Fixed-dose combination of rosuvastatin and ezetimibe

Česká verzia

Authors: Martin Šatný
Authors place of work: Centrum preventivní kardiologie, 3. interní klinika – klinika endokrinologie a metabolismu 1. LF UK a VFN v Praze
Published in the journal: Vnitř Lék 2020; 66(8): 513-517
Category:

Summary

Atherosclerotic cardiovascular diseases (ASCVD) play a significant role in morbidity and mortality not only in developed but also increasingly in developing countries. The only causal risk factor (RF) of ASKVO is LDL-cholesterol. The basic pillar of pharmacotherapy of dyslipidaemias are statins, which should be titrated to the maximum (tolerated) dose and then combined with ezetimibe if the LDL-cholesterol targets for the specific categories of CV risk are not reached. Combination therapy is known to be far more effective than increasing the statin dose. Fixed combinations of statins with ezetimibe can be advantageously used to improve adherence.

Keywords:

cardiovascular disease – CV risk – dyslipidemia – rosuvastatin – ezetimibe – fixed combination.

Zdroje

1. ÚZIS. Zdravotnická ročenka České republiky 2018, dostupné z: https://www.uzis.cz/ res/f/008280/zdrroccz-2018.pdf.

2. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the manage‑ ment of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal (online). 2019 (cit. 2019-09-01). DOI: 10.1093/eurheartj/ehz455. ISSN 0195668X. Dostupné z: https://academic.oup.com/eurheartj/advance‑article/doi/10.1093/ eurheartj/ehz455/5556353

3. Scheidt‑Nave C, DU Y, Knopf H, et al. Verbreitung von Fettstoffwechselstörungen bei Erwachsenen in Deutschland. Bundesgesundheitsblatt – Gesundheitsforschung - Gesundheit‑sschutz(online). 2013; 56(5–6): 661–667 (cit. 2019-08-14). DOI: 10.1007/s00103-013-1670-0. ISSN 1436-9990. Dostupné z: http://link.springer.com/10.1007/s00103-013-1670-0.

4. Sanin V, Koenig W. Therapie der Hypercholesterinämie in der Primärprävention. DMW - Deutsche Medizinische Wochenschrift (online). 2019; 144(05): 322–328 (cit. 2019-08-14). DOI: 10.1055/a-0657-1668. ISSN 0012-0472. Dostupné z: http://www.thieme‑connect.de/ DOI/DOI?10.1055/a-0657-1668

5. Rosuvastatin (SPC). Souhrn informací o přípravku. Dostupný na: www.sukl.cz.

6. Rosuvastatin/ezetimib (SPC). Souhrn informací o přípravku. Dostupný na: www.sukl.cz.

7. Lund TM, Torsvik H, Falch D, et al. Effect of morning versus evening intake of simvastatin on the serum cholesterol level in patients with coronary artery disease. Am J Cardiol 2002; 90(7): 784–786.

8. Rosuvastatin. Pubchem diabase. Dostupné z: https://pubchem.ncbi.nlm.nih.gov/com‑ pound/Rosuvastatin#section=Top.

9. Ezetimib (SPC). Souhrn informací o přípravku. Dostupný na: www.sukl.cz.

10. Ezetimib. Pubchem diabase. Dostupné z: https:/ / pubchem.ncbi.nlm.nih.gov/ com‑ pound/ Ezetimibe#section=Top.

11. Drug Information 2016. Bethesda: American Society of Health‑System Pharmacists 2016: 1865–1866.

12. Athyros VG, Alexandrides TK, Bilianou H, et al. The use of statins alone, or in combi‑ nation with pioglitazone and other drugs, for the treatment of non‑alcoholic fatty liver disease/non‑alcoholic steatohepatitis and related cardiovascular risk. An Expert Panel Statement. Metabolism 2017; 71: 17–32. doi: 10.1016/j.metabol.2017. 02. 014.

13. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97(8 A): 52C– 60C.

