Ann Arbor, MI, United States
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Xie L.,STATinMED Research Inc. | Zhou S.,Sanofi S.A. | Wei W.,Sanofi S.A. | Gill J.,Sanofi S.A. | And 3 more authors.
Diabetes Technology and Therapeutics | Year: 2013

Objective: The study was designed to evaluate real-world data on clinical and economic outcome differences between patients with type 2 diabetes mellitus (T2DM) who use insulin glargine with vial-and-syringe delivery and those who switch to pen administration. Subjects and Methods: This retrospective study analyzed medical and pharmacy claims information from the national managed-care IMPACT® database (Ingenix Inc., Salt Lake City, UT). Adults with T2DM treated with insulin glargine were evaluated. Clinical and economic outcomes over 1 year were compared between individuals who had converted from administering glargine via vial-and-syringe to the SoloSTAR® (sanofi-aventis U.S., Bridgewater, NJ) pen (Switchers) and patients who continued to use vial-and-syringe administration (Continuers). Patients from each cohort were matched using propensity score matching for a comparison sample. Results: In total, 3,893 eligible patients were identified (665 Switchers and 3,228 Continuers), with a matched cohort with 603 patients in each group. Baseline characteristics were similar between groups. One-year treatment persistence was significantly higher with Switchers versus Continuers (65.3% vs. 49.8%; P<0.0001). Medication possession ratio was also significantly higher among Switchers (0.79 vs. 0.76; P=0.0173). Insulin use and glycemic control were similar between groups. Healthcare utilization and total costs were also similar between groups. Higher prescription costs among Switchers were offset by lower overall and diabetes-related outpatient and inpatient costs. Conclusions: Switching from insulin glargine vial-and-syringe administration to pen delivery resulted in improved treatment adherence and persistence, with comparable clinical and economic outcomes. © Mary Ann Liebert, Inc.


Wei W.,Sanofi S.A. | Pan C.,PRO Unlimited | Xie L.,STATinMED Research Inc. | Baser O.,University of Michigan
Endocrine Practice | Year: 2014

Objective: To evaluate real-world treatment persistence among patients with type 2 diabetes mellitus (T2DM) initiating treatment with insulin.Methods: Patient-level data were pooled from 3 previously published observational retrospective studies evaluating patients with T2DM who were previously on oral antidiabetic drugs (OADs) and initiated with a basal analog insulin (insulin glargine or insulin detemir). Treatment persistence was defined as remaining on the study drug during the 1-year follow-up period without discontinuation or switching after study drug initiation. Analyses were conducted to identify baseline factors associated with persistence with insulin therapy and to estimate the association between insulin treatment persistence and patients' clinical and economic outcomes during the follow-up period.Results: A total of 4,804 patients with T2DM (insulin glargine: n = 4,172, insulin detemir: n = 632) were included. The average insulin persistence rate over the 1-year follow-up period was 65.0%. A significantly higher persistence rate was associated with older age, initiation with insulin glargine using either disposable pens or vial-And-syringe, and with baseline exenatide or sitagliptin use. Higher insulin treatment persistence was also associated with lower hemoglobin A1c (A1C) at follow-up, a greater reduction in A1C from baseline, and lower health care utilization.Conclusion: In real-world settings, treatment persistence among patients with T2DM initiating basal insulin is influenced by the type of insulin and patient factors. Greater insulin treatment persistence is linked to improved clinical outcomes and reduced health care utilization © 2014 AACE.


