A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels
Keywords:
Adherence, evolocumab, LDL-C, PCSK9 inhibitors, persistence, real-world evidence
Abstract
Background: Treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduces low-density lipoprotein cholesterol (LDL-C) levels and decreases the incidence of major ischaemic events in clinical trials. However, less is known about the efficacy of PCSK9 inhibition in clinical practice. This study aimed to describe the change in LDL-C levels over time and LDL-C goal achievement in patients with/without atherosclerotic cardiovascular disease (ASCVD), who were prescribed evolocumab in clinical practice, and to describe adherence to and persistence with treatment.
Methods: Patients in Sweden with at least one evolocumab prescription filled between July 2015 and May 2020 were included. Medical history and lipid-lowering therapy (LLT) were sourced from national registries. LDL-C levels before and after treatment initiation were assessed using medical records. Persistence with and adherence to evolocumab and oral LLT were assessed up to 12 months after treatment initiation using the refill-gap method and proportion of days covered, respectively.
Results: Of the 2,360 patients with at least one prescription for evolocumab, 2,341 were included; 1,858 had ASCVD. Persistence with (76%) and adherence to (86%) evolocumab were high throughout the 12 months following initiation. Mean LDL-C levels decreased by 53% (95% confidence interval [CI]: 51–55%) in patients adherent to evolocumab (n = 567) and 59% (95% CI: 55–63%) in patients adherent to evolocumab and oral LLT (n = 186). Similar reductions in LDL-C were observed in patients with/without ASCVD. Reduced LDL-C levels remained stable during follow-up. Amongst patients adherent to evolocumab and those adherent to evolocumab and oral LLT, 23 and 55% achieved the LDL-C goal of <1.4 mmol/L, respectively.
Conclusions: The evolocumab LDL-C-lowering effect observed in clinical trials was confirmed in clinical practice in Sweden, particularly in patients also treated with oral LLT. During follow-up, adherence to and persistence with evolocumab were high, with stable reduced levels of LDL-C during observation.
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References
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43. Gencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5:952–7. doi: 10.1001/jamacardio.2020.0882
44. Taylor BA, Thompson PD. Statins and their effect on PCSK9-impact and clinical relevance. Curr Atheroscler Rep. 2016;18:46. doi: 10.1007/s11883-016-0604-3
45. Paquette M, Faubert S, Saint-Pierre N, Baass A, Bernard S. Sex differences in LDL-C response to PCSK9 inhibitors: a real world experience. J Clin Lipidol. 2023;17:142–9. doi: 10.1016/j.jacl.2022.12.002
2. Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017;38:2459–72. doi: 10.1093/eurheartj/ehx144
3. Packard C, Chapman MJ, Sibartie M, Laufs U, Masana L. Intensive low-density lipoprotein cholesterol lowering in cardiovascular disease prevention: opportunities and challenges. Heart. 2021;107:1369–75. doi: 10.1136/heartjnl-2020-318760
4. Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372:1489–99. doi: 10.1056/NEJMoa1501031.
5. Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372:1500–9. doi: 10.1056/NEJMoa1500858
6. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713–22. doi: 10.1056/NEJMoa1615664
7. Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379:2097–107. doi: 10.1056/NEJMoa1801174
8. Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41:111–88. doi: 10.1093/eurheartj/ehz455
9. Blanco-Ruiz M, Amaya-Pascasio L, de Torres Chacón R, Álvarez Soria MJ, Arjona-Padillo A, Carrillo Bailén MM, et al. Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The IRIS-PCSK9I study. Atherosclerosis Plus. 2021;45:32–8. doi: 10.1016/j.athplu.2021.08.009
10. Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, et al. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022;8(4): 447–460. doi: 10.1093/ehjqcco/qcac009
11. Anell A. The public-private pendulum--patient choice and equity in Sweden. N Engl J Med. 2015;372:1–4. doi: 10.1056/NEJMp1411430
12. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2017. Available from: https://www.whocc.no/ [cited 01 March 2023].
