An observational study in Primary Hypercholesterolemia and Mixed Dyslipidemia, sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Observational
Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD.
This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.
This non-interventional study will be conducted in order to further understand the potential risks and benefits of bempedoic acid/fixed dose combination (FDC) with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of LDL-C) as well as safety (clinical events associated with the treatment modalities). No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.
Browse Hypercholesterolemia studies →Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of participants treated or intended to be treated with bempedoic acid/ FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the patient in the study under no reimbursement conditions (Part 1) or under reimbursed conditions (Part 2) at enrollment and who are unable to reach their LDL-C goals with the maximum tolerated dose of statins or patients who are determined by their treating physician to be statin intolerant.
Exclusion Criteria:
Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.
Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe
This is a non-interventional study. No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.
Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Systematic Coronary Risk Estimation (SCORE) System Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Second Manifestations of Arterial Disease (SMART) Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Framingham Risk Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe
Time frame: Baseline up to 12 months
Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline in Inflammatory Marker hsCRP Levels
Time frame: Baseline up to 12 months
Mean Change From Baseline In Uric Acid Levels
Time frame: Baseline up to 12 months
Number of Participants With Relevant Cardiovascular (CV) Events
Time frame: Baseline up to 12 months
Number of Participants With Adverse Effects and Adverse Drug Reactions Associated With Bempedoic Acid/FDC Ezetimibe
Time frame: Baseline up to 12 months
Types of Practitioners Caring for Patients Treated With Bempedoic acid/ FDC with Ezetimibe
Time frame: Baseline up to 12 months
Number of Participants Who Reported Use of Lipid-modifying Treatments Prior To Or Concomitantly To Receiving Bempedoic Acid/FDC With Ezetimibe
Time frame: Baseline up to 12 months
Mean Treatment Duration, By Therapy
Time frame: Baseline up to 12 months
Mean Dosage of Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Mean Length of Prescription Intervals of Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Number of Participants Who Permanently Discontinued or Switched From Bempedoic Acid/FDC Treatment
Time frame: Baseline up to 12 months
Healthcare Resource Use In Participants Who Were Treated With Bempedoic Acid/FDC With Ezetimibe Treatment
Time frame: Baseline up to 12 months
Mean Change From Baseline In EuroQol (EQ-5D-5L) and PAM-13
Time frame: Baseline up to 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company