14. Ridker PM, Pradhan A, MacFadyen JG, et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. The Lancet (on‑ line). 2012; 380(9841): 565–571 (cit. 2020-11-14). ISSN 01406736. Dostupné z: doi:10.1016/ S0140-6736(12)61190-8.

15. Šatný M, Vrablík M. Desatero užití ezetimibu aneb stručný průvodce jeho použitím v současnosti. AtheroRev 2019; 4(3): 181–184.

16. Hong SJ, Jeong HS, Ahn, JC, et al. A phase III, multicenter, randomized, double‑blind, active comparator clinical trial to compare the efficacy and safety of combination therapy with ezetimibe and rosuvastatin versus rosuvastatin monotherapy in patients with hyper‑ cholesterolemia: I‑ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) ran‑ domized controlled trial. Clin Ther 2018; 40(2): 226–241. doi: 10.1016/ j.clinthera.2017. 12. 018.

17. Kim KJ, Kim SH, Yoon YW, et al. Effect of fixed‑dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS‑ROZE (Multicenter Ran‑ domized Study of ROsuvastatin and eZEtimibe). Cardiovasc Ther 2016; 34(5): 371–382. doi: 10.1111/ 1755-5922.12213.

18. Ballantyne CM, Weiss R, Moccetti T, et al. Efficacy and safety of rosuvastatin 40 mg alo‑ ne or in combination with ezetimibe in patients at high risk of cardiovascular disease (re‑ sults from the EXPLORER study). Am J Cardiol 2007; 99: 673–680.

19. Bays HE, Davidson MH, Massaad R, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up‑titration of rosuvastatin in patients with hypercholes‑ terolemia (the ACTE Study). Am J Cardiol 2011; 108: 523–530.

20. Ballantyne CM, Hoogeveen RC, Raya JL, et al. Efficacy, safety and effect on biomarkers related to cholesterol and lipoprotein metabolism of rosuvastatin 10 or 20 mg plus ezeti‑ mibe 10 mg vs. simvastatin 40 or 80 mg plus ezetimibe 10 mg in high‑risk patients: Results of the GRAVITY randomized study. Atherosclerosis 2014; 232: 86–93.

21. Masuda J, Tanigawa T, Yamada T, et al. Effect of combination therapy of ezetimibe and rosuvastatin on regression of coronary atherosclerosis in patients with coronary artery disease. Int Heart J 2015; 56: 278–228.

22. Kyselák O, Šoška V. Fixní kombinace rosuvastatinu s ezetimibem – lékový profil. Kar‑ diol Rev Int Med 2018; 20(2): 142–146.

23. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy af‑ ter Acute Coronary Syndromes. New England Journal of Medicine (online). 2015; 372(25): 2387–2397 (cit. 2019-09-12). DOI: 10.1056/NEJMoa1410489. ISSN 0028-4793. Dostupné z: http://www.nejm.org/doi/10.1056/NEJMoa1410489.

24. Rossebo AB, Pedersen TR, Boman K, et al. Intensive Lipid Lowering with Simvastatin and Ezetimibe in Aortic Stenosis. New England Journal of Medicine (online). 2008; 359(13): 1343–1356 (cit. 2019-09-12). DOI: 10.1056/NEJMoa0804602. ISSN 0028-4793. Dostupné z: http://www.nejm.org/doi/abs/10.1056/NEJMoa0804602.

25. Baigent, C, Landray MJ, Reith C, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo‑controlled trial. The Lancet (online). 2011; 377(9784): 2181–2192 (cit. 2019-09-12). DOI: 10.1016/S0140-6736(11)60739-3. ISSN 01406736. Dostupné z: https://linkinghub.elsevier.com/retrieve/pii/S0140673611607393.

26. Soška V. Vliv kombinace simvastatinu s ezetimibem na krevní lipidy a na kardiovaskulární příhody u diabetiků (komentář k výsledkům subanalýzy studie IMPROVE‑IT). Vnitř Lék 2015; 61: 965–969.