Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)

Author:

Cherrington Andrea L.1ORCID,Tripputi Mark T.2,Younes Naji2ORCID,Herman William H.34ORCID,Katona Aimee3,Groessl Erik J.5,Craig Jacqueline6,Gonzalez Jeffrey S.78ORCID,Garg Rajesh9,Casula Sabina10,Kuo Shihchen3ORCID,Florez Hermes J.91112, ,Crandall J.P.,McKee M.D.,Behringer-Massera S.,Brown-Friday J.,Xhori E.,Ballentine-Cargill K.,Duran S.,Estrella H.,Gonzalez de la torre S.,Lukin J.,Phillips L.S.,Burgess E.,Olson D.,Rhee M.,Wilson P.,Raines T.S.,Boers J.,Costello J.,Maher-Albertelli M.,Mungara R.,Savoye L.,White C.A.,Gullett C.,Holloway L.,Morehead F.,Person S.,Sibymon M.,Tanukonda S.,Adams C.,Ross A.,Balasubramanyam A.,Gaba R.,Gonzalez Hattery E.,Ideozu A.,Jimenez J.,Montes G.,Wright C.,Hollander P.,Roe E.,Jackson A.,Smiley A.,Burt P.,Estrada L.,Chionh K.,Ismail-Beigi F.,Falck-Ytter C.,Sayyed Kassem L.,Sood A.,Tiktin M.,Kulow T.,Newman C.,Stancil K.A.,Cramer B.,Iacoboni J.,Kononets M.V.,Sanders C.,Tucker L.,Werner A.,Maxwell A.,McPhee G.,Patel C.,Colosimo L.,Krol A.,Goland R.,Pring J.,Alfano L.,Kringas P.,Hausheer C.,Tejada J.,Gumpel K.,Kirpitch A.,Schneier H.,Green J.B.,AbouAssi H.,Chatterjee R.,Feinglos M.N.,English Jones J.,Khan S.A.,Kimpel J.B.,Zimmer R.P.,Furst M.,Satterwhite B.M.,Thacker C.R.,Evans Kreider K.,Mariash C.N.,Mather K.J.,Ismail H.M.,Lteif A.,Mullen M.,Hamilton T.,Patel N.,Riera G.,Jackson M.,Pirics V.,Aguillar D.,Howard D.,Hurt S.,Bergenstal R.,Carlson A.,Martens T.,Johnson M.,Hill R.,Hyatt J.,Jensen C.,Madden M.,Martin D.,Willis H.,Konerza W.,Yang S.,Kleeberger K.,Passi R.,Fortmann S.,Herson M.,Mularski K.,Glauber H.,Prihoda J.,Ash B.,Carlson C.,Ramey P.A.,Schield E.,Torgrimson-Ojerio B.,Arnold K.,Kauffman B.,Panos E.,Sahnow S.,Bays K.,Berame K.,Cook J.,Ghioni D.,Gluth J.,Schell K.,Criscola J.,Friason C.,Jones S.,Nazarov S.,Barzilay J.,Rassouli N.,Puttnam R.,Ojoawo B.,Nelson R.,Curtis M.,Hollis B.,Sanders-Jones C.,Stokes K.,El-Haqq Z.,Kolli A.,Tran T.,Wexler D.,Larkin M.E.,Meigs J.,Chambers B.,Dushkin A.,Rocchio G.,Yepes M.,Steiner B.,Dulin H.,Cayford M.,Chu K.,DeManbey A.,Hillard M.,Martin K.,Thangthaeng N.,Gurry L.,Kochis R.,Raymond E.,Ripley V.,Stevens C.,Park J.,Aroda V.,Ghazi A.,Magee M.,Ressing A.,Loveland A.,Hamm M.,Hurtado M.,Kuhn A.,Leger J.,Manandhar L.,Mwicigi F.,Sanchez O.,Young T.,Garg R.,Lagari-Libhaber V.,Florez H.J.,Valencia W.M.,Marks J.,Casula S.,Oropesa-Gonzalez L.,Hue L.,Cuadot A.,Nieto-Martinez R.,Riccio Veliz A.K.,Gutt M.,Kendal Y.J.,Veciana B.,Ahmann A.,Aby-Daniel D.,Joarder F.,Morimoto V.,Sprague C.,Yamashita D.,Cady N.,Rivera-Eschright N.,Kirchhoff P.,Morales Gomez B.,Adducci J.,Goncharova A.,Hox S.H.,Petrovitch H.,Matwichyna M.,Jenkins V.,Broadwater L.,Ishii R.R.,Bermudez N.O.,Hsia D.S.,Cefalu W.T.,Greenway F.L.,Waguespack C.,King E.,Fry G.,Dragg A.,Gildersleeve B.,Arceneaux J.,Haynes N.,Thomassie A.,Pavlionis M.,Bourgeois B.,Hazlett C.,Mudaliar S.,Henry R.,Boeder S.,Pettus J.,Diaz E.,Garcia-Acosta D.,Maggs S.,DeLue C.,Stallings A.,Castro E.,Hernandez S.,Krakoff J.,Curtis J.M.,Killean T.,Khalid M.,Joshevama E.,Diaz E.,Martin D.,Tsingine K.,Karshner T.,Albu J.,Pi-Sunyer F.X.,Frances S.,Maggio C.,Ellis E.,Bastawrose J.,Gong X.,Banerji M.A.,August P.,Lee M.,Lorber D.,Brown N.M.,Josephson D.H.,Thomas L.L.,Tsovian M.,Cherian A.,Jacobson M.H.,Mishko M.M.,Kirkman M.S.,Buse J.B.,Diner J.,Dostou J.,Machineni S.,Young L.,Bergamo K.,Goley A.,Kerr J.,Largay J.F.,Guarda S.,Cuffee J.,Culmer D.,Fraser R.,Almeida H.,Coffer S.,Debnam E.,Kiker L.,Morton S.,Josey K.,Fuller G.,Garvey W.T.,Cherrington A.L.,Dyer D.,Lawson M.C.R.,Griffith O.,Agne A.,McCullars S.,Cohen R.M.,Craig J.,Rogge M.C.,Burton K.,Kersey K.,Wilson C.,Lipp S.,Vonder Meulen M.B.,Adkins