A 52-week placebo-controlled trial of evolocumab in hyperlipidemia

DJ Blom, T Hala, M Bolognese… - … England Journal of …, 2014 - Mass Medical Soc
… a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab.
… , placebo-controlled, phase 3 trial, we compared evolocumab with placebo in patients with …

Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long …

MJ Koren, RP Giugliano, FJ Raal, D Sullivan… - Circulation, 2014 - Am Heart Assoc
… for 52 weeks (Figure 1). Ninety-two percent of patients in the evolocumab+SOC group
completed 52 weeks of follow-up, and 89% of patients in the SOC group completed 52 weeks of …

Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study

RS Rosenson, ML Daviglus, Y Handelsman, P Pozzilli… - Diabetologia, 2019 - Springer
… In this study, evolocumab was dosed at day 1, week 4 and week 8. Thus, week 12 was at the
end … In the BANTING trial, we observed that a substantially greater proportion of participants …

The efficacy advantage of evolocumab (AMG 145) dosed at 140 mg every 2 weeks versus 420 mg every 4 weeks in patients with hypercholesterolemia: Evidence from …

XX He, R Zhang, PY Zuo, YW Liu, XN Zha… - European Journal of …, 2017 - Elsevier
… This study overcomes the limitations of individual trials and demonstrates that evolocumab
has greater efficacy at 140 mg Q2W than at 420 mg Q4W in modulating LDL-C levels and …

Effects of evolocumab on vitamin E and steroid hormone levels: results from the 52-week, phase 3, double-blind, randomized, placebo-controlled DESCARTES study

DJ Blom, CS Djedjos, ML Monsalvo, I Bridges… - Circulation …, 2015 - Am Heart Assoc
… As expected, vitamin E levels changed similarly to lipids among patients treated for 52 weeks
with evolocumab. No adverse effects were observed in steroid or gonadal hormones, even …

Long-term low-density lipoprotein cholesterol–lowering efficacy, persistence, and safety of evolocumab in treatment of hypercholesterolemia: Results up to 4 years …

MJ Koren, MS Sabatine, RP Giugliano… - JAMA …, 2017 - jamanetwork.com
… receive evolocumab plus standard of care (SOC) or SOC alone for the first 52 weeks during
… longest clinical trial exposure to a PCSK9 inhibitor to date, evolocumab produced sustained …

Effect of evolocumab on non‐high‐density lipoprotein cholesterol, apolipoprotein B, and lipoprotein (a): a pooled analysis of phase 2 and phase 3 studies

PP Toth, SR Jones, ML Monsalvo… - Journal of the …, 2020 - Am Heart Assoc
… parameters were balanced between the pooled evolocumab dosing group and placebo or
ezetimibe comparators across all 12‐week randomized trials that contributed to this analysis. …

Evaluation of the efficacy, safety and glycaemic effects of evolocumab (AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic …

DJ Blom, MJ Koren, E Roth… - Diabetes, obesity …, 2017 - Wiley Online Library
… (DESCARTES) was a 52-week placebo-controlled trial of evolocumab that randomized
905 … duration of 52 weeks and the possibility that potential effects of evolocumab on insulin …

Effect of evolocumab on lipoprotein particles

PP Toth, N Sattar, DJ Blom, SS Martin, SR Jones… - The American Journal of …, 2018 - Elsevier
… lipids in patients treated for 52 weeks with evolocumab (Table 2). At week 52, average LDL-C
trial demonstrates that evolocumab induces marked reductions in LDL-C and LDL-P after …

Safety and tolerability of very low LDL-C levels in patients treated with 52 weeks of evolocumab (AMG 145)

MJ Koren, D Blom, RP Giugliano, E Stroes… - Circulation, 2014 - Am Heart Assoc
Introduction: Evolocumab (AMG 145), a fully human monoclonal antibody to proprotein
convertase subtilisin-kexin type 9 (PCSK9), can reduce LDL-C to very low levels, particularly …