Dataset Information

Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia.

ABSTRACT:

Objectives

The objective of this study is to report the dose response in ODYSSEY phase 3 clinical trials of proprotein convertase subtilisin kexin type 9 inhibition with alirocumab in patients not at prespecified lipid goals who received a per-protocol dose increase from 75 every 2 weeks (Q2W) to 150 mg Q2W.

Methods

Patients (n=2181) receiving statins were enrolled in six phase 3 randomized, double-blind, double-dummy trials (24-104 weeks): alirocumab versus placebo or ezetimibe 10 mg/day. The 75 mg subcutaneous Q2W dose was increased to 150 mg at week 12 if week 8 LDL cholesterol (LDL-C) was greater than or equal to 70 mg/dl (>100 mg/dl in OPTIONS studies for patients without previous coronary heart disease, but with other risk factors). LDL-C percentage reductions from baseline (on-treatment data, n=1291) were compared at week 12 versus week 24.

Results

Most patients (n=951; 73.7%) with 75 mg Q2W dose plus background statin achieved LDL-C less than 70 or less than 100 mg/dl at week 8. In 340 (26.3%) patients, alirocumab dose was increased to 150 mg Q2W at week 12, and 60.9% of these patients achieved LDL-C goals at week 24, with an additional 14.2% reduction in LDL-C from week 12 to week 24. Adverse event rates were comparable in patients with versus without a dose increase (72.4 vs. 71.8% in placebo-controlled trials; 67.0 vs. 67.6% in ezetimibe-controlled trials).

Conclusion

Most patients achieved LDL-C goals with alirocumab 75 mg Q2W plus statins. Of those (26.3%) receiving a dose increase, 60.9% achieved LDL-C goals at week 24 with an additional 14.2% reduction in LDL-C.

SUBMITTER: Kastelein JJ

PROVIDER: S-EPMC5400401 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia.

Kastelein John J P JJ Kereiakes Dean J DJ Cannon Christopher P CP Bays Harold E HE Minini Pascal P Lee L Veronica LV Maroni Jaman J Farnier Michel M

Coronary artery disease 20170501 3

<h4>Objectives</h4>The objective of this study is to report the dose response in ODYSSEY phase 3 clinical trials of proprotein convertase subtilisin kexin type 9 inhibition with alirocumab in patients not at prespecified lipid goals who received a per-protocol dose increase from 75 every 2 weeks (Q2W) to 150 mg Q2W.<h4>Methods</h4>Patients (n=2181) receiving statins were enrolled in six phase 3 randomized, double-blind, double-dummy trials (24-104 weeks): alirocumab versus placebo or ezetimibe 1 ...[more]

PMID: 27740972

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Dataset Information

Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia.

Objectives

Methods

Results

Conclusion

Publications

Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia.

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