Hyperlipidemia Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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