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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.

Levin P.,Model N | Wei W.,Sanofi S.A. | Wang L.,STATinMED Research | Pan C.,PRO Unlimited | And 2 more authors.
Current Medical Research and Opinion | Year: 2012

Objective: To investigate the real-world use of combination insulin glargine/exenatide therapy for type 2 diabetes mellitus (T2DM) and associated treatment persistence and glycemic control. Methods: In this retrospective study, data were extracted from a national US insurance claims database for patients with T2DM for whom insulin glargine and exenatide were co-prescribed in differing order: insulin glargine added after exenatide (EXE+); exenatide added after insulin glargine (GLA+); glargine and exenatide initiated together (GLA+EXE). Patients had continuous health plan coverage for 6 months pre- (baseline) and 1-year post-index (follow-up). Results: A total of 453 patients were eligible for analysis: 141 patients were included in the EXE+cohort, 281 in the GLA+cohort, and 31 in the GLA+EXE cohort. There were significant differences between the groups at baseline, including a significantly lower A1C in the GLA+versus the EXE+cohort (p=0.0023). Around one third of patients stayed on both drugs up until the end of the follow-up period (GLA+: 30.2%; EXE+: 29.0%; GLA+EXE: 29.0%). However, more patients stayed on insulin glargine than on exenatide in each cohort. Significant A1C reductions were observed in each of the cohorts at follow-up: GLA+: -0.4%; EXE+: -0.9%; GLA+EXE: -1.2%; p<0.01, and were significantly higher in the GLA+EXE and EXE+cohorts than in the GLA+cohort (p=0.03 and p=0.002, respectively). The mean number of hypoglycemic events increased slightly from baseline but remained low in each of the cohorts (GLA+: 0.12 to 1.42; EXE+: 0.09 to 1.04; GLA+EXE: 0.23 to 1.87 per patient, all p>0.1). Conclusions: Combined therapy with insulin glargine and exenatide resulted in A1C reductions in T2DM patients with poor glycemic control without a significantly increased risk of hypoglycemia irrespective of treatment order. Limitations of this study are the between-cohort differences at baseline, lack of a comparator group, and small n number, particularly in the GLA+EXE cohort. © 2012 Informa UK Ltd All rights reserved.

Xie L.,STATinMED Research | Wei W.,Sanofi S.A. | Pan C.,PRO Unlimited | Du J.,STATinMED Research | Baser O.,STATinMED Research
Advances in Therapy | Year: 2011

Introduction: Real-world data comparing outcomes of type 2 diabetes mellitus (T2DM) patients initiating different insulin regimens can help with treatment decisions and patient management. Clinical and economic outcomes following initiation with insulin glargine disposable pen (GLA-P) or insulin detemir disposable pen (DET-P) in T2DM patients were compared over 1-year follow-up. Methods: This retrospective cohort analysis was conducted on data in a US national managed care claims database (July 2006 to September 2010) from patients initiating insulin treatment with GLA-P or DET-P. Treatment persistence, adherence, glycated hemoglobin (A1C), hypoglycemic events, and healthcare costs during follow-up were compared. Results: In all, 1682 patients were identified; 1016 (60.4%) started using GLA-P, 666 (39.6%) started using DET-P. After 1:1 propensity score matching, each cohort comprised 640 patients. Patients initiating GLA-P were significantly more likely to persist and adhere to treatment, and used a lower daily consumption dose. Over the last quarter of follow-up, fewer GLA-P users switched to DET-P compared with those switching from DET-P to GLA-P. GLA-P was associated with lower A1C levels and higher reduction of A1C levels from baseline, with no significant difference in the number of patients having hypoglycemic events. Patients in both cohorts had similar total and diabetes-related healthcare costs, but healthcare costs were lower in the GLA-P cohort for each 1% reduction in A1C from baseline. Conclusion: This real-world study demonstrates that patients initiating GLA-P were more likely to persist with and adhere to treatment, with better glycemic control and similar overall hypoglycemia rate at no increase in healthcare cost. © 2011 Springer Healthcare.

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.

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.

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.

Xie L.,STATinMED Research | Frech-Tamas F.,Daiichi Sankyo | Marrett E.,Daiichi Sankyo | Baser O.,STATinMED Research | Baser O.,University of Michigan
Current Medical Research and Opinion | Year: 2014

