Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial

Erik Stroes, David Colquhoun, David Sullivan, Fernando Civeira, Robert S. Rosenson, Gerald F. Watts, Eric Bruckert, Leslie Cho, Ricardo Dent, Beat Knusel, Allen Xue, Rob Scott, Scott M. Wasserman, Michael Rocco, Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients With Statin Intolerance Journal of the American College of Cardiology. ,vol. 63, pp. 2541- 2548 ,(2014) , 10.1016/J.JACC.2014.03.019

Terry Jacobson, None, National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2 Journal of Clinical Lipidology. ,vol. 9, pp. S1- S122.e1 ,(2015) , 10.1016/J.JACL.2015.09.002

John R. Guyton, Harold E. Bays, Scott M. Grundy, Terry A. Jacobson, An assessment by the Statin Intolerance Panel: 2014 update. Journal of Clinical Lipidology. ,vol. 8, ,(2014) , 10.1016/J.JACL.2014.03.002

Patrick M. Moriarty, Terry A. Jacobson, Eric Bruckert, Paul D. Thompson, John R. Guyton, Marie T. Baccara-Dinet, Daniel Gipe, Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. Journal of Clinical Lipidology. ,vol. 8, pp. 554- 561 ,(2014) , 10.1016/J.JACL.2014.09.007

, Z. Reiner, A. L. Catapano, G. De Backer, I. Graham, M.-R. Taskinen, O. Wiklund, S. Agewall, E. Alegria, M. J. Chapman, P. Durrington, S. Erdine, J. Halcox, R. Hobbs, J. Kjekshus, P. P. Filardi, G. Riccardi, R. F. Storey, D. Wood, J. Bax, A. Vahanian, A. Auricchio, H. Baumgartner, C. Ceconi, V. Dean, C. Deaton, R. Fagard, G. Filippatos, C. Funck-Brentano, D. Hasdai, R. Hobbs, A. Hoes, P. Kearney, J. Knuuti, P. Kolh, T. McDonagh, C. Moulin, D. Poldermans, B. A. Popescu, Z. Reiner, U. Sechtem, P. A. Sirnes, M. Tendera, A. Torbicki, P. Vardas, P. Widimsky, S. Windecker, D. Reviewers:, C. Funck-Brentano, D. Poldermans, G. Berkenboom, J. De Graaf, O. Descamps, N. Gotcheva, K. Griffith, G. F. Guida, S. Gulec, Y. Henkin, K. Huber, Y. A. Kesaniemi, J. Lekakis, A. J. Manolis, P. Marques-Vidal, L. Masana, J. McMurray, M. Mendes, Z. Pagava, T. Pedersen, E. Prescott, Q. Rato, G. Rosano, S. Sans, A. Stalenhoef, L. Tokgozoglu, M. Viigimaa, M. E. Wittekoek, J. L. Zamorano, , , ESC/EAS Guidelines for the management of dyslipidaemias: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS)☆☆☆ Atherosclerosis. ,vol. 32, pp. 1769- 1818 ,(2011) , 10.1093/EURHEARTJ/EHR158

Warner M. Mampuya, David Frid, Michael Rocco, Julie Huang, Danielle M. Brennan, Stanley L. Hazen, Leslie Cho, Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience American Heart Journal. ,vol. 166, pp. 597- 603 ,(2013) , 10.1016/J.AHJ.2013.06.004

Beth A. Parker, Jeffrey A. Capizzi, Adam S. Grimaldi, Priscilla M. Clarkson, Stephanie M. Cole, Justin Keadle, Stuart Chipkin, Linda S. Pescatello, Kathleen Simpson, C. Michael White, Paul D. Thompson, Effect of Statins on Skeletal Muscle Function Circulation. ,vol. 127, pp. 96- 103 ,(2012) , 10.1161/CIRCULATIONAHA.112.136101

Dean J. Kereiakes, Jennifer G. Robinson, Christopher P. Cannon, Christelle Lorenzato, Robert Pordy, Umesh Chaudhari, Helen M. Colhoun, Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study. American Heart Journal. ,vol. 169, pp. 906- 915 ,(2015) , 10.1016/J.AHJ.2015.03.004

Jennifer G Robinson, Michel Farnier, Michel Krempf, Jean Bergeron, Gérald Luc, Maurizio Averna, Erik S Stroes, Gisle Langslet, Frederick J Raal, Mahfouz El Shahawy, Michael J Koren, Norman E Lepor, Christelle Lorenzato, Robert Pordy, Umesh Chaudhari, John JP Kastelein, None, Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events The New England Journal of Medicine. ,vol. 372, pp. 1489- 1499 ,(2015) , 10.1056/NEJMOA1501031

Roderick J. Little, Ralph D'Agostino, Michael L. Cohen, Kay Dickersin, Scott S. Emerson, John T. Farrar, Constantine Frangakis, Joseph W. Hogan, Geert Molenberghs, Susan A. Murphy, James D. Neaton, Andrea Rotnitzky, Daniel Scharfstein, Weichung J. Shih, Jay P. Siegel, Hal Stern, The Prevention and Treatment of Missing Data in Clinical Trials The New England Journal of Medicine. ,vol. 367, pp. 1355- 1360 ,(2012) , 10.1056/NEJMSR1203730