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
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.
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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In adults with a prior MI or unstable angina,*
PRALUENT significantly reduced all-cause mortality, nonfatal stroke, and nonfatal MI (secondary composite endpoint)
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
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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