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There are noteworthy similarities and differences between our trial and the previous FOURIER and SPIRE (Studies of PCSK9 Inhibition and the Reduction of … 14,298 unrelatedEuropean-ancestry patients. Dr Honarpour reported support from Amgen during the conduct of the study and other support from Amgen outside the submitted work; in addition, he had a patent to related to evolocumab issued. Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85). HHS Szarek M, Steg PG, DiCenso D, et al. Dr Kurtz reported other support from Amgen during the conduct of the study. This site needs JavaScript to work properly. Data were analyzed between May 2017 and February 2019. Dr Ezhov reported personal fees from Amgen during the conduct of the study and personal fees from AstraZeneca, Berlin Chemie, Egis, KRKA, NovoNordisk, Pfizer, Recordati, and Sanofi outside the submitted work. Bohula EA, Giugliano RP, Leiter LA, Verma S, Park JG, Sever PS, Lira Pineda A, Honarpour N, Wang H, Murphy SA, Keech A, Pedersen TR, Sabatine MS. [ Time Frame: 5 years ], To evaluate the long-term effect of evolocumab treatment on CV death. COVID-19 is an emerging, rapidly evolving situation. N Engl J Med. • The FOURIER trial was a multinational, randomized, double-blind, placebo-controlled trial of the efficacy of evolocumab in patients with. [ Time Frame: 5 years ], To evaluate the long-term effects of evolocumab treatment on CHD death. Front Cardiovasc Med. Original Investigation. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128475. To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization. Keywords provided by University of Sydney: Why Should I Register and Submit Results? Their simulation based on FOURIER trial patients showed that 10-year risk was 35.9% without treatment and 24.9% with treatment. FOURIER is the first cardiovascular outcomes trial with one of the new cholesterol-lowering PCSK9 inhibitors, in this case Amgen's evolocumab (Repatha). Lancet Diabetes Endocrinol. Circulation. Slides: Extending the evidence: What did the FOURIER trial learns us on managing high risk patients? The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. The Thrombolysis in Myocardial Infarction Study Group, Harvard University. [ Time Frame: 5 years ], To assess the effect modification by baseline characteristics on defined study outcomes above. FOURIER Trial Participants (Participants who completed trial) ⇓ (1) Registration (Enrolment) -Patients' consent -Collect patient contact details (n=10,000) ⇓ (2) Follow-Up -Participants send study survey at 6 months, 12 months,and then yearly until the end of 2021 ⇓ (3) Central Review -Source documentation collection for 10% of non-fatal outcome events and all deaths FOURIER… Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Dr Keech reported personal fees from Amgen, Mylan, Novartis, Pfizer, Sanofi, Bayer, and AstraZeneca outside the submitted work. Data were analyzed between May 2017 and February 2019. Qamar A, Giugliano RP, Keech AC, Kuder JF, Murphy SA, Kurtz CE, Wasserman SM, Sever PS, Pedersen TR, Sabatine MS. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. Conclusions and relevance: Mickiewicz A, Futema M, Ćwiklinska A, Kuchta A, Jankowski M, Kaszubowski M, Chmara M, Wasąg B, Fijałkowski M, Jaguszewski M, Humphries SE, Gruchała M. Life (Basel). More than double the number of events were prevented with evolocumab vs placebo as compared with the analysis of only first events. enrolled in the FOURIER trial. • The FOURIER trial was a multinational, randomized, double-blind, placebo-controlled trial of the efficacy of evolocumab in patients with. Higher Responsiveness to Rosuvastatin in Polygenic versus Monogenic Hypercholesterolaemia: A Propensity Score Analysis. 2020 May 20;10(5):73. doi: 10.3390/life10050073. 2017;5:941-50 & Supplementary Appendix. [ Time Frame: 5 years ], To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death). Subjects who completed the FOURIER OUTCOMES trial (defined as attendance at close-out visit irrespective of treatment compliance) will be approached by FOURIER OUTCOMES site investigators and asked about their interest in taking part in this trial. The 2019 European Society of Cardiology and European Atherosclerosis Society dyslipidaemia guidelines endorse treating older patients, but add specific considerations to assess comorbidities before initiating treatment. The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. Reductions in total events were driven by fewer total myocardial infarctions (RR, 0.74; 95% CI, 0.65-0.84; P < .001), strokes (RR, 0.77; 95% CI, 0.64-0.93; P = .007), and coronary revascularizations (RR, 0.78; 95% CI, 0.71-0.87; P < .001). As described in this document, the FOURIER trial showed that evolocumab combined with statins is effective in reducing the incidence of cardiovascular events such as heart attack and stroke, but did not show a statistically significant reduction in cardiovascular mortality. Murphy SA, Pedersen TR, Gaciong ZA, et al. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. The mean age of patients was 63 years, 69% of patients were taking high-intensity statin therapy, and the median LDL-C at baseline was 92 mg/dL (to convert to millimoles per liter, multiply by 0.0259). Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial J Am Coll Cardiol. To assess the effect modification by baseline characteristics on defined study outcomes above. Efficacy and safety of evolocumab in chronic kidney disease in the FOURIER trial. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Low density lipoprotein cholesterol (LDL-c), To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularisation in participants completing participation in the FOURIER OUTCOMES trial. 2020 Oct 7;16:403-418. doi: 10.2147/VHRM.S261719. Dr Sabatine reported grants from Amgen during the conduct of the study; grants from Abbott Laboratories, AstraZeneca, Critical Diagnostics, Daiichi-Sankyo, Eisai, Genzyme, Gilead, GlaxoSmithKline, Intarcia, Janssen Research and Development, Medicines Company, MedImmune, Merck, Novartis, Poxel, Pfizer, Roche Diagnostics, and Takeda; and other support from Alnylam, Amgen, AstraZeneca, Bristol-Myers Squibb, CVS Caremark, Dyrnamix, Esperion, Intarcia, Ionis, Janssen Research and Development, Medicines Company, MedImmune, Merck, MyoKardia, and Novartis outside the submitted work. The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and first cardiovascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, but patients remain at high risk of recurrent cardiovascular events. Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. This study … eCollection 2020. Nashawi M, Sheikh O, Mir M, Te T, Chilton R. Cardiovasc Endocrinol Metab. Trial design and primary outcomes of the FOURIER trial 0:18; Clinical effects of evolocumab in those with LDL-c ≤ 70 mg/dL (1.8 mmol/L) 4:07 Efficacy of evolocumab in higher risk patients: those with diabetes and those with CKD 6:39; Evolocumab therapy in high-risk subgroups of patients with coronary disease 8:38; Treatment with evolocumab in patients with PAD 15:24 Spiral, Imperial College Digital Repository. The systemic implication of novel non-statin therapies in cardiovascular diabetology: PCSK9 as a case model. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513. Pedersen TR. 2018 Apr 17;319(15):1566-1579. doi: 10.1001/jama.2018.2525. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. 2019 Mar 6;6:14. doi: 10.3389/fcvm.2019.00014. Navarese EP, Robinson JG, Kowalewski M, Kolodziejczak M, Andreotti F, Bliden K, Tantry U, Kubica J, Raggi P, Gurbel PA. JAMA. Importance: Dr Gaciong reported personal fees from Amgen outside the submitted work. The FOURIER trial was approved by all relevant institutional review boards, and written informed consent was obtained from all participants. 2020 May 5;9(4):143-152. doi: 10.1097/XCE.0000000000000204. The FOURIER trial was a randomized, double-blind, placebo-controlled clinical trial that enrolled 27564 patients between 40 and 85 years of age who had established atherosclerotic CV disease, determined by a prior myocardial infarction (MI), prior nonhemorrhagic stroke, or symptomatic peripheral ar- Please remove one or more studies before adding more. FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is … 2019; 73 : 2961-2970 View in Article For every 1000 patients treated for 3 years, evolocumab prevented 22 first PEP events and 52 total PEP events. Next came the FOURIER trial of evolocumab, a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg/dL or higher who were receiving statin therapy. See this image and copyright information in PMC. [ Time Frame: 5 years ], To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization. Objective: 2020 Aug 11;9(1):129-144. doi: 10.1080/21556660.2020.1801452. Secondary analysis of a randomized, double-blind clinical trial. Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. Focus on Cerebrovascular Disease. Curr Cardiol Rev. Clipboard, Search History, and several other advanced features are temporarily unavailable. To assess the effect modification of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above. Video navigation menu. Similar conclusions regarding MACEs were drawn from an analysis of the FOURIER trial, using the PCSK9 inhibitor evolocumab added to statin in patients with stable, established atherosclerotic cardiovascular disease . 1.  |  Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial. Trial registration: The FOURIER Trial studied 27,564 patients who had a prior MI, ischemic stroke, or symptomatic peripheral artery disease and a LDL ≥70 mg/dL or a non-HDL-C ≥100 mg/dL with optimal statin therapy. The most eagerly awaited study presented at last week’s American College of Cardiology meeting was Amgen’s FOURIER clinical trial. To evaluate the long-term effect of evolocumab treatment on the individual components of the primary endpoint and any other CV hospitalizations. J Am Coll Cardiol. Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178.  |  Total events were significantly reduced with evolocumab vs placebo for the component of myocardial infarction (incidence rate ratio [RR], 0.74; 95% CI, 0.65-0.84; Total events were reduced with evolocumab (incidence rate ratio [RR], 0.81; 95% CI, 0.73-0.90; Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. FOURIER (Further cardiovascular Outcomes Research with PCSK9 Inhibition in subjects with Elevated Risk). Slides: Extending the evidence: What did the FOURIER trial learns us on managing high risk patients? Dr Jukema reported research grants from and/or was speaker (with or without lecture fees) at CME-accredited meetings sponsored by Amgen, Astra-Zeneca, Biotronik, Boston Scientific, Daiichi Sankyo, Lilly, Medtronic, Merck-Schering-Plough, Pfizer, Sanofi Aventis, and The Medicine Company. Epub 2018 Mar 12. clinically evident atherosclerotic cardiovascular disease. Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update. Get the latest research from NIH: https://www.nih.gov/coronavirus. Volume 74, Issue 9, 3 September 2019, Pages 1167-1176. FOURIER was a randomised, double blind trial, comparing evolocumab with placebo in 27,564 patients with atherosclerotic cardiovascular disease receiving statin therapy (median follow-up 2.2 years). Design, setting, and participants: No other disclosures were reported. • We performed a nested cohort study of. Circulation 2019;140:A10668. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death). Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. Results: eCollection 2019. In a prespecified analysis, total cardiovascular events were evaluated between treatment arms. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). To evaluate the effect of evolocumab on total cardiovascular events, given the importance of total number of cardiovascular events to patients, clinicians, and health economists. National Health and Medical Research Council, Australia. eCollection 2020 Dec. Vasc Health Risk Manag. U.S. Department of Health and Human Services. 2017;13(4):319-324. doi: 10.2174/1573403X13666170918165713. There were 2192 total primary events in the evolocumab group and 2714 total events in the placebo group. eCollection 2020. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Effects of Evolocumab on Cardiovascular Events. With more than 13,700 patients in two randomized groups, FOURIER … 2020 Feb 25;5:5. doi: 10.1038/s41525-019-0111-x. There were 2907 first PEP events and 4906 total PEP events during the trial. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen today announced a new analysis from the Repatha ® (evolocumab) cardiovascular outcomes (FOURIER) study that evaluates the effectiveness of Repatha in patients who have suffered a recent myocardial infarction (MI). Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial. enrolled in the FOURIER trial. Dr Toth reported personal fees from Amgen outside the submitted work. ClinicalTrials.gov Identifier: NCT04128475. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513. • We performed a nested cohort study of. [ Time Frame: 5 years ], To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularization in patients completing participation in the FOURIER OUTCOMES trial. Dr Pedersen reported grants from Amgen during the conduct of the study and speakers bureau and personal fees from the Amgen Advisory Board outside the submitted work. Figure 1.. First, Additional, and Total Primary…, Figure 1.. First, Additional, and Total Primary End Point Events During Follow-up by Randomization Group, Figure 2.. Risk Differences for 1000 Patients…, Figure 2.. Risk Differences for 1000 Patients Treated for 3 Years With Evolocumab for the…, Figure 3.. Total Events During Follow-up by…, Figure 3.. Total Events During Follow-up by Randomization Group for Components of the Primary End…, Figure 4.. Total Events During Follow-up by…, Figure 4.. Total Events During Follow-up by Randomization Group for Key Secondary End Point of…, NLM THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen today announced a new analysis from the Repatha ® (evolocumab) cardiovascular outcomes (FOURIER) study that evaluates the effectiveness of Repatha in patients who have suffered a recent myocardial infarction (MI). Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial. The FOURIER trial was a randomized, double-blind, placebo-controlled clinical trial that enrolled 27 564 patients between 40 and 85 years of age who had established atherosclerotic CV disease, determined by a prior myocardial infarction (MI), prior nonhemorrhagic stroke, or symptomatic peripheral artery diseas… And finally, the simulation based on real-world FOURIER-like patients indicated that 10-year CV risk preceding treatment was 41.4% versus 29.3% risk after treatment. J Drug Assess. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Slides (presentation) - Sep. 9, 2019 - ESC Paris, France - Marc S. Sabatine, MD, MPH, BWH, Boston, USA - CME symposium held during ESC 2019 METHODS: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). The protocol of the FOURIER clinical trial reads as follows: “Given that evolocumab is expected to reduce LDL-C by even more than 1.0 mmol (39 mg/dL) in patients already on an intense dose statin therapy (based on phase 1b results), it is expected that the FOURIER study will demonstrate that evolocumab administration will produce a significant reduction of cardiovascular events, … ... LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial. Get the latest public health information from CDC: https://www.coronavirus.gov. 14,298 unrelatedEuropean-ancestry patients. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Dr Giugliano reported grants from Amgen during the conduct of the study and personal fees from Akcea, Amgen, Bristol-Myers Squibb, CVS Caremark, Daiichi Sankyo, Pfizer, Merck, and Amarin outside the submitted work. Conflict of Interest Disclosures: Ms Murphy reported research grants and personal fees from Amgen during the conduct of the study and research grant support through Brigham and Women's Hospital from Abbott Laboratories; AstraZeneca; Critical Diagnostics; Daiichi-Sankyo; Eisai; Genzyme; Gilead; GlaxoSmithKline; Intarcia; Janssen Research and Development; the Medicines Company; MedImmune; Merck; Novartis; Poxel; Pfizer; Roche Diagnostics; and Takeda. Late-Breaking Clinical Trial presented August 29, 2017. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. NIH Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Information provided by (Responsible Party): To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularization in patients completing participation in the FOURIER OUTCOMES trial. To evaluate the long-term effects of evolocumab treatment on CHD death. Epub 2017 Nov 13. Data were analyzed between May 2017 and February 2019. Please enable it to take advantage of the complete set of features! European Society of Cardiology Congress 2017. Evaluating the promise of inclusion of African ancestry populations in genomics. Association Between Baseline LDL-C Level and Total and Cardiovascular Mortality After LDL-C Lowering: A Systematic Review and Meta-analysis. clinically evident atherosclerotic cardiovascular disease. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown. USA.gov. COVID-19 is an emerging, rapidly evolving situation. ... LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial. Sabatine MS, et al. The FOURIER trial was a randomized, double-blind, placebo-controlled clinical trial that enrolled 27564 patients between 40 and 85 years of age who had established atherosclerotic CV disease, determined by a prior myocardial infarction (MI), prior nonhemorrhagic stroke, or symptomatic peripheral ar- Now to the details of FOURIER. Presented by Dr. Nicholas A. Marston at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 17, 2019. To evaluate the long-term effect of evolocumab treatment on CV death. For general information, Learn About Clinical Studies. DEFINE-FLAIR and IFR-SWEDEHEART Trial: Ajay J. Kirtane, MD RESOLVE and SAVORY: Study Author Raj Makkar, MD The REACH Trial: Robert P. Nolan, … Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial J Am Coll Cardiol. [ Time Frame: 5 years ]. Dr Tikkanen reported grants and personal fees from Amgen and personal fees from Pfizer during the conduct of the study and personal fees from Amgen outside the submitted work. These data provide further support for the benefit of continuing aggressive lipid-lowering therapy to prevent recurrent cardiovascular events. This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. The present analyses were conducted from September 2019 to February 2020. FOURIER is the first cardiovascular outcomes trial with one of the new cholesterol-lowering PCSK9 inhibitors, in this case Amgen's evolocumab (Repatha). [ Time Frame: 5 years ], To assess the effect modification of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above. There are noteworthy similarities and differences between our trial and the previous FOURIER and SPIRE (Studies of PCSK9 Inhibition and the Reduction of … The FOURIER (Further cardiovascular OUt- comes Research with PCSK9 Inhibition in sub- jects with Elevated Risk) trial tested the fully human monoclonal antibody evolocumab at either 140 mg every 2 weeks (Q2W) or 420 mg every 4 weeks (Q4W) given by subcutaneous (SC) injection (these are considered to be equipotent regimens). The investigators deserve congratulations for completing an impressive trial. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. The 2019 European Society of Cardiology and European Atherosclerosis Society dyslipidaemia guidelines endorse treating older patients, but add specific considerations to assess comorbidities before initiating treatment.  |  The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. JAMA Cardiol. 2018 Jul 10;138(2):131-140. doi: 10.1161/CIRCULATIONAHA.118.034032. Bittner VA, Szarek M, Aylward PE, et al., on behalf of the ODYSSEY OUTCOMES Committees and Investigators. Epub 2017 Mar 17. The mean baseline LDL-C was 92 mg/dL and the on-treatment LDL-C was 30 mg/dL, a reduction in mean LDL cholesterol of 59%. Slides (presentation) - Sep. 9, 2019 - ESC Paris, France - Marc S. Sabatine, MD, MPH, BWH, Boston, USA - CME symposium held during ESC 2019 Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Trial Design. 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