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

UNLABELLED: 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.

AIM: To conduct comparative analysis of efficacy and safety of the rosuvastatin compound akorta and original rosuvastatin crestor.

MATERIAL AND

METHODS

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.

RESULTS

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.

CONCLUSION

The study has shown equivalence of the original rosuvastatin compound crestor and generic compound acorta within the aim of dyslipidemia correction.