9 Références

     

[1] Guo JJ, Pandey S, Doyle J, et al. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health 2010;13:657–66 10.1111/j.1524-4733.2010.00725.x [20412543]

[2] Bowman L, Mafham M, Wallendszus K, et al. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med 2018;379:1529–39 10.1056/NEJMoa1804988 [30146931]

[3] Roe MT, Armstrong PW, Fox KAA, et al. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med 2012;367:1297–309 10.1056/NEJMoa1205512 [22920930]

[4] Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ 1995;311:485 10.1136/bmj.311.7003.485 [7647644]

[5] Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med 2001;2:205–07 10.1186/cvm-2-5-205 [11806796]

[6] FDA Announces New Recommendations On Evaluating Cardiovascular Risk In Drugs Intended To Treat Type 2 Diabetes 2022. Available at: https://www.pharmaceuticalonline.com/doc/fda-announces-new-recommendations-on-0001 Accessed November 19, 2022.

[7] FDA. Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes: Guidance for Industry.

[8] Low Wang CC, Everett BM, Burman KD, et al. Cardiovascular Safety Trials for All New Diabetes Mellitus Drugs? Circulation 2019;139:1741–43 10.1161/CIRCULATIONAHA.118.038771 [30933621]

[9] Chertow GM, Pergola PE, Farag YMK, et al. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med 2021;384:1589–600 10.1056/nejmoa2035938 [33913637]

[10] Mackenzie IS, Ford I, Nuki G, et al. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial. The Lancet 2020;396:1745–57 10.1016/S0140-6736(20)32234-0 [33181081]

[11] Becker MA, Schumacher HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005;353:2450–61 10.1056/NEJMoa050373 [16339094]

[12] White WB, Chohan S, Dabholkar A, et al. Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Am Heart J 2012;164:14–20 10.1016/j.ahj.2012.04.011 [22795277]

[13] Locatelli F, Hannedouche T, Fishbane S, et al. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol 2019;14:1701–10 10.2215/CJN.01380219 [31420350]

[14] Austeng D, Morken TS, Bolme S, et al. Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction. BMC Ophthalmol 2016;16:169 10.1186/s12886-016-0348-4 [27716253]

[15] Walsh M, Manns B, Garg AX, et al. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol 2015;10:1602–08 10.2215/CJN.12371214 [26138259]

[16] Lemaire M, Islam QS, Shen H, et al. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. The American Journal of Clinical Nutrition 2011;94:585–93 10.3945/ajcn.110.009316 [21715512]

[17] Yamada S, Fujii T, Sonohara F, et al. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg 2021;156:418–28 10.1001/jamasurg.2021.0108 [33656542]

[18] Koster RW, Beenen LF, van der Boom EB, et al. Safety of mechanical chest compression devices AutoPulse and LUCAS in cardiac arrest: a randomized clinical trial for non-inferiority. Eur. Heart J. 2017;38:3006–13 10.1093/eurheartj/ehx318 [29088439]

[19] Reith C, Baigent C, Blackwell L, et al. Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials. The Lancet 2022;400:832–45 10.1016/S0140-6736(22)01545-8

[20] Wang C-H, Li C-H, Hsieh R, et al. Proton pump inhibitors therapy and the risk of pneumonia: a systematic review and meta-analysis of randomized controlled trials and observational studies. Expert Opinion on Drug Safety 2019;18:163–72 10.1080/14740338.2019.1577820 [30704306]

[21] Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007;357:2001–15 10.1056/NEJMoa0706482 [17982182]

[22] Eggermont AMM, Chiarion-Sileni V, Grob J-J, et al. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. N Engl J Med 2016;375:1845–55 10.1056/NEJMoa1611299 [27717298]

[23] Michielin O, van Akkooi ACJ, Ascierto PA, et al. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†. Annals of Oncology 2019;30:1884–901 10.1093/annonc/mdz411 [31566661]

[24] Gail MH. Using absolute risks to assess the risks and benefits of treatment. Thorax 2014;69:604–05 10.1136/thoraxjnl-2014-205175 [24550059]

[25] Bonaca MP, Bhatt DL, Cohen M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med 2015;372:1791–800 10.1056/NEJMoa1500857 [25773268]

[26] Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009;361:1045–57 10.1056/NEJMoa0904327 [19717846]

[27] Baigent C, Emberson J, Haynes R, et al. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. The Lancet 2022 10.1016/S0140-6736(22)02074-8

[28] Steg PG, Bhatt DL. Is There Really a Benefit to Net Clinical Benefit in Testing Antithrombotics? Circulation 2018;137:1429–31 10.1161/CIRCULATIONAHA.117.033442 [29610124]

