Comparison of text processing methods in social media-based signal detection.

PURPOSE: Adverse event (AE) identification in social media (SM) can be performed using various types of natural language processing (NLP) and machine learning (ML). These methods can be categorized by complexity and precision level. Co-occurrence-based ML methods are rather basic, as they identify simultaneous appearance of drugs and clinical events in a single post. In contrast, statistical learning methods involve more complex NLP and identify drugs, events, and associations between them. We aimed to compare the ability of co-occurrence and NLP to identify AEs and signals of disproportionate reporting (SDR) in patient-generated SM. We also examined the performance of lift in SM-based signal detection (SD). METHODS: Our examination was performed in a corpus of SM posts crawled from open online patient forums and communities, using the spontaneously reported VigiBase data as reference data set. RESULTS: We found that co-occurrence and NLP produce AEs, which are 57% and 93% consistent with VigiBase AEs, respectively. Among the SDRs identified both in SM and in VigiBase, up to 55.3% were identified earlier in co-occurrence, and up to 32.1% were identified earlier in NLP-processed SM. Using lift in SM SD provided performance similar to frequentist methods, both in co-occurrence and in NLP-processed AEs. CONCLUSION: Our results indicate that using SM as a data source complementary to traditional pharmacovigilance sources should be considered further. Various levels of SM processing may be considered, depending on the preferred policies and tolerance for false-positive to false-negative balance in routine pharmacovigilance processes.

Impact of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes uncontrolled on basal insulin: A longitudinal study of a US administrative claims database.

AIM: To evaluate the effect of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) on clinical and economic outcomes in patients with type 2 diabetes (T2D). METHODS: We conducted a retrospective observational claims study using IMPACT (Impact National Managed Care Benchmark Database) in adult patients with T2D who initiated basal insulin between January 1, 2005 and December 31, 2012, with or without OADs, who remained uncontrolled (glycated haemoglobin [HbA1c] ≥7.0%). Patients were categorized into 3 groups: early, delayed, and no intensification with a GLP-1 RA. We evaluated changes from baseline to follow-up at 12 months for HbA1c level, rate of hypoglycaemic events, and healthcare costs, and we assessed the association between baseline patient characteristics and subsequent treatment intensification. RESULTS: A total of 139 patients (9.0% of 1552 eligible patients) met criteria for inclusion in the early intensification group, 588 patients (37.9%) met criteria for inclusion in the delayed intensification group, and 825 patients (53.2%) met criteria for inclusion in the no intensification group. Mean baseline HbA1c values were 9.16%, 9.07%, and 9.34%, respectively. At follow-up, delayed intensification was associated with significantly smaller decreases in HbA1c from baseline (-0.68%) compared with early intensification (-1.01%). Rates of overall hypoglycaemia were numerically greater in the delayed intensification group than in the early intensification group (0.26 vs 0.06 events/patient-years of exposure, respectively). Change in semi-annual total healthcare costs was greater in the no intensification group (+5266 USD) compared with the early intensification group (-560 USD) and the delayed intensification group (+1943 USD). CONCLUSIONS: Timely addition of a GLP-1 RA to therapy for patients with T2D who were not adequately controlled with basal insulin is associated with better clinical and economic outcomes.

Relationship between treatment persistence and A1C trends among patients with type 2 diabetes newly initiating basal insulin.

This study examines the relationship between glycated haemoglobin (A1C) levels and treatment persistence with, or time to discontinuation of, basal insulin in patients with type 2 diabetes (T2D) newly initiating insulin. Claims data were extracted from the Optum Clinformatics database from January 2010 to June 2015. Adult patients with T2D initiating insulin glargine 100 U/mL (Gla-100) or insulin detemir (DET) with ≥1 A1C measurement during 12-month baseline and 18-month follow-up periods were included. Patients with a refill gap of >90 days were considered non-persistent; otherwise, patients were considered persistent with insulin. The main outcome was A1C, measured closest to the end of each quarter during the follow-up period. A total of 3993 of 109 934 patients met the inclusion criteria (43.0% persistent; 57.0% non-persistent). Persistent patients were older (54.7 vs 52.7 years; P < .001), were more likely to be male (59.4% vs 54.4%; P = .002), and had significantly lower mean unadjusted A1C values at 18 months (8.26% vs 8.60%; P < .001) and quarterly. Only 43.0% of adults initiating basal insulin persisted with treatment for 18 months, with earlier discontinuation associated with higher A1C.

