INTRODUCTION. ⢠The supplementation of oral antidiabetic drugs (OADs) with basal analog insulins, such as insulin glargine or insulin detemir, can provide ...
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Congestive heart failure
32 (5.0)
31 (4.8)
0.8972
Peripheral vascular disease
24 (3.8)
33 (5.2)
0.2226
53 (8.3)
67 (10.5)
0.1794
Treatment Persistence and Adherence
Neuropathy
74 (11.6)
66 (10.3)
0.4737
Nephropathy
30 (4.7)
39 (6.1)
0.2653
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0.6578
Sulfonylureas
440 (68.8)
442 (69.1)
0.9039
Dipeptidyl peptidase 4
190 (29.7)
177 (27.7)
0.4217
GLP-1
135 (21.1)
126 (19.7)
0.5324
Thiazolidinediones
242 (37.8)
262 (40.9)
0.2526
Meglitinides
37 (5.8)
36 (5.6)
0.9041
Alpha-glucosidase
8 (1.3)
8 (1.3)
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Health care utilization, n (%) 48 (7.5)
67 (10.5)
Any diabetes-related hospitalization
37 (5.8)
46 (7.2)
Cost, $, mean (SD)
0.3070
6,736 (11,343)
7,915 (13,702)
0.0938
Total diabetes-related cost
2,671 (4,706)
3,246 (7,412)
0.0975
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Total cost
Economic Outcomes
• All-cause hospitalizations were similar for both the GLA-P and DET-P groups (13.9% vs 12.5%, P = 0.4574), as were diabetes-related hospitalizations (10.2% vs 8.0%, P = 0.1729). Furthermore, there were no significant differences between numbers of hospitalizations, ER visits, office visits or endocrinologist visits. • Total health care costs were similar for patients in the GLA-P cohort compared with the DET-P cohort ($16,063 vs $15,350; P = 0.5293), as were diabetes-related health care costs ($7,050 vs $6,287; P = 0.1656) and study drug costs ($1,066 vs $1,016; P = 0.2878). • However, population-wise analysis showed that for each 1% reduction in A1C from baseline to the end of the follow-up period, diabetes-related health care costs were lower in the GLA-P cohort compared with the DET-P cohort ($5,732 vs $6,287), as were total health care costs ($13,059 vs $15,350).
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Mean A1C Reduction From Baseline
Mean A1C at 1-year Follow-Up
• The current study suggests that in a real-world setting, when initiating analog insulin treatment via disposable pen, insulin glargine, compared with insulin detemir, may improve patient persistence and compliance with treatment. GLA-P
• When compared with insulin detemir, insulin glargine provides greater A1C reduction with a manageable safety profile at no increased cost and may, therefore, be a more cost-effective treatment option.
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CONCLUSIONS
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• At the end of the 1-year follow-up, patients who initiated with GLA-P had significantly lower mean (SD) A1C levels (8.1 [1.6] % vs 8.4 [1.8] %; P = 0.0260) as well as significantly greater reductions in A1C levels from baseline (−1.2 [2.1] % vs −1.0 [2.0] %; P = 0.0467) (Figure 3). • There was no significant difference in the proportion of patients achieving A1C < 7.0% (23.9% vs 23.3%; P = 0.79). • The mean (SD) DACON dose of analog insulin was significantly lower in the GLA-P cohort than in the DET-P cohort (29.0 [19.1] units/day vs 31.8 [23.3] units/day; P = 0.0342). • Population-wise, for each 1% reduction in A1C from baseline to the end of the follow-up period, the mean required DACON dose was lower in the GLA-P cohort compared with the DET-P cohort (23.6 vs 31.8 units/day). • The proportion of patients who had a hypoglycemic event during the 1-year follow-up was similar for both cohorts (7.9% vs 5.9%; P = 0.1531), as was the mean (SD) number of hypoglycemic events per patient per year (0.23 [1.26] vs 0.13 [0.87]; P = 0.09). • The mean (SD) number of hypoglycemia-related ER visits or hospitalizations per patient per year was low, but significantly higher in the GLA-P cohort compared with the DET-P cohort (0.04 [0.24] vs 0.02 [0.13]; P = 0.0455).