Dalal M.R.,Sanofi S.A. | Xie L.,STATinMED Research Inc | Baser O.,STATinMED Research Inc | Baser O.,University of Michigan | And 2 more authors.
Endocrine Practice | Year: 2015

Objective: To evaluate real-world outcomes in patients with type 2 diabetes mellitus (T2DM) receiving basal insulin who initiate add-on therapy with a rapid-acting insulin (RAI) or a glucagon-like peptide 1 (GLP-1) receptor agonist. Methods: Data were extracted retrospectively from a U. S. health claims database. Adults with T2DM on basal insulin who added an RAI (basal + RAI) or GLP-1 receptor agonist (basal + GLP-1) were included. Propensity score matching (with a 1 up to 3 ratio) was used to control for differences in baseline demographics, clinical characteristics, and health resource utilization. Endpoints included prevalence of hypoglycemia, pancreatic events, all-cause and diabetes-related resource utilization, and costs at 1-year follow-up. Results: Overall, 6,718 matched patients were included: 5,013 basal + RAI and 1,705 basal + GLP1. Patients in both groups experienced a similar proportion of any hypoglycemic event (P = .4079). Hypoglycemic events leading to hospitalization were higher in the basal + RAI cohort (2.7% vs. 1.8%; P = .0444). The basal + GLP-1 cohort experienced fewer all-cause (13.55% vs. 18.61%; P<.0001) and diabetes-related hospitalizations (11.79% vs. 15.68%; P<.0001). The basal + GLP-1 cohort had lower total all-cause health care costs ($18,413 vs. $20,821; P = .0002) but similar diabetes-related costs ($9,134 vs. $8,985; P<.0001) compared with the basal + RAI cohort. Conclusions: Add-on therapy with a GLP-1 receptor agonist in T2DM patients receiving basal insulin was associated with fewer hospitalizations and lower total all-cause costs compared with add-on therapy using an RAI and could be considered as an alternative to an RAI in certain patients with T2DM who do not achieve effective glycemic control with basal insulin. Copyright © 2015 AACE.


Baser O.,University of Michigan | Baser O.,STATinMED Research Inc. | Supina D.,Johnson and Johnson Pharmaceutical Services | Sengupta N.,Johnson and Johnson Pharmaceutical Services | And 2 more authors.
Current Medical Research and Opinion | Year: 2011

Background: Venous thromboembolism (VTE) occurs most often during hospitalization for major surgery or trauma but may also occur up to several months after surgery. Since the potential for VTE exists in a range of clinical settings, an assessment of its impact on overall outcomes and costs to the patient and to the healthcare system is warranted. Objective: To evaluate the effects of VTE (deep vein thrombosis, pulmonary embolism, or both) occurring within the first 30 days of hospital discharge for total hip replacement (THR) or total knee replacement (TKR) surgery on inpatient costs, mortality, rehospitalization, and major bleeding within 1 year after initial hospitalization for THR or TKR surgery. Methods: The Medicare Provider Analysis and Review (MEDPAR) file for calendar years 20052007 provided hospital discharge abstracts for the fee-for-service, acute-care hospitalizations of all Medicare recipients. All patients included in the analysis underwent THR (n51,108) or TKR (n115,627). VTE events were diagnosed within the first 30 days and within 1 year post discharge. Propensity score matching was used to control for differences in baseline characteristics in patients with and without VTE events. Total cost was measured as Medicare cost plus beneficiary out-of-pocket cost. Results: VTE occurred in 0.74 of patients undergoing THR. For patients with VTE versus no VTE, mortality was higher (2.9 vs 0.4, P<0.001) and rehospitalization within 1 year was more frequent (51.9 vs 22.4, P<0.001), as were complications such as bleeding (11.2 vs 2.7, P<0.001). Risk-adjusted Medicare cost and total healthcare cost, including beneficiary cost share in 1 year, were significantly higher for VTE patients versus patients with no VTE ($18,929 vs $3763, P<0.001). VTE occurred in 0.70 of patients undergoing TKR. For patients with VTE versus no VTE, mortality was higher (2.5 vs 0.15, P<0.001), and rehospitalization within 1 year was more frequent (48.7 vs 20.7, P<0.001), as were complications such as bleeding (13.7 vs 2.1, P<0.001). For TKR surgery, risk-adjusted total healthcare cost, including beneficiary cost share in 1 year, was significantly different for VTE versus no VTE ($17,996 vs $4358, P<0.001). Limitations: Study limitations include a reliance on ICD-9-CM codes, which could be inaccurate, and the inability (1) to control for unmeasured confounders, such as surgeons' skills; (2) to include outpatient medical care costs; and (3) to ensure that all patients were enrolled continuously throughout the study period. Conclusions: VTE after THR or TKR is associated with higher mortality, rehospitalization, and bleeding within 1 year, compared with no VTE. Risk-adjusted total, Medicare, and beneficiary healthcare costs were significantly higher for both THR and TKR patients with VTE (P<0.001). © 2011 Informa UK Ltd All rights reserved.