DOES CLINICAL INERTIA VARY BY PERSONALIZED A1C GOAL? A STUDY OF PREDICTORS AND PREVALENCE OF CLINICAL INERTIA IN A U.S. MANAGED-CARE SETTING.

OBJECTIVE: Clinical inertia is defined as failure to initiate or intensify therapy despite an inadequate treatment response. We assessed the prevalence and identified the predictors of clinical inertia among patients with type 2 diabetes (T2DM) based on personalized goals. METHODS: Three hemoglobin A1c (A1C) targets (American Diabetes Association A1C <7.0%; modified Ismail-Beigi et al; and Healthcare Effectiveness Data and Information Set) were used when identifying adult patients with T2DM who experienced above-target A1C values during the index period (July 1, 2008 to June 30, 2012) in a U.S. managed-care claims database (IMPACT™). Clinical inertia was defined as no intensification of treatment during the response period. Demographic and clinical characteristics were analyzed to identify predictors of treatment intensification. RESULTS: Irrespective of A1C target, the majority of patients with T2DM (70.4 to 72.8%) experienced clinical inertia in the 6 months following the index event, with 5.3 to 6.2% of patients intensifying treatment with insulin. Patients with a lower likelihood of intensification were older, used >1 oral antidiabetes drug during the baseline period, and had an above-target A1C more recently. Treatment intensification was associated with patients who had point-of-service insurance, mental illness, an endocrinologist visit in the baseline period, or higher index A1C. CONCLUSION: The prevalence of clinical inertia among patients with T2DM in a U.S. managed-care setting is high and has increased over more recent years. Factors predicting increased risk of clinical inertia may help identify "at-risk" populations and assist in developing strategies to improve their management.

Effect of adherence and insulin delivery system on clinical and economic outcomes among patients with type 2 diabetes initiating insulin treatment.

BACKGROUND: Adherence to insulin affects real-world health outcomes and may itself be affected by the choice of insulin delivery device (pen or vial/syringe). The choice of insulin delivery device may also have direct effects on effectiveness. OBJECTIVE: This study aimed to estimate the effects of insulin adherence and delivery device on real-world health outcomes. METHODS: This study included adults with type 2 diabetes mellitus initiating insulin, with continuous health plan insurance for 6 or more months before initiation (baseline) and 1 or more year after. Measured outcomes included glycosylated hemoglobin (Hb A1c) reduction, hospitalization rate, total health care costs, and pharmacy costs over 1 year of follow-up. Adherence (defined as having insulin fills sufficient for the entire quarter), pen or vial/syringe use, and disease-related patient characteristics were assessed in each quarter. To account for the time-varying relationship between adherence, patient characteristics, and outcomes, marginal structural generalized linear models were used to estimate the effect of adherence and device use. Mean outcomes were predicted for different combinations of adherence and device choice. RESULTS: Among the 13,428 patients (mean age 54 years; 46% women; baseline Hb A1c 9.3%), adherent pen users had greater reductions in Hb A1c (-0.35%; P = 0.045), lower hospitalization rates (-0.36; P < 0.01), and higher pharmacy costs ($2923; P < 0.01) than did nonadherent vial users, and similar total health care costs ($3906 lower; P = 0.1). Pen use and adherent vial use decreased hospitalization rate and increased pharmacy but not total costs. CONCLUSIONS: Adherence and pen use have beneficial effects on patients' real-world outcomes, with the most favorable effects attributable to adherent pen use.

Real-world insulin treatment persistence among patients with type 2 diabetes.

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.

Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis.

