LDL-C reduction: PRALUENT vs ezetimibe
LDL-C reduction at 24 weeks on top of maximally tolerated statins (vs ezetimibe) in the COMBO II Study with PRALUENT 75 mg Q2W/150 mg Q2W1,2
COMBO II (Study 9) was a multicenter, double-blind, ezetimibe-controlled trial that compared PRALUENT (n=479) with ezetimibe (n=241). Patients were taking maximally tolerated doses of statins and required additional LDL-C reduction. Patients received either PRALUENT 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy. Up-titration of PRALUENT to 150 mg Q2W occurred at Week 12 in patients with LDL-C ≥70 mg/dL at Week 8. 18% of PRALUENT patients needed to be up-titrated at Week 12 from 75 mg to 150 mg Q2W.1,3
82% of patients achieved LDL-C goal (<70 mg/dL) at Week 8 and did not require dose adjustment at Week 12 in the COMBO II Study1,3
- In COMBO II, adverse reactions occurring in ≥5% of PRALUENT-treated patients and more frequently than with ezetimibe were accidental overdose, upper respiratory tract infection, hypertension, headache, and arthralgia2
Significant reductions in LDL-C were also seen in FH trials
For adults with established CV disease or primary hyperlipidemia, including HeFH,
PRALUENT offers a once-monthly starting dose option
LDL-C–lowering power with the
from baseline at 24 weeks with PRALUENT 300 mg Q4W/150 mg Q2W vs -1% for placebo (P<0.0001) in the cohort of patients on background statin in the CHOICE I Study1,4
CHOICE I (Study 7) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT 300 mg Q4W(n=458), PRALUENT 75 mg Q2W (n=115), and placebo (n=230). Patients were stratified based on whether or not they were treated concomitantly with statin. The mean age was 61 years (range 21-88), 42% were women, 87% were Caucasian, 11% were Black, and 3% were Hispanic/Latino. In the cohort of patients on background statin, the mean baseline LDL-C was 113 mg/dL. A primary efficacy endpoint measure at Week 24 was the mean percent change in LDL-C from baseline. The dose was up-titrated to 150 mg Q2W at Week 12, based on prespecified LDL-C criteria at Week 8, in approximately 20% of patients treated with PRALUENT 75 mg Q2W or 300 mg Q4W.1
The recommended starting dose of PRALUENT is 75 mg once every 2 weeks administered subcutaneously or 300 mg once every 4 weeks (monthly) for the prevention of CV events and primary hyperlipidemia, including HeFH. If the LDL-C response is inadequate, the dosage may be adjusted to 150 mg administered every 2 weeks.
In adults with HeFH undergoing LDL apheresis, the recommended dose of PRALUENT is 150 mg once every 2 weeks administered subcutaneously. PRALUENT can be administered without regard to the timing of LDL apheresis.
The recommended dose of PRALUENT for patients with HoFH is 150 mg once every 2 weeks administered subcutaneously.
Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.
- PRALUENT once-monthly (Q4W) 300-mg dose: administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 weeks1
- For patients receiving PRALUENT 300-mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, because LDL-C can vary between doses in some patients.2 If LDL-C reduction is inadequate, the dose may be adjusted to 150 mg every 2 weeks1
- The once-monthly 300-mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg 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 arms1
PRALUENT provided powerful LDL-C reductions in primary hyperlipidemia studies
from baseline at 24 weeks with PRALUENT 75 mg Q2W/150 mg vs -2% for placebo (P<0.0001) in the COMBO I Study1
COMBO I (Study 3) 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 lipid-modifying 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.1
with PRALUENT 150 mg Q2W vs +1% for placebo at Week 24 (P<0.0001) in the LONG TERM Study1
LONG TERM trial (Study 2) 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.1
LDL-C reductions with PRALUENT as monotherapy1
In patients wtih moderate CV risk, PRALUENT as monotherapy had significant and consistent LDL-C reduction1
- The mean percent change in LDL-C at Week 24 from baseline was -45% with PRALUENT vs -14% with ezetimibe
- The treatment difference between PRALUENT and ezetimibe in mean LDL-C percent change was -31% (95% CI: -40%, -22%; P<0.0001)
MONO (Study 10) was a multicenter, double-blind, ezetimibe-controllerd trial comparing PRALUENT 75 mg Q2W (n=52) to ezetimibe 10 mg/day (n=51) in patients with moderate CV risk, not taking statins or other lipid-modifying therapies. Baseline LDL-C was between 100 mg/dL and 190 mg/dL.1
LDL-C = low-density lipoprotein cholesterol; Q2W = every 2 weeks; Q4W = once monthly.