Real-world utilization patterns and outcomes of colesevelam hcl in the ge electronic medical record Public Deposited

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  • Ye, Xin
    • Other Affiliation: Daiichi-Sankyo, Inc, Parsippany, NJ, USA
  • Powers, Ben
    • Other Affiliation: St. Luke’s Health System, Boise, ID, USA
  • Maciejewski, Matthew L
    • Other Affiliation: Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, USA; Division of General Internal Medicine, Duke University, Durham, NC, USA
  • Farley, Joel
    • Affiliation: Eshelman School of Pharmacy, Division of Pharmaceutical Outcomes and Policy
  • Hansen, Richard A
    • Other Affiliation: Department of Pharmacy Care Systems, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA
  • Qian, Chunlin
    • Other Affiliation: Daiichi-Sankyo, Inc, Parsippany, NJ, USA
  • Abstract Background In randomized controlled trials (RCTs), colesevelam HCI, added to other anti-diabetic therapy, reduced hemoglobin A1C by approximately 0.3% to 0.4% over 16- to 26-weeks compared with an increase of approximately 0.1% to 0.2% for placebo, for a placebo-adjusted treatment effect of approximately 0.5%. Evidence on real-world effectiveness is unknown. This retrospective cohort study examined A1C changes following colesevelam HCL initiation in patients with diabetes, regardless of concomitant anti-diabetic medication use. Methods 2000–2011 GE Centricity electronic medical records data were used to identify patients with type 2 diabetes mellitus (T2DM) aged 18 or older initiating colesevelam HCL. The sample was further restricted to uncontrolled patients with database activity ≥ 395 days before and after colesevelam HCL initiation, A1C > 7% during 90 days prior to starting colesevelam HCL, without prior use of bile acid sequestrants, and with at least one A1C result between 42 to 210 days after initiation. Three overlapping time intervals were created for A1C measurement, including 16-weeks, 26-weeks, and 52-weeks following therapy initiation. The last observed A1C lab measurement during each interval was used to define change from baseline. Mean change in A1C was examined using paired t-tests. Sensitivity analyses considered only patients who remained on colesevelam HCL through each respective measurement period, as well as the effect of concomitant diabetes medications. Results Of 1,709,393 patients in the GE database with T2DM, 1,747 met inclusion criteria. The cohort was 58% female, 38% age ≥ 65, and the majority was white. For the 16-week endpoint (N = 1,385), A1C dropped from a mean of 8.22% to 7.75% (mean change −0.47%; P < 0.0001). For the 26- and 52-week endpoints (N = 1,747), A1C dropped from a mean of 8.25% to 7.81% (mean change −0.44%; P < 0.0001) and 8.25% to 7.79% (mean change −0.46%; P < 0.0001), respectively. Sensitivity analyses showed that A1C reductions were of similar direction and magnitude for patients who remained on treatment, and for the subgroups of patients stratified by receipt of concomitant T2DM treatments. Conclusions The 0.44% to 0.47% A1C reduction observed in this study was similar to the reduction observed in RCTs, supporting the real-world effectiveness of colesevelam HCL in reducing A1C.
Date of publication
  • 23866087
  • doi:10.1186/1472-6823-13-24
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Richard A Hansen et al.; licensee BioMed Central Ltd.
Journal title
  • BMC Endocrine Disorders
Journal volume
  • 13
Journal issue
  • 1
Page start
  • 24
  • English
Is the article or chapter peer-reviewed?
  • Yes
  • 1472-6823
Bibliographic citation
  • BMC Endocrine Disorders. 2013 Jul 17;13(1):24
  • Open Access
  • BioMed Central Ltd

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