Atorvastatin 10 mg plus ezetimibe 10 mg versus atorvastatin 20 mg to lower LDL in Bangladeshi adults

Efficacy and Safety of Atorvastatin and Ezetimibe (10/10mg) Fixed Dose Combination Versus Atorvastatin (20mg) Monotherapy in Bangladeshi Population

This trial will test whether a once-daily fixed pill of atorvastatin 10 mg plus ezetimibe 10 mg lowers LDL cholesterol as well as atorvastatin 20 mg in adults in Bangladesh with high LDL.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beximco Pharmaceuticals Ltd. (Industry-sponsored)
• Locations: 1 site (Dhaka, Dhaka Division)
• Trial ID: NCT06789432 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional trial compares a fixed-dose combination pill of atorvastatin 10 mg plus ezetimibe 10 mg to atorvastatin 20 mg monotherapy over a 3-month treatment period. Adults aged over 18 with elevated LDL-C and low-to-moderate cardiovascular risk will receive one of the treatments and return for follow-up visits at 6 and 12 weeks for clinical checks and laboratory tests. The trial will measure changes in LDL-C from baseline and monitor safety measures such as liver enzymes, creatinine, and adverse events. Patients with significant hepatic or renal impairment, active hepatitis, pregnancy or lactation, or other major comorbidities will be excluded.

Who should consider this trial

Good fit: Adults in Bangladesh over age 18 with confirmed elevated LDL-C who fall into the low-to-moderate cardiovascular risk categories and meet laboratory safety criteria are ideal candidates.

Not a fit: Patients with significant liver or kidney disease, active hepatitis, pregnancy or breastfeeding, or other major medical instability are unlikely to benefit from or be eligible for this comparison.

Why it matters

Potential benefit: If successful, the fixed-dose combination could provide similar or better LDL lowering using a lower statin dose, potentially reducing statin-related side effects while improving lipid control.

How similar studies have performed: Adding ezetimibe to a statin has been shown in prior large trials to provide additional LDL lowering and clinical benefit, so the combination approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* Men and women aged \>18 years.
* Patients with a confirmed diagnosis of elevated LDL-C levels necessitating medical management.
* Patients in the low to moderate cardiovascular disease (CVD) risk category according to ESC guidelines (2019)

  * Low-risk: Increased LDL-C level without any co-morbidities
  * Moderate-risk: Young patients (T1DM \<35 years; T2DM \<50 years) with DM duration \<10 years, without other risk factors.

Exclusion Criteria:

* History of hypersensitivity to any study drugs.
* Clinically significant hepatic impairment (ALT, AST level \> 2xULN) and/or renal impairment (Serum creatinine level ≥2xULN).
* Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.
* Pregnant or lactating females.
* The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.

Where this trial is running

Dhaka, Dhaka Division

• Popular Medical College & Hospital — Dhaka, Dhaka Division, Bangladesh (Recruiting)

Study contacts

• Principal investigator: Prof. Abdullah Al Shafi Majumder, MD, FACC, FRCP (E), FRCP (G) — Professor, Dept. of Cardiology, Popular Medical College, Dhaka.
• Study coordinator: Dr. Md. Alimur Reza, MBBS, MPH

Conditions Hyperlipidemia; increased LDL-C level; Atorvastatin and Ezetimibe