Wang L.,STATinMED Research Inc. | Baser O.,University of Michigan | Baser O.,STATinMED Research Inc. | Kutikova L.,Amgen | And 2 more authors.
Supportive Care in Cancer | Year: 2015

Purpose: The study aims to assess the relative efficacy of granulocyte colony-stimulating factor (G-CSF) products administered as primary prophylaxis (PP) to patients with cancer receiving myelosuppressive chemotherapy. Methods: A systematic literature review identified publications (January 1990 to September 2013) of randomized controlled trials evaluating PP with filgrastim, pegfilgrastim, lenograstim, or lipegfilgrastim in adults receiving myelosuppressive chemotherapy for solid tumors or non-Hodgkin lymphoma. Direct, indirect, and mixed-treatment comparison (MTC) were used to estimate the odds ratio and 95 % credible interval of febrile neutropenia (FN) during cycle 1 and all cycles of chemotherapy combined without adjusting for differences in relative dose intensity (RDI) between study treatment arms. Results: Twenty-seven publications representing 30 randomized controlled trials were included. Using MTC over all chemotherapy cycles, PP with filgrastim, pegfilgrastim, lenograstim, and lipegfilgrastim versus no G-CSF PP or placebo were associated with statistically significantly reduced FN risk. FN risk was also significantly reduced with pegfilgrastim PP versus filgrastim PP. Over all chemotherapy cycles, there was a numerical but statistically nonsignificant increase in the FN risk for lipegfilgrastim PP versus pegfilgrastim PP. Using MTC in cycle 1, PP with filgrastim, pegfilgrastim, and lipegfilgrastim versus no G-CSF PP or placebo were associated with statistically significantly reduced FN risk. Conclusions: In this meta-analysis, using MTC without adjustment for RDI, PP with all G-CSFs evaluated reduced the FN risk in patients receiving myelosuppressive chemotherapy. Future studies are needed to assess the influence of RDI on FN outcomes and to eliminate potential bias between G-CSF arms receiving more intensive chemotherapy than control arms. © 2015, The Author(s).


PubMed | Amgen Inc., University of Michigan, Amgen and STATinMED Research Inc.
Type: Journal Article | Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer | Year: 2015

The study aims to assess the relative efficacy of granulocyte colony-stimulating factor (G-CSF) products administered as primary prophylaxis (PP) to patients with cancer receiving myelosuppressive chemotherapy.A systematic literature review identified publications (January 1990 to September 2013) of randomized controlled trials evaluating PP with filgrastim, pegfilgrastim, lenograstim, or lipegfilgrastim in adults receiving myelosuppressive chemotherapy for solid tumors or non-Hodgkin lymphoma. Direct, indirect, and mixed-treatment comparison (MTC) were used to estimate the odds ratio and 95 % credible interval of febrile neutropenia (FN) during cycle 1 and all cycles of chemotherapy combined without adjusting for differences in relative dose intensity (RDI) between study treatment arms.Twenty-seven publications representing 30 randomized controlled trials were included. Using MTC over all chemotherapy cycles, PP with filgrastim, pegfilgrastim, lenograstim, and lipegfilgrastim versus no G-CSF PP or placebo were associated with statistically significantly reduced FN risk. FN risk was also significantly reduced with pegfilgrastim PP versus filgrastim PP. Over all chemotherapy cycles, there was a numerical but statistically nonsignificant increase in the FN risk for lipegfilgrastim PP versus pegfilgrastim PP. Using MTC in cycle 1, PP with filgrastim, pegfilgrastim, and lipegfilgrastim versus no G-CSF PP or placebo were associated with statistically significantly reduced FN risk.In this meta-analysis, using MTC without adjustment for RDI, PP with all G-CSFs evaluated reduced the FN risk in patients receiving myelosuppressive chemotherapy. Future studies are needed to assess the influence of RDI on FN outcomes and to eliminate potential bias between G-CSF arms receiving more intensive chemotherapy than control arms.


