Statin- is a class of drugs used to lower the cholesterol level by inhibiting the enzyme HMG-CoA reductase. Increased cholesterol level results in several cardiovascular diseases. Statins are most effective in the treatment of cardiovascular disease. Cardiovascular disease is a fatal disease that affects the heart or the blood vessel system within a person's entire body. It is not a single disease or condition. Rather, it is a group of over 60 different disorders. Its several types are high blood pressure, stroke, heart attack, coronary artery disease, angina, pectoris, arrhythmias, cardiomyopathy. The symptoms associated with this disorder are chest pain or discomfort, pain in one or both arms, the left shoulder, neck, jaw, or back, shortness of breath, dizziness, faster heartbeats, nausea, abnormal heartbeats, fatigue.
The investigational product Lipitor is used to decrease the amount of cholesterol in the blood. It decreases the risk of stroke, heart attack, and other heart diseases. It works by slowing down the production of cholesterol in the body. Here we have to compare the dose of efficacy Study of Atorvastatin (Lipitor) (20, 40mg) versus Simvastatin (standard drug) (40, 80mg).
Mode of action is as follows :-
i) Absorption- oral, through veins.
iii) Metabolism- liver, kidney.
iv) Excretion- renal.
The patients included in the study should be between the age of 30 to 80 years old. Their plasma LDL cholesterol concentrations should be more than 160 mg/dl and plasma HDL cholesterol concentrations should be more than 40 mg/dl. Triglyceride concentrations should be less than 400 mg/dl. The exclusion criteria for the patients are primary hypothyroidism, nephrotic syndrome, type 1 or uncontrolled type 2 diabetes mellitus, hepatic dysfunction, body mass index > 32 kg/mÂ², uncontrolled hypertension, myocardial infarction, coronary angioplasty, coronary artery bypass graft, significant abnormalities that could compromise with the safety of patient or successful participation in the study, Medications known to effect lipid levels, interact with study medications, or effect clinical laboratory parameters (erythromycin, anticoagulants, immunosuppressive agents, lipid-regulating drugs, systemic steroids).
The condition Cardiovascular diseases and Hypercholesterolemia studied under both the comparator arms i.e. Atorvastatin and Simvastatin to prove the superiority, inferiority or equality of two drugs. Here, the trial design of the study is studied under phase III clinical trial. The trial is multicentric with the trial sites spread at different geographical locations. The allocated study is randomized and prospective in nature. The model is parallel in which the patients are arranged in two parallel study arm and selected randomly. The study is open label i.e. there is no bliniding, both the investigator and patient are aware about the treatment. Double-blind, randomized, placebo-controlled. The alternative design can also be used for the purpose like, Randomized, double blind, placebo control, parallel assignment efficacy study, or , Randomized, double-blind, crossover study, or, Multicentre, randomized, double blind, prospective study. The primary purpose of the study is treatment of a population of patients for the two comparator arms: Atorvastatin and Simvastatin.
The baseline value of LDL-Cholesterol, HDL-Cholesterol and Triglycerides are estimated before analyzing their value after introducing the drug. Then for the different doses of the drugs Atorvastatin (20 mg and 40mg) and Simvastatin (40 mg and 80 mg), mean percent change in plasma lipids, LDL-Cholesterol, HDL-Cholesterol and Triglycerides are estimated. This will help in determining the efficacy of the drugs involved in the study. The primary end point of the study is efficacy of the two drugs involved. For launching the IP (LIPITOR) in the market, the drug should prove itself efficient enough and more powerful than the standard drug (Simvastatin). This include differences in the metabolic effects of Simvastatin and Atorvastatin.
The half life of Atorvastatin is 20 hrs is much more than the 2 hour half-life of Simvastatin. More prolonged inhibition of cholesterol biosynthesis by Atorvastatin. The IP (Atorvastatin) has a positive dose-response relationship over the range of 10-80 mg. LDL-Cholesterol has been reduced from 40% to 60%. Thus, the investigational product has proved itself to be more efficient than the standard drug. Hence, it can be launched into the market.
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