The impact of persistence with therapy on inpatient admissions and emergency room visits in the US among patients with multiple sclerosis.

OBJECTIVE: Disease-modifying therapy (DMT) for multiple sclerosis (MS) can reduce relapses and delay progression; however, poor adherence and persistence with DMT can result in sub-optimal outcomes. The associations between DMT adherence and persistence and inpatient admissions and emergency room (ER) visits were investigated. METHODS: Patients with MS who initiated a DMT in a US administrative claims database were followed for 1 year. Persistence to initiated DMT was measured as the time from DMT initiation to discontinuation (a gap of >60 days without drug 'on hand') or end of 1-year follow-up. Adherence to initiated DMT was measured during the persistent period and was operationalized as the medication possession ratio (MPR). Patients with an MPR <0.80 were considered non-adherent. Claims during the 1-year follow-up period were evaluated for the presence of an all-cause inpatient admission or an ER visit. Adjusted odds ratios (AORs) for inpatient admission or ER visit comparing persistent vs non-persistent and adherent vs non-adherent patients were estimated using logistic regression models adjusted for patient characteristics. RESULTS: The final sample included 16,218 patients. During the 1-year follow-up period, 35.3% of patients discontinued their initiated DMT and 13.9% were not adherent while on therapy. During that same period, 10.0% of patients had an inpatient admission and 24.9% had an ER visit. The likelihoods of inpatient admission and ER visit were significantly decreased in persistent patients (AOR [95% CI] = 0.50 [0.45, 0.56] and 0.65 [0.60, 0.69], respectively) and in adherent patients (AOR [95% CI] = 0.83 [0.71, 0.97] and 0.86 [0.77, 0.95], respectively). CONCLUSIONS: Persistence and adherence with initiated DMT are associated with decreased likelihoods of inpatient admission or ER visit, which may translate to improved clinical outcomes.

The Additional Cost Burden of Preexisting Medical Conditions During Pregnancy and Childbirth.

OBJECTIVES: To identify the prevalence of comorbidities in pregnant women and examine the incremental costs of these conditions on the care for mothers and their newborns. METHODS: This was a retrospective comparative cohort study of women ages 15-49 years with a documented live-birth delivery using de-identified claims from the MarketScan Research Commercial Claims and Encounters database incurred between January 1, 2007, and December 31, 2011. Total health care costs from date of first pregnancy-related claim through 3 months postdelivery were reported; pregnancy-related comorbidities prior to the pregnancy diagnosis were identified and categorized in the 12 months prior to the pregnancy diagnosis, and costs associated with each condition were compiled. A subset of newborns was matched to their mothers using a unique family identifier and their costs were captured for the three months following birth. Comparisons of costs for both mothers and newborns were made using both unadjusted and multivariate analyses between mothers with and without each condition. RESULTS: A total of 322,141 women with live births were identified; 135,572 of these mothers were linked to their newborn(s). Prevalent conditions included back disorders (8.9%), mental disorders (6.5%), headache (5.5%), allergic rhinitis (5.5%), and osteoarthritis (4.8%). Diabetes (0.97%) and hypertension (1.9%) were associated with the highest adjusted incremental costs of care in both mothers ($6,211 [95% confidence interval 5,720-6,702] and $3,367 [95% CI 2,935-3,799] respectively) and newborns ($2,067 [95% CI 1,515-2618]; and $1,210 [95% CI 725-1,695] respectively). The two most common conditions, back disorders and mental disorders, were associated with unadjusted costs of $1,895/$978 (mothers/infants) and $2,097/$1,902 (mothers/infants) respectively. CONCLUSION: Preexisting conditions common in pregnant women may result in additional resource utilization and costs for both mothers and newborns.

Topiramate use during pregnancy and major congenital malformations in multiple populations.

