. 2015 Apr 2:16:8.

doi: 10.1186/s40360-015-0007-z.

Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs

M Elle Saine^{1

2}, Dean M Carbonari^{3

4}, Craig W Newcomb⁵, Melissa S Nezamzadeh^{6

7}, Kevin Haynes^{8

9

10}, Jason A Roy^{11

12}, Serena Cardillo¹³, Sean Hennessy^{14

15}, Crystal N Holick¹⁶, Daina B Esposito¹⁷, Arlene M Gallagher¹⁸, Harshvinder Bhullar¹⁹, Brian L Strom^{20

21

22}, Vincent Lo Re 3rd^{23

24

25}

Affiliations

¹ 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.
² 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.
³ 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.
⁴ 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.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ 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.
⁹ 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.
¹⁰ HealthCore, Inc, Wilmington, DE, USA. khaynes@healthcore.com.
¹¹ 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.
¹² 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.
¹³ Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
¹⁴ 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.
¹⁵ 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.
¹⁶ HealthCore, Inc, Wilmington, DE, USA. CHolick@healthcore.com.
¹⁷ HealthCore, Inc, Wilmington, DE, USA. desposito@healthcore.com.
¹⁸ Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK. arlene.gallagher@mhra.gsi.gov.uk.
¹⁹ Cegedim Strategic Data Medical Research, London, UK. Harshvinder.BHULLAR@cegedim.com.
²⁰ 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.
²¹ 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.
²² Rutgers Biomedical & Health Sciences, Rutgers, the State University of New Jersey, Newark, NJ, USA. bstrom@ca.rutgers.edu.
²³ 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.
²⁴ 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.
²⁵ Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. vincentl@mail.med.upenn.edu.

PMID: 25889498
PMCID: PMC4404079
DOI: 10.1186/s40360-015-0007-z

Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs

M Elle Saine et al. BMC Pharmacol Toxicol. 2015.

. 2015 Apr 2:16:8.

doi: 10.1186/s40360-015-0007-z.

Authors

Affiliations

¹ 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.
² 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.
³ 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.
⁴ 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.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ 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.
⁹ 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.
¹⁰ HealthCore, Inc, Wilmington, DE, USA. khaynes@healthcore.com.
¹¹ 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.
¹² 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.
¹³ Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
¹⁴ 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.
¹⁵ 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.
¹⁶ HealthCore, Inc, Wilmington, DE, USA. CHolick@healthcore.com.
¹⁷ HealthCore, Inc, Wilmington, DE, USA. desposito@healthcore.com.
¹⁸ Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK. arlene.gallagher@mhra.gsi.gov.uk.
¹⁹ Cegedim Strategic Data Medical Research, London, UK. Harshvinder.BHULLAR@cegedim.com.
²⁰ 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.
²¹ 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.
²² Rutgers Biomedical & Health Sciences, Rutgers, the State University of New Jersey, Newark, NJ, USA. bstrom@ca.rutgers.edu.
²³ 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.
²⁴ 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.
²⁵ Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. vincentl@mail.med.upenn.edu.

PMID: 25889498
PMCID: PMC4404079
DOI: 10.1186/s40360-015-0007-z

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov identifiers NCT01086280 , NCT01086293 , NCT01086319 , NCT01086306 , and NCT01377935.

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Figures

**Figure 1**
**Selection of saxagliptin patients. a**: Clinical Practice Research Datalink (CPRD). b: The Health Improvement Network (THIN). c: US Medicare. d: HealthCore Integrated Research Database^SM (HIRD^SM).

See this image and copyright information in PMC

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Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs

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Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs

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