Abstract | PURPOSE: METHODS: Patients were randomized to subcutaneous alirocumab 150 mg or placebo every 2 weeks (Q2W) for 78 weeks. The primary endpoint was percent change in LDL-C from baseline to week 24. RESULTS: Mean baseline LDL-C levels were 196.3 mg/dl in the alirocumab (n = 71) and 201.0 mg/dl in the placebo groups (n = 35). Significant mean (standard error [SE]) reductions in LDL-C from baseline to week 24 were observed with alirocumab (-45.7 [3.5] %) versus placebo (-6.6 [4.9] %), a difference of -39.1 (6.0) % (P < 0.0001). Absolute mean (SE) LDL-C levels were reduced from baseline by 90.8 (6.7) mg/dl with alirocumab at week 24, with reductions maintained to week 78. Treatment-emergent adverse events were generally comparable between groups. Injection-site reactions were more frequent in the alirocumab group (8.3 %) versus placebo (5.7 %); most were mild in severity and did not result in study medication discontinuation. CONCLUSIONS: In patients with heFH and very high LDL-C baseline levels despite maximally tolerated statin ± other LLT, alirocumab 150 mg Q2W demonstrated significant reductions in LDL-C levels with 41 % of patients achieving predefined LDL-C goals. Alirocumab was generally well tolerated.
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Authors | Henry N Ginsberg, Daniel J Rader, Frederick J Raal, John R Guyton, Marie T Baccara-Dinet, Christelle Lorenzato, Robert Pordy, Erik Stroes |
Journal | Cardiovascular drugs and therapy
(Cardiovasc Drugs Ther)
Vol. 30
Issue 5
Pg. 473-483
(Oct 2016)
ISSN: 1573-7241 [Electronic] United States |
PMID | 27618825
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Anticholesteremic Agents
- Cholesterol, LDL
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- PCSK9 Inhibitors
- PCSK9 protein, human
- Proprotein Convertase 9
- alirocumab
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Topics |
- Adult
- Antibodies, Monoclonal
(therapeutic use)
- Antibodies, Monoclonal, Humanized
- Anticholesteremic Agents
(therapeutic use)
- Cholesterol, LDL
(blood)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Hyperlipoproteinemia Type II
(blood, drug therapy)
- Male
- Middle Aged
- PCSK9 Inhibitors
- Proprotein Convertase 9
(immunology)
- Treatment Outcome
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