title: Effects of Vascular and Nonvascular Adverse Events and of Extended-Release Niacin With Laropiprant on Health and Healthcare Costs.
abstract: Extended-release niacin with laropiprant did not significantly reduce the risk of major vascular events and increased the risk of serious adverse events in Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE), but its net effects on health and healthcare costs are unknown.
  
  
  
  25 673 participants aged 50 to 80 years with previous cardiovascular disease were randomized to 2 g of extended-release niacin with 40 mg of laropiprant daily versus matching placebo, in addition to effective statin-based low-density lipoprotein cholesterol-lowering treatment. The net effects of niacin-laropiprant on quality-adjusted life years and hospital care costs (2012 UK £; converted into US $ using purchasing power parity index) during 4 years in HPS2-THRIVE were evaluated using estimates of the impact of serious adverse events on health-related quality of life and hospital care costs. During the study, participants assigned niacin-laropiprant experienced marginally but not statistically significantly lower survival (0.012 fewer years [standard error (SE) 0.007]), fewer quality-adjusted life years (0.023 [SE 0.007] fewer using UK EQ-5D scores; 0.020 [SE 0.006] fewer using US EQ-5D scores) and accrued greater hospital costs (UK £101 [SE £37]; US $145 [SE $53]). Stroke, heart failure, musculoskeletal events, gastrointestinal events, and infections were associated with significant decreases in health-related quality of life in both the year of the event and in subsequent years. All serious vascular and nonvascular events were associated with substantial increases in hospital care costs.
  
  
  
  In HPS2-THRIVE, the addition of extended-release niacin-laropiprant to statin-based therapy reduced quality of life-adjusted survival and increased hospital costs.
  
  
  
  URL: http://clinicaltrials.gov. Unique identifier: NCT00461630.
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Seamus
authors.initials: S
authors.lastname: Kent
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Haynes
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Jemma C
authors.initials: JC
authors.lastname: Hopewell
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Parish
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Alastair
authors.initials: A
authors.lastname: Gray
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Landray
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Rory
authors.initials: R
authors.lastname: Collins
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
authors.forename: Jane
authors.initials: J
authors.lastname: Armitage
authors.affiliation: From the Health Economics Research Centre (S.K., A.G., B.M.) and Clinical Trial Service Unit and Epidemiological Studies Unit (R.H., J.C.H., S.P., M.J.L., R.C., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom. boby.mihaylova@dph.ox.ac.uk.
authors.forename: Borislava
authors.initials: B
authors.lastname: Mihaylova
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control*; D002681:China / Q000453:epidemiology; D003362:Cost-Benefit Analysis; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D016527:Drug Costs; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology; D005260:Female; D017721:Hospital Costs; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D015994:Incidence; D007211:Indoles / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D015415:Biomarkers; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D007211:Indoles; D008055:Lipids; C518174:MK-0524; D009525:Niacin
keywords: cardiovascular disease; clinical trial; hospital costs; niacin; quality of life