Bezpieczeństwo terapii skojarzonej rosuwastatyną i ezetimibem Artykuł przeglądowy
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Opublikowane:
cze 30, 2020
Słowa kluczowe:
statyny, ezetimib, terapia skojarzona, hipercholesterolemia, ryzyko sercowo-naczyniowe
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Abstrakt
Aktualne wytyczne europejskie dotyczące postępowania w dyslipidemiach wprowadziły istotne zmiany w stosunku do zaleceń z 2016 r., obniżając docelowe wartości cholesterolu frakcji lipoprotein o niskiej gęstości (LDL, low-density lipoprotein). U pacjentów wysokiego i bardzo wysokiego ryzyka sercowo-naczyniowego zaleca się redukcję stężenia cholesterolu LDL o co najmniej 50%, do wartości, odpowiednio, poniżej 70 i 55 mg/dl. Jednak u wielu chorych zastosowanie nawet silnej statyny w monoterapii nie wystarcza do osiągnięcia zalecanych celów terapeutycznych. Leczenie skojarzone silną statyną (np. rosuwastatyną) w połączeniu z ezetimibem pozwala na obniżenie stężenia cholesterolu LDL nawet o 65%. Jednocześnie dołączenie ezetimibu do terapii statyną nie zwiększa ryzyka działań niepożądanych. Jak wykazano w badaniu IMPROVE-IT, terapia skojarzona statyną i ezetimibem jest bezpieczna i dobrze tolerowana.
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Jak cytować
Semczuk-Kaczmarek , K., & Kapłon-Cieślicka , A. (2020). Bezpieczeństwo terapii skojarzonej rosuwastatyną i ezetimibem . Medycyna Faktów , 13(2(47), 158-167. https://doi.org/10.24292/01.MF.0220.4
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Bibliografia
1. Mach F, Baigent C, Catapano AL et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020; 41(1): 111-88.
2. Szymański FM, Barylski M, Cybulska B et al. Rekomendacje dotyczące leczenia dyslipidemii w Polsce – III Deklaracja Sopocka Interdyscyplinarne stanowisko grupy ekspertów wsparte przez Sekcję Farmakoterapii Sercowo-Naczyniowej Polskiego Towarzystwa Kardiologicznego. Cardiol J. 2018; 25(6): 655-65.
3. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016; 37(39): 2999-3058.
4. Li L, Zhang M, Su F et al. Combination therapy analysis of ezetymibe and statins in Chinese patients with acute coronary syndrome and type 2 diabetes. Lipids Health Dis. 2015; 14: 10.
5. Kapłon-Cieślicka A, Michalak M, Kołtowski Ł et al. How has the treatment of hypercholesterolemia in Poland changed over the last six years? Cardiol J. 2017; 24(3): 266-75.
6. Śliż D, Mamcarz A, Filipiak KJ et al. 3ST-POL trial: standards of statin use in Poland in the context of the European Society of Cardiology guidelines. Pol Arch Med Wewn. 2010; 120(9): 328-33.
7. Hermans MP, Van Mieghem W, Vandenhoven G, et al. Centralized Pan-European survey on the undertreatment of hypercholesterolaemia \(CEPHEUS). Acta Cardiol. 2009; 64(2): 177-85.
8. Zdrojewski T, Solnica B, Cybulska B et al. Prevalence of lipid abnormalities in Poland. The NATPOL 2011 survey. Kardiol Pol. 2016; 74(3): 213-23.
9. Kosteva K, De Backer G, De Bacquer D et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol. 2019; 26(8): 824-35.
10. Wełnicki M, Janiszewski M, Mamcarz A. 10 powodów, dla których warto stosować skojarzenie statyny i ezetimibu. Medycyna Faktów 2018; 11: 176-81.
11. Williams B, Mancia G, Spiering W et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018; 36(10): 1953-2041.
12. Tykarski A, Filipiak KJ, Januszewicz A et al. Zasady postępowania w nadciśnieniu tętniczym – 2019 rok. Nadciśnienie Tętnicze w Praktyce. 2019; 5(1): 1-86.
