated patients globally. Female gender, hypothyroidism, high doses of statins, advanced age, use of antiarrhythmics and obesity are the main factors increasing the risk of intolerance.
The benefits
However, today bempedoic acid represents an “important new weapon – Pasquale Perrone Filardi, president of the Italian Society of Cardiology (Sic) told ANSA – and the study presented at the ACC is the first carried out on intolerant subjects to evaluate its effectiveness ». In 90% of cases, he explains, «intolerance leads to myalgia, or rather severe muscle pain, and cramps. In intolerants, bempedoic acid has been shown to effectively reduce cholesterol and cardiovascular risks; in particular, the study showed a 23% reduction in the risk of heart attack in high-risk patients. But the benefits are not only addressed to this particular category of subjects: «Now we have a new weapon available to everyone – underlines Perrone Filardi -. In fact, bempedoic acid, in addition to being indicated for intolerant people, can be effectively combined with statin or antilipid drug therapy in all patients who need an aggressive reduction in cholesterol levels.