Here are examples of top-line data news releases for recent cardiovascular outcomes trials (CVOT) that successfully achieved their primary endpoint. Note that most of the drugs used in these CVOT trials had previously passed Phase 3 trial(s) and been approved for use by FDA and/or EMA for glucose lowering/glucose control (SGLT2 inhibitors, GLP1-R agonists), LDL-C lowering (PCSK9 inhibitors), certain inflammatory conditions (canakinumab), anticoagulant therapy (Xarelto/rivaroxaban) prior to the completion of their respective CVOT trials. Apabetalone lacks any previous Phase 3 data and FDA/EMA approval, which adds an additional burden of proof.
CANTOS for canakinumab anti-IL1B antibody:
https://www.novartis.com/news/media-releases/novartis-phase-iii-study-shows-acz885-canakinumab-reduces-cardiovascular-risk
EMPA-REG OUTCOMES for Jardiance/empagliflozin SGLT2 inhibitor:
https://www.boehringer-ingelheim.com/press-release/jardiance-demonstrated-cardiovascular-cv-risk-reduction-people-type-2-diabetes-high
CANVAS and CANVAS-R for Invokana/canaglifloxin SGLT2 inhibitor:
No top-line data reveal for CVOT study. CANVASS and CANVASS-R analyzed together and full data set published in NEJM and presented at ADA June 12, 2017
https://www.janssen.com/invokana-canagliflozin-significantly-reduces-combined-risk-cardiovascular-death-myocardial
FOURIER for Repatha/evolocumab PCSK9 inhibitor:
https://www.amgen.com/media/news-releases/2017/02/amgen-announces-repatha-evolocumab-significantly-reduced-the-risk-of-cardiovascular-events-in-fourier-outcomes-study/
ODYSSEY for Praluent/alirocumab PCSK9 inhibitor:
No top-line data reveal prior to full data set being revealed and presented at March 10, 2018 ACC meeting.
https://mediaroom.sanofi.com/en/press-releases/2018/praluent-alirocumab-significantly-reduced-risk-of-cardiovascular-events-in-high-risk-patients/
COMPASS for Xarelto/rivaroxaban anticoagulant:
https://www.janssen.com/phase-3-compass-study-xarelto-rivaroxaban-stopping-early-efficacy-study-meets-primary-endpoint-0
LEADER trial for Victoza/liraglutide GLP1-R agonist:
https://www.novonordisk.com/media/news-details.1991879.html
SUSTAIN-6 for semaglutide GLP1-R agonist:
https://www.novonordisk.com/media/news-details.2007805.html
REVEAL for anacetrapib CETP inhibitor:
http://investors.merck.com/news/press-release-details/2017/Merck-Provides-Update-on-REVEAL-Outcomes-Study-of-Anacetrapib/default.aspx