13. Simons LA, Chung E, Ortiz M. Long-term persistence with single-pill, fixed-dose combination therapy versus two pills of amlodipine and perindopril for hypertension: Australian experience. Curr Med Res Opin. 2017; 33(10): 1783-7.
14. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002; 360(9326): 7-22.
15. Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta‑analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376: 1670-81.
16. Kashef MA, Giugliano G. Legacy effect of statins: 20-year follow up of the West of Scotland Coronary Prevention Study (WOSCOPS). Glob Cardiol Sci Pract. 2016; 2016(4): e201635.
17. Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol. 2018; 15(12): 757-69.
18. Davidson MH, Clark JA, Glass LM et al. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol. 2006; 97: 32‑43.
19. Naci H, Brugts J, Ades T. Comparative tolerability and harms of individual statins: a study‑level network meta‑analysis of 246 955 participants from 135 randomized, controlled trials. Circ Cardiovasc Qual Outcomes. 2013; 6: 390-9.
20. Finegold JA, Manisty CH, Goldacre B et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo‑controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014; 21: 464-74.
21. Rosenson RS, Baker SK, Jacobson TA el al. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014; 8: 58-71.
22. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta analysis of randomised statin trials. Lancet. 2010; 375: 735-42.
23. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive dose compared with moderate dose statin therapy: a metaanalysis. JAMA. 2011; 305: 2556-64.
24. Rojas-Fernandez CH, Goldstein LB, Levey AI et al. An assessment by the Statin Cognitive Safety Task Force: 2014 update. J Clin Lipidol. 2014; 8: 5-16.
25. Shepherd J, Blauw GJ, Murphy MB et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002; 350: 1623-30.
26. Ott BR, Daiello LA, Dahabreh IJ et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med. 2015; 30, 348-58.
27. McKinney JS, Kostis WJ. Statin therapy and the risk of intracerebral hemorrhage: a meta analysis of 31 randomized controlled trials. Stroke. 2012; 43: 2149-56.
28. Pandor A, Ara RM, Tumur I et al. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med. 2009; 265: 568-80.
29. Morrone D, Weintraub WS, Toth PP et al. Lipid‑altering efficacy of ezetymibe plus statin and statin monotherapy and identification of factors associated with treatment response: a pooled analysis of over 21,000 subjects from 27 clinical trials. Atherosclerosis. 2012; 223: 251-61.
30. Kashani A, Sallam T, Bheemreddy S et al. Review of side-effect profile of combination ezetymibe and statin therapy in randomized clinical trials. Am J Cardiol. 2008; 101: 1606-13.
31. Cannon CP, Blazing MA, Giugliano RP et al. Ezetymibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372: 2387-97.
32. Baigent C, Landray MJ, Reith C et al. SHARP Investigators: The effects of lowering LDL cholesterol with simvastatin plus ezetymibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011; 377(9784): 2181-92.
33. Phan BA, Dayspring TD, Toth PP. Ezetymibe therapy: mechanism of action and clinical update. Vasc Health Risk Manag. 2012; 8: 415-27.
34. Baigent C, Blackwell L, Emberson J et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376: 1670-81.
35. Cholesterol Treatment Trialists C. Efficacy and safety of statin therapy in older people: a meta analysis of individual participant data from 28 randomised controlled trials. Lancet. 2019; 393: 407-15.
36. Leeper NJ, Ardehali R, DeGoma MD et al. Statin use in patients with extremely low low-density lipoprotein levels is associated with improved survival. Circulation. 2007; 116(6): 613-8.
37. Giugliano RP, Wiviott SD, Blazing MA et al. Longterm safety and efficacy of achieving very low levels of low density lipoprotein cholesterol: A prespecified analysis of the IMPROVE-IT trial. JAMA Cardiology. 2017; 2(5): 547-55.
