The high efficiency of the drug is in its double mechanism of action: rosuvastatin, within the liver reduces cholesterol synthesis and lowers concentration of low-density lipoprotein cholesterol (LDL-C), total cholesterol and triglycerides. Ezetimibe selectively inhibits intestinal absorption of cholesterol and related plant sterols.
Different investigational and clinical studies have established that cardiovascular morbidity and mortality vary directly with the level of total cholesterol and studies identifies a direct link between the decline in the level of cholesterol in LDL and a decrease in the incidence of cardiovascular disease², which occupy the first place in the structure of adult mortality in Russia³. According to Russian and International recommendations, statins are the drugs of choice or lowering LDL-C in patients with hypercholesterolemia. However, statin monotherapy does not always give the necessary results, a third of all patients are not reaching a safe level of LDL-C while taking statin medications⁵. According to Russian and International Recommendations, if the target level of LDL-C is not reached, it is necessary to add ezetimibe to statins.
The new Egis’ development is a first combination of rosuvastatin and ezetimibe in Russia, which reduces elevated the LDL—cholesterol to the safe level in 3 times stronger in comparison to doubled dose of rosuvastatin alone⁶. The product allows a larger number of patients to reach the safe level of LDL -C.6, 7
The dose is one tablet once a day. Fixed dose combination product will improve adherence to medication and patient compliance compare to the patients who take rosuvastatin and ezetimibe separately.
“Adherence to mediaсion is a recognized problem in patients due to polypharmacy, and any approach that can reduce the pill burden and ease adherence to medication could be beneficial. Single-pill regimen is an advantage of our new product that we provide with the Russian medical community and patients,” says Olga Gultikova, Medical Advisor of EGIS-RUS LLC. “We are convinced that the new product will help to increase the effectiveness of the treatment of cardiovascular diseases.”
1. Государственный реестр лекарственных средств. [Электронный ресурс], 20 сентября 2019. URL: https://grls.rosminzdrav.ru/grls.aspx
2. Risk Factors for Heart Disease - British Heart Foundation (no date). Available at: https://www.bhf.org.uk/heart-health/risk-factors (Accessed:20 September 2019).
3. Данные Росстата 2018 г. https://www.gks.ru/free_doc/doc_2018/info/oper-12-2018.pdf (Accessed:20 September 2019).
4. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal (2019) 00, 178 doi:10.1093/eurheartj/ehz455. Российские рекомендации НОА 2017 год, Москва
5. Titus Schleyer, Siu Hui, Jane Wang, Zuoyi Zhang, Kristina Knapp, Jarod Baker, Monica Chase, Robert Boggs, Ross J. Simpson. Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study. Journal of Managed Care & Specialty Pharmacy, 2019; 25 (5): 544 DOI: 10.18553/jmcp.2019.25.5.544
6. Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.