10/18/2024

Janusmed sex and gender

Janusmed sex and gender – Evolocumab

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Evolocumab

Evolocumab

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  1. Food and Drug Administration (FDA) . Clinical Pharmacology and Biopharmaceutics Review - REPATHA (evolocumab). US Food and Drug Administration [www]. [updated 2015-10-01, cited 2017-03-21].

  2. Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F et al. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012;380:2007-17.

  3. Raal FJ, Giugliano RP, Sabatine MS, Koren MJ, Langslet G, Bays H et al. Reduction in lipoprotein(a) with PCSK9 monoclonal antibody evolocumab (AMG 145): a pooled analysis of more than 1,300 patients in 4 phase II trials. J Am Coll Cardiol. 2014;63:1278-88.

  4. Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015;385:331-40.

  5. Kiyosue A, Honarpour N, Kurtz C, Xue A, Wasserman SM, Hirayama A. A Phase 3 Study of Evolocumab (AMG 145) in Statin-Treated Japanese Patients at High Cardiovascular Risk. Am J Cardiol. 2016;117:40-7.

  6. Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ et al. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016;316:2373-2384.

  7. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017. doi: 10.1056/NEJMoa1615664. [Epub ahead of print]

  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.]

  1. Food and Drug Administration (FDA) . Clinical Pharmacology and Biopharmaceutics Review - REPATHA (evolocumab). US Food and Drug Administration [www]. [updated 2015-10-01, cited 2017-03-21].
  2. Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F et al. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012;380:2007-17.
  3. Raal FJ, Giugliano RP, Sabatine MS, Koren MJ, Langslet G, Bays H et al. Reduction in lipoprotein(a) with PCSK9 monoclonal antibody evolocumab (AMG 145): a pooled analysis of more than 1,300 patients in 4 phase II trials. J Am Coll Cardiol. 2014;63:1278-88.
  4. Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015;385:331-40.
  5. Kiyosue A, Honarpour N, Kurtz C, Xue A, Wasserman SM, Hirayama A. A Phase 3 Study of Evolocumab (AMG 145) in Statin-Treated Japanese Patients at High Cardiovascular Risk. Am J Cardiol. 2016;117:40-7.
  6. Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ et al. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016;316:2373-2384.
  7. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017. doi: 10.1056/NEJMoa1615664. [Epub ahead of print]
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.]