Long-term safety of alirocumab – further insights from the ODYSSEY OUTCOMES trial

Česká verzia

Authors: Roman Margóczy
Authors place of work: II. klinika kardiológie a angiológie LF SZU a Oddelenie funkčnej diagnostiky SÚSCCH, Banská Bystrica
Published in the journal: AtheroRev 2023; 8(1): 11-15
Category: Clinical Studies

Summary

Hypercholesterolemia is one of the major risk factor for atherosclerotic coronary heart disease, especially coronary heart disease. Most effective class of medications for prevention of cardiovascular events and LDL-C reduction are the statins. Recently published real-world studies [1] indicate that 42.9–67.0 % of patients are statin intolerant before receiving PCSK9 inhibitor therapy. PCSK9 inhibitor therapy becomes an important part of long-term lipid lowering therapy, long-term safety remains unclear.

Keywords:

alirocumab – long-term safety

Zdroje

1. Moriarty PM, Thompson PD, Cannon CP et al. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol 2020; 14(1): 88–97. e2. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacl.2020.01.001>.

2. Mach F, Baigent C, Catapano AL et al. [ESC Scientific Document Group]. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J 2020; 41(1): 111–188. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehz455>.

3. Sabatine MS, Giuliano RP, Keech AC et al. [FOURIER Steering Committee and Investigators]. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376(18): 1713–1722. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1615664>.

4. Schwartz GG, Steg PG, Szarek M et al. [ODYSSEY OUTCOMES Committees and Investigators]. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med 2018; 379(22): 2097–2107. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1801174>.

5. Farnier M, Kees Hovingh G, Langslet G et al. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis 2018; 278: 307–314. Dostupné z DOI: <http://dx.doi.org/10.1016/j.atherosclerosis. 2018.08.036>.

6. Shukla AK, Mehani R. Safety and efficacy of alirocumab: A meta-analysis of 12 randomized controlled trials. J Family Med Prim Care 2019; 8(7): 2249–2257. Dostupné z DOI: <http://dx.doi.org/10.4103/jfmpc. jfmpc_406_19>.

7. Gaudet D, López-Sendón JL, Averna M et al. ODYSSEY APPRISE Study Investigators Safety and efficacy of alirocumab in a real-life setting: the ODDYSEY APPRISE study. Eur J Prev Cardiol 2022; 28(17):1864–1872. Dostupné z DOI: <http://dx.doi.org/10.1093/eurjpc/zwaa097>.

8. Goodman SG, Steg PG, Szarek M et al. [ODYSSEY OUTCOMES Investigators]. Longer-term safety of alirocumab with 24,610 patient-years of placebo- controlled observation: Further insights from the ODYSSEY OUTCOMES trial. ESC Barcelona August 26–29 2022. Dostupné z WWW: <https:// esc365.escardio.org/presentation/249976?query=Shaun%20G.%20Goodman,% 20Philippe%20Gabriel%20Steg,%20Michael%20Szarek%20>.

9. Steg PG, Szarek M, Bhatt DL, Bittner VA et al. Effect of Alirocumab on Mortality After Acute Coronary Syndromes. Circulation 2019; 140(2): 103–112. Dostupné z DOI: <http://doi: 10.1161/CIRCULATIONAHA. 118.038840>.

10. Ray KK, Colhoun HM, Szarek M et al. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial. Lancet Diabetes Endocrinol 2019; 7(8): 618–628. Dostupné z DOI: <http://doi: 10.1016/S2213– 8587(19)30158–5>.

11. Schwartz GG, Steg PG, Szarek M et al. Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial. Circulation 2020; 141(20): 1608–1617. Dostupné z DOI: <http://doi: 10.1161/CIRCULATIONAHA. 120.046524>.