OBJECTIVE: To evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017-31 December 2019) and the COVID-19 era (1 March 2020-31 December 2020), before the introduction of COVID-19 vaccines. DESIGN: Observational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality. DATA SOURCE: Optum's de-identified Clinformatics Data Mart Database (CDM). PARTICIPANTS: Individuals from the US general population and four subgroups of interest: influenza-vaccinated, paediatric (<18 years of age), elderly (≥65 years of age) and pregnant women. RESULTS: During the COVID-19 era, the incidence of several cardiac conditions, coagulation disorders and acute liver injury increased across all populations assessed while the rates of some dermatological and neurological HOIs decreased relative to the pre-COVID-19 era. The incidence of acute respiratory distress syndrome (ARDS) varied considerably by subgroup: among the elderly, it decreased annually during the pre-COVID-19 era but peaked during the COVID-19 era; among pregnant women, it slightly increased annually during the pre-COVID-19 era and substantially increased during the COVID-19 era; among paediatrics, it decreased annually over the entire study. The incidence of the majority of HOIs increased with age, but were generally comparable between sexes with few exceptions. Cardiac, gastrointestinal, neurological and haematological HOIs, along with acute kidney injury and ARDS, were more common in males, whereas several immunological HOIs and chilblain-like lesions were more common in females. Pregnancy-related HOIs did not increase during the COVID-19 era, except for spontaneous abortions which increased annually over the entire study. CONCLUSION: These observations help contextualise fluctuations in background rates of adverse events noted during the COVID-19 era, and provide insight on how their use may impact safety surveillance for other vaccines.

Risk of Anaphylaxis Among New Users of GLP-1 Receptor Agonists: A Cohort Study.

OBJECTIVE: To assess risk of anaphylaxis among patients with type 2 diabetes mellitus who are initiating therapy with a glucagon-like peptide 1 receptor agonist (GLP-1 RA), with a focus on those starting lixisenatide therapy. RESEARCH DESIGN AND METHODS: A cohort study was conducted in three large, U.S. claims databases (2017-2021). Adult (aged ≥18 years) new users of a GLP-1 RA who had type 2 diabetes mellitus and ≥6 months enrollment in the database before GLP-1 RA initiation (start of follow-up) were included. GLP-1 RAs evaluated were lixisenatide, an insulin glargine/lixisenatide fixed-ratio combination (FRC), exenatide, liraglutide or insulin degludec/liraglutide FRC, dulaglutide, and semaglutide (injectable and oral). The first anaphylaxis event during follow-up was identified using a validated algorithm. Incidence rates (IRs) and 95% CIs were calculated within each medication cohort. The unadjusted IR ratio (IRR) comparing anaphylaxis rates in the lixisenatide cohort with all other GLP-1 RAs combined was analyzed post hoc. RESULTS: There were 696,089 new users with 456,612 person-years of exposure to GLP-1 RAs. Baseline demographics, comorbidities, and use of other prescription medications in the 6 months before the index date were similar across medication cohorts. IRs (95% CIs) per 10,000 person-years were 1.0 (0.0-5.6) for lixisenatide, 6.0 (3.6-9.4) for exenatide, 5.1 (3.7-7.0) for liraglutide, 3.9 (3.1-4.8) for dulaglutide, and 3.6 (2.6-4.9) for semaglutide. The IRR (95% CI) for the anaphylaxis rate for the lixisenatide cohort compared with the pooled other GLP-1 RA cohort was 0.24 (0.01-1.35). CONCLUSIONS: Anaphylaxis is rare with GLP-1 RAs. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.

Yellow fever vaccine usage in the United States and risk of neurotropic and viscerotropic disease: A retrospective cohort study using three healthcare databases.

