The goal of this clinical trial is to evaluate the efficacy and safety of a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy in the Bangladeshi population.
Researchers will compare atorvastatin (10 mg) and ezetimibe (10 mg) to atorvastatin (20 mg) monotherapy to see if atorvastatin (10 mg) and ezetimibe (10 mg) FDC works to treat dyslipidemia.
Participants will:
* Take a fixed-dose combination of atorvastatin (10 mg) and ezetimibe (10 mg) compared to atorvastatin (20 mg) monotherapy for 3 months * Follow-up visits at 6 weeks and 12 weeks for checkups and tests
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
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.
Dr. Md. Alimur Reza
Lead sponsor
Beximco Pharmaceuticals Ltd.
Sponsor institution