Pharmacovigilance in the Real World
Authors: William D. Leslie, John T. Schousboe
Journal: Annals of Internal Medicine (2018)

Editorials5 February 2019Pharmacovigilance in the Real WorldWilliam D. Leslie, MD, MSc and John T. Schousboe, MD, PhDWilliam D. Leslie, MD, MScUniversity of Manitoba, Winnipeg, Manitoba, Canada (W.D.L.)Search for more papers by this author and John T. Schousboe, MD, PhDPark Nicollet Clinic and HealthPartners Institute, Bloomington, Minnesota, and University of Minnesota, Minneapolis, Minnesota (J.T.S.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-3550 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Let the eye of vigilance never be closed.—Thomas JeffersonThe pathway to drug approval demands proof of efficacy and safety. The gold standard for establishing treatment benefit is the randomized controlled trial (RCT), which is also important for assessing tolerability of the new treatment and excluding frequent adverse effects. However, RCTs need to be supplemented with larger postmarketing safety monitoring studies to identify infrequent or rare complications. Observational data are generally seen as poor substitutes for assessing treatment efficacy because confounding can lead to false inferences. However, RCTs often have low sensitivity to detect infrequent or rare adverse events because ...References1. Fralick M, Kim SC, Schneeweiss S, Kim D, Redelmeier DA, Patorno E. Fracture risk after initiation of use of canagliflozin. A cohort study. Ann Intern Med. 2019;170:155-63. doi:10.7326/M18-0567 LinkGoogle Scholar2. Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, et al; CANVAS Program Collaborative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377:644-57. [PMID: 28605608] doi:10.1056/NEJMoa1611925 CrossrefMedlineGoogle Scholar3. Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, et al. Effects of canagliflozin on fracture risk in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2016;101:157-66. [PMID: 26580237] doi:10.1210/jc.2015-3167 CrossrefMedlineGoogle Scholar4. Das SR, Everett BM, Birtcher KK, Brown JM, Cefalu WT, Januzzi JL, et al; Writing Committee. 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2018. [PMID: 30497881] doi:10.1016/j.jacc.2018.09.020 CrossrefMedlineGoogle Scholar5. Zhang YS, Weng WY, Xie BC, Meng Y, Hao YH, Liang YM, et al. Glucagon-like peptide-1 receptor agonists and fracture risk: a network meta-analysis of randomized clinical trials. Osteoporos Int. 2018;29:2639-44. [PMID: 30083774] doi:10.1007/s00198-018-4649-8 CrossrefMedlineGoogle Scholar6. Azharuddin M, Adil M, Ghosh P, Sharma M. Sodium-glucose cotransporter 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus: a systematic literature review and Bayesian network meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2018;146:180-90. [PMID: 30389620] doi:10.1016/j.diabres.2018.10.019 CrossrefMedlineGoogle Scholar7. Ruanpeng D, Ungprasert P, Sangtian J, Harindhanavudhi T. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and fracture risk in patients with type 2 diabetes mellitus: a meta-analysis. Diabetes Metab Res Rev. 2017;33. [PMID: 28440590] doi:10.1002/dmrr.2903 CrossrefMedlineGoogle Scholar8. Tang HL, Li DD, Zhang JJ, Hsu YH, Wang TS, Zhai SD, et al. Lack of evidence for a harmful effect of sodium-glucose co-transporter 2 (SGLT2) inhibitors on fracture risk among type 2 diabetes patients: a network and cumulative meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2016;18:1199-206. [PMID: 27407013] doi:10.1111/dom.12742 CrossrefMedlineGoogle Scholar9. Ueda P, Svanström H, Melbye M, Eliasson B, Svensson AM, Franzén S, et al. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. BMJ. 2018;363:k4365. [PMID: 30429124] doi:10.1136/bmj.k4365 CrossrefMedlineGoogle Scholar10. Toulis KA, Bilezikian JP, Thomas GN, Hanif W, Kotsa K, Thayakaran R, et al. Initiation of dapagliflozin and treatment-emergent fractures. Diabetes Obes Metab. 2018;20:1070-4. [PMID: 29193543] doi:10.1111/dom.13176 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: University of Manitoba, Winnipeg, Manitoba, Canada (W.D.L.)Park Nicollet Clinic and HealthPartners Institute, Bloomington, Minnesota, and University of Minnesota, Minneapolis, Minnesota (J.T.S.)Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3550.Corresponding Author: William D. Leslie, MD, MSc, Department of Medicine (C5121), University of Manitoba, 409 Tache Avenue, Winnipeg, Manitoba R2H 2A6, Canada; e-mail, [email protected]mb.ca.Current Author Addresses: Dr. Leslie: Department of Medicine (C5121), University of Manitoba, 409 Tache Avenue, Winnipeg, Manitoba R2H 2A6, Canada.Dr. Schousboe: HealthPartners Institute, 3311 Old Shakopee Road, Bloomington, MN 55425.This article was published at Annals.org on 1 January 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoFracture Risk After Initiation of Use of Canagliflozin Michael Fralick , Seoyoung C. Kim , Sebastian Schneeweiss , Dae Kim , Donald A. Redelmeier , and Elisabetta Patorno Metrics Cited byMachine Learning in Causal Inference: Application in PharmacovigilanceReal-Life Active Surveillance of a Naphazoline/ Hypromellose Fixed Combination’s Safety Profile in Peruvian PopulationCanagliflozin: no increased risk for fracture versus GLP-1 agonists 5 February 2019Volume 170, Issue 3Page: 201-202KeywordsDatabasesDrug safetyDrugsFallsHazard ratioObservational studiesSafetySafety studiesType 2 diabetes ePublished: 1 January 2019 Issue Published: 5 February 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...