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New Haven, MI, United States

Xie L.,STATinMED Research | Wei W.,Sanofi S.A. | Pan C.,PRO Unlimited | Baser O.,University of Michigan
Journal of Medical Economics | Year: 2013

Objective: To evaluate the real-world rates of hypoglycemia and related costs among patients with type 2 diabetes mellitus (T2DM) who initiated insulin glargine with either a disposable pen or vial-and-syringe. Methods: Pooled data were evaluated from six previously published, retrospective, observational studies using US health plan insurance claims databases to investigate adults with T2DM who initiated insulin glargine. The current study evaluated baseline characteristics, hypoglycemic events, and costs during the 6 months prior to and 12 months following insulin glargine initiation. Comparisons were made between patients initiating treatment with a disposable pen (GLA-P) and vial-and-syringe (GLA-V). Multivariate analyses using baseline characteristics as covariates determined predictors of hypoglycemia after initiating insulin glargine. Results: This study included 23,098 patients (GLA-P: 14,911; GLA-V: 8187). Overall annual prevalence of hypoglycemia was low (6.3% overall, 2.2% related to hospital admission or emergency department visit). Prevalence was significantly lower with GLA-P (5.5% vs 7.7%; p<0.0001). Furthermore, average glycated hemoglobin HbA1c reduction was higher with GLA-P (-1.22% vs-0.86%; p=0.0012). The average annual hypoglycemia-related cost associated with initiating insulin glargine was $293, with GLA-P being 46% lower than GLA-V ($225 vs $417; p=0.001). Patients who had already developed microvascular complications at the time of initiating insulin therapy were at higher risk for developing hypoglycemia. Limitations: This study is limited by the use of retrospective data and ICD-9-CM codes, which are subject to coding error. In addition, this pooled analysis used unmatched cohorts, with multivariate regression analyses employed to adjust for between-group differences. Finally, results describe a managed care sample and cannot be generalized to all patients with T2DM. Conclusions: Patients with T2DM initiating insulin glargine treatment showed low rates of hypoglycemia, especially when using a disposable pen device. Hypoglycemia-related costs were low, contributing a very small proportion to overall diabetes-related healthcare costs. © 2013 All rights reserved. Source

Baser O.,University of Michigan | Verpillat P.,Sanofi S.A. | Gabriel S.,Sanofi S.A. | Wang L.,STATinMED Research
Vascular Disease Management | Year: 2013

Objective. This study aimed to assess annual prevalence and incidence of critical limb ischemia (CLI) and associated outcomes (amputation, leg revascularization, death) in elderly persons in the United States. Method. Medicare beneficiaries ages 65 and older were retrospectively analyzed and compared for demographic and clinical characteristics from January 2007 to December 2008. Using the direct standardization method, year, age, gender, and race, as well as diabetes-specific prevalence and incidence rates were estimated for the CLI burden in the United States. Potential risk factors for CLI outcomes, events, and mortality were selected using Cox proportional hazard regression models. CLI prevalence and incidence was 0.23% and 0.20% respectively. Similar to prevalence, incidence increased sharply among beneficiaries ages 65 to 69 (0.13%) to 85 and older (0.31%). Results. Among black patients, 0.41% had CLI, compared to 0.18% among white patients. Diabetes caused 7.6 times increased CLI risk compared to nondiabetic patients. In the multivariate analysis, younger, male, diabetic (HR 1.21), or proliferative retinopathy (HR 1.112) patients were significantly associated with nontraumatic amputation, while hypertension (HR 1.043), angina pectoris (HR 1.074), myocardial infarction (HR 1.08), or hyperlipidemia (HR 1.1) were significantly related to leg revascularization. Black patients had a lower revascularization probability and a higher amputation probability than white patients (after adjustment for age, gender, CLI severity, comorbidities), and displayed a longer time to first revascularization and shorter time to amputation. Older, male and black patients had higher CLI prevalence. Conclusion. CLI management differs among the US population according to ethnicity, leading to varying outcomes (revascularization, amputation). Since outcome event risk varies, patients should be examined individually. Source

Baser O.,University of Michigan | Xie L.,STATinMED Research | Mardekian J.,Pfizer | Schaaf D.,Pfizer | And 2 more authors.
Pain Practice | Year: 2014

