Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients

Launched by UNIVERSITY OF SALERNO · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a new medication called bempedoic acid when used alongside other treatments for patients who cannot tolerate statins, which are common cholesterol-lowering medications. Statins can cause unpleasant side effects for some people, leading to what is called "statin intolerance." In this study, researchers want to see if combining bempedoic acid with other medications, like PCSK9 inhibitors and ezetimibe, can help lower cholesterol levels more effectively for those who still need help reaching their cholesterol goals.

To be eligible for the trial, participants must be adults aged 18 or older who are considered at high or very high risk for heart problems and have not been able to reach their recommended cholesterol levels despite using other cholesterol-lowering treatments. This includes patients who have tried at least two different statins and experienced side effects. If you join the study, you will receive either bempedoic acid in addition to your current medications or a placebo (a harmless substitute) to compare the effects. It’s important to know that this trial is not yet recruiting participants, but it aims to provide more options for managing cholesterol in those who struggle with statin use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • High- or very-high-risk patients who do not reach the recommended LDL-C target despite lipid-lowering pharmacological therapy for primary or secondary prevention (≤70 mg/dl in high-risk patients, ≤55 mg/dl in very-high-risk patients and ≤40 mg/dl in patients with 2 major cardiovascular events within 2 years)
• • Patients treated with PCSK9 inhibitors plus ezetimibe for at least 12 weeks
• • Patients with statin intolerance, defined as inability to tolerate at least two statins, one at the lowest starting daily dose and another at any daily dose, either due to objectionable symptoms (real or perceived) or abnormal laboratory analysis, temporally related to statin treatment, reversible upon statin discontinuation, reproducible by rechallenge (restarting medication), and excluding other known factors)
• • Age ≥18 years
• Exclusion Criteria:
• • Fasting blood triglycerides greater than or equal to 500 mg/dL
• • Body Mass Index (BMI) greater than or equal to 50 kg/m2
• • Severe chronic kidney disease (GFR\< 30 ml/min) or glomerular nephropathy
• • Recent history (\<4 weeks) of clinically significant cardiovascular disease or planning to undergo a major surgical or interventional procedure
• • Statin assumption (including low/medium dose and low/medium intensity statins)
• • Uncontrolled hypertension
• • Uncontrolled hypothyroidism or hyperthyroidism
• • Liver disease or dysfunction (Child-Pugh B)
• • Gastrointestinal conditions or procedures that could affect drug absorption
• • Active malignancy
• • Unexplained creatine kinase elevations \>3 times the upper limit of normal
• • Lipid-modifying therapies prohibited: mipomersen within 6 months of screening, lomitapide, or apheresis within 3 months of screening, inhibitor cholesterol ester transfer protein inhibitors within 2 years of screening (with the exception of evacetrapib, which must have been discontinued ≥3 months prior to screening); and red yeast rice extract and berberine-containing products within 2 weeks of screening
• • Participation in other studies
• • Unavailable to sign the informed consent