13. WHO. Classifications. Available from: http://www.who.int/classifications/icd/en/ [cited 01 March 2023].
14. (NOMESCO) NMSC. NOMESCO classification of surgical procedures. Available from: https://norden.diva-portal.org/smash/get/diva2:970547/FULLTEXT01.pdf [cited 01 March 2023].
15. Klassifikation av vårdåtgärder (KVÅ). Socialstyrelsen. Available from: https://www.socialstyrelsen.se/statistik-och-data/klassifikationer-och-koder/kva/ [cited 01 March 2023].
16. Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24:659–67. doi: 10.1007/s10654-009-9350-y
17. Tandvårds- och läkemedelsförmånsverket TLV. Repatha fortsätter att ingå i högkostnadsskyddet med ny bredare begränsning – Läs beslutet i sin helhet. Available from: https://www.tlv.se/download/18.4705150a16733f9541fa8198/1543244475065/bes181123_repatha.pdf [cited 01 March 2023].
18. Sveriges Kommuner och Landsting. Repatha (evolocumab) och Praluent (alirokumab) för behandling av hyperkolesterolemi. Available from: https://janusinfo.se/download/18.797b37df1779adf8a693f210/1613459610916/Repatha-och-Praluent-181220-INAKTUELL.pdf [cited 01 March 2023].
19. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499–502. doi: 10.1093/clinchem/18.6.499
20. Civeira F, International Panel on Management of Familial H. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004;173:55–68. doi: 10.1016/j.atherosclerosis.2003.11.010
21. Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11:44–7. doi: 10.1111/j.1524-4733.2007.00213.x
22. Trevisan M, Fu EL, Xu Y, Jager K, Zoccali C, Dekker FW, et al. Pharmacoepidemiology for nephrologists (part 1): concept, applications and considerations for study design. Clin Kidney J. 2021;14:1307–16. doi: 10.1093/ckj/sfaa244
23. Karlsson SA, Hero C, Eliasson B, Franzen S, Svensson AM, Miftaraj M, et al. Refill adherence and persistence to lipid-lowering medicines in patients with type 2 diabetes: a nation-wide register-based study. Pharmacoepidemiol Drug Saf. 2017;26:1220–32. doi: 10.1002/pds.4281
24. Gupta M, Mancini GBJ, Wani RJ, Ahooja V, Bergeron J, Manjoo P, et al. Real-world insights into evolocumab use in patients with hyperlipidemia: Canadian analysis from the ZERBINI Study. CJC Open. 2022;4:558–67. doi: 10.1016/j.cjco.2022.03.003
25. Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002;288:455–61. doi: 10.1001/jama.288.4.455
26. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–97. doi: 10.1056/NEJMra050100
27. Fitzmaurice GM, Ravichandran C. A primer in longitudinal data analysis. Circulation. 2008;118:2005–10. doi: 10.1161/CIRCULATIONAHA.107.714618
28. Harrell F. Regression modeling strategies: with applications to linear models, logistic and ordinal regression, and survival analysis. 2nd ed. Cham: Springer International Publishing; 2015.
29. Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J. 2016;37:2999–3058. doi: 10.1093/eurheartj/ehw272
30. Jackson C. Multi-state models for panel data: the msm package for R. J Stat Softw. 2011;38:1–28.
31. Piccinni C, Antonazzo IC, Maggioni AP, Pedrini A, Calabria S, Ronconi G, et al. PCSK9 inhibitors’ new users: analysis of prescription patterns and patients’ characteristics from an Italian real-world study. Clin Drug Investig. 2020;40:173–81. doi: 10.1007/s40261-019-00877-3
32. Leitner DR, Toplak H, Kedenko L, Steinmaurer T, Graff V, Metzner T, et al. Efficacy and tolerability of alirocumab in Austrian clinical practice – results of the non-interventional PEARL-AT study. Curr Med Res Opin. 2020;36:1419–25. doi: 10.1080/03007995.2020.1786678
33. Iqbal S, Sabbour HM, Siddiqui MS, Tikriti AA, Santos RD, Buckley A. The First Report of a real-world experience with a PCSK9 inhibitor in a large familial hyperlipidemia and very-high-risk Middle Eastern population. Clin Ther. 2022;44:1297–309. doi: 10.1016/j.clinthera.2022.08.005.