Figure 2. Kaplan-Meier Curve for Time to Discontinuation of Initiated Insulin Therapy Among the Matched GLA-P and DET-P Cohorts.
OAD, n (%)
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Clinical Outcomes
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• During the follow-up period, significantly more patients in the GLA-P cohort persisted with their treatment than those in the DET-P cohort (64.8% vs 50.9%; P < 0.0001) (Figure 1). • In addition, the mean (SD) number of days that patients persisted with their treatment was significantly higher in the GLA-P cohort than in the DET-P cohort (236.3 [118.8] days vs 212.8 [114.9] days; P = 0.0003). • Kaplan-Meier analysis showed that the GLA-P cohort was less likely to discontinue treatment early compared with the DET-P cohort (P = 0.0458) (Figure 2). • At the end of the 1-year follow-up, fewer patients in the GLA-P cohort switched to insulin detemir compared with patients in the DET-P cohort who switched to insulin glargine (1.4% vs 5.9%; P < 0.0001). • Patient adherence to treatment was also significantly higher in the GLA-P cohort compared with the DET-P cohort for mean MPR (0.48 vs 0.44; P = 0.0049) and mean adjusted MPR (0.70 vs 0.63; P = 0.0001). In addition, significantly more patients on GLA-P had an adjusted MPR ≥ 0.8 compared with DET-P (48.3% vs 41.6%; P = 0.0157).
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• These data may assist clinical decision-making in the routine practice setting for the treatment of patients with T2DM and may help optimize patient management.
300
Treatment Persistence (Days) (1-Year Follow-Up)
• These findings need to be confirmed with randomized pragmatic clinical trials.
LIMITATIONS
• The population comprised managed care enrollees and, therefore, is not necessarily representative of the US population as a whole. • Data on weight changes were not available. • Information on dosing (once daily vs twice daily), which could have implications for patient treatment compliance, was not available in this database. • The pharmacy claim data used in this study may not accurately reflect daily insulin dose as patients may discard unused insulin portions at the in-use expiration date or skip doses, which may artificially inflate or deflate the dose results and affect the accuracy of persistence measurement. • As with any retrospective analysis, the findings from the current study are only hypothesisgenerating; randomized pragmatic clinical trials are needed to establish causality of the observed data.
REFERENCES 1. Rosenstock J, et al. Diabetologia. 2008;51:408-16. 2. Magwire ML. Am J Ther. 2010 Sep 10. [Epub ahead of print].
Acknowledgments This study was funded by sanofi-aventis U.S. The authors received writing/editorial support in the preparation of this poster provided by Pim Dekker, PhD, of Excerpta Medica, funded by sanofi-aventis U.S.
DISCLOSURES Xie, Du, and Baser: employees at STATinMed, which received funding to carry out this work from sanofi-aventis U.S. Wei: employee of sanofi-aventis U.S. Pan: employee of PRO Unlimited, which received funding to carry out this work from sanofi-aventis U.S.
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Figure 3. Reductions in A1C Levels From Baseline and A1C Levels at the End of 1-year Follow-Up.
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Figure 1. Persistence With Treatment for the Matched GLA-P and DET-P Cohorts: Percentage of Patients.
Table. Baseline Characteristics of the Matched GLA-P and DET-P Cohorts.
• A total of 1,682 patients initiated analog insulin treatment, of which 1,016 (60.4%) used GLA-P and 666 (39.6%) used DET-P. • After propensity score matching, each cohort contained 640 patients, balancing the cohorts in terms of demographics, comorbidities, A1C, baseline medication, and health care costs calculated for the 6-month baseline period (Table).
