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ODYSSEY OUTCOMES Trial Design

PRALUENT was studied in the longest PCSK9i CV outcomes trial to date based on a median follow-up time of 2.8 years1,2

Evaluated in ~19,000 patients with established CV disease1

A total of 99.5% of patients were followed for survival until the end of the trial. The median follow-up duration was 2.8 years1

PRIMARY ENDPOINT1

  • Length of time until patients experienced a MACE occurrence, defined as:
    • CHD death
    • Nonfatal MI
    • Fatal or nonfatal ischemic stroke
    • Unstable angina requiring hospitalization

MAJOR SECONDARY ENDPOINTS2

  • In order of hierarchial testing
    • CHD event (including CHD death, nonfatal MI, UA requiring hospitalization, and an ischemia-driven coronary revascularization procedure)
    • Major CHD event (including death from CHD and nonfatal MI)
    • CV event (including any nonfatal CHD event, death from CV causes, or nonfatal ischemic stroke)
    • Composite of all-cause death, nonfatal MI, nonfatal ischemic stroke
    • CHD death
    • CV death
    • All-cause death

Double-blind treatment period (~2 to 5 years)1,2

On top of maximally tolerated statins:

R = Randomization

Dosing to target range

At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL), PRALUENT was adjusted to 150 mg Q2W. For patients who had their dose adjusted to 150 mg Q2W and who had two consecutive LDL-C values below 25 mg/dL, down-titration from 150 mg Q2W to 75 mg Q2W was performed. Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL were switched to placebo in a blinded fashion. Approximately 2615 (27.7%) of 9451 patients treated with PRALUENT required dose adjustment to 150 mg Q2W. Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W. Overall, 730 (7.7%) of 9451 patients switched to placebo.

MECHANISM OF ACTION

See how PRALUENT works

See how PRALUENT works

VIEW LDL-C RESULTS

Help patients get to LDL-C goal

Help patients get to LDL-C goal

NEED HELP? CONTACT A REP

Learn more about the ODYSSEY OUTCOMES trial from a PRALUENT Field Representative

INDICATIONS AND USAGE

PRALUENT (alirocumab) 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. PRALUENT® (alirocumab) Prescribing Information. Sanofi and Regeneron Pharmaceuticals.
  2. 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.

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SAUS.PRL.19.02.1357b Last Update: May 2019

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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