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PRALUENT® (alirocumab) Efficacy

In patients with clinical ASCVD or HeFH, on top of maximally tolerated statins,

PRALUENT is the only PCSK9 inhibitor with 2 powerful levels of efficacy to help you choose the appropriate LDL-C reduction for each patient1
  • 75 mg is the recommended starting dose

COMBO I (Study 2) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT (n=209) with placebo (n=107). Patients were taking maximally tolerated doses of statins with or without other lipid-modifying therapy, and required additional LDL‑C reduction. The mean age was 63 years (range 39-87), 34% were women, 82% were Caucasian, 16% were Black, and 11% were Hispanic/Latino. Mean baseline LDL-C was 102 mg/dL. The primary efficacy endpoint, measured at week 24, was the mean percent change in LDL-C from baseline. Patients started on PRALUENT 75 mg Q2W in addition to existing statin therapy: Up-titration to 150 mg Q2W occurred at week 12 in 17% of patients who did not achieve their predefined target LDL-C at week 8. Overall, 84% had clinical ASCVD.1

LONG TERM trial (Study 1) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT 150 mg Q2W (n=1553) with placebo (n=788). The average LDL-C at baseline was 122 mg/dL. The primary efficacy endpoint, measured at week 24, was the mean percent change in LDL-C from baseline. Overall, 69% were non-FH patients with clinical ASCVD and 18% had HeFH.1

Only 17% of patients required dose adjustment at week 12 from 75 mg to 150 mg in the COMBO I Study1
COMBO I (Study 2) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT (n=209) with placebo (n=107). Patients were taking maximally tolerated doses of statins with or without other lipid-modifying therapy, and required additional LDL‑C reduction. The mean age was 63 years (range 39-87), 34% were women, 82% were Caucasian, 16% were Black, and 11% were Hispanic/Latino. Mean baseline LDL-C was 102 mg/dL. The primary efficacy endpoint, measured at week 24, was the mean percent change in LDL-C from baseline. Patients started on PRALUENT 75 mg Q2W in addition to existing statin therapy: Up-titration to 150 mg Q2W occurred at week 12 in 17% of patients who did not achieve their predefined target LDL-C at week 8. Overall, 84% had clinical ASCVD.1
Praluent vs. Ezeitmibe LDLc Reduction
82% OF PATIENTS ACHIEVED LDL-C GOAL (<70 mg/dL) at week 8 and did not require dose adjustment at week 12 in the COMBO II Study2
  • In COMBO II, adverse reactions occurring in ≥5% of PRALUENT-treated patients and more frequently than with ezetimibe were accidental overdose, upper respiratory tract infection, hypertension, headache, and arthralgia
Rapid and sustained 58% LDL-C reduction1
 Praluent vs. Placebo
  • Recommended starting dose: 75 mg once every 2 weeks administered subcutaneously or alternatively 300 mg once every 4 weeks (monthly) for patients who prefer less frequent dosing. The majority of patients achieve sufficient LDL-C reduction with the 75-mg dosage1
  • PRALUENT once-monthly 300-mg dose: Administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 weeks1
  • At week 24: The treatment difference between PRALUENT 300 mg Q4W/150 mg Q2W and placebo in mean percent change in LDL-C from baseline was -56%1
  • For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, since in some patients LDL-C can vary considerably between doses with this regimen
  • The once-monthly (Q4W) 300 mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind. The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms

References:

  1. PRALUENT® (alirocumab) Prescribing Information. Sanofi and Regeneron Pharmaceuticals.
  2. Data on file, Sanofi and Regeneron.

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