BACKGROUND: We measured birth prevalence of major congenital malformations (MCMs) after topiramate use during pregnancy to screen for a possible signal of increased risk. METHODS: Using four healthcare databases, we identified three cohorts of pregnant women: cohort 1, used topiramate during the first trimester; cohort 2, used topiramate or another antiepileptic drug previously but not during pregnancy; and cohort 3, were pregnant and did not use topiramate but had indications for use individually matched to those of users. Cohort 1 was compared with cohorts 2 and 3. MCMs were a code for any major congenital malformation dated within 30 days of the delivery date on the mother's claims or within 365 days after infant birth date, excluding a genetic or syndromic basis, and with procedure or healthcare usage consistent with the MCM diagnosis code in the 365 days after infant birth. RESULTS: Of the 10 specific common MCMs evaluated, 1 (conotruncal heart defects) had a prevalence ratio greater than 1.5 for both primary comparisons, and 4 (ventricular septal defect, atrial septal defect, hypospadias, coarctation of the aorta) had a prevalence ratio greater than 1.5 for one of the two comparisons. Following screening of organ systems with elevated MCMs, the prevalence ratio was greater than 1.5 for patent ductus arteriosus in both comparisons and for obstructive genitourinary defects in one comparison. CONCLUSION: To evaluate a large number of MCMs across many pregnancies, we used crude methods for detecting potential signals. Therefore, these results should be seen as potential signals, not causal.

The prevalence of complications and healthcare costs during pregnancy.

OBJECTIVE: To study the economic burden of pregnancy in the US, common complications during pregnancy, and the incremental costs attributable to these complications. METHODS: A retrospective comparative cohort study was conducted of pregnant women aged 15-49 years using de-identified medical and pharmacy claims from the Truven Health MarketScan Commercial Claims and Encounters database incurred between January 1, 2007 and December 31, 2011. The total healthcare costs are reported (adjusted to 2011 dollars) from the date of the first pregnancy-related claim through to 3 months post-delivery and these costs were compared to matched controls of non-pregnant women. Pregnancy-related complications were categorized, and the incremental costs associated with each complication were estimated using multivariate analyses. RESULTS: A total of 322,141 eligible women with live births were studied. Compared to matched controls, the average costs of care for pregnant women were nearly $13,000 higher through 3 months post-delivery. A total of 46.9% of women had at least one pre-specified pregnancy complication; the most commonly observed were fetal abnormality (24.7%) and early or threatened labor (16.3%). Multiple gestation (1.9%) resulted in the highest adjusted incremental cost ($12,212; 95% CI = 11,298, 13,216); hypertension ($6152; 95% CI = 5312, 6992) and diabetes ($5081; 95% CI = 4244, 5918) were also among those complications that led to high incremental costs of care. CONCLUSION: Pregnancy and delivery are frequently compounded by complications that lead to increased costs and resource utilization.

Costs of Newborn Care Following Complications During Pregnancy and Delivery.

The aim of this study is examine the impact of pregnancy and delivery complications on the healthcare costs of newborns during the first 3 months of life. We conducted a retrospective cohort study of newborns born to women ages 15-49 using de-identified medical and pharmacy claims from the Truven Health MarketScan Commercial Claims and Encounters database incurred between January 1, 2007 and December 31, 2011. Total healthcare costs and resource utilization were examined and compared for the first 3 months of life between cohorts of newborns either with or without evidence of categorized maternal complications. Incremental costs were also determined using multivariable analysis for the conditions found to be the most prevalent in the study population. A total of 137,040 infants were studied, 75.4% of which were born to mothers who had experienced at least one complication during pregnancy or delivery. Fetal abnormalities (26.2%), early or threatened labor (16.6%), and hemorrhage (10.8%) were the most frequently observed complications. Diabetes (8.0%) and hypertension (7.7%) were also common, with the majority of other conditions present in 1% or less of the study population. Adjusted analyses found significant differences for seven conditions where incremental costs ranged from $987 to $10,287. Complications are common during pregnancy and delivery and some complications may lead to increased healthcare costs for newborns immediately following birth.

Economic burden associated with adverse events in patients with metastatic melanoma.

