Comparative safety and effectiveness of sitagliptin in patients with type 2 diabetes: retrospective population based cohort studyBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2267 (Published 25 April 2013) Cite this as: BMJ 2013;346:f2267
- D T Eurich, associate professor12,
- S Simpson, associate professor23,
- A Senthilselvan, professor1,
- C V Asche, director45,
- J K Sandhu-Minhas, research associate2,
- F A McAlister, professor67
- 1Department of Public Health Sciences, School of Public Health, University of Alberta, Edmonton, AB, Canada, T6G 2G3
- 2Alliance for Canadian Health Outcomes Research in Diabetes, University of Alberta, Edmonton, AB, Canada, T6G 2E1
- 3Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada, T6G 2B7
- 4Center for Health Outcomes, University of Illinois College of Medicine at Peoria, Peoria, IL, 61656-1649, USA
- 5Department of Pharmacy Administration, University of Illinois at Chicago College of Pharmacy, Chicago, IL, 60612-7231, USA
- 6Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada, T6G 2B7
- 7Patient Health Outcomes Research and Clinical Effectiveness, University of Alberta, Edmonton, AB, Canada, T6G 2B7
- Correspondence to: D T Eurich 2-040 Li Ka Shing Center for Health Research Innovation, University of Alberta, Edmonton, AB, Canada, T6G 2E1
- Accepted 27 March 2013
Objective To determine if the use of sitagliptin in newly treated patients with type 2 diabetes is associated with any changes in clinical outcomes.
Design Retrospective population based cohort study.
Setting Large national commercially insured US claims and integrated laboratory database.
Participants Inception cohort of new users of oral antidiabetic drugs between 2004 and 2009 followed until death, termination of medical insurance, or December 31 2010.
Main outcome measure Composite endpoint of all cause hospital admission and all cause mortality, assessed with time varying Cox proportional hazards regression after adjustment for demographics, clinical and laboratory data, pharmacy claims data, healthcare use, and time varying propensity scores.
Results The cohort included 72 738 new users of oral antidiabetic drugs (8032 (11%) used sitagliptin; 7293 (91%) were taking it in combination with other agents) followed for a total of 182 409 patient years. The mean age was 52 (SD 9) years, 54% (39 573) were men, 11% (8111) had ischemic heart disease, and 9% (6378) had diabetes related complications at the time their first antidiabetic drug was prescribed. 14 215 (20%) patients met the combined endpoint. Sitagliptin users showed similar rates of all cause hospital admission or mortality to patients not using sitagliptin (adjusted hazard ratio 0.98, 95% confidence interval 0.91 to 1.06), including patients with a history of ischemic heart disease (adjusted hazard ratio 1.10, 0.94 to 1.28) and those with estimated glomerular filtration rate below 60 mL/min (1.11, 0.88 to 1.41).
Conclusions Sitagliptin use was not associated with an excess risk of all cause hospital admission or death compared with other glucose lowering agents among newly treated patients with type 2 diabetes. Most patients prescribed sitagliptin in this cohort were concordant with clinical practice guidelines, in that it was used as add-on treatment.
We acknowledge the tremendous support from Betsey Jackson at Health Data Services Corporation (www.hdscorp.biz), P O Box 53, Carlisle, MA 01741, USA, for providing independent database acquisition services.
Contributors: All authors contributed to the conception and design of the study. DTE, JKS-M, AS, SS, and FAM contributed to the analysis and interpretation of data. DTE and JKS-M drafted the article, all authors revised it critically for important intellectual content, and all authors provided final approval of the version to be published. DTE is the guarantor.
Funding: This work was funded by operating grants from the Canadian Diabetes Association (OG-2-09-2691-DE) and the Canadian Institutes of Health Research (CIHR) (MOP-126093). DTE receives salary support from Alberta Innovates Health Solution (AIHS) and the CIHR. FAM is a senior health scholar with AIHS. The study sponsors played no role in study design or conduct; collection, analysis, or interpretation of data; writing of the report; or the decision to submit the paper for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the ethics review board of the University of Alberta, Edmonton, Alberta, Canada, and the New England Institutional Review Board, United States.
Data sharing: No additional data available.
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