38. Hsia J, MacFadyen JG, Monyak J et al. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol < 50mg/dl with rosuvastatin: The JUPITER trial (justification for the use of statins in prevention: An intervention trial evaluating rosuvastatin). J Am Coll Cardiol. 2011; 57(16): 1666-75.
39. Sabatine MS, Giugliano RP, Keech AC et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017; 376: 1713-22.
40. Giugliano RP, Pedersen TR, Park JG et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017; 390: 1962-71.
41. Robinson JG, Rosenson RS, Farnier M et al. Safety of very low low-density lipoprotein cholesterol levels with alirocumab: pooled data from randomized trials. J Am Coll Cardiol. 2017; 69: 471-82.
42. Boekholdt SM, Hovingh GK, Mora S et al. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. J Am Coll Cardiol. 2014; 64(5): 485-94.
2. Szymański FM, Barylski M, Cybulska B et al. Rekomendacje dotyczące leczenia dyslipidemii w Polsce – III Deklaracja Sopocka Interdyscyplinarne stanowisko grupy ekspertów wsparte przez Sekcję Farmakoterapii Sercowo-Naczyniowej Polskiego Towarzystwa Kardiologicznego. Cardiol J. 2018; 25(6): 655-65.
3. Catapano AL, Graham I, De Backer G et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016; 37(39): 2999-3058.
4. Li L, Zhang M, Su F et al. Combination therapy analysis of ezetymibe and statins in Chinese patients with acute coronary syndrome and type 2 diabetes. Lipids Health Dis. 2015; 14: 10.
5. Kapłon-Cieślicka A, Michalak M, Kołtowski Ł et al. How has the treatment of hypercholesterolemia in Poland changed over the last six years? Cardiol J. 2017; 24(3): 266-75.
6. Śliż D, Mamcarz A, Filipiak KJ et al. 3ST-POL trial: standards of statin use in Poland in the context of the European Society of Cardiology guidelines. Pol Arch Med Wewn. 2010; 120(9): 328-33.
7. Hermans MP, Van Mieghem W, Vandenhoven G, et al. Centralized Pan-European survey on the undertreatment of hypercholesterolaemia \(CEPHEUS). Acta Cardiol. 2009; 64(2): 177-85.
8. Zdrojewski T, Solnica B, Cybulska B et al. Prevalence of lipid abnormalities in Poland. The NATPOL 2011 survey. Kardiol Pol. 2016; 74(3): 213-23.
9. Kosteva K, De Backer G, De Bacquer D et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol. 2019; 26(8): 824-35.
10. Wełnicki M, Janiszewski M, Mamcarz A. 10 powodów, dla których warto stosować skojarzenie statyny i ezetimibu. Medycyna Faktów 2018; 11: 176-81.
11. Williams B, Mancia G, Spiering W et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018; 36(10): 1953-2041.
12. Tykarski A, Filipiak KJ, Januszewicz A et al. Zasady postępowania w nadciśnieniu tętniczym – 2019 rok. Nadciśnienie Tętnicze w Praktyce. 2019; 5(1): 1-86.
13. Simons LA, Chung E, Ortiz M. Long-term persistence with single-pill, fixed-dose combination therapy versus two pills of amlodipine and perindopril for hypertension: Australian experience. Curr Med Res Opin. 2017; 33(10): 1783-7.
14. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002; 360(9326): 7-22.
15. Cholesterol Treatment Trialists Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta‑analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376: 1670-81.
16. Kashef MA, Giugliano G. Legacy effect of statins: 20-year follow up of the West of Scotland Coronary Prevention Study (WOSCOPS). Glob Cardiol Sci Pract. 2016; 2016(4): e201635.
17. Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol. 2018; 15(12): 757-69.
18. Davidson MH, Clark JA, Glass LM et al. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol. 2006; 97: 32‑43.
19. Naci H, Brugts J, Ades T. Comparative tolerability and harms of individual statins: a study‑level network meta‑analysis of 246 955 participants from 135 randomized, controlled trials. Circ Cardiovasc Qual Outcomes. 2013; 6: 390-9.