BACKGROUND: There are currently many approved agents for the treatment of metastatic melanoma (MM), the most aggressive form of skin cancer. Treatments may include systemic therapies such as ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, interferon α, dacarbazine- or temozolomide-based combination chemotherapy/biochemotherapy, paclitaxel, paclitaxel/cisplatin, and paclitaxel/carboplatin, as well as the targeted therapies vemurafenib, dabrafenib, and trametinib for patients with BRAF V600 mutation. However, all treatment options are associated with different adverse events (AEs) and, in some instances, considerable toxicity. The occurrence of such treatment-related AEs can lead to higher health care resource utilization and increasing treatment and patient management costs. An understanding of the economic burden of these AEs will therefore enable better management of health care expenditures, not just for existing therapies, but also for new and novel treatments in development. OBJECTIVE: To estimate the incremental health care costs of specific AEs among patients with MM treated with paclitaxel, vemurafenib, ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, or interferon α, along with AEs known to be associated with dabrafenib and trametinib. METHODS: This cohort study employed a retrospective administrative claims-based analysis of MarketScan commercial and Medicare supplemental databases from July 1, 2004, to April 30, 2012. Patients included those aged ≥ 18 years who had diagnosed melanoma (ICD-9-CM code 172.xx)with ≥ 1 diagnosis of metastasis and ≥ 1 claim for any of the 7 study treatments. Health care encounters for AEs of interest were based on ICD-9-CM diagnosis/procedure codes. Incremental cost per AE was determined by comparing the 30-day expenditures in patients with the event to patients without the event based on a shadow event date. Multivariate generalized linear models (GLMs) with a log-link function and gamma distribution were utilized to control for baseline differences between groups. RESULTS: A total of 2,621 patients with MM were included. Mean age was 56.0 years (SD ± 13.0); 64% were male; and 24% had a diagnosis of primary or secondary brain cancer at the time of MM diagnosis. GLM-based estimate of 30-day incremental costs by AE category were metabolic, $9,135 (95% CI = $6,404-$12,392); hematologic/lymphatic, $8,450 (95% CI = $6,528-$10,633); cardiovascular, $6,476 (95% CI = $4,667-$8,541); gastrointestinal, $6,338 (95% CI = $4,740-$8,122); skin/subcutaneous, -$900 (95% CI = -$1,899-$237); central nervous system/psychiatric, $5,903 (95% CI = $3,842-$8,313); and pain, $5,078 (95% CI = $3,392-$7,012). CONCLUSIONS: Incremental costs associated with many MM treatment-related AEs are substantial. New approaches to prevent and/or better manage these events may reduce overall health care costs.

Retrospective analysis of long-term adherence to and persistence with DPP-4 inhibitors in US adults with type 2 diabetes mellitus.

INTRODUCTION: Patients with type 2 diabetes mellitus (T2DM) must remain adherent and persistent on antidiabetic medications to optimize clinical benefits. This analysis compared adherence and persistence among adults initiating dipeptidyl peptidase-4 inhibitors (DPP-4is), sulfonylureas (SUs), and thiazolidinediones (TZDs) and between patients initiating saxagliptin or sitagliptin, two DPP-4is. METHODS: This retrospective cohort study utilized the US MarketScan(®) (Truven Health Analytics, Ann Arbor, MI, USA) Commercial and Medicare Supplemental health insurance claims databases. Adults aged ≥18 years with T2DM who initiated a DPP-4i, SU, or TZD from January 1, 2009 to January 31, 2012 were included. Patients must have been continuously enrolled for ≥1 year prior to and ≥1 year following initiation. Adherence was measured using proportion of days covered (PDC), with PDC ≥ 0.80 considered adherent. Persistence was measured as time to discontinuation, defined as last day with drug prior to a 60+ days gap in therapy. Multivariable logistic regression and Cox proportional hazards models compared the outcomes between cohorts, controlling for baseline differences. RESULTS: The sample included 238,372 patients (61,399 DPP-4i, 134,961 SU, 42,012 TZD). During 1-year follow-up, 47.3% of DPP-4i initiators, 41.2% of SU initiators, and 36.7% of TZD initiators were adherent. Adjusted odds of adherence were significantly greater among DPP-4i initiators than SU (adjusted odds ratio [AOR] = 1.678, P < 0.001) and TZD initiators (AOR = 1.605, P < 0.001). During 1-year follow-up, 55.0% of DPP-4i initiators, 47.8% of SU initiators, and 42.9% of TZD initiators did not discontinue therapy. Adjusted hazards of discontinuation were significantly greater for SU (adjusted hazard ratio [AHR] = 1.390, P < 0.001) and TZD initiators (AHR = 1.402, P < 0.001) compared with DPP-4i initiators. Saxagliptin initiators had significantly better adherence (AOR = 1.213, P < 0.001) compared with sitagliptin initiators, and sitagliptin initiators had significantly greater hazard of discontinuation (AHR = 1.159, P < 0.001). Results were similar over a 2-year follow-up. CONCLUSIONS: US adults with T2DM who initiated DPP-4i therapy, particularly saxagliptin, had significantly better adherence and persistence compared with patients who initiated SUs or TZDs.

