دورية أكاديمية
Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM-INSULIN trial.
| العنوان: | Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM-INSULIN trial. |
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| المؤلفون: | Cariou, B, Leiter, L A, Müller-Wieland, D, Bigot, G, Colhoun, H M, Del Prato, S, Henry, R R, Tinahones, F J, Letierce, A, Aurand, L, Maroni, J, Ray, K K, Bujas-Bobanovic, M |
| سنة النشر: | 2017 |
| المجموعة: | Sistema Sanitario Público de Andalucía (SSPA): Repositorio |
| مصطلحات موضوعية: | Alirocumab, Diabetes, Insulin, LDL-C, ODYSSEY, PCSK9, Adolescent, Adult, Aged, Antibodies, Monoclonal, Humanized, Cardiovascular Diseases, Diabetes Mellitus, Type 1, Type 2, Double-Blind Method, Drug Interactions, Female, Humans, Hypercholesterolemia, Male, Middle Aged, Research Design, Risk Factors, Young Adult |
| الوصف: | The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk. ODYSSEY DM-INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients. Participants had low-density lipoprotein cholesterol (LDL-C) levels at screening≥70mg/dL (1.81mmol/L) with stable maximum tolerated statin therapy or were statin-intolerant, and taking (or not) other lipid-lowering therapy; they also had established CV disease or at least one additional CV risk factor. Eligible patients were randomized 2:1 to 24weeks of alirocumab 75mg every 2weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C≥70mg/dL at week 8 underwent a blinded dose increase to 150mg Q2W at week 12. Primary endpoints were the difference between treatment arms in percentage change of calculated LDL-C from baseline to week 24, and alirocumab safety. This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017. The ODYSSEY DM-INSULIN study will provide information on the efficacy and safety of alirocumab in insulin-treated individuals with T1 or T2 DM who are at high CV risk and have hypercholesterolaemia not adequately controlled by the maximum tolerated statin therapy. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1878-1780 |
| العلاقة: | http://hdl.handle.net/10668/11012Test; https://doi.org/10.1016/j.diabet.2017.01.004Test |
| DOI: | 10.1016/j.diabet.2017.01.004 |
| الإتاحة: | https://doi.org/10.1016/j.diabet.2017.01.004Test http://hdl.handle.net/10668/11012Test |
| حقوق: | Attribution-NonCommercial-NoDerivatives 4.0 International ; http://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; open access |
| رقم الانضمام: | edsbas.83C6E93A |
| قاعدة البيانات: | BASE |
| تدمد: | 18781780 |
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| DOI: | 10.1016/j.diabet.2017.01.004 |