A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: Atorvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02979704

No.BSMMU/2016/8307

Details and patient eligibility

About

This study will be conducted to assess the status of oxidative stress inflammation and thrombogenesis in patients with hyperlipidemia and to compare the antioxidative, anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.

Full description

Hyperlipidemia is the major risk factor for development of atherosclerosis which ultimately leads to cardiovascular disease (CVD), an important cause of mortality and morbidity worldwide. Atherosclerosis was previously considered as a lipid storage disease but now growing evidence indicates that increased oxidative stress, vascular inflammation and platelet activation play an important role in the initiation and progression of atherosclerosis. Among the hypolipidemic drugs, statins, 3-hydroxyl-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, have proved to be very much effective. Therefore, statins are the most widely used hypolipidemic agents. Evidence shows that besides hypolipidemic action statins possess antioxidative, anti-inflammatory and antithrombogenic effects known as pleiotropic action which might play an important role in attenuating the atherosclerotic process. However, pleiotropic effect varies with different members of statins.

The present prospective interventional study would be conducted in the Department of Pharmacology, Department of Cardiology and Internal Medicine, BSMMU from March 2016 to August 2017. Total 90 cases will be selected according to inclusion and exclusion criteria. The cases will be subdivided into 2 groups: group A and B. Group A consisting of 45 patients who will receive rosuvastatin (5-10) mg orally once daily and Group B consisting of 45 patients who will receive atorvastatin (10-20) mg orally once daily for 08 weeks. Patient's blood sample will be collected to measure baseline lipid profile, malondialdehyde (MDA), erythrocytic glutathione (GSH), high sensitive C-reactive protein (hs-CRP), prothrombin time (PT), platelet count. After obtaining baseline data patients will be assigned to the respective group. Parameters of baseline will again be evaluated after 08 weeks of therapeutic intervention. Regularity of drug intake will be ensured over telephone, pill count, and from the patient's compliance sheet. Patient's data will be recorded in a predetermined data sheet. Patients will be informed about study, its merits and demerits in easy language and then informed consent will be taken.Therefore, the present study has been designed to compare the antioxidative, anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin in hyperlipidemic patients to establish the superiority of a particular statin, so that it will provide a better therapeutic option in order to prevent CVD related mortality and morbidity.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from (20-75) yrs, both male and female having LDL cholesterol: 160-190 mg/dl, triglyceride (TG): 200-499 mg/dl will be recruited in the study

Exclusion criteria

• Patients age <25 years or >75 years
• Patients are on lipid lowering medications
• Patients taking omega-3 fatty acid or garlic
• Patients with history of hypersensitivity on any member of statin
• Patients taking anti-inflammatory medications (steroid or NSAIDS)
• Patients taking antioxidant vitamins (vitamin A, C, E)
• Patients with impaired renal function
• Patients with impaired liver function
• Pregnant women and nursing mother
• Patients having serious infections or terminal illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Rosuvastatin

Active Comparator group

Description:

Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.

Treatment:

Drug: Rosuvastatin

Atorvastatin

Active Comparator group

Description:

Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks

Treatment:

Drug: Atorvastatin