Topiramate use in pregnancy and the birth prevalence of oral clefts.

PURPOSE: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. METHODS: This retrospective cohort study used 1997-2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records). We compared the prevalence of OCs in infants of women exposed to TPM in the first trimester (TPM cohort) with the prevalence in infants of women formerly exposed to TPM or other antiepileptic drugs (formerly exposed [FE] cohort) and infants of women with similar medical profiles (SMPs) to the TPM cohort that were not exposed to TPM (SMP cohort). To control for confounding, we used stratification and standardization for individual variables and propensity score deciles. RESULTS: The birth prevalence of OCs was 0.36% (7/1945) in the TPM cohort, 0.14% (20/13 512) in the FE cohort, and 0.07% (9/13 614) in the SMP cohort. Standardized by site, the prevalence ratio (PR) for TPM versus FE was 2.5 (95% CI: 1.0-6.0) and for TPM versus SMP was 5.4 (95% CI: 2.0-14.6). Adjustment for covariates one at a time or by propensity score yielded similar results. CONCLUSION: Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC.

Rate of hypoglycemia in patients with type 2 diabetes receiving metformin plus saxagliptin versus metformin plus sulfonylurea: a retrospective observational cohort study using administrative claims data.

OBJECTIVES: Hypoglycemia is a limiting factor in the management of diabetes. Studies comparing oral antidiabetic medications are needed to identify treatment options that can help clinicians and patients minimize their associated hypoglycemia risk. The purpose of this study was to compare hypoglycemia rates in patients with type 2 diabetes on metformin who initiated treatment with saxagliptin versus sulfonylurea (SU). METHODS: This retrospective analysis utilized US healthcare claims data from the Truven Health MarketScan Research Databases. Data were from adults on metformin monotherapy who added saxagliptin or SU between 1 August 2009 and 31 December 2010. Hypoglycemia event rates were compared during the 4 months after initiation of saxagliptin or SU. A hypoglycemia event was defined as a diagnosis of hypoglycemia on an outpatient or emergency room claim, a principal diagnosis on a hospital claim, or a glucagon injection in an outpatient setting. Patients taking SU were matched to patients taking saxagliptin (5 to 1) using propensity scores, and the rate ratio was further adjusted using multivariate regression. A total of 22,592 patients (1567 taking saxagliptin; 21,025 taking SU) qualified. RESULTS: During 120 days of follow-up, there were 396 hypoglycemia events. Most of the hypoglycemia events (91.9%) occurred in the outpatient setting. There were no inpatient or emergency room hypoglycemia events in the saxagliptin cohort. The overall unadjusted rate of hypoglycemia was significantly lower in the saxagliptin cohort than in the SU cohort (1.74 vs 5.58 per 100 person-years; p < 0.001). The rate of hypoglycemia also was significantly lower in the saxagliptin cohort versus the propensity-matched SU cohort (1.74 vs 4.45 per 100 person-years; p = 0.005). Matching reduced the treatment effect by approximately 20%. The rate ratio comparing saxagliptin with the unmatched and propensity-matched SU cohorts was 0.31 (95% CI: 0.14-0.6) and 0.39 (95% CI: 0.17-0.77), respectively. The multivariate adjustment decreased the hypoglycemia rate ratio 0.37 (95% CI: 0.19-0.74). CONCLUSION: In a database reflective of real-world clinical practice, saxagliptin had a lower risk of hypoglycemia than SU in patients with type 2 diabetes receiving metformin. These results add confidence to similar findings from clinical trials.

Predictors of medication adherence in patients with type 2 diabetes mellitus.

