6/28/23, 11:06 PM HPS2-THRIVE Pathway Feedback Search Clinical Topics Home Studies HPS2 THRIVE HPS2 THRIVE Disease Disease Disease Acute ischemic stroke Coronary artery disease Diabete Trial question What is the effect of ER niacin with laropiprant in patients with atherosclerotic vascular disease? Study design Multi-center Double blinded RCT Population Characteristics of study participants 17.0% female N = 25673 83.0% male 25673 patients (4444 female, 21229 male) Inclusion criteria: adult patients with a history of myocardial infarction, cerebrovascular disease, peripheral arterial disease, or diabetes mellitus with evidence of symptomatic coronary disease Key exclusion criteria: clinically significant hepatic, renal, muscle-related, or other disease, receiving concurrent treatment with potentially interacting drugs, or receiving LDL cholesterol- lowering treatment that was more effective than simvastatin at a dose of 40 mg plus ezetimibe at a dose of 10 mg daily Interventions N=12838 niacin-laropiprant (e 2 g of ER niacin and 40 mg of laropiprant daily) N=12835 placebo (matching placebo daily) Primary outcome Major vascular event https://web.pathway.md/studies/rec6Otyb52e4mfUhE 1/2 6/28/23, 11:06 PM HPS2-THRIVE Pathway 13.7 % 13.7 13.2 10.3 % 6.8 % 3.4 % No significant difference 0.0 % Niacin-laropiprant Placebo No significant difference in major vascular event (13.2% vs. 13.7%; RR 0.96, 96% CI 0.9 to 1.03) Secondary outcomes No significant difference in major vascular events excluding hemorrhagic stroke (12.4% vs. 13.1%; RR 0.95, 95% CI 0.88 to 1.01) No significant difference in major vascular events excluding both hemorrhagic stroke and revascularization procedures (7.9% vs. 8.4%; RR 0.95, 95% CI 0.87 to 1.03) No significant difference in death from any cause (6.2% vs. 5.7%; RR 1.09, 95% CI 0.99 to 1.21) Safety outcomes Significant differences in fatal or nonfatal serious adverse events (55.6% vs. 52.7%, p < 0.001), disturbance in diabetes leading to hospitalization (11.1% vs. 7.5%, p < 0.001), proportional increase in diabetes diagnosis (5.7% vs. 4.3%, p < 0.001), excess of gastrointestinal serious adverse events (4.8% vs. 3.8%, p < 0.001), excess of musculoskeletal serious adverse events (3.7% vs. 3.0%, p < 0.001), skin-related serious adverse events (0.7% vs. 0.4%, p = 0.003), excess infections (8.0% vs. 6.6%, p < 0.001), and excess of bleeding events (2.5% vs. 1.9%, p < 0.001). Conclusion In adult patients with a history of myocardial infarction, cerebrovascular disease, peripheral arterial disease, or diabetes mellitus with evidence of symptomatic coronary disease, niacin- laropiprant was not superior to placebo with respect to major vascular event. Reference HPS-THRIVE Collaborative Group, Landray MJ, Haynes R et al. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014 Jul 17;371(3):203-12. Open reference URL https://web.pathway.md/studies/rec6Otyb52e4mfUhE 2/2