Baser O.,University of Michigan | Baser O.,STATinMed Research | Sengupta N.,Janssen Scientific Affairs LLC | Dysinger A.,University of Michigan | Wang L.,STATinMED Research Inc.
American Journal of Managed Care | Year: 2012

Objectives: To evaluate the real-world use of venous thromboembolism (VTE) prophylaxis among medical inpatients and the impact of VTE prophylaxis on outcomes and cost. Study Design: Retrospective analysis of patientlevel administrative claims data for medical inpatients at risk of VTE and linked outpatient data. Methods: Data were analyzed from patients admitted to the hospital from 2005 to 2007 (calendar years) with a primary diagnosis of chronic heart failure, thromboembolic stroke, severe lung disease, acute infection, or cancer (index hospitalization), according to whether they received VTE prophylaxis or not. The number of VTE events, time to VTE event, length of hospital stay, and number of major or minor bleeding events were analyzed from the index date until the end of follow-up (180 days postdischarge) or death. Results: Overall, 7127 of 13,293 patients (53.6%) received VTE prophylaxis. Prophylaxis significantly reduced the incidence of VTE compared with no prophylaxis (0.06% vs 3.44%, respectively; P <.00001) and increased the median time to VTE (182 vs 27 days, respectively). Prophylaxis also significantly reduced the incidence of VTE in the 180 days postdischarge. Readmission rates were similar between groups. Major bleeding occurred in 1.57% of patients receiving low molecular weight heparin + warfarin versus <.6% receiving any other form of prophylaxis. The development of VTE or major or minor bleeding events significantly increased total medical costs versus no VTE events (P <.0001) or no bleeding events (P <.0003). Conclusions: This real-world analysis showed that thromboprophylaxis was underutilized in medical patients, even though the clinical and economic impact of VTE was significant.


Baser O.,Statinmed Research inc | Baser O.,University of Michigan | Tangirala K.,Sanofi S.A. | Wei W.,Sanofi S.A. | Xie L.,Statinmed Research inc
ClinicoEconomics and Outcomes Research | Year: 2013

In patients with type 2 diabetes mellitus, basal-bolus strategies can improve treatment by offering dosing fexibility, and improved satisfaction, adherence, and clinical outcomes. The purpose of this study was to compare real-world outcomes between US patients initiating analog insulin therapy with insulin glargine and those initiating with a premixed analog insulin (PMX). Methods: This was a retrospective study of data from patients ($18 years) with type 2 diabetes mellitus in the IMPACT® database who initiated insulin treatment with insulin glargine (GLA) or a PMX. Clinical and economic outcomes were measured over one year, including persistence and adherence, consumption of insulin, glycemic outcomes, incident hypoglycemia, and health care resource utilization and cost. Results: Data from 2,502 patients were included in the analyses (n = 834 for PMX, n = 1,668 for GLA). Compared with PMX, persistence was higher and consumption of insulin was lower for GLA (both P, 0.0001). Adherence, glycemic outcomes, and hypoglycemia-related events were similar between groups, as were health care utilization and total health care costs. Diabetes-related drug and supply costs were lower for GLA than for PMX (P, 0.0001 and P = 0.046, respectively). Conclusion: In US patients with type 2 diabetes mellitus, initiating insulin with once-daily GLA, rather than a PMX, is associated with increased treatment persistence and similar clinical and hypoglycemic outcomes, but lower diabetes pharmacy and supply costs. GLA may be a more fexible option than PMX. However, these results also show suboptimal glycemic control in the real-world setting despite change in treatment regimens and call for optimization in management of patients with type 2 diabetes mellitus. © 2013 Baser et al.


