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LDL-C Efficacy

In adults with established cardiovascular disease,

PRALUENT demonstrated powerful and sustained levels of LDL-C reduction 

LDL-C reduction in ODYSSEY OUTCOMES
LDL-C levels in ODYSSEY OUTCOMES1
ODYSSEY OUTCOMES (Study 1): A multicenter, double-blind, placebo-controlled trial comparing PRALUENT (n=9462) with placebo (n=9462) in adults who were hospitalized with an ACS event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive or at maximally tolerated dose of a statin, with or without other LMT. Mean baseline LDL-C was 92.4 mg/dL. The primary composite endpoint was the time to first occurrence of MACE (CHD death, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization). Patients were randomized to receive PRALUENT 75 mg Q2W or placebo Q2W. Up-titration to PRALUENT 150 mg Q2W occurred at month 2 in 27.7% of patients based on prespecified LDL-C criteria (LDL-C ≥50 mg/dL); 30.8% of up-titrated patients were down-titrated to the 75 mg Q2W dose. Patients with 2 consecutive LDL-C values below 15 mg/dL (7.7%) were switched to placebo in a blinded fashion. The median follow-up was 2.8 years.2
  • In the intention-to-treat analysis, mean LDL-C levels were 92 mg/dL at baseline. At month 48 they were reduced to 66 mg/dL with PRALUENT vs 103 mg/dL with placebo1
  • The on-treatment analysis excluded values measured after discontinuation of PRALUENT and after blinded substitution of placebo for PRALUENT
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FH I and FH II (Studies 4 and 5) were 2 multicenter, placebo-controlled, double-blind trials that compared PRALUENT (n=490) with placebo (n=245). The trials were similar with regard to both design and eligibility criteria. All patients had HeFH, were taking a maximally tolerated dose of statin with or without other lipid-modifying therapy, and required additional LDL-C reduction. The mean age was 52 years (range 20-87), 45% were women, 94% were Caucasian, 1% were Black, and 3% were Hispanic/Latino. The average LDL-C at baseline was 141 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 patients (42%) who did not achieve their predefined target LDL-C (<70 mg/dL or <100 mg/dL based on CV risk) at week 8.2

HeFH diagnosis by genotyping or by clinical criteria2

  • “Definite FH” using either the Simon Broome or WHO/Dutch Lipid Clinic Network criteria
LDL-C reduction at 24 weeks on top of maximally tolerated statins (vs ezetimibe) in the COMBO II Study with PRALUENT 75 mg Q2W/150 mg Q2W3

COMBO II (Study 9) was a multicenter, double-blind, ezetimibe-controlled trial that compared PRALUENT (n=479) with ezetimibe (n=241). Patients were taking maximally tolerated doses of statins and required additional LDL-C reduction. Patients received either PRALUENT 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy. Up-titration of PRALUENT to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL at week 8. 18% of PRALUENT patients needed to be up-titrated at week 12 from 75 mg to 150 mg Q2W.2,4

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 arthralgia3

CHOICE I (Study 7) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT 300 mg Q4W (n=458), PRALUENT 75 mg Q2W (n=115), and placebo (n=230). Patients were stratified based on whether or not they were treated concomitantly with statin. The mean age was 61 years (range 21-88), 42% were women, 87% were Caucasian, 11% were Black, and 3% were Hispanic/Latino. In the cohort of patients on background statin, the mean baseline LDL-C was 113 mg/dL. A primary efficacy endpoint measure at week 24 was the mean percent change in LDL-C from baseline. The dose was up-titrated to 150 mg Q2W at week 12, based on prespecified LDL-C criteria at week 8, in approximately 20% of patients treated with PRALUENT 75 mg Q2W or 300 mg Q4W.2

The recommended starting dose of PRALUENT is 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 dosage. If the LDL-C response is inadequate after 4 to 8 weeks of initiating PRALUENT, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks
  • PRALUENT once-monthly 300 mg dose: Administered as 2 consecutive, subcutaneous 150 mg injections at 2 different injection sites every 4 weeks2
  • 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 regimen2. If LDL-reduction is inadequate, the dose may be adjusted to 150 mg every 2 weeks, starting the new dose on the next scheduled dosing date
  • 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
COMBO I (Study 3) 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.2
LONG TERM trial (Study 2) 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.2
LDL-C reductions with PRALUENT as monotherapy2
In patients with moderate CV risk, PRALUENT as monotherapy had significant and consistent LDL-C reduction2
  • The mean percent change in LDL-C at week 24 from baseline was -45% with PRALUENT vs -14% with ezetimibe
  • The treatment difference between PRALUENT and ezetimibe in mean LDL-C percent change was -31% (95% CI: -40%, -22%; P<0.0001)
MONO (Study 10) was a multicenter, double-blind, ezetimibe-controlled trial comparing PRALUENT 75 mg Q2W (n=52) to ezetimibe 10 mg/day (n=51) in patients with moderate CV risk, not taking statins or other lipid modifying therapies. Baseline LDL-C was between 100 mg/dL and 190 mg/dL.2

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GET DOSING INFO

PRALUENT offers flexible LDL-C lowering dosing options

PRALUENT offers flexible LDL-C lowering dosing options

MECHANISM OF ACTION

See how PRALUENT works

See how PRALUENT works

INDICATIONS AND USAGE

PRALUENT is indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).
IMPORTANT SAFETY INFORMATION
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT, including hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.
  • Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia (including heterozygous familial hypercholesterolemia (HeFH)) (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.
  • The most commonly occurring adverse reactions in the cardiovascular outcomes trial (>5% of patients treated with PRALUENT and occurring more frequently than placebo) were non-cardiac chest pain, nasopharyngitis, and myalgia.
  • In the primary hyperlipidemia (including HeFH) clinical trials, local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.
  • The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75mg 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.
  • In a cardiovascular outcomes trial, local injection site reactions were reported in 3.8% of patients treated with PRALUENT versus 2.1% patients treated with placebo, and led to permanent discontinuation in 0.3% of patients versus <0.1% of patients, respectively.
  • In the primary hyperlipidemia trials, liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo.
  • In the primary hyperlipidemia trials, the most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).
  • PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.

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References:
  1. Schwartz GG, Steg PG, Szarek M, et al; for the ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379:2097-2107.
  2. PRALUENT® (alirocumab) Prescribing Information. Sanofi and Regeneron Pharmaceuticals.
  3. Data on file. Efficacy in COMBO II: calculated LDL-C over time. Sanofi and Regeneron Pharmaceuticals. 2016.
  4. Data on file. Excerpts from clinical summary of efficacy (hypercholesterolemia). Sanofi and Regeneron Pharmaceuticals. 2014.
  5. Data on file. CHOICE I: calculated LDL-C in patients receiving concomitant statin therapy. Sanofi and Regeneron Pharmaceuticals.

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IMPORTANT SAFETY INFORMATION
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT, including hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization
  • Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve