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Last update: March 2019

Efficacy of 75 mg Praluent* starting strength vs ezetimibe within ODYSSEY COMBO II2

Praluent Efficacy 75mg

In the ODYSSEY COMBO II study, 720 patients with high cardiovascular risk and elevated LDL-C despite maximally tolerated statins were randomised to Praluent* every 2 weeks (n = 479) or ezetimibe (10 mg once daily) (n = 241)

  • The primary efficacy endpoint was percentage change in calculated LDL-C level from baseline to Week 242
  • At Week 24, mean reductions in LDL-C from baseline were 50.6 ± 1.4% for Praluent vs. 20.7 ± 1.9% for ezetimibe for a mean treatment difference between groups of −29.8 ± 2.3 [95% CI −34.4 to −25.3; p<0.0001 intention-to-treat (itt) analysis

† All patients had hypercholesterolaemia and established coronary heart disease or coronary heart disease risk equivalents (ischaemic stroke, peripheral artery disease, moderate chronic kidney disease, or diabetes mellitus plus ≥ 2 additional risk factors)
‡ ITT analysis, n = 467 for Praluent and n = 240 for ezetimibe
CI, confidence interval; ITT, Intention-to-treat

Efficacy of 150 mg Praluent* starting strength vs Placebo within ODYSSEY LONG TERM3

Praluent Efficacy 150mg

The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.

In ODYSSEY LONG TERM3 2431 patients at high risk for cardiovascular events (17.7% had heterozygous familial hypercholesterolaemia (HeFH)) and elevated LDL-C despite maximally tolerated statins with or without other lipid lowering therapy were randomised to Praluent (150 mg every two weeks) (n = 1553) or placebo (n = 788).

  • The primary efficacy endpoint was percentage change in calculated LDL-C level from baseline to Week 243
  • At Week 24, mean reductions in LDL-C from baseline were −61.0 ± 0.7% for Praluent vs. +0.8 ± 1.0% for placebo for a mean difference between groups of −61.9 ± 1.3 [95% CI −64.3 to −59.4; p<0.0001] (ITT analysis§)

§ITT analysis, n = 1530 for Praluent and n = 780 for placebo
CI, confidence interval; ITT, Intention-to-treat

Details of the key clinical trials can be found by clicking here.

References

  • Praluent Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/medicine/30956. Accessed March 2019.
  • Cannon CP et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J 2015; 36:1186–94.
  • Robinson J et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. NEJM 2015; 372:1489–99.