Evaluating the safety and effectiveness of atorvastatin and ezetimibe combination therapy

An Observational Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe in Real World Patients With Primary Hypercholesterolemia

This study is testing if a combination of two cholesterol-lowering medications, atorvastatin and ezetimibe, can safely help people with high cholesterol reduce their LDL levels over 24 weeks.

Quick facts

• Study type: Observational
• Enrollment: 2700 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT05559606 on ClinicalTrials.gov

What this trial studies

This observational study focuses on real-world patients diagnosed with primary hypercholesterolemia who are starting a fixed dose combination therapy of atorvastatin and ezetimibe for a duration of 24 weeks. The study aims to collect and analyze data regarding the efficacy and safety of this combination therapy, particularly in lowering LDL-C levels, which is crucial for reducing cardiovascular disease risk. Participants will be monitored for their cholesterol levels and other relevant demographic data will be collected to assess the therapy's impact. The study is particularly relevant given the concerns about statin dosage and the potential benefits of combining ezetimibe with atorvastatin.

Who should consider this trial

Good fit: Ideal candidates include adults aged 19 and older who are starting fixed dose combination therapy with atorvastatin and ezetimibe for the first time.

Not a fit: Patients who are already on a different cholesterol-lowering regimen or those who have achieved their target LDL-C levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a safer and more effective treatment option for patients with primary hypercholesterolemia.

How similar studies have performed: Previous studies have shown positive outcomes with combination therapies for hypercholesterolemia, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
2. Any male/female subjects 19 years old or older.
3. Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia.
4. Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration.
5. Those who failed to reach to the target LDL-C level per risk group based on the risk group classification specified in the therapeutic guideline for dyslipidemia (2018).

   \[Risk Group, Target LDL-C (mg/dL) Level\]
   * Very High Risk \<70

     * Coronary artery disease
     * Atherosclerotic ischemic stroke and transient cerebral ischemic attack
     * Peripheral arterial disease
   * High Risk \<100

     * Carotid disease (When significant carotid artery stenosis is diagnosed)
     * Abdominal aneurysm
     * Diabetes (For patients with major risk factors such as damage to target organs or cardiovascular diseases, the target level may be lowered based on the patient conditions)
   * Moderate Risk \<130

     * 2 or more major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
   * Low Risk \<160

     * 1 or less major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
6. Those who fully understand the clinical trial, are cooperative throughout the trial and capable of participating in the trial until it ends.

Exclusion Criteria:

1. Those who are hypersensitive to major ingredients or other ingredients of the investigational drug.
2. Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions.
3. Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)).
4. Patients with serious nephropathy.
5. Those who have medical history of myopathy and rhabdomyolysis.
6. Female patients who are pregnant, suspected to be pregnant or breastfeeding.
7. Those who are administrating glecaprevir and pibrentasvir.
8. The drug contains lactose, thus those who have genetic problems, including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
9. Those who are currently participating in other clinical trials (any trials with drugs or medical devices) or who have been administered with investigational drugs of other clinical trials within 4 weeks from the baseline. However, those participating in non-interventional trials or being observed after the drug administration is complete may take part in the trial.
10. Those who are currently hospitalized or are expected to be hospitalized.
11. Those who are suffering from severe or unstable medical and mental illnesses that may impact the trial as assessed by the investigators.

Where this trial is running

Seoul

• Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Study coordinator: MyungSook Hong

Conditions Primary Hypercholesterolemia; Hypercholesterolemia; Atorvastatin; Ezetimibe