TY - JOUR
T1 - A real-world study of treatment patterns and outcomes in US managed-care patients with type 2 Diabetes initiating injectable therapies
AU - Wei, Wenhui
AU - Buysman, Erin
AU - Grabner, Michael
AU - Xie, Lin
AU - Brekke, Lee
AU - Ke, Xuehua
AU - Chu, James W.
AU - Levin, Philip A.
N1 - Funding Information:
The authors received writing/editorial support in preparation of this manuscript provided by Tessa Hartog, PhD, of Excerpta Medica, funded by Sanofi US, Inc. W. W. is an employee of Sanofi US, Inc. E. B. and L. B. are employees of Optum, under contract with Sanofi US, Inc. M. G. and X. K. are employees of HealthCore, Inc., under contract with Sanofi US, Inc., for the conduct of this study. L. X. is an employee of STATinMED Research, under contract with Sanofi US, Inc. J. W. C. is a consultant and member of the lecture bureau for Sanofi US, Inc.; is a member of the lecture bureaus for AstraZeneca and for Eli Lilly and Company; and has received research funding from Novo Nordisk, Inc. P. A. L. is a consultant, member of the advisory panel, member of the speakers bureau for and has received research support from Sanofi US, Inc.; is a consultant, member of the advisory panel, member of the speakers bureau for and has received research support from Novo Nordisk, Inc.; is a member of the speakers bureau for and has received research support from Eli Lilly and Company; is a member of the speakers bureau for and has received research support from Amylin Pharmaceuticals; has received research support from Roche; and is a member of the speakers bureaus for BMS, Boehringer Ingelheim and AstraZeneca. W. W. proposed and co-developed the study concept, co-developed the analysis plan, interpreted the results of the analyses throughout the manuscript development; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. E. B. co-developed the concept and co-developed the analysis plan; collected the data, conducted statistical analyses and interpreted the results throughout the manuscript development, prepared the study report and conducted additional analyses; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. M. G. co-developed the concept and co-developed the analysis plan; collected data, performed the analysis, interpreted the results of the analyses throughout the manuscript development and prepared the study report; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. L. X. conducted the pooled analysis; interpreted the results of the analyses throughout the manuscript development; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. L. B. co-developed the analysis plan; collected data, performed the analysis, interpreted the results of the analyses throughout the manuscript development and prepared the study report; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. X. K. collected data, performed the analysis, interpreted the results of the analyses throughout the manuscript development and prepared the study report; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. J. W. C. provided key clinical insights in interpreting the results of the analyses from a clinician's point of view throughout the manuscript development; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work. P. A. L. provided key clinical insights in interpreting the results of the analyses from a clinician's point of view throughout the manuscript development; reviewed the manuscript, provided comments and approved the final version for submission; and is willing to be accountable for the accuracy and integrity of the work.
Publisher Copyright:
© 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Aims: Examine real-world outcomes in patients with type 2 diabetes mellitus (T2DM) initiating injectable therapy as part of the Initiation of New Injectable Treatment Introduced after Antidiabetic Therapy with Oral-only Regimens (INITIATOR) study. Materials and methods: Linked insurance claims and medical record data were collected from 2 large US health insurers (April 1, 2010 to March 31, 2012) of T2DM adults initiating treatment with glargine (GLA) or liraglutide (LIRA). Baseline characteristics were examined and changes in 12-month follow-up outcomes were described for both treatment groups: HbA1c, weight change, hypoglycaemia, persistence, healthcare utilisation and costs. Results: A total of 4490 patients were included (GLA, 2116; LIRA, 2374). At baseline, GLA patients had significantly higher HbA1c vs LIRA patients (9.72% vs 8.19%; P <.001), lower likelihood of having HbA1c < 7% (7.1% vs 23.8%; P <.001), lower bodyweight (100.9 kg vs 110.9 kg, P <.001), higher Charlson Comorbidity Index score (0.88 vs 0.63; P <.001), and higher diabetes-related costs ($3492 vs $2089; P <.001), respectively. During 12-months of follow-up, treatment persistence was 64%, mean HbA1c reduction was −1.24% and weight change was + 1.17 among GLA patients, and was 49%, −0.51% and −2.74 kg, respectively, among LIRA patients. Diabetes-related costs increased significantly from baseline to follow-up for LIRA patients ($2089 vs $3258, P <.001) but not for GLA patients ($3492 vs $3550, P =.890). Conclusions: There were clinically relevant baseline differences in both groups, suggesting that GLA and LIRA are prescribed for different patient groups, and highlighting that efficacy results from clinical trials do not always translate into real-world practice. Significant increases in healthcare costs were observed in the LIRA group, warranting further cost-effectiveness analysis.
AB - Aims: Examine real-world outcomes in patients with type 2 diabetes mellitus (T2DM) initiating injectable therapy as part of the Initiation of New Injectable Treatment Introduced after Antidiabetic Therapy with Oral-only Regimens (INITIATOR) study. Materials and methods: Linked insurance claims and medical record data were collected from 2 large US health insurers (April 1, 2010 to March 31, 2012) of T2DM adults initiating treatment with glargine (GLA) or liraglutide (LIRA). Baseline characteristics were examined and changes in 12-month follow-up outcomes were described for both treatment groups: HbA1c, weight change, hypoglycaemia, persistence, healthcare utilisation and costs. Results: A total of 4490 patients were included (GLA, 2116; LIRA, 2374). At baseline, GLA patients had significantly higher HbA1c vs LIRA patients (9.72% vs 8.19%; P <.001), lower likelihood of having HbA1c < 7% (7.1% vs 23.8%; P <.001), lower bodyweight (100.9 kg vs 110.9 kg, P <.001), higher Charlson Comorbidity Index score (0.88 vs 0.63; P <.001), and higher diabetes-related costs ($3492 vs $2089; P <.001), respectively. During 12-months of follow-up, treatment persistence was 64%, mean HbA1c reduction was −1.24% and weight change was + 1.17 among GLA patients, and was 49%, −0.51% and −2.74 kg, respectively, among LIRA patients. Diabetes-related costs increased significantly from baseline to follow-up for LIRA patients ($2089 vs $3258, P <.001) but not for GLA patients ($3492 vs $3550, P =.890). Conclusions: There were clinically relevant baseline differences in both groups, suggesting that GLA and LIRA are prescribed for different patient groups, and highlighting that efficacy results from clinical trials do not always translate into real-world practice. Significant increases in healthcare costs were observed in the LIRA group, warranting further cost-effectiveness analysis.
KW - basal insulin
KW - database research
KW - incretin therapy
KW - observational study
KW - type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85010417609&partnerID=8YFLogxK
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U2 - 10.1111/dom.12828
DO - 10.1111/dom.12828
M3 - Article
C2 - 27860158
AN - SCOPUS:85010417609
SN - 1462-8902
VL - 19
SP - 375
EP - 386
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 3
ER -