CardioSource WorldNews | Page 41

...AND MORE POWER IF YOU NEED IT Stephanie: Has ASCVD and achieved LDL-C reduction beyond statins1* PRALUENT is the only PCSK9 inhibitor that offers 2 doses with 2 levels of efficacy In COMBO I 44% 58% LDL-C reduction at 24 weeks on top of statins starting with PRALUENT 75 mg† In the LONG TERM Study T:14” B:14.25” S:12.5” LDL-C reduction at 24 weeks on top of statins with PRALUENT 150 mg The recommended starting dose is 75 mg every 2 weeks1 CLINICAL STUDIES COMBO I (Study 2) 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 lipidmodifying 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. The primary efficacy endpoint, measured at week 24, was the mean percent change in LDL-C from baseline.1 LONG TERM trial (Study 1) 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. The primary efficacy endpoint, measured at week 24, was the mean percent change in LDL-C from baseline.1 IMPORTANT SAFETY INFORMATION • 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 • 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 Please see brief summary of Prescribing Information on next page. Learn more at PraluentHCP.com