BACKGROUND: Yellow fever (YF) vaccines are highly effective and have a well-established safety profile despite the risk of rare serious adverse events (SAEs), vaccine-associated neurotropic (YEL-AND) and viscerotropic disease (YEL-AVD). This study aimed to describe US civilian YF vaccine usage, the population characteristics and pre-existing immunosuppressive medical conditions among those vaccinated, and to provide updated risk estimates of neurotropic and viscerotropic disease post-vaccination. METHODS: A retrospective cohort study was conducted using de-identified patient information from Optum Electronic Healthcare Record (EHR) (2007-2019), Optum Clinformatics Data Mart (CDM) (2004-2019) and IBM MarketScan (2007-2019) databases. YF vaccine recipients were identified using relevant vaccination and procedural codes. Demographic characteristics and pre-existing medical conditions were described. Incidence proportions with 95% confidence intervals (CI) of neurotropic and viscerotropic diseases occurring ≤ 30 days post-vaccination, after exclusion of unlikely cases based on current clinical guidelines of YEL-AND and YEL-AVD, were calculated. RESULTS: A total of 92,205, 46,539 and 125,235 YF vaccine recipients were retrieved from Optum EHR, Optum CDM and IBM MarketScan databases, respectively. The majority of vaccine recipients were aged < 60 years (highest proportion aged 18-29 years) with a higher proportion of females overall. Few vaccine recipients (<1%) had conditions predisposing them to immunosuppression. Four non-fatal cases of neurotropic disease and zero cases of viscerotropic disease were identified. The incidence proportion of post-vaccination neurotropic disease was 1.41 (95% CI: 0.15-6.61) and 3.04 (95% CI: 0.86-8.11) per 100,000 vaccine recipients in Optum EHR and IBM MarketScan, respectively, with no events identified in Optum CDM. CONCLUSIONS: This study provides updated insights into current YF vaccine usage in US civilian recipients and supports the safety profile of YF vaccines in US practice. The low frequency of pre-existing immunosuppressive medical conditions among vaccine recipients suggests good adherence to vaccination guidelines by healthcare practitioners. The risk of developing neurotropic and viscerotropic disease post-vaccination remains rare.

Using Electronic Clinical Decision Support in Patient-Centered Medical Homes to Improve Management of Diabetes in Primary Care: The DECIDE Study.

This prospective, randomized, real-world study aimed to examine the impact of electronic health record-based clinical decision support (CDS) tools on the management of diabetes in small- to medium-sized primary care practices participating in Delaware's patient-centered medical home project. Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals. Physicians and staff reported that the CDS toolkit empowered them to be more involved in clinical decision-making, thereby helping to improve diabetes care. However, all cited significant barriers to fully implementing team-based CDS, predominantly involving time and reimbursement.

Outcomes and healthcare resource utilization associated with medically attended hypoglycemia in older patients with type 2 diabetes initiating basal insulin in a US managed care setting.

OBJECTIVE: To assess health outcomes and the economic burden of hypoglycemia in older patients with type 2 diabetes initiating basal insulin (BI). RESEARCH DESIGN AND METHODS: Medicare Advantage claims data were extracted for patients with type 2 diabetes initiating BI and patients were stratified into two groups: those with medically attended hypoglycemia during the first year of BI treatment (HG group) and those without (non-HG group). Main outcome measures were hospitalization, mortality, healthcare utilization and costs 1 year before and 1 year after BI initiation. RESULTS: Of 31,035 patients included (mean age 72 years [SD 9.2]), 3066 (9.9%; HG group) experienced hypoglycemia during 1 year post-BI initiation. After adjustment for demographic, comorbidity and medication history, hypoglycemia was associated with risk of hospitalization (HR 1.59; 95% CI: 1.53-1.65) and death (HR 1.50; 95% CI: 1.40-1.60). Healthcare utilization was higher pre-index and showed greater increases post-BI initiation in the HG vs. the non-HG group. Per-patient healthcare costs were substantially higher for the HG group than the non-HG group, both pre-index ($54,057 vs. $30,249, respectively) and post-BI initiation ($75,398 vs. $27,753, respectively). CONCLUSIONS: Based on available claims data, hypoglycemia during the first year of BI treatment is associated with risk of hospitalization or death in older people, increasing healthcare utilization and costs. Due to the observational nature of this study, causality cannot be attributed, and further prospective studies into the effect of hypoglycemia on health outcomes in this population are warranted.

A Real-World Observational Study of Time to Treatment Intensification Among Elderly Patients with Inadequately Controlled Type 2 Diabetes Mellitus.

