Evolocumab is now available on the Pharmaceutical Benefits Scheme (PBS) for high-risk atherosclerotic cardiovascular disease (ASCVD) in non-familial hypercholesterolaemia.
The PBS criteria must include low-density lipoprotein (LDL) levels >2.6mmol/L, symptomatic ASCVD with additional risk factors and the patient must have had ≥ 12 weeks of optimised therapy.
In the FOURIER trial, evolocumab was demonstrated to significantly reduce LDL cholesterol levels by 59% compared to placebo.
Evolocumab significantly reduced the risk of the primary composite endpoint (hazard ratio 0.85) of cardiovascular death, myocardial infarction, hospitalisation for unstable angina or coronary revascularisation, as well as key secondary composite endpoint (hazard 0.80) of cardiovascular death, myocardial infarction or stroke.
Adverse effects include injection side reactions, nausea, back or joint pain, nasopharyngitis, the common cold, flu-like symptoms, and in rarer situations, hypersensitivity reactions including angioedema.
- Repatha® (Evolocumab) Australian approved product information. North Ryde: Amgen Australia Pty Ltd. Approved May 2019.
- 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(18): 1713-22.