Alirocumab is now available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of primary (heterozygous familial or non-familial) hypercholesterolaemia. Alirocumab is a monoclonal antibody that inhibits PCSK9 (proprotein convertase subtilisin/kexin type 9). Inhibition of this enzyme reduces the breakdown of low-density lipoprotein (LDL) receptors, increasing the number of these receptors available to clear LDL cholesterol from the blood.
The ODYSSEY OUTCOMES trial is a large, double-blind, placebo-controlled study of patients who have had an acute coronary syndrome and are receiving high-intensity statin therapy. An on-treatment analysis demonstrated that the mean LDL level was 62.7% lower in the alirocumab group compared to the placebo group at four months and 54.7% lower at 48 months.
With the exception of local injection-site reactions, the incidence of adverse events did not differ significantly between the two groups over a mean follow-up period of 2.8 years. Injection-site reactions are typically mild and transient and include itching, redness and swelling. It is recommended to rotate injection sites to minimise these effects.
Further information on PBS eligibility criteria is available on the PBS website.
- Praluent® (Alirocumab) Australian approved product information. Macquarie Park: Sanofi-Aventis Australia. Approved January 2020.
- 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.