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

HPS2-THRIVE is a clinical trial conducted independently by Oxford University, investigating the effects of ER niacin/laropiprant on vascular events. The trial includes 25,673 high-risk patients with occlusive arterial disease from China, Scandinavia, and the UK. Results on vascular events and safety assessments will be available in 2013.

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

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  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

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