OBJECTIVE: Medical professionals are often challenged by lack of patient compliance with pharmaceutical treatments. Research has shown that patients with diabetes have one of the lowest medication adherence rates at 65% to 85%. Some causes have been identified in the literature, but the influence of type of medication is unknown. This study assessed the impact of a broad range of factors on medication adherence and persistence among adult patients with type 2 diabetes mellitus. METHODS: Patients were selected from the Truven Health MarketScan Research Databases of healthcare administrative claims (2009 through 2012), assigned to mutually exclusive cohorts based on initiation of saxagliptin (a dipeptidyl peptidase-4 [DPP-4] inhibitor), or a glucagon-like peptide 1 (GLP-1) receptor agonist (daily or twice daily formulation), sulfonylurea (SU), or thiazolidinedione (TZD), and screened for continuous enrollment 1 year before and after drug initiation. Adherence and persistence were measured using proportion of days covered and time to discontinuation, respectively. Multivariate models were used to examine the impact of study drug and demographic and clinical factors. RESULTS: Overall, 45.1% of patients were adherent with their study drug over the 1 year follow-up period. Adherence was higher among patients who were male, older, or residing in non-Southern states. Adherence was better with mail-order use and lower levels of cost sharing. Patients taking a GLP-1 (OR = 0.40, 95% CI = 0.37, 0.42), SU (OR = 0.49, 95% CI = 0.46, 0.52), or TZD (OR = 0.54, 95% CI = 0.51, 0.57) were less likely to be adherent compared with those taking saxagliptin. Results were mixed regarding the impact of comorbidities and polypharmacy on medication adherence. Influencing factors may be the type of comorbidity, overall health level, number of drugs, and complexity of the drug regimen. KEY LIMITATIONS: Adherence was measured using data for prescriptions dispensed and it is not known whether patients actually took the medications, hence adherence may be overestimated. Whether patients who discontinued the study drugs switched to other diabetes medications or discontinued treatment completely was not measured. CONCLUSION: Identified risk factors can guide medical professionals in their attempts to increase the likelihood of patient adherence to drug treatment regimens.

Fractures in women treated with raloxifene or alendronate: a retrospective database analysis.

BACKGROUND: Raloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published. The purpose of this retrospective cohort study was to evaluate fracture and breast cancer rates among patients treated with raloxifene or alendronate. METHODS: Females ≥45 years who initiated raloxifene or alendronate in 1998-2006 Truven Health Analytics MarketScan® Databases, had continuous enrollment 12 months prior to and at least 12 months after the index date, and had a treatment medication possession ratio ≥80% were included in this study. Rates of vertebral and nonvertebral fractures and breast cancer during 1, 3, 5, 6, 7, and 8 years of treatment with raloxifene or alendronate were evaluated. Fracture rates were adjusted for potential treatment bias using inverse probability of treatment weights. Multivariate hazard ratios were estimated for vertebral and nonvertebral fractures. RESULTS: Raloxifene patients had statistically significantly lower rates of vertebral fractures in 1, 3, 5, and 7 years and for nonvertebral fractures in 1 and 5 years. There were no statistically significant differences in the adjusted fracture rates between raloxifene and alendronate cohorts, except in the 3-year nonvertebral fracture rates where raloxifene was higher. Multivariate hazard ratios of raloxifene versus alendronate cohorts were not significantly different for vertebral and nonvertebral fracture in 1, 3, 5, 6, 7, and 8 years. Unweighted and weighted breast cancer rates were lower among raloxifene recipients. CONCLUSIONS: Patients treated with alendronate and raloxifene had similar adjusted fracture rates in up to 8 years of adherent treatment, and raloxifene patients had lower breast cancer rates.

Intent-to-treat analysis of health care expenditures of patients treated with atypical antipsychotics as adjunctive therapy in depression.

OBJECTIVE: To compare health care utilization and expenditures in patients with depression whose initial antidepressant (AD) treatment was augmented with a second-generation antipsychotic. METHODS: Claims data from January 1, 2001, through June 30, 2009, were used to select patients aged 18 to 64 years with depression treated with ADs augmented with aripiprazole, olanzapine, or quetiapine. Patients were required to have 6 months of continuous eligibility before the first AD prescription and 6 months after the second-generation antipsychotic augmentation (index) date. Utilization and expenditures were assessed for 6 months after the index date. Multivariate regression was used to estimate adjusted expenditures and risks for hospitalizations and emergency department visits. RESULTS: A total of 483 patients treated with aripiprazole, 978 with olanzapine, and 2471 with quetiapine were selected. Mean adjusted expenditures for aripiprazole were significantly lower than those for olanzapine for each service category (all-cause, all-cause medical care, mental health-related, and mental health-related medical care) and were significantly lower than those for quetiapine for each category with the exception of mental health-related. The adjusted risks for hospitalization and emergency department visits were significantly higher for quetiapine than for aripiprazole. CONCLUSIONS: Compared with patients treated with ADs and aripiprazole, those treated with ADs and olanzapine or quetiapine had greater utilization and higher expenditures.

