[Comparative Analysis of the Efficacy and Safety of Rosuvastatin and Original Rosuvastatin]. 2016

B Ya Bart, and E E Luchinkina, and I G Gordeev, and G P Arutyunov, and E O Taratukhin On Behalf Of The Workgroup Of Paritet Trial
Pirogov Russian National Research Medical University,Moscow, Russia.

The study is one of the priority points of the Russian Scientific Medical Society of Internal Medicine, initiated due to known high average level of LDL cholesterol in Russian population and necessity for its optimized control by better access to treatment. To conduct comparative analysis of efficacy and safety of the rosuvastatin compound akorta and original rosuvastatin crestor. To randomized crossover study (PARITET) 60 patients were included with the diagnosis dyslipidemia. Total duration of treatment phase was 14 weeks - two times by 7 weeks, when the drugs were crossed, separated by 4 weeks washout. Main endpoints were the rate of low density lipoprotein cholesterol (LDL-C) decrease comparing to baseline, and reach of LDL-C guidelines-based target level. After the first 7-week treatment the rate of decrease in akorta group was 49.0+/-15.6%, in crestor 52.6+/-17.4% (p=0.606). After the second period, in respective groups prescription of crestor led to LDL-C decrease by 43.4+/-17.9%, akorta - by 47.2+/-16.3% (p=0.724). After the first period of treatment the value of target levels reach did not differ significantly (akorta - 70.0%, crestor - 83.3%; p>0.05). After the second period in the group crestor-akorta the value was significantly better than in akorta-crestor group (60.0% and 83.3%; p<0.05). Secondary efficacy endpoints were comparable in both groups. Safety parameters were comparable in both groups. The study has shown equivalence of the original rosuvastatin compound crestor and generic compound acorta within the aim of dyslipidemia correction.

UI MeSH Term Description Entries
D008078 Cholesterol, LDL Cholesterol which is contained in or bound to low density lipoproteins (LDL), including CHOLESTEROL ESTERS and free cholesterol. LDL Cholesterol,Cholesteryl Linoleate, LDL,LDL Cholesteryl Linoleate,Low Density Lipoprotein Cholesterol,beta-Lipoprotein Cholesterol,Cholesterol, beta-Lipoprotein,beta Lipoprotein Cholesterol
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068718 Rosuvastatin Calcium A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES. Crestor,Rosuvastatin,ZD 4522,ZD4522,Calcium, Rosuvastatin
D000924 Anticholesteremic Agents Substances used to lower plasma CHOLESTEROL levels. Cholesterol Inhibitors,Hypocholesteremic Agents,Anticholesteremic Drugs,Anticholesteremics,Inhibitors, Cholesterol,Agents, Anticholesteremic,Agents, Hypocholesteremic,Drugs, Anticholesteremic
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D016568 Drugs, Generic Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies. Drugs, Nonproprietary,Generic Drug,Generic Drugs,Drug, Generic,Nonproprietary Drugs
D018592 Cross-Over Studies Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed) Cross-Over Design,Cross-Over Trials,Crossover Design,Crossover Studies,Crossover Trials,Cross Over Design,Cross Over Studies,Cross Over Trials,Cross-Over Designs,Cross-Over Study,Crossover Designs,Crossover Study,Design, Cross-Over,Design, Crossover,Designs, Cross-Over,Designs, Crossover,Studies, Cross-Over,Studies, Crossover,Study, Cross-Over,Study, Crossover,Trial, Cross-Over,Trial, Crossover,Trials, Cross-Over,Trials, Crossover
D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. HMG-CoA Reductase Inhibitor,HMG-CoA Reductase Inhibitors,Hydroxymethylglutaryl-CoA Reductase Inhibitor,Statin,Statins, HMG-CoA,Inhibitors, HMG-CoA Reductase,Inhibitors, Hydroxymethylglutaryl-CoA,Inhibitors, Hydroxymethylglutaryl-Coenzyme A,Statins,HMG CoA Reductase Inhibitor,HMG CoA Reductase Inhibitors,HMG-CoA Statins,Hydroxymethylglutaryl CoA Reductase Inhibitor,Hydroxymethylglutaryl CoA Reductase Inhibitors,Hydroxymethylglutaryl-CoA Inhibitors,Hydroxymethylglutaryl-Coenzyme A Inhibitors,Inhibitors, HMG CoA Reductase,Inhibitors, Hydroxymethylglutaryl CoA,Inhibitors, Hydroxymethylglutaryl Coenzyme A,Inhibitors, Hydroxymethylglutaryl-CoA Reductase,Reductase Inhibitor, Hydroxymethylglutaryl-CoA,Reductase Inhibitors, HMG-CoA,Reductase Inhibitors, Hydroxymethylglutaryl-CoA,Statins, HMG CoA

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