PRALUENT is the only PCSK9 inhibitor that offers 2 doses with 2 levels of efficacy
IMPORTANT SAFETY INFORMATION
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Stephanie : Has ASCVD and achieved LDL-C reduction beyond statins 1 *
PRALUENT is the only PCSK9 inhibitor that offers 2 doses with 2 levels of efficacy
In COMBO I
44 %
LDL-C reduction at 24 weeks on top of statins starting with PRALUENT 75 mg †
In the LONG TERM Study reduction at 24 weeks on top of statins with PRALUENT 150 mg
58 %
LDL-C
The recommended starting dose is 75 mg every 2 weeks 1
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 .
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