A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia

Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia

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.

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Atorvastatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Recruiting
    • BSMMU
    • Contact: Samia Tonu, MBBS; Phone Number: +8801769350011; Email: tonusamia@gmail.com
    • Contact: Nargis Akhter, Mphill, MSc; Phone Number: +880152391036; Email: nargisakhter@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin; Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.	Drug: Rosuvastatin; 45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks; Other Names: Rocovas
Active Comparator: Atorvastatin; Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks	Drug: Atorvastatin; 45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks; Other Names: Tiginor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia	Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L	[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia	Reduction of inflammation will be measured by change in level of hs-CRP in mg/L	[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia	Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood	[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia	Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec	[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia	Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb	[0 weeks (baseline), 8 weeks (end)] [safety Issue: No]

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Samia Tonu, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: No.BSMMU/2016/8307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No