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Repatha® has demonstrated an overall safety profile comparable to that of control in the FOURIER study of 27,564 patients.2
  • No neutralising antibodies were identified2
  • No new safety issues were observed despite the very low LDL-C levels achieved over a median of 2.2 years3
  • Patients with diabetes achieved similar relative and greater absolute CV risk reductions as patients without diabetes4

Adverse events and laboratory test results2

Repatha® did not increase the risk of new-onset diabetes, even in patients with prediabetes, nor did it worsen glycaemia over several years4,5

*The between-group difference was nominally significant (p<0.001).
The total numbers of patients were 8337 in the evolocumab group and 8339 in the placebo group, because patients with prevalent diabetes at the start of the trial were excluded.
Measurement of HbA1c was a prespecified exploratory end point.
§In the study, 2690 recent MI patients received Repatha®, 2254 of whom achieved LDL-C levels <55 mg/dl.
25% RRR reported as the key secondary endpoint: composite of cardiovascular death, MI or stroke. HR: 0.75; 95% CI: 0.62-0.91; p=0.003. ARR: 3.2%; 95% CI: 1.2-5.2.
ACS = Acute coronary syndrome; ARR = Absolute risk reduction; CV = Cardiovascular; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; EVOPACS = EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes; FOURIER = Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk; HbA1c = Glycated haemoglobin; IQR = Interquartile range; LDL-C = Low-density lipoprotein cholesterol; LDL receptor; MI = Myocardial infarction; PCSK9 = Protein convertase subtilisin/kexin type 9; RRR = Relative risk reduction; ULN = Upper limit of normal.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: 31 March 2021.
  2. Sabatine MS, et al. N Engl J Med. 2017;376:1713-22.
  3. Giugliano RP, et al. Lancet. 2017;390:1962-71.
  4. Sabatine MS, et al. Lancet Diabetes Endocrinol. 2017;5:941-50.
  5. Sabatine MS, et al. Lancet Diabetes Endocrinol. 2017;5:941-50. (Supplementary appendix)
  6. Gencer B, et al. JAMA Cardiol. 2020;5(8):1-6. Main paper & Supplementary appendix.

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