PubMed | STATinMED Research Inc.
Type: Journal Article | Journal: Diabetes technology & therapeutics | Year: 2013

The study was designed to evaluate real-world data on clinical and economic outcome differences between patients with type 2 diabetes mellitus (T2DM) who use insulin glargine with vial-and-syringe delivery and those who switch to pen administration.This retrospective study analyzed medical and pharmacy claims information from the national managed-care IMPACT() database (Ingenix Inc., Salt Lake City, UT). Adults with T2DM treated with insulin glargine were evaluated. Clinical and economic outcomes over 1 year were compared between individuals who had converted from administering glargine via vial-and-syringe to the SoloSTAR() (sanofi-aventis U.S., Bridgewater, NJ) pen (Switchers) and patients who continued to use vial-and-syringe administration (Continuers). Patients from each cohort were matched using propensity score matching for a comparison sample.In total, 3,893 eligible patients were identified (665 Switchers and 3,228 Continuers), with a matched cohort with 603 patients in each group. Baseline characteristics were similar between groups. One-year treatment persistence was significantly higher with Switchers versus Continuers (65.3% vs. 49.8%; P<0.0001). Medication possession ratio was also significantly higher among Switchers (0.79 vs. 0.76; P=0.0173). Insulin use and glycemic control were similar between groups. Healthcare utilization and total costs were also similar between groups. Higher prescription costs among Switchers were offset by lower overall and diabetes-related outpatient and inpatient costs.Switching from insulin glargine vial-and-syringe administration to pen delivery resulted in improved treatment adherence and persistence, with comparable clinical and economic outcomes.


Baser O.,University of Michigan | Baser O.,STATinMED Research Inc. | Wei W.,Sanofi S.A. | Henk H.J.,Innovus | And 2 more authors.
Current Medical Research and Opinion | Year: 2012

Background: Triple-negative breast cancer (TNBC) makes up 10-17% of all breast cancers and, due to lack of receptor expression, is unresponsive to therapies that target hormonal receptors or HER2. Unique in its tumor aggression and high rates of recurrence, TNBC is less likely to be detected by mammogram and has a poorer prognosis than other breast cancer subtypes (non-TNBC). Objectives: To examine the survival, healthcare utilization, and healthcare cost for women with TNBC compared with non-TNBC breast cancer. Methods: The study population was derived from a US managed care cancer registry linked to health insurance claims and social security mortality data. Based on initial type and stage at diagnosis, patients were divided into two cohorts: patients with TNBC and those with non-TNBC. Records were analyzed from initial diagnosis until death, disenrollment, or end of observation period. Survival and annual healthcare utilization and costs were estimated and compared between cohorts after adjusting for baseline demographic characteristics, comorbidities, and prior resource use. Subgroup analyses were performed in patients diagnosed with stage IIII and IV breast cancer. Results: The study included women diagnosed with TNBC (n=450) and non-TNBC (n=1807). Median follow-up time for all patients was 716days (688.5 and 733days for TNBC and non-TNBC patients, respectively). After initial diagnosis, overall mortality risk for the TNBC cohort was twice as high as the non-TNBC cohort (HR=2.02, p<0.0001). Patients with TNBC had more annual hospitalizations, hospitalized days, and number of emergency room visits relative to non-TNBC. Despite similar annual total healthcare costs, adjusted inpatient costs for patients with non-TNBC averaged 77% higher ($8395 vs. $4745, p<0.0001). Furthermore, payer reimbursements were higher for TNBC than non-TNBC patients ($8213 vs. $4486, p<0.0001). Conclusions: While it does not control for race or socioeconomic status, this study found that in a US managed care setting, patients with TNBC compared with non-TNBC have significantly shorter survival, accompanied by higher inpatient utilization and healthcare costs. © 2012 Informa UK Ltd All rights reserved.

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