Monoclonal antibodies to pcsk9, the new class of injectable cholesterol lowering drugs,

Page 8

Zaid A, Roubtsova A, Essalmani R, Marcinkiewicz J, Chamberland A, Hamelin J, et al. Proprotein convertase subtilisin/kexin type 9 ( PCSK9): hepatocyte-specific low-density lipoprotein receptor degradation and critical role in mouse liver regeneration. Hepatology. 2008;48(2):646-54. 12. Seidah NG. Proprotein convertase subtilisin kexin 9 ( PCSK9) inhibitors in the treatment of hypercholesterolemia and other pathologies. Current pharmaceutical design. 2013;19(17):3161-72. 13. U.S. Food and Drug Administration. FDA approves Praluent to treat certain patients with high cholesterol 2015 [cited November 17, 2015]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm. 14. U.S. Food and Drug Administration. Prescription information of PRALUENT (alirocumab) injection, for subcutaneous use; Initial U.S. Approval: 2015 [ cited November 17, 2015]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbl.pdf. 15. Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, et al. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. The New England journal of medicine. 2012;366(12):1108-18. 16. Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. The New England journal of medicine. 2012;367(20):1891-900. 17. Stein EA, Gipe D, Bergeron J, Gaudet D, Weiss R, Dufour R, et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet. 2012;380(9836):29-36. 18. Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. The New England journal of medicine. 2015;372(16):1489-99. 19. The U.S. Food and Drug Administration. FDA approves Repatha to treat certain patients with high cholesterol 2015 [ cited November 19, 2015]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm. 20. Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. The New England journal of medicine. 2015;372(16):1500-9. 21. Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) [cited November 21, 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT01764633. 22. Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, et al. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, doseranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015;115(9):1212-21. 23. The evaluation of bococizumab (PF-04950615;RN316) in reducing the occurrence of major cardiovascular events in high risk subjects (SPIRE-1) [cited November 20, 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT01975376. 24. The evaluation of bococizumab (PF-04950615; RN316) in reducing the occurrence of major cardiovascular events in high risk subjects (SPIRE-2) [cited November 20, 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT01975389. 11.


Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.