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• This was a retrospective analysis of data from over 40 US health care plans (86.4 million patients) collected in the Integrated Health Care Information Services database from July 1, 2005, through September 30, 2010. SoloSTAR® was FDA approved in April 2007. • Patients were included if they: were diagnosed with T2DM; were aged ≥ 18 years; had glycated hemoglobin A1C (A1C) data at baseline; were receiving at least one OAD or glucagon-like peptide 1 (GLP-1) medication; and were insulin-naive before initiation of GLA-P or DET-P. • Patients had to be continuously enrolled in a health plan for 6 months prior to the start of GLA-P or DET-P use (baseline period) and during the 1-year follow-up period after initiation. • Propensity score matching at a ratio of 1:1 was applied to match patients in the GLA-P and DET-P cohorts based on baseline demographics, comorbidities, A1C levels, OADs and/or GLP-1 medication use, health care utilization, and cost data. • Several endpoints were compared between the matched cohorts over the 1-year follow-up period. – treatment persistence, defined as remaining on therapy without discontinuation during the 1-year follow-up from initiation; study medication was considered discontinued if the prescription was not refilled within the expected time of medication coverage, defined as the 90th percentile of the time, stratified by the metric quantity supplied, between first and second fills among patients with at least one refill – time to discontinuation: measured as the number of days of being persistent with initiated therapy from the index date – treatment adherence: measured by both the traditional medication possession ratio (MPR), and the adjusted MPR taking into account the differences in insulin device package size during the 1-year follow-up – glycemic control: measured by A1C level at the end of the 1-year follow-up period and the change from baseline A1C level – daily average consumption (DACON): measured during the 1-year follow-up period in units per day – hypoglycemic events: defined as a health care encounter with a diagnosis code for hypoglycemia (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes: 250.8; 251.0; 251.1; or 251.2)
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RESULTS
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• To compare clinical outcomes and health care costs associated with basal analog insulin initiation using insulin glargine disposable pens (GLA-P) (SoloSTAR®, sanofi-aventis, Paris, France) and insulin detemir disposable pens (DET-P) (FlexPen®, Novo Nordisk, Bagsværd, Denmark).
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Comorbidity, n (%)
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OBJECTIVE
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– health care utilization: included the number of office visits, emergency room (ER) visits, and endocrinologist visits, and the number and total duration of hospital admissions – health care costs: both total and diabetes-related costs were assessed from the perspective of US health care plan administrators during the 1-year follow-up; costs were measured as standardized allowed payment (adjusted for inflation in 2009 $) by the health plan to the provider • P ercentages, means, standard deviations (SDs), and P values were obtained and calculated using standard statistical tests. • Time to discontinuation was analyzed using Kaplan-Meier analysis and stratified log-rank test.
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• The supplementation of oral antidiabetic drugs (OADs) with basal analog insulins, such as insulin glargine or insulin detemir, can provide clinically important improvements in glycemic control, with low hypoglycemic rates.1 • Insulin glargine and insulin detemir can be administered using disposable pen devices and evidence suggests that pen devices may be easier, less painful, and preferred by patients, compared with vials and syringes. As a result, it is thought that pen devices may improve adherence and help overcome the barriers to insulin use. • Few studies have compared real-world outcomes following initiation of different analog insulin pen regimens; such information would assist with treatment decisions and help optimize the management of patients with type 2 diabetes mellitus (T2DM).
METHODS
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STATinMED Research, Ann Arbor, MI; sanofi-aventis U.S., Bridgewater, NJ; PRO Unlimited, Boca Raton, FL; University of Michigan, Ann Arbor, MI; USA
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INTRODUCTION
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Lin Xie , Wenhui Wei , Chunshen Pan , Juan Du , Onur Baser 1
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Real-World Clinical and Economic Outcomes in Patients With Type 2 Diabetes Initiating Insulin Glargine Disposable Pen vs Insulin Detemir Disposable Pen in a US Managed Care Setting