[29] Barnett AS, Cyr DD, Goodman SG, et al. Net clinical benefit of rivaroxaban compared with warfarin in atrial fibrillation: Results from ROCKET AF. International Journal of Cardiology 2018;257:78–83 10.1016/j.ijcard.2017.06.110 [29506743]

[30] Pocock SJ, Ariti CA, Collier TJ, et al. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur. Heart J. 2012;33:176–82 10.1093/eurheartj/ehr352 [21900289]

[31] Péron J, Giai J, Maucort-Boulch D, et al. The Benefit-Risk Balance of Nab-Paclitaxel in Metastatic Pancreatic Adenocarcinoma. Pancreas 2019;48:275–80 10.1097/MPA.0000000000001234 [30629024]

[32] Buyse M, Saad ED, Peron J, et al. The Net Benefit of a treatment should take the correlation between benefits and harms into account. Journal of Clinical Epidemiology 2021;137:148–58 10.1016/j.jclinepi.2021.03.018 [33774140]

[33] Ioannidis JPA, Lau J. Improving safety reporting from randomised trials. Drug Safety 2002;25:77–84 10.2165/00002018-200225020-00002 [11888350]

[34] Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001;285:437–43 10.1001/jama.285.4.437 [11242428]

[35] Duffy J, Hirsch M, Pealing L, et al. Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation. BJOG 2018;125:795–803 10.1111/1471-0528.14969 [29030992]

[36] Favier R, Crépin S. The reporting of harms in publications on randomized controlled trials funded by the "Programme Hospitalier de Recherche Clinique," a French academic funding scheme. Clin Trials 2018;15:257–67 10.1177/1740774518760565 [29498543]

[37] Sivendran S, Latif A, McBride RB, et al. Adverse event reporting in cancer clinical trial publications. JCO 2014;32:83–89 10.1200/JCO.2013.52.2219 [24323037]

[38] Pitrou I, Boutron I, Ahmad N, et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009;169:1756–61 10.1001/archinternmed.2009.306 [19858432]

[39] Edwards A, Elwyn G, Mulley A. Explaining risks: turning numerical data into meaningful pictures. BMJ 2002;324:827–30 10.1136/bmj.324.7341.827 [11934777]

[40] Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. New Engl J Med 1988;318:1728–33 10.1056/NEJM198806303182605 [3374545]

[41] Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981–92 10.1056/NEJMoa1107039 [21870978]

[42] Valgimigli M, Frigoli E, Heg D, et al. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med 2021;385:1643–55 10.1056/NEJMoa2108749 [34449185]

[43] Sibbing D, Aradi D, Jacobshagen C, et al. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. The Lancet 2017;390:1747–57 10.1016/S0140-6736(17)32155-4 [28855078]

[44] Raskob GE, van Es N, Verhamme P, et al. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med 2018;378:615–24 10.1056/NEJMoa1711948 [29231094]

[45] Cates C. Confidence intervals for the number needed to treat. Pooling numbers needed to treat may not be reliable. BMJ 1999;318:1764–65 10.1136/bmj.318.7200.1764c [10381732]

[46] Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med 2002;21:1575–600 10.1002/sim.1188 [12111921]

[47] Zhao Y, Slate EH, Xu C, et al. Empirical comparisons of heterogeneity magnitudes of the risk difference, relative risk, and odds ratio. Syst Rev 2022;11:26 10.1186/s13643-022-01895-7 [35151340]

[48] Poole C, Shrier I, VanderWeele TJ. Is the Risk Difference Really a More Heterogeneous Measure? Epidemiology 2015;26:714–18 10.1097/EDE.0000000000000354 [26196684]

[49] Glasziou PP, Irwig LM. An evidence based approach to individualising treatment. BMJ 1995;311:1356–59 10.1136/bmj.311.7016.1356 [7496291]

[50] Pauker SG, Kassirer JP. The threshold approach to clinical decision making. New Engl J Med 1980;302:1109–17 10.1056/NEJM198005153022003 [7366635]

[51] Aguilar MI, Hart R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database Syst Rev 2005:CD001927 10.1002/14651858.CD001927.pub2 [16034869]

[52] Steyerberg EW, Moons KGM, van der Windt DA, et al. Prognosis Research Strategy (PROGRESS) 3: prognostic model research. PLOS Medicine 2013;10:e1001381 10.1371/journal.pmed.1001381 [23393430]

[53] Camilleri M, Northcutt AR, Kong S, et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. The Lancet 2000;355:1035–40 10.1016/S0140-6736(00)02033-X [10744088]