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 - 14/11/17

Doi : 10.1016/j.diabet.2017.01.004

B. Cariou ^a,^⁎ , L.A. Leiter ^b, D. Müller-Wieland ^c, G. Bigot ^d, H.M. Colhoun ^e, S. Del Prato ^f, R.R. Henry ^g, F.J. Tinahones ^h, A. Letierce ⁱ, L. Aurand ^j, J. Maroni ^k, K.K. Ray ^l, M. Bujas-Bobanovic ^m
^a Institut du thorax, CHU Nantes, INSERM, CNRS, UNIV Nantes, 44093 Nantes cedex 1, France
^b Li KaShing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada
^c Department of Internal Medicine I, University Hospital Aachen, Aachen, Germany
^d IVIDATA, 92300 Levallois-Perret, France
^e University of Edinburgh, Edinburgh, Scotland, UK
^f Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
^g University of California San Diego School of Medicine, Center for Metabolic Research, Veterans Affairs, San Diego Healthcare System, San Diego, CA, USA
^h CIBERobn, Hospital Virgen de la Victoria, Málaga University, Spain
ⁱ Sanofi, 91380 Chilly-Mazarin, France
^j Sanofi, Bridgewater, NJ, USA
^k Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
^l Department of Primary Care and Public Health, School of Public Health, Imperial College, London, UK
^m Sanofi, 75008 Paris, France

^⁎Corresponding author. Department of Endocrinology, Institut du Thorax, CHU de Nantes, 44093 Nantes cedex 1, France. Tel.: +332 53 48 27 07.

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Abstract

Aims

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.

Methods

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.

Results

This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017.

Conclusion

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.

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Keywords : Alirocumab, Diabetes, Insulin, LDL-C, ODYSSEY, PCSK9

Abbreviations : AE, Apo, ASCVD, CHD, CV, CVD, DM, HDL-C, I-TAQ, ITT, LDL-C, LDL-P, LLT, Lp(a), MI, mITT, MMRM, PAD, PCSK9, Q2W, TG, T1, T2, UA