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Fase 3-studieprogrammet

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  • Oppdatert : 2018-06-01

Det kliniske studieprogrammet for Praluent omfatter 10 fase 3-studier (5 placebokontrollerte og 5 ezetimib-kontrollerte studier) med 5 296 pasienter med hyperkolesterolemi eller blandet dyslipidemi.1

Figur 1: Oversikt over klinisk studieprogram (inkludert pågående studie) 1-12

Oversikt studier
Grafisk framstilt av Sanofi

Det primære effektendepunktet i alle fase 3-studiene var gjennomsnittlig LDL-C-reduksjon i prosent i uke 24 i forhold til baseline, sammenlignet med placebo eller ezetimib. Det primære endepunktet ble møtt i alle studiene.1

Figur 2: Oppsummering av fase 3-studieprogrammet – doseringsregime på 75 mg og/eller 150 mg hver 2. uke (Q2W)1

Effekten av alirokumab ble studert i ti fase 3-studier (fem placebokontrollerte og fem ezetimibkontrollerte studier)
Grafisk framstilt av Sanofi

Referanser

1. Praluent SPC 16.11.17 Pkt. 5.1
2. European Medicines Agency (2015). European Public Assessment Report (EPAR) Praluent EMA/CHMP/392430/2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003882/WC500194524.pdf (18.02.2018)
3. Kastelein JJP, Ginsberg HN, Langslet G et al. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J 2015; 36: 2996-03
4. Ginsberg HN, Rader D, Raal FJ et al. ODYSSEY HIGH FH: Efficacy and Safety of Alirocumab in Patients With Severe Heterozygous Familial Hypercholesterolemia. Data presented at the American Heart Association Scientific Sessions; Chicago, Illinois; 15–19 November 2014.
5. Kereiakes DJ, Robinson JG, Cannon CP et al. 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. Am Heart J. 2015; 169:906–91
6. Cannon CP, Cariou B, Blom D et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolemia
on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J 2015; 36:1186-94
7. Robinson JG, Farnier M, Krempf M et al. Efficacy and safety  of Alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015; Vol. 372: 1489-99
8. Moriarty P.M., Thompson P.D., Cannon C.P. et al. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial.J Clin Lipidol 2015; 9:758-69
9. Roth EM, Taskinen MR, Ginsberg HN et al. Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24 week, double-blind, randomized Phase 3 trial. Int J Cardiol. 2014; 176:55–61.
10. Bays H, Gaudet D, Weiss R et al. Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J Clin Endocrinol Metab 2015; 100: 3140–48.
11. Farnier M, Jones P, Severance R et al. Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular risk patients: The ODYSSEY OPTIONS II randomized trial. Atherosclerosis. 2016; 244:138–46.
12. Schwartz GG, Bessac L, Berdan LG et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014;168:682-689

*Heterozygot familiær hyperkolesterolemi
**MACE=Major Adverse Cardiovascular Events (Død av koronar hjertesykdom, ikke-dødelig hjerteinfarkt, iskemisk slag og ustabil angina som krever hospitalisering)

SANO.ALI.17.09.0259j