CardioSource WorldNews | Page 34

When maximally tolerated statins and diet aren’t enough to get patients with clinical ASCVD or HeFH to their LDL-C goal... ADD PRALUENT® (alirocumab): POWER LIKE NEVER BEFORE... Larry: Has ASCVD and achieved LDL-C reduction beyond statins1* (recommended starting dose) INDICATIONS AND USAGE • PRALUENT is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemi a or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C • The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined IMPORTANT SAFETY INFORMATION • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included 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 (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza • Local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT (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 • Neurocognitive events were reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those treated with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each) *Not actual patients; individual results may vary. †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 8.1 LDL-C = low-density lipoprotein cholesterol; ASCVD = atherosclerotic cardiovascular disease; HeFH = heterozygous familial hypercholesterolemia.