Complementary Efforts Make for Efficient Research
Authors: Joseph V. Selby
Journal: Annals of Internal Medicine (2016)

Editorials7 June 2016Complementary Efforts Make for Efficient ResearchJoseph V. Selby, MD, MPHJoseph V. Selby, MD, MPHFrom Patient-Centered Outcomes Research Institute, Washington, DC.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-0869 Annals Author Insight Video - Joseph V. Selby, MD, MPH In this video, Joseph V. Selby, MD, MPH, offers additional insight into his editorial, "Complementary Efforts Make for Efficient Research." SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Discussions of randomized and observational studies of effectiveness or safety often come down to one versus the other. This is a story of complementarity. A 2007 meta-analysis of 42 small, diverse, randomized trials suggested that rosiglitazone increased risk for myocardial infarction in patients with type 2 diabetes (1). A lack of definitive data led to debate, uncertainty, patient concern, a U.S. Food and Drug Administration (FDA) boxed warning, and rapid decline in rosiglitazone use. However, in 2013, readjudication of results from a large safety trial required by the European Medicines Agency, begun when the drug was introduced, resulted in exoneration ...References1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457-71. [PMID: 17517853] CrossrefMedlineGoogle Scholar2. Department of Health and Human Services, Food and Drug Administration. Re-adjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes Trial (RECORD); 2013. Accessed at www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrinologicand MetabolicDrugsAdvisoryCommittee/UCM354859.pdf on 10 April 2016. Google Scholar3. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-28. [PMID: 26378978] doi:10.1056/NEJMoa1504720 CrossrefMedlineGoogle Scholar4. Maruthur NM, Tseng E, Hutfless S, Wilson LM, Suarez-Cuervo C, Berger Z, et al. Diabetes medications as monotherapy or metformin-based combination therapy for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2016;164:740-51. [PMID: 27088241]. doi:10.7326/M15-2650 LinkGoogle Scholar5. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-26. [PMID: 23992601] doi:10.1056/NEJMoa1307684 CrossrefMedlineGoogle Scholar6. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, et al; TECOS Study Group. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373:232-42. [PMID: 26052984] doi:10.1056/NEJMoa1501352 CrossrefMedlineGoogle Scholar7. Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, et al; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015;385:2067-76. [PMID: 25765696] doi:10.1016/S0140-6736(14)62225-X CrossrefMedlineGoogle Scholar8. Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. Developing the Sentinel System—a national resource for evidence development. N Engl J Med. 2011;364:498-9. [PMID: 21226658] doi:10.1056/NEJMp1014427 CrossrefMedlineGoogle Scholar9. Toh S, Hampp C, Reichman ME, Graham DJ, Balakrishnan S, Pucino F, et al. Risk for hospitalized heart failure among new users of saxagliptin, sitagliptin, and other antihyperglycemic drugs. A retrospective cohort study. Ann Intern Med. 2016;164:705-14. doi:10.7326/M15-2568 LinkGoogle Scholar10. Hernandez AF, Fleurence RL, Rothman RL. The ADAPTABLE Trial and PCORnet: shining light on a new research paradigm. Ann Intern Med. 2015;163:635-6. [PMID: 26301537]. doi:10.7326/M15-1460 LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Patient-Centered Outcomes Research Institute, Washington, DC.Disclosures: The author has disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0869.Corresponding Author: Joseph V. Selby, MD, MPH, Patient-Centered Outcomes Research Institute, 1828 L Street, Suite 900, Washington, DC 20036; e-mail, [email protected]org.This article was published at www.annals.org on 26 April 2016. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Joseph V. Selby, MD, MPH In this video, Joseph V. Selby, MD, MPH, offers additional insight into his editorial, "Complementary Efforts Make for Efficient Research." FiguresReferencesRelatedDetailsSee AlsoRisk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs Sengwee Toh , Christian Hampp , Marsha E. Reichman , David J. Graham , Suchitra Balakrishnan , Frank Pucino , Jack Hamilton , Samuel Lendle , Aarthi Iyer , Malcolm Rucker , Madelyn Pimentel , Neesha Nathwani , Marie R. Griffin , Nancy J. Brown , and Bruce H. Fireman Metrics 7 June 2016Volume 164, Issue 11Page: 771-772KeywordsCardiovascular disease riskClinical trialsCohort studiesDrug safetyElectronic medical recordsFood and Drug AdministrationHeart failureInformation storage and retrievalObservational studiesSafety ePublished: 3 May 2016 Issue Published: 7 June 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...