GENERICS STATINS: ARE ALL SO EASY WITH EVIDENCE OF CLINICAL EQUIVALENCE?
Aim – to analyze the results of the completed and published in Russia to date, controlled studies on the direct comparison of generic statins relevant original drug. Materials and methods. The analysis included five studies, published in the Russian peer-reviewed medical journals, the purpose of whi...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
ABV-press
2015-10-01
|
| Series: | Klinicist |
| Subjects: | |
| Online Access: | https://klinitsist.abvpress.ru/Klin/article/view/220 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | Aim – to analyze the results of the completed and published in Russia to date, controlled studies on the direct comparison of generic statins relevant original drug. Materials and methods. The analysis included five studies, published in the Russian peer-reviewed medical journals, the purpose of which was direct comparison of the clinical efficacy of generic and the corresponding originalstatin. To assess the extent of the confirmity of the original drug and generic previously developed system of quality assessment was used, which included a comparison of two separate drugs for safety and efficacy. In addition, the analysis of the effectiveness of statins separately on the lipid profile was performed. Separately the results of randomized KARDIOKANON in patients with stable coronary artery disease were analyzed at compared treatment generally required component of it were statins. Mandatory component of therapy in a group of patients was the original statin in another – generic. In these two groups of patients we compared the frequency of fixed low-density lipoprotein cholesterol level achievement. Results. Five studies (4 study with simvastatin drug and one with atorvastatin) answered the criteria of randomized study and quality of ran-domization assessment was performed, efficiency, safety, and adherence to therapy were assessed. Among 4 generics of simvastatin studies only 2 performed full conformity to the lipid-lowering effect with the original drug, the rest – revealed differences in the impact on the atherogenic index. Not all generic simvastatin demonstrated compliance with the original drug therapy safety. In assessing the generic by more rigorous criteri generics more likely appear to reveal the discrepancy between it and the original drug. Conclusion. Because there is evidence that statin do not always perform full compliance with original drug, it is desirable to perform strictly designed clinical studies with the most commonly used generic statins. |
|---|---|
| ISSN: | 1818-8338 |