Objective: Evaluate prevalence and risk-adjusted healthcare costs of diagnosed opioid abuse in the national Veterans Health Administration (VHA). Costs were compared between patients with and without diagnosed opioid abuse. Design: Medical and pharmacy claims analysis of VHA data (10/01/2006 to 09/30/2010) were retrospectively analyzed. Prevalence was calculated as the percent of patients with diagnosed opioid abuse for the entire VHA membership and those with noncancer pain diagnoses, compared between patients prescribed opioids prior to abuse diagnosis and those not prescribed opioids through the VHA system. Healthcare utilization and costs were estimated using matching techniques and generalized linear models to control for clinical and demographic differences between patients with and without diagnosed opioid abuse. Separate comparisons were made (with diagnosed abuse vs. without) for each cohort: patients with/without opioid prescriptions. Results: Five-year diagnosed opioid abuse was 1.11%. Among patients prescribed opioids, 5-year abuse prevalence was 3.04%. Pain patients prescribed opioids had the highest abuse rate at 3.26%. Adjusted annual healthcare costs for diagnosed opioid abuse patients were higher than for those without diagnosed abuse, (prescribed opioids overall healthcare costs: $28,882, with diagnosed abuse vs. $13,605 for those without; not prescribed opioids: $25,197 vs. $6350, P-value< 0.0001; opioid-specific healthcare costs for patients prescribed opioids: $8956 vs. $218; patients not prescribed opioids: $8733 vs. $20). Conclusions: Diagnosed opioid abuse prevalence is almost 7-fold higher in the veteran's administration population than in commercial health plans and translates to a significant economic burden. Appropriate interventions should be considered to prevent and reduce opioid abuse. © 2013 World Institute of Pain. Source

Baser O.,University of Michigan | Baser O.,STATinMED Research | Wei W.,Sanofi S.A. | Baser E.,STATinMED Research | Xie L.,STATinMED Research
Journal of Medical Economics | Year: 2011

Objective: To evaluate clinical and economic outcomes in patients with type 2 diabetes mellitus (T2DM) who failed oral anti-diabetic drug (OAD) therapy and initiated either insulin glargine with disposable pen (GLA-P) or exenatide BID (EXE). Research design and methods: This retrospective study used data from a large US-managed care claims database and included adult T2DM patients initiating treatment with GLA-P or EXE in 2007 or 2008. Propensity score matching was used to control observed baseline differences between treatment groups. Primary study end-points included treatment persistence, A1C, healthcare utilization, and healthcare costs during the 1-year follow-up period. Results: Two thousand three hundred and thirty nine patients were included in the study (GLA-P: 381; EXE: 1958); 626 patients were in the 1:1 matched cohort (54% male; mean age: 54 years; mean A1C: 9.2%). At follow-up, patients in the GLA-P group were significantly more persistent in treatment than EXE patients (48% vs 15% in persistence rate and 252 vs 144 days in persistence days; both p<0.001). GLA-P patients also had significantly lower A1C at follow-up (8.02% vs 8.32%; p=0.042) and greater A1C reduction from baseline (-1.23% vs -0.92%; p=0.038). There were no significant differences in claims-based hypoglycemia rates and overall diabetes-related healthcare utilization and cost. Limitations: Since this was a retrospective analysis, causality of treatment benefits cannot be established. The study was specific to two treatments and may not generalize to other models of insulin administration. Some of the results, although statistically significant, may not be found clinically important. Conclusions: In a real-world setting among T2DM patients who failed to achieve or sustain glycemic goal with OADs, initiation of GLA-P instead of EXE may be a more effective option because it was associated with greater treatment persistence, greater A1C reduction without a significantly higher rate of hypoglycemia, and similar healthcare costs. © 2011 Informa UK Ltd All rights reserved. Source

Wang L.,STATinMED Research | Sengupta N.,Janssen Global Services | Baser O.,University of Michigan
Thrombosis Journal | Year: 2011

Background: To assess the incidence of venous thromboembolism (VTE) and bleeding events with or without thromboprophylaxis and the associated costs in a cohort of medically ill patients in both in-hospital and outpatient settings.Methods: A large hospital drug database and linked outpatient files were used to identify patients eligible for this analysis, based on demographic and clinical characteristics.Results: Among 11,135 patients identified, 1592 (14.30%) were admitted with chronic heart failure, 1684 (15.12%) with thromboembolic stroke, 3834 (34.43%) with severe lung disease, 1658 (14.89%) with acute infection, and 2367 (21.26%) with cancer. Of the 11,135 patients, 5932 received anticoagulant therapy at some point during their hospitalization and until 30 days after discharge. VTE events occurred in 1.30% of patients who received anticoagulant prophylaxis versus 2.99% of patients who did not. Risk-adjusted total healthcare costs for patients with a VTE or major or minor bleeding event were significantly higher than for those without events (VTE: $52,157 ± 24,389 vs $24,164 ± 11,418; major bleeding: $33,656 ± 18,196 vs $24,765 ± 11,974; minor bleeding: $33,690 ± 14,398 vs $23,610 ± 11,873). In a multivariate analysis, appropriate anticoagulant prophylaxis use was significantly associated with a reduced risk of clinical VTE, compared with no anticoagulant use (hazard ratio: 0.37). Patients admitted with thromboembolic stroke were less likely to have a VTE than patients admitted with cancer (hazard ratio: 0.42).Conclusions: In this analysis, VTE and major bleeding event rates were lower for patients who received prophylaxis compared with those who did not. Prophylaxis use was associated with lower healthcare costs. © 2011 Wang et al; licensee BioMed Central Ltd. Source

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