Abstract | OBJECTIVES: 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.
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Authors | John J P Kastelein, Dean J Kereiakes, Christopher P Cannon, Harold E Bays, Pascal Minini, L Veronica Lee, Jaman Maroni, Michel Farnier |
Journal | Coronary artery disease
(Coron Artery Dis)
Vol. 28
Issue 3
Pg. 190-197
(05 2017)
ISSN: 1473-5830 [Electronic] England |
PMID | 27740972
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Cholesterol, LDL
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Hypolipidemic Agents
- alirocumab
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Topics |
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Cholesterol, LDL
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Dyslipidemias
(drug therapy)
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Hypolipidemic Agents
(therapeutic use)
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