title: Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs.
abstract: The patterns and determinants of saxagliptin use among patients with type 2 diabetes mellitus (T2DM) are unknown in real-world settings. We compared the characteristics of T2DM patients who were new initiators of saxagliptin to those who were new initiators of non-dipeptidyl peptidase-4 (DPP-4) inhibitor oral anti-diabetic drugs (OADs) and identified factors associated with saxagliptin use.
  
  
  
  We conducted a cross-sectional study within the Clinical Practice Research Datalink (CPRD), The Health Improvement Network (THIN), US Medicare, and the HealthCore Integrated Research Database (HIRD(SM)) across the first 36 months of saxagliptin availability (29 months for US Medicare). Patients were included if they were: 1) ≥18 years old, 2) newly prescribed saxagliptin or a non-DPP-4 inhibitor OAD, and 3) enrolled in their respective database for 180 days. For each saxagliptin initiator, we randomly selected up to ten non-DPP-4 inhibitor OAD initiators matched on age, sex, and geographic region. Conditional logistic regression was used to identify determinants of saxagliptin use.
  
  
  
  We identified 64,079 saxagliptin initiators (CPRD: 1,962; THIN: 2,084; US Medicare: 51,976; HIRD(SM): 8,057) and 610,660 non-DPP-4 inhibitor OAD initiators (CPRD: 19,484; THIN: 19,936; US Medicare: 493,432; HIRD(SM): 77,808). Across all four data sources, prior OAD use, hypertension, and hyperlipidemia were associated with saxagliptin use. Saxagliptin initiation was also associated with hemoglobin A1c results >8% within the UK data sources, and a greater number of hemoglobin A1c measurements in the US data sources.
  
  
  
  In these UK and US data sources, initiation of saxagliptin was associated with prior poor glycemic control, prior OAD use, and diagnoses of hypertension and hyperlipidemia.
  
  
  
  ClinicalTrials.gov identifiers NCT01086280 , NCT01086293 , NCT01086319 , NCT01086306 , and NCT01377935.
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. msaine@mail.med.upenn.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. msaine@mail.med.upenn.edu.
authors.forename: M Elle
authors.initials: ME
authors.lastname: Saine
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. dcarbo@mail.med.upenn.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. dcarbo@mail.med.upenn.edu.
authors.forename: Dean M
authors.initials: DM
authors.lastname: Carbonari
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. cnewcomb@mail.med.upenn.edu.
authors.forename: Craig W
authors.initials: CW
authors.lastname: Newcomb
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. MNezamzadeh@glgroup.com.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. MNezamzadeh@glgroup.com.
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Nezamzadeh
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. khaynes@healthcore.com.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. khaynes@healthcore.com.|HealthCore, Inc, Wilmington, DE, USA. khaynes@healthcore.com.
authors.forename: Kevin
authors.initials: K
authors.lastname: Haynes
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. jaroy@mail.med.upenn.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jaroy@mail.med.upenn.edu.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Roy
authors.affiliation: Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
authors.forename: Serena
authors.initials: S
authors.lastname: Cardillo
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. hennessy@upenn.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
authors.forename: Sean
authors.initials: S
authors.lastname: Hennessy
authors.affiliation: HealthCore, Inc, Wilmington, DE, USA. CHolick@healthcore.com.
authors.forename: Crystal N
authors.initials: CN
authors.lastname: Holick
authors.affiliation: HealthCore, Inc, Wilmington, DE, USA. desposito@healthcore.com.
authors.forename: Daina B
authors.initials: DB
authors.lastname: Esposito
authors.affiliation: Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK. arlene.gallagher@mhra.gsi.gov.uk.
authors.forename: Arlene M
authors.initials: AM
authors.lastname: Gallagher
authors.affiliation: Cegedim Strategic Data Medical Research, London, UK. Harshvinder.BHULLAR@cegedim.com.
authors.forename: Harshvinder
authors.initials: H
authors.lastname: Bhullar
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. bstrom@ca.rutgers.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. bstrom@ca.rutgers.edu.|Rutgers Biomedical & Health Sciences, Rutgers, the State University of New Jersey, Newark, NJ, USA. bstrom@ca.rutgers.edu.
authors.forename: Brian L
authors.initials: BL
authors.lastname: Strom
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, USA. vincentl@mail.med.upenn.edu.|Department of Biostatistics and Epidemiology, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. vincentl@mail.med.upenn.edu.|Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. vincentl@mail.med.upenn.edu.
authors.forename: Vincent
authors.initials: V
authors.lastname: Lo Re
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004151:Dipeptides / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy; D006973:Hypertension / Q000150:complications / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D006113:United Kingdom; D014481:United States; D055815:Young Adult
chemical_list: D000218:Adamantane; D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human; C502994:saxagliptin