Potential health care cost savings associated with early treatment of multiple sclerosis using disease-modifying therapy.

BACKGROUND: Clinical trials have shown that treatment with disease-modifying therapies (DMTs), such as interferon, at the time of clinically isolated syndrome can delay the onset of multiple sclerosis (MS). OBJECTIVES: The objective of this study was to assess health care utilization and expenditures associated with treating patients early with DMTs rather than delaying until patients meet the full diagnostic criteria of MS. METHODS: A retrospective study used insurance claims data (2000-2008) of enrolled patients before documented MS (1 inpatient or 2 outpatient claims with International Classification of Diseases, 9th Revision, Clinical Modification 340 coding). Treatment cohorts were early DMT (DMT claim before the first documented MS; N = 227) and delayed DMT (DMT started after documented MS; N = 3724). Comparisons during 1 year of follow-up were adjusted for confounding using multivariate methods. RESULTS: Adjusted annual per-patient expenditures (including patient out of pocket) for early versus delayed were as follows: total ($28,280 vs $29,102; P = 0.44), excluding DMT cost ($15,214 vs $17,630; P < 0.01), and MS-related ($9365 vs $13,661; P < 0.01). Hospitalizations were 10.1% versus 16.5% (adjusted odds ratio [OR] = 0.51; 95% CI, 0.32-0.81). CONCLUSIONS: Analysis indicated that early DMT treatment was associated with fewer hospitalizations than delayed treatment, and there was no statistically significant difference in annual health care expenditures. This suggests that the drug costs of early therapy were offset by savings in other medical expenditures.

Effect of early clopidogrel discontinuation on rehospitalization in acute coronary syndrome: results from two distinct patient populations.

PURPOSE: Results of a study of the association between early discontinuation of clopidogrel therapy and rehospitalization rates among patients with acute coronary syndrome (ACS) are reported. SUMMARY: In a retrospective observational study, analyses of two nationally representative cohorts of adults hospitalized for acute myocardial infarction (AMI) or coronary stent insertion were conducted to assess risk factors for ACS-related adverse outcomes (rehospitalization for AMI or coronary revascularization) during the 12 months after completion of an initial 28-day course of clopidogrel therapy. Case data were sourced from a commercial insurance claims database, a pharmacy administrative claims database, and a combined dataset that linked hospital discharge and outpatient service data; a time-varying method was used to differentiate adverse events occurring "on" and "off" clopidogrel therapy. One cohort analysis (n = 42,757) indicated that patients who discontinued clopidogrel early (i.e., within 12 months of index discharge) were at significantly increased risk for ACS-related rehospitalization during the 12-month study period (hazard ratio [HR] = 1.11; 95% confidence interval [CI], 1.02-1.20; p < 0.05). In the other cohort analysis (n = 3,171), early clopidogrel discontinuation was associated with an increased risk of rehospitalization or inpatient death (HR = 1.75; 95% CI, 1.59-1.91; p < 0.0001). CONCLUSION: Observational evidence from analyses of data on two large cohorts of patients with primarily employer-sponsored health insurance suggests that early discontinuation of clopidogrel therapy after hospitalization for AMI or coronary stent insertion is associated with a significant increase in the risk of ACS-related rehospitalization within the 12-month postdischarge period.

Insulin use and persistence in patients with type 2 diabetes adding mealtime insulin to a basal regimen: a retrospective database analysis.