34. Schubert J, Lindahl B, Melhus H, Renlund H, Leosdottir M, Yari A, et al. Low-density lipoprotein cholesterol reduction and statin intensity in myocardial infarction patients and major adverse outcomes: a Swedish nationwide cohort study. Eur Heart J. 2021;42:243–52. doi: 10.1093/eurheartj/ehaa1011.
35. SWEDEHEART. SWEDEHEART Annual Report 2020. Available from: https://www.ucr.uu.se/swedeheart/dokument-sh/arsrapporter-sh/1-swedeheart-annual-report-2020-english-2/viewdocument/3140 [cited 01 March 2023].
36. De Backer G, Jankowski P, Kotseva K, Mirrakhimov E, Reiner Z, Ryden L, et al. Management of dyslipidaemia in patients with coronary heart disease: results from the ESC-EORP EUROASPIRE V survey in 27 countries. Atherosclerosis. 2019;285:135–46. doi: 10.1016/j.atherosclerosis.2019.03.014
37. Kotseva K, Wood D, De Bacquer D, De Backer G, Ryden L, Jennings C, et al. EUROASPIRE IV: a European Society of Cardiology survey on the lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries. Eur J Prev Cardiol. 2016;23:636–48. doi: 10.1177/2047487315569401
38. Khalaf K, Johnell K, Austin PC, Tyden P, Midlov P, Perez-Vicente R, et al. Low adherence to statin treatment during the 1st year after an acute myocardial infarction is associated with increased 2nd-year mortality risk-an inverse probability of treatment weighted study on 54 872 patients. Eur Heart J Cardiovasc Pharmacother. 2021;7:141–7. doi: 10.1093/ehjcvp/pvaa010
39. Rodriguez F, Maron DJ, Knowles JW, Virani SS, Lin S, Heidenreich PA. Association of statin adherence with mortality in patients with atherosclerotic cardiovascular disease. JAMA Cardiol. 2019;4:206–13. doi: 10.1001/jamacardio.2018.4936
40. Gargiulo P, Basile C, Cesaro A, Marzano F, Buonocore D, Asile G, et al. Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: a single country, multicenter, observational study (AT-TARGET-IT). Atherosclerosis. 2023;366:32–9. doi: 10.1016/j.atherosclerosis.2023.01.001
41. Masana L, Ibarretxe D, Plana N. Reasons why combination therapy should be the new standard of care to achieve the LDL-cholesterol targets: lipid-lowering combination therapy. Curr Cardiol Rep. 2020;22:66. doi: 10.1007/s11886-020-01326-w
42. de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA. 2004;292:1307–16. doi: 10.1001/jama.292.11.1307
43. Gencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5:952–7. doi: 10.1001/jamacardio.2020.0882
44. Taylor BA, Thompson PD. Statins and their effect on PCSK9-impact and clinical relevance. Curr Atheroscler Rep. 2016;18:46. doi: 10.1007/s11883-016-0604-3
45. Paquette M, Faubert S, Saint-Pierre N, Baass A, Bernard S. Sex differences in LDL-C response to PCSK9 inhibitors: a real world experience. J Clin Lipidol. 2023;17:142–9. doi: 10.1016/j.jacl.2022.12.002
Published
2024-02-01
How to Cite
Svensson M. K., James S., Ravn-Fischer A., Villa G., Schalin L., Cars T., Gustafsson S., & Hagström E. (2024). A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels. Upsala Journal of Medical Sciences, 129, e9618. https://doi.org/10.48101/ujms.v129.9618
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Original Articles
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