20. Finegold JA, Manisty CH, Goldacre B et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo‑controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014; 21: 464-74.
21. Rosenson RS, Baker SK, Jacobson TA el al. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014; 8: 58-71.
22. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta analysis of randomised statin trials. Lancet. 2010; 375: 735-42.
23. Preiss D, Seshasai SR, Welsh P et al. Risk of incident diabetes with intensive dose compared with moderate dose statin therapy: a metaanalysis. JAMA. 2011; 305: 2556-64.
24. Rojas-Fernandez CH, Goldstein LB, Levey AI et al. An assessment by the Statin Cognitive Safety Task Force: 2014 update. J Clin Lipidol. 2014; 8: 5-16.
25. Shepherd J, Blauw GJ, Murphy MB et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002; 350: 1623-30.
26. Ott BR, Daiello LA, Dahabreh IJ et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med. 2015; 30, 348-58.
27. McKinney JS, Kostis WJ. Statin therapy and the risk of intracerebral hemorrhage: a meta analysis of 31 randomized controlled trials. Stroke. 2012; 43: 2149-56.
28. Pandor A, Ara RM, Tumur I et al. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med. 2009; 265: 568-80.
29. Morrone D, Weintraub WS, Toth PP et al. Lipid‑altering efficacy of ezetymibe plus statin and statin monotherapy and identification of factors associated with treatment response: a pooled analysis of over 21,000 subjects from 27 clinical trials. Atherosclerosis. 2012; 223: 251-61.
30. Kashani A, Sallam T, Bheemreddy S et al. Review of side-effect profile of combination ezetymibe and statin therapy in randomized clinical trials. Am J Cardiol. 2008; 101: 1606-13.
31. Cannon CP, Blazing MA, Giugliano RP et al. Ezetymibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372: 2387-97.
32. Baigent C, Landray MJ, Reith C et al. SHARP Investigators: The effects of lowering LDL cholesterol with simvastatin plus ezetymibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011; 377(9784): 2181-92.
33. Phan BA, Dayspring TD, Toth PP. Ezetymibe therapy: mechanism of action and clinical update. Vasc Health Risk Manag. 2012; 8: 415-27.
34. Baigent C, Blackwell L, Emberson J et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010; 376: 1670-81.
35. Cholesterol Treatment Trialists C. Efficacy and safety of statin therapy in older people: a meta analysis of individual participant data from 28 randomised controlled trials. Lancet. 2019; 393: 407-15.
36. Leeper NJ, Ardehali R, DeGoma MD et al. Statin use in patients with extremely low low-density lipoprotein levels is associated with improved survival. Circulation. 2007; 116(6): 613-8.
37. Giugliano RP, Wiviott SD, Blazing MA et al. Longterm safety and efficacy of achieving very low levels of low density lipoprotein cholesterol: A prespecified analysis of the IMPROVE-IT trial. JAMA Cardiology. 2017; 2(5): 547-55.
38. Hsia J, MacFadyen JG, Monyak J et al. Cardiovascular event reduction and adverse events among subjects attaining low-density lipoprotein cholesterol < 50mg/dl with rosuvastatin: The JUPITER trial (justification for the use of statins in prevention: An intervention trial evaluating rosuvastatin). J Am Coll Cardiol. 2011; 57(16): 1666-75.
39. Sabatine MS, Giugliano RP, Keech AC et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017; 376: 1713-22.
40. Giugliano RP, Pedersen TR, Park JG et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017; 390: 1962-71.
41. Robinson JG, Rosenson RS, Farnier M et al. Safety of very low low-density lipoprotein cholesterol levels with alirocumab: pooled data from randomized trials. J Am Coll Cardiol. 2017; 69: 471-82.
42. Boekholdt SM, Hovingh GK, Mora S et al. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. J Am Coll Cardiol. 2014; 64(5): 485-94.