BACKGROUND: The objective of this study was to characterize insulin use and examine factors associated with persistence to mealtime insulin among patients with type 2 diabetes (T2D) on stable basal insulin therapy initiating mealtime insulin therapy. METHODS: Insulin use among patients with T2D initiating mealtime insulin was investigated using Thomson Reuters MarketScan® research databases from July 2001 through September 2006. The first mealtime insulin claim preceded by 6 months with 2 claims for basal insulin was used as the index event. A total of 21 months of continuous health plan enrollment was required. Patients were required to have a second mealtime insulin claim during the 12-month follow-up period. Persistence measure 1 defined non-persistence as the presence of a 90-day gap in mealtime insulin claims, effective the date of the last claim prior to the gap. Persistence measure 2 required 1 claim per quarter to be persistent. Risk factors for non-persistence were assessed using logistic regression. RESULTS: Patients initiating mealtime insulin (n = 4752; 51% male, mean age = 60.3 years) primarily used vial/syringe (87%) and insulin analogs (60%). Patients filled a median of 2, 3, and 4 mealtime insulin claims at 3, 6, and 12 months, respectively, with a median time of 76 days between refills. According to measure 1, persistence to mealtime insulin was 40.7%, 30.2%, and 19.1% at 3, 6, and 12 months, respectively. Results for measure 2 were considerably higher: 74.3%, 55.3%, and 42.2% of patients were persistent at 3, 6, and 12 months, respectively. Initiating mealtime insulin with human insulin was a risk factor for non-persistence by both measures (OR < 0.80, p < 0.01). Additional predictors of non-persistence at 12 months included elderly age, increased insulin copayment, mental health comorbidity, and polypharmacy (p < 0.05 for all). CONCLUSIONS: Mealtime insulin use and persistence were both considerably lower than expected, and were significantly lower for human insulin compared to analogs.

The direct and indirect cost burden of acute coronary syndrome.

OBJECTIVE: Quantify the incremental health care costs and workplace absence and short-term disability costs, to payers and employers, of patients hospitalized for acute coronary syndrome (ACS). METHODS: Retrospective study using medical insurance claims for the years 2002 to 2007. Patients were aged 18 to 64 years and hospitalized for ACS between January 1, 2003, and December 31, 2006; comparison patients without evidence of coronary artery disease were also selected. The incremental impact of ACS was estimated using weighted regression. RESULTS: 30,200 ACS patients were selected. Incremental annual direct costs of ACS were $40,671 (P < 0.001). For the indirect cost sub-analyses, incremental short-term disability costs of ACS were $999 (P < 0.001) and incremental absence costs were insignificant (P = 0.314) but from a small sample (N = 416). CONCLUSIONS: Patients with ACS impose a substantial direct cost burden on employers and payers and a substantial indirect cost burden on employers. Acute coronary syndrome is more costly to employers and payers than other health conditions that are common among employed persons. Rehospitalizations after the initial hospitalization are common and represent a large portion of the cost.

A retrospective database analysis of insulin use patterns in insulin-naïve patients with type 2 diabetes initiating basal insulin or mixtures.

OBJECTIVE: To describe insulin persistence among patients with type 2 diabetes initiating insulin therapy with basal insulin or insulin mixtures and determine factors associated with nonpersistence. RESEARCH DESIGN AND METHODS: The Thomson Reuters MarketScan((R)) databases were used to retrospectively analyze insulin-naïve patients with type 2 diabetes by initiating insulin therapy. Insulin use was described using a variety of measures. The persistence to insulin was described using both a gap-based measure and the number of claims measure. RESULTS: Patients in the basal insulin cohort (N = 15,255) primarily used insulin analogs (88.1%) and vial and syringe (97%). Patients in the mixture cohort (N = 2,732) were more likely to initiate on human insulin mixtures (62.5%) and vial and syringe (68.1%). Average time between insulin refills was 80 and 71 days for basal and mixture initiators, respectively. Nearly, 75% of basal insulin initiators and 65% of insulin mixture initiators had a 90-day gap in insulin prescriptions. More than half of all the patients had at least one insulin prescription per quarter. Patients initiating with insulin analogs were more likely to be persistent compared with those initiating with human insulin across both cohorts and measures of persistence (P < 0.001). CONCLUSION: Persistence to insulin therapy is poorer than one would anticipate, but appears to be higher in users of insulin analogs and insulin mixtures.

Predictors of initiating rapid-acting insulin analog using vial/syringe, prefilled pen, and reusable pen devices in patients with type 2 diabetes.