C.,Onadeko T.,Rasouli N.,Baker C.,Schroeder E.,Razzaghi M.,Lyon C.,Penaloza R.,Underkofler C.,Lorch R.,Douglass S.,Steiner S.,Sivitz W.I.,Cline E.,Knosp L.K.,McConnell J.,Lowe T.,Herman W.H.,Pop-Busui R.,Tan M.H.,Martin C.,Waltje A.,Katona A.,Goodhall L.,Eggleston R.,Kuo S.,Bojescu S.,Bule S.,Kessler N.,LaSalle E.,Whitley K.,Seaquist E.R.,Bantle A.,Harindhanavudhi T.,Kumar A.,Redmon B.,Bantle J.,Coe M.,Mech M.,Taddese A.,Lesne K.,Smith S.,Desouza C.,Kuechenmeister L.,Shivaswamy V.,Burbach S.,Rodriguez M.G.,Seipel K.,Alfred A.,Morales A.L.,Eggert J.,Lord G.,Taylor W.,Tillson R.,Schade D.S.,Adolphe A.,Burge M.,Duran-Valdez E.,Martinez J.,Bancroft A.,Kunkel S.,Ali Jamaleddin Ahmad F.,Hernandez McGinnis D.,Pucchetti B.,Scripsick E.,Zamorano A.,DeFronzo R.A.,Cersosimo E.,Abdul-Ghani M.,Triplitt C.,Juarez D.,Mullen M.,Garza R.I.,Verastiqui H.,Wright K.,Puckett C.,Raskin P.,Rhee C.,Abraham S.,Jordan L.F.,Sao S.,Morton L.,Smith O.,Osornio Walker L.,Schnurr-Breen L.,Ayala R.,Kreymer R.B.,Sturgess D.,Utzschneider K.M.,Kahn S.E.,Alarcon-Casas Wright L.,Boyko E.J.,Tsai E.C.,Trence D.L.,Trikudanathan S.,Fattaleh B.N.,Montgomery B.K.,Atkinson K.M.,Kozedub A.,Concepcion T.,Moak C.,Prikhodko N.,Rhothisen S.,Elasy T.A.,Martin S.,Shackelford L.,Goidel R.,Hinkle N.,Lovell C.,Myers J.,Lipps Hogan J.,McGill J.B.,Salam M.,Schweiger T.,Kissel S.,Recklein C.,Clifton M.J.,Tamborlane W.,Camp A.,Gulanski B.,Inzucchi S.E.,Pham K.,Alguard M.,Gatcomb P.,Lessard K.,Perez M.,Iannone L.,Magenheimer E.,Montosa A.,Fradkin J.,Burch H.B.,Bremer A.A.,Nathan D.M.,Lachin J.M.,Krause-Steinrauf H.,Younes N.,Bebu I.,Butera N.,Buys C.J.,Fagan A.,Gao Y.,Ghosh A.,Gramzinski M.R.,Hall S.D.,Kazemi E.,Legowski E.,Liu H.,Suratt C.,Tripputi M.,Arey A.,Backman M.,Bethepu J.,Lund C.,Mangat Dhaliwal P.,McGee P.,Mesimer E.,Ngo L.,Steffes M.,Seegmiller J.,Saenger A.,Arends V.,Gabrielson D.,Conner T.,Warren S.,Day J.,Huminik J.,Scrymgeour A.,Soliman E.Z.,Pokharel Y.,Zhang Z.M.,Campbell C.,Hu J.,Keasler L.,Hensley S.,Li Y.,Mihalcea R.,Min D.J.,Perez-Rosas V.,Prosser L.,Resnicow L.,Ye W.,Shao H.,Zhang P.,Luchsinger J.,Sanchez D.,Assuras S.,Groessl E.,Sakha F.,Chong H.,Hillery N.,Abdouch I.,Bahtiyar G.,Brantley P.,Broyles F.E.,Canaris G.,Copeland P.,Craine J.J.,Fein W.L.,Gliwa A.,Hope L.,Lee M.S.,Meiners R.,Meiners V.,O’Neal H.,Park J.E.,Sacerdote A.,Sledge E.,Soni L.,Steppel-Reznik J.,Turchin A.

Affiliation:

1. 1Divisions of Preventive and General Internal Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL

2. 2The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD

3. 3Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI

4. 4Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI

5. 5Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA

6. 6University of Cincinnati, Cincinnati, OH

7. 7Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY

8. 8Endocrinology, Department of Medicine, and Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY

9. 9Department of Medicine, University of Miami, Miami, FL

10. 10Endocrinology, Diabetes, and Metabolism, Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL

11. 11Geriatric Research, Education, and Clinical Center, Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL

12. 12Medical University of South Carolina, Charleston, SC

Abstract

OBJECTIVE Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8–8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI.

Funder

National Institute of Diabetes and Digestive and Kidney Diseases

American Diabetes Association

National Heart, Lung, and Blood Institute

Centers for Disease Control and Prevention

Publisher

American Diabetes Association

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