1 / 14

HPS2-THRIVE: Treatment of HDL to Reduce the Incidence of Vascular Events

HPS2-THRIVE: Treatment of HDL to Reduce the Incidence of Vascular Events. Financial Disclosure : Designed , conducted and analysed by Oxford University independently of the grant source (Merck & Co). No honoraria or consultancy fees accepted. . Jane Armitage on behalf of the

zitkalasa
Download Presentation

HPS2-THRIVE: Treatment of HDL to Reduce the Incidence of Vascular Events

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. HPS2-THRIVE: Treatment of HDL to Reduce the Incidence of Vascular Events Financial Disclosure: Designed, conducted and analysed by Oxford University independently of the grant source (Merck & Co). No honoraria or consultancy fees accepted. Jane Armitage on behalf of the THRIVE Collaborative Group

  2. 25,673 high-risk patients with occlusive arterial disease from China, Scandinavia and UK Randomized comparison: ER niacin/laropiprant (ERN/LRPT) 2g daily versus placebo Primary end point: Major vascular events after median follow-up of 4 years Pre-specified safety analyses: Median follow-up of 3.4 years (to January 2012) Background LDL-lowering therapy with: Simvastatin 40mg (+/- ezetimibe 10mg) daily

  3. HPS2-THRIVE: Design and randomization

  4. Reasons for withdrawal (%) before randomization

  5. Medical reasons for withdrawal before randomization

  6. Lipid levels by region: effect of 8 weeks ERN/LRPT during pre-randomization run-in

  7. Characteristics of randomized participants

  8. Reasons for discontinuation of study treatment overall and in various categories Myopathy (muscle symptoms with CK >10x ULN) and rhabdomyolysis (subset with end-organ damage) Confirmed elevation of ALT >3x ULN on 2 occasions within about one week Presumed drug-related hepatitis: symptoms with either (i) ALT >5x ULN; or (ii) ALT >3x ULN with bilirubin >3x ULN or ALP >3x ULN plus no other cause identified Pre-specified interim safety assessments ULN = upper limit of normal

  9. Reasons for stopping study treatment in pre-specified categories after 3.4 years ####

  10. Skin and gastrointestinal reasons for stopping study treatment after 3.4 years

  11. Myopathy by study treatment and by region after 3.4 years Two-thirds of myopathy cases presented within the first year

  12. Effect of ERN/LRPT on liver safety after 3.4 years

  13. Largest ever randomized trial of effects of ER niacin on safety and CV events in diverse high-risk patients Among those tolerating ERN/LRPT for 8 weeks, 76% remain compliant with active treatment after 3 years (vs 85% allocated placebo) ERN/LRPT increases risk of myopathy among patients on statin therapy, particularly in the Chinese No clear adverse effects of ERN/LRPT on liver, but known niacin side-effects on skin & GI confirmed Effects of 4 years of ERN/LRPT on vascular events in HPS2-THRIVE available in 2013 HPS2-THRIVE summary

More Related