PRALUENT^®: a powerful^¥ PCSK9i that ticks all the boxes^1–4

PRALUENT indication

Primary hypercholesterolaemia and mixed dyslipidaemia²

PRALUENT^® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia,as an adjunct to diet:

• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Established atherosclerotic cardiovascular disease²

PRALUENT^® is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

• in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Dosing information

Adults²

Prior to initiating PRALUENT secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.

The usual starting dose for PRALUENT is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.

The dose of PRALUENT can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration).

If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.

Adapted from PRALUENT^® Summary of Product Characteristics. 
*Lipid levels can be assessed 8 weeks after treatment intiation or titration and dose adjusted accordingly.²

If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.

^*62.7% LDL-C reduction compared to placebo at 4 months in ODYSSEY OUTCOMES trial.^1
†MACE: primary composite endpoint of CHD death, non-fatal myocardial infarction, fatal and non-fatal ischaemic stroke, or unstable angina requiring hospitalisation. HR 0.85 (95% CI 0.78, 0.93), P=0.0003.^1,2
‡With only nominal statistical significance by hierarchical testing; HR 0.85 (95% Cl 0.73, 0.98), P=0.0261.^1,2
¥PRALUENT significantly reduced risk of MACE (primary endpoint) in the overall trial population (N=18,924) in the ODYSSEY OUTCOMES trial (15% RRR, HR 0.85 (95% CI 0.78, 0.93), P=0.0003) and was associated with a reduction in all-cause mortality (15% RRR, HR 0.85 (95% CI 0.73, 0.98), P=0.0261) with only nominal statistical significance by hierarchical testing. 62.7% LDL-C reduction compared to placebo at 4 months in ODYSSEY OUTCOMES trial. 4 weeks to reach maximal effect based on a summary of ten phase 3 trials (five placebo-controlled, five ezetimibe-controlled) in high and very high-CV-risk patients. LDL-C reduction was sustained at 54.5% relative to placebo at 4 years in patients following an ACS event in the ODYSSEY OUTCOMES trial.^1,2
§In a CVOT, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI 0.73, 0.98), P=0.0261.^2
‖A post hoc assessment using data from the ODYSSEY OUTCOMES trial. The proportion of patients achieving the updated LDL-C goals of <55 mg/dL at least one baseline measurement is presented.^4
¶For patients requiring LDL-C reduction >60%, PRALUENT is the only PCSK9i with once-monthly single injection in a pre-filled pen.²
   

ACS = acute coronary syndrome; CHD = coronary heart disease; CI = confidence interval; CV = cardiovascular; CVOT = cardiovascular outcomes trial; HR = hazard ratio; LDL-C = low-density lipoprotein cholesterol;LDL = low-density lipoprotein; LLT = lipid-lowering therapy; MACE = major adverse cardiovascular event; PCSK9i = proprotein convertase subtilisin/kexin type inhibitor; RRR = relative risk reduction.
   

1. J Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097–2107.

2. PRALUENT (alirocumab) Summary of Product Characteristics. Gulf SmPC revision date of November 2020 and KSA SmPC revision date of June 2021.

3. Frias JP, Koren MJ, Loizeau V, et al. The SYDNEY device study: a multicenter, randomized open-label usability study of a 2-mL alirocumab autoinjector device. Clin Ther. 2020;42(1):94–107.

4. J Landmesser U, McGinniss J, Steg PG, et al. Achievement of ESC/EAS LDL-C treatment goals after an acute coronary syndrome with statin and alirocumab. Eur J Prev Cardiol. 2022;29(14):1842–1851.

5. J Steg PG, Szarek M, Bhatt DL, et al. Effect of alirocumab on mortality after acute coronary syndromes. Circulation. 2019;140(2):103–112.