BACKGROUND: Limited data are available on the predictors of insulin delivery device choice. This study assessed the patient- and health-care-system-related factors that predict the initiation of one rapid-acting insulin analog (RAIA) delivery system over another. METHODS: A retrospective analysis using a claims database (January 1, 2007, through March 31, 2009) was conducted. Patients were required to be diagnosed with type 2 diabetes mellitus, and have >or=12 months of continuous eligibility prior to their first prescription of a RAIA on or after January 1, 2008. The three cohorts in the study were vial/syringe (n = 6820), prefilled pen (n = 5840), and reusable pen (n = 2052). Multiple factors were examined using stepwise logistic regression. RESULTS: Factors that increased the likelihood of initiating RAIA using prefilled pen versus vial/syringe included endocrinologist visit [odds ratio (OR) = 3.13, 95% confidence interval (CI) = 2.56, 3.82], prior basal insulin use with pen (OR = 4.85, 95% CI = 4.21, 5.59), and use of >or=1 oral antihyperglycemic agents (OR = 1.32, 95% CI = 1.20, 1.45). Factors that decreased the likelihood included inpatient admission (OR = 0.76, 95% CI = 0.70, 0.83), nursing home visit (OR = 0.22, 95% CI = 0.18, 0.27), and obesity (OR = 0.67, 95% CI = 0.53, 0.83). There were fewer differences between prefilled and reusable pen initiators. Factors that increased the likelihood of initiating with prefilled versus reusable pen included endocrinologist visit (OR = 1.87, CI = 1.50, 2.34) and inpatient admission (OR = 1.46, 95% CI = 1.30, 1.64). CONCLUSION: Significant differences in predictors were observed between prefilled pen and vial/syringe initiators. The differences were fewer between prefilled and reusable pen initiators. These differences should be taken into consideration when evaluating outcomes associated with specific insulin delivery systems.

Productivity losses among treated depressed patients relative to healthy controls.

OBJECTIVES: Estimate the productivity-related cost of depression in an employed population. METHODS: By using administrative data, annual short-term disability (STD) and absenteeism costs ($2005) were compared for patients with depression and treated with antidepressants and for a matched control group without depression. RESULTS: Mean annual STD costs were $1038 among treated depressed patients versus $325 among controls and $1685 among a subgroup of severely depressed treated patients versus $340 among their controls. After controlling for demographic and employment characteristics, treated patients with depression had STD costs that were $356 higher per patient and those with severe depression had costs that were $861 higher. The marginal impact of treated depression on absenteeism was $377. CONCLUSIONS: Even when depressed patients are treated with antidepressants, there are substantial productivity losses. Therapies that can better manage depression may provide opportunities for savings to employers.

Economic and clinical impact of inpatient diabetic hypoglycemia.

OBJECTIVE: To assess the clinical and economic impact of hypoglycemia that develops during hospitalization of patients with diabetes. METHODS: In this retrospective cohort study, data from 70 hospitals were used to identify the first inpatient encounter for adult patients with diabetes. Patients were included if all blood glucose measurements were 70 mg/dL or higher during the first 24 hours and their primary discharge diagnosis was for a condition other than hypoglycemia. Those who developed laboratory evidence of hypoglycemia (blood glucose <70 mg/dL after 24 hours) were compared with patients whose blood glucose values were all 70 mg/dL or higher. An alternative definition of hypoglycemia (blood glucose <50 mg/dL after 24 hours) was also evaluated. We adjusted for potential confounders with multivariate models. RESULTS: Hypoglycemia had an adverse effect on all outcomes among more than 100,000 diabetic patients. After adjustment, patients with diabetes who developed hypoglycemia had higher charges (38.9%), longer lengths of stay (3.0 days), higher mortality (odds ratio, 1.07; 95% confidence interval, 1.02-1.11), and higher odds of being discharged to a skilled nursing facility (odds ratio, 1.58; 95% confidence interval, 1.48-1.69) than diabetic patients without hypoglycemia (P<.01 for all). In all cases, using the lower threshold (<50 mg/dL) to define hypoglycemia resulted in similar findings with a larger magnitude of differences. CONCLUSIONS: Although a direct causal relationship cannot be inferred, these study findings suggest the importance of carefully maintaining euglycemia during hospitalizations. Whether the observed worse outcomes were due to hypoglycemia itself or whether they were a marker of worse outcomes due to other causes requires further research.