Objective: Fixed-dose combination therapy reduces pill burden and may, therefore, improve medication adherence and health outcomes. This study compared adherence to and persistence with single-, double-, and triple-pill treatment regimens among hypertensive patients in a US clinical practice setting.Methods: Adults with hypertension treated with three anti-hypertensive medications were identified. Index date was the first occurrence of a single-, double-, or triple-pill regimen with olmesartan or valsartan plus amlodipine and hydrochlorothiazide from July 2010 to September 2011. Patients were followed for 12 months to assess adherence (proportion of days covered [PDC]≥80%) and time to discontinuation (medication gap ≥60 days) of the index regimen. Multivariate regression models were used to compare adjusted outcomes.Results: The number of prescribed pills in the index regimen was monotonically related to adherence with 55.3%, 40.4% and 32.6% of patients having PDC ≥80% in the single-, double- and triple-pill cohorts, respectively. In adjusted analysis, patients in the double- (odds ratio [OR]: 0.45; 95% confidence interval [CI]: 0.42-0.48) and triple-pill (OR: 0.26; 95% CI: 0.22-0.30) cohorts were less likely to be adherent to their index regimens than those in the single-pill cohort. Double-pill (hazard ratio [HR]: 1.89; 95% CI: 1.74-2.06) and triple-pill patients (HR: 2.49; 95% CI: 2.14-2.88) were more likely to discontinue treatment than single-pill patients.Conclusions: Greater pill burden was directly and significantly associated with decreased adherence and persistence with antihypertensive therapies in real-practice settings. Use of fixed-dose combinations that reduce pill burden could help patients to continue treatment and may result in improved clinical outcomes. Typical of observational studies, the potential for residual confounding of adherence estimates remains due to lack of randomization of treatment groups. © 2014 All rights reserved: reproduction in whole or part not permitted.

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.

Wang L.,STATinMED Research | Wei W.,Sanofi S.A. | Miao R.,Sanofi S.A. | Xie L.,STATinMED Research | And 2 more authors.
BMJ Open | Year: 2013

Objectives: To compare real-world outcomes of initiating insulin glargine (GLA) versus neutral protamine Hagedorn (NPH) insulin among employees with type 2 diabetes mellitus (T2DM) who had both employer-sponsored health insurance and short-temdisability coverages. Design: Retrospective cohort study. Setting: MarketScan Commercial Claims and Encounters/Health and Productivity Management Databases 2003-2009. Participants: Adult employees with T2DM who were previously treated with oral antidiabetic drugs and/or glucagon-like-peptide 1 receptor agonists and initiated GLA or NPH were included if they were continuously enrolled in healthcare and short-term-disability coverages for 3 months before (baseline) and 1 year after (follow-up) initiation. Treatment selection bias was addressed by 2:1 propensity score matching. Sensitivity analyses were conducted using different matching ratios. Primary and secondary outcome measures: Outcomes during 1-year follow-up were measured and compared: insulin treatment persistence and adherence; hypoglycaemia rates and daily average consumption of insulin; total and diabetes-specific healthcare resource utilisation and costs and loss in productivity, as measured by short-term disability, and the associated costs. Results: A total of 534 patients were matched and analysed (GLA: 356; NPH 178) with no significant differences in baseline characteristics. GLA patients were more persistent and adherent (both p<0.05), had lower rates of hospitalisation (23% vs 31.4%; p=0.036) and endocrinologist visits (19.1% vs 26.9%; p=0.038), similar hypoglycaemia rates (both 4.4%; p=1.0), higher diabetes drug costs ($2031 vs $1522; p<0.001), but similar total healthcare costs ($14 550 vs $16 093; p=0.448) and total diabetes-related healthcare costs ($4686 vs $5604; p=0.416). Short-term disability days and costs were numerically lower in the GLA cohort (16.0 vs 24.5 days; p=0.086 and $2824 vs $4363; p=0.081, respectively). Sensitivity analyses yielded similar findings.

Lewis-Beck C.,Freddie Mac | Abouzaid S.,Eisai Inc | Xie L.,STATinMED Research | Baser O.,STATinMED Research | And 2 more authors.
Patient Preference and Adherence | Year: 2013

Background: Plaque psoriasis is a chronic disease characterized by scaly plaques on the skin that can itch and bleed. Psoriasis covering over 10% of the body is classified as moderate to severe, and can impact patient quality of life. Objectives: To assess the relationship between plaque psoriasis self-reported severity symptoms and health-related quality of life, work productivity, and activity impairment among patients with moderate-to-severe psoriasis. Methods: The study sample included 199 patients recruited from internet panels, of which 179 respondents had plaque psoriasis and 20 had plaque and inverse psoriasis. Itching, pain, and scaling symptoms were studied. A structural equation modeling framework was used to estimate the effect of these symptoms on patient outcomes. First, each severity variable was regressed on a set of covariates to generate a predicted severity score. These predicted values were placed in a second-stage model with patient mental and physical scores (Short-Form 12 questionnaire), work productivity, and activity impairment indicators as dependent variables. Results: Itching severity had a marginal negative effect (P < 0.06) on patients' Short-Form 12 physical and mental component scores. Pain severity also negatively affected physical and mental health scores (P < 0.02). Patients were more likely to miss work because of itching (odds ratio [OR]: 2.31, 95% confidence interval [CI]: 1.30, 4.10), pain (OR: 1.78, 95% CI: 1.25, 2.52), and scaling (OR: 2.15, 95% CI: 1.31, 3.52) symptoms. These symptoms also lowered self-reported productivity. As itching (OR: 1.74, 95% CI: 1.03, 2.95), scaling (OR: 1.84, 95% CI: 1.16, 2.90), and pain symptoms (OR: 1.53, 95% CI: 1.12, 2.09) increased, so did the odds that a patient would be less productive at work. Conclusion: Plaque psoriasis significantly affects patient quality of life. In addition to greater mental and physical pain, patients are more likely to miss work and have diminished productivity as symptom severity increases. © 2013 Lewis-Beck et al, publisher and licensee Dove Medical Press Ltd.

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