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ODYSSEY OUTCOMES

PRALUENT is indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

In adults with a prior MI or unstable angina,

PRALUENT significantly reduced the risk of MACE and is the ONLY PCSK9i with an observed reduction in all-cause mortality

Because statistical testing of the all-cause mortality endpoint was performed outside of the hierarchy, this result is not considered statistically significant.

~90% of patients in ODYSSEY OUTCOMES were on a high-intensity statin1

Components of the primary endpoint*†

  • 8% RRR of CHD death
  • 14% RRR of nonfatal MI
  • 27% RRR of stroke (fatal or nonfatal)
  • 39% RRR of UA requiring hospitalization

Mortality endpoint

  • Because statistical testing of this endpoint was performed outside of the hierarchy, this result is not considered statistically significant
  • *RRR for the components of the primary endpoint were associated with reduction in the risk of CHD death (HR 0.92; 95% CI, 0.76, 1.11), nonfatal MI (HR 0.86; 95% Cl, 0.77, 0.96), fatal or nonfatal stroke (HR 0.73; 95% Cl, 0.57, 0.93), and unstable angina requiring hospitalization (HR 0.61; 95% Cl, 0.41, 0.92).
  • CHD death was not statistically significant. Because statistical testing of the remaining component endpoints was performed outside of the hierarchy, the results are not considered statistically significant.

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The 75 mg PRALUENT dose was used 78% of the time in the study2

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.1
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Risk of composite all cause-mortality, nonfatal stroke, nonfatal MI

(HR 0.86; 95% CI 0.79, 0.93. P<0.001)2,3

Because statistical testing of these individual endpoints was performed outside of the hierarchy, these results are not considered statistically significant.

ODYSSEY OUTCOMES is the longest PCSK9i CV outcomes trial to date based on median follow-up of 2.8 years1,2

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*In ODYSSEY OUTCOMES.

Evaluated in ~19,000 patients in the ODYSSEY OUTCOMES trial1

*In ODYSSEY OUTCOMES.

Unstable angina requiring hospitalization.

CHD event defined as: major CHD event,§ unstable angina requiring hospitalization, ischemia-driven coronary revascularization procedure.2

§Major CHD event defined as: CHD death, nonfatal MI.2

||Cardiovascular event defined as follows: CV death, any nonfatal CHD event, and nonfatal ischemic stroke.2

The hierarchical analysis was stopped after the first nonsignificant P value was observed, in accordance with the hierarchical testing plan. Subsequent endpoints are not statistically significant.2

Learn more about ODYSSEY OUTCOMES.

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Common Adverse Reactions Observed In ODYSSEY OUTCOMES Trial

  • 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 (7.0% PRALUENT, 6.8% placebo), nasopharyngitis (6.0% PRALUENT, 5.6% placebo), and myalgia (5.6% PRALUENT, 5.3% placebo)
  • 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

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Learn more about CV outcomes results from a PRALUENT Field Representative

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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ACS = acute coronary syndrome; CHD = coronary heart disease; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction; RRR = relative risk reduction; UA = unstable angina.
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.
  3. Data on file. Excerpts from ODYSSEY OUTCOMES CSR. Sanofi and Regeneron Pharmaceuticals. 2018.

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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