BACKGROUND: Among elderly patients, the management of type 2 diabetes mellitus (T2DM) is complicated by population heterogeneity and elderly-specific complexities. Few studies have been done to understand treatment intensification among elderly patients failing multiple oral antidiabetic drugs (OADs). OBJECTIVE: To examine the association between time to treatment intensification of T2DM and elderly-specific patient complexities. METHODS: In this observational, retrospective cohort study, elderly (aged ≥ 65 years) Medicare beneficiaries (n = 16,653) with inadequately controlled T2DM (hemoglobin A1c ≥ 8.0% despite 2 OADs) were included. Based on the consensus statement for diabetes care in elderly patients published by the American Diabetes Association and the American Geriatric Society, elderly-specific patient complexities were defined as the presence or absence of 5 geriatric syndromes: cognitive impairment; depression; falls and fall risk; polypharmacy; and urinary incontinence. RESULTS: Overall, 48.7% of patients received intensified treatment during follow-up, with median time to intensification 18.5 months (95% CI = 17.7-19.3). Median time to treatment intensification was shorter for elderly patients with T2DM with polypharmacy (16.5 months) and falls and fall risk (12.7 months) versus those without polypharmacy (20.4 months) and no fall risk (18.6 months). Elderly patients with urinary incontinence had a longer median time to treatment intensification (18.6 months) versus those without urinary incontinence (14.6 months). The median time to treatment intensification did not significantly differ by the elderly-specific patient complexities that included cognitive impairment and depression. However, after adjusting for demographic, insurance, clinical characteristics, and health care utilization, we found that only polypharmacy was associated with time to treatment intensification (adjusted hazard ratio, 1.10; 95% CI = 1.04-1.15; P = 0.001). CONCLUSIONS: Less than half of elderly patients with inadequately controlled T2DM received treatment intensification. Elderly-specific patient complexities were not associated with time to treatment intensification, emphasizing a positive effect of the integrated health care delivery model. Emerging health care delivery models that target integrated care may be crucial in providing appropriate treatment for elderly T2DM patients with complex conditions.

Much ado about nothing? A real-world study of patients with type 2 diabetes switching Basal insulin analogs.

INTRODUCTION: Type-2 diabetes mellitus (T2DM) is a progressive disease, and many patients eventually require insulin therapy. This study examined real-world outcomes of switching basal insulin analogs among patients with T2DM. METHODS: Using two large United States administrative claims databases (IMPACT(®) and Humana(®)), this longitudinal retrospective study examined two cohorts of adult patients with T2DM. Previously on insulin glargine, Cohort 1 either continued insulin glargine (GLA-C) or switched to insulin detemir (DET-S), while Cohort 2 was previously on insulin detemir, and either continued insulin detemir (DET-C) or switched to insulin glargine (GLA-S). One-year follow-up treatment persistence and adherence, glycated hemoglobin (HbA1c), hypoglycemia events, healthcare utilization and costs were assessed. Selection bias was minimized by propensity score matching between treatment groups within each cohort. RESULTS: A total of 5,921 patients (mean age 60 years, female 50.0%, HbA1c 8.6%) were included in the analysis (Cohort 1: IMPACT(®): n = 536 DET-S matched to n = 2,668 GLA-C; Humana(®): n = 256 DET-S matched to n = 1,262 GLA-C; Cohort 2: n = 419 GLA-S matched to n = 780 DET-C), with similar baseline characteristics between treatment groups in each cohort. During 1-year follow-up, in Cohort 1, DET-S patients, when compared with GLA-C patients, had lower treatment persistence/adherence with 33-40% restarting insulin glargine, higher rapid-acting insulin use, worse HbA1c outcomes, significantly higher diabetes drug costs, and similar hypoglycemia rates, health care utilization and total costs. However, in Cohort 2 overall opposite outcomes were observed and only 19.8% GLA-S patients restarted insulin detemir. CONCLUSIONS: This study showed contrasting clinical and economic outcomes when patients with T2DM switched basal insulin analogs, with worse outcomes observed for patients switching from insulin glargine to insulin detemir and improved outcomes when switching from insulin detemir to insulin glargine. Further investigation into the therapeutic interchangeability of insulin glargine and insulin detemir in the real-world setting is needed.

Real-world rates, predictors, and associated costs of hypoglycemia among patients with type 2 diabetes mellitus treated with insulin glargine: results of a pooled analysis of six retrospective observational studies.

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.

Does pen help? A real-world outcomes study of switching from vial to disposable pen among insulin glargine-treated patients with type 2 diabetes mellitus.

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.

Combination therapy with insulin glargine and exenatide: real-world outcomes in patients with type 2 diabetes.

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.

A real-world study of patients with type 2 diabetes initiating basal insulins via disposable pens.

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.