John J. Sheehan

Association Between Hospitalization for Heart Failure and Dipeptidyl Peptidase 4 Inhibitors in Patients With Type 2 Diabetes: An Observational Study

OBJECTIVE To examine, among patients with type 2 diabetes, the association between hospitalization for heart failure (hHF) and treatment with dipeptidyl peptidase 4 inhibitors (DPP-4is) versus sulfonylureas (SUs), and treatment with saxagliptin versus sitagliptin. RESEARCH DESIGN AND METHODS This was a retrospective, observational study using a U.S. insurance claims database. Patients initiated treatment between 1 August 2010 and 30 August 2013, and had no use of the comparator treatments in the prior 12 months (baseline). Each comparison consisted of patients matched 1:1 on a propensity score. Time to each outcome was compared between matched groups using Cox models. Analyses were stratified by the presence of baseline cardiovascular disease (CVD). Secondary analyses examined associations between comparator treatments and other selected cardiovascular events. RESULTS After matching, the study included 218,556 patients in comparisons of DPP-4i and SU, and 112,888 in comparisons of saxagliptin and sitagliptin. The hazard ratios (HRs) of hHF were as follows: DPP-4i versus SU (reference): HR 0.95 (95% CI 0.78–1.15), P = 0.580 for patients with baseline CVD; HR 0.59 (95% CI 0.38–0.89), P = 0.013 for patients without baseline CVD; saxagliptin versus sitagliptin (reference): HR 0.95 (95% CI 0.70–1.28), P = 0.712 for patients with baseline CVD; HR 0.99 (95% CI 0.56–1.75), P = 0.972 for patients without baseline CVD. Comparisons of the individual secondary and composite cardiovascular outcomes followed a similar pattern. CONCLUSIONS In patients with type 2 diabetes, there was no association between hHF, or other selected cardiovascular outcomes, and treatment with a DPP-4i relative to SU or treatment with saxagliptin relative to sitagliptin.

Treatment intensification for patients with type 2 diabetes and poor glycaemic control.

To identify the time to and patient characteristics associated with treatment intensification in patients with type 2 diabetes (T2D) and poor glycaemic control.

Evaluating the Quality of Comprehensive Cardiometabolic Care for Patients With Type 2 Diabetes in the U.S.: The Diabetes Collaborative Registry

The prevalence of diabetes continues to escalate (1,2) with profound impact on complications and mortality (3–5). Evidence-based guidelines (6–9) and performance measures have been developed (10–12). However, there is currently no sustainable nationwide mechanism by which to 1 ) systematically evaluate and track the quality of care in primary and specialty settings or 2 ) evaluate the real-world treatment strategies and their effects on health outcomes. Over the past two decades, quality-oriented registries in cardiovascular disease have pioneered mechanisms of quality assessment, benchmarking, and feedback to individual providers and institutions, and there is evidence that such initiatives can translate into improved quality of care and patient outcomes (13–17). In an effort to extend these efforts to diabetes and cardiometabolic care, the Diabetes Collaborative Registry (DCR) was formed in 2014 by the American College of Cardiology, the American Diabetes Association, the American College of Physicians, the American Association of Clinical Endocrinologists, and the Joslin Diabetes Center. The DCR is a real-world, quality-oriented registry covering the spectrum from primary to specialty outpatient care in the U.S., thereby permitting evaluations of multidisciplinary diabetes care across the spectrum of the disease process (from diagnosis to complications) and the relationship between treatment patterns and health outcomes. Despite evidence-based guidelines for treating patients with diabetes (1,7,9,18,19), a divide exists between the recommendations and their practical application (20). The DCR seeks to fill this void through collecting data on a national level, allowing for regular feedback and benchmarking that we envision will result in rapid-cycle quality improvement efforts. Through measuring adherence to clinical guidelines, quantifying local performance, and reporting these …

Change in HbA1c associated with treatment intensification among patients with type 2 diabetes and poor glycemic control

Abstract Objective: We conducted a retrospective cohort study to investigate the HbA1c change associated with treatment intensification in a real-world population of patients with type 2 diabetes (T2D). Methods: Using a large US insurance claims database, patients aged ≥18 years with a T2D diagnosis and HbA1c ≥8.0% (64 mmol/mol) after ≥3 months of oral pharmacotherapy with metformin (± other oral antidiabetes agents) were identified (index date). Continuous enrollment was required for ≥12 months before (baseline) and after the index date with no baseline use of injectable antidiabetes drugs. We defined treatment intensification as prescriptions for injectable or additional oral antidiabetes drugs. Time to intensification was classified as timely (within 6 months) or not (≥6 months or not intensified). Linear regression models with propensity score 1:1 matching were performed to assess the effect of timely intensification on HbA1c. Results: Of the 11,525 patients meeting the inclusion criteria, only 37% had treatment intensified within 6 months. Mean age at index date was 57 years, 40% of the sample was female. The mean baseline A1C was 9.4% and 9.0%, while post-index A1C was 7.9% and 8.2% for timely intensified patients versus not, respectively. Patients with timely intensification had significantly greater HbA1c reduction compared with others (−0.33%, 95% CI: −0.41% to −0.25%) within 1 year of follow up. Conclusions: In this analysis of patients with T2D and treatment failure in a real-world setting, earlier treatment intensification was associated with better glycemic control as indicated by lower HbA1c values.

Response and remission rates with adjunctive aripiprazole in patients with major depressive disorder who exhibit minimal or no improvement on antidepressant monotherapy.

The efficacy of adjunctive aripiprazole in patients with major depressive disorder (MDD) with no improvement after 8 weeks of prior antidepressant monotherapy has not been evaluated.

Prevalence of pre-existing risk factors for adverse events associated with atypical antipsychotics among commercially insured and medicaid insured patients newly initiating atypical antipsychotics.

BACKGROUND Atypical antipsychotics (AA) differ from one another in their adverse event (AE) profiles. Patient-specific pre-existing risk factors for AEs, including comorbidities and concomitant medications, may render the use of certain AAs potentially inappropriate, and others relatively safer or more tolerable. OBJECTIVE To quantify the prevalence of pre-existing risk factors for AEs and potential drug-drug interactions (DDIs) associated with AA treatment among patients with schizophrenia (SCZ), bipolar disorder (BD), or major depressive disorder (MDD) newly-initiating AA treatment. METHODS Retrospective, observational study using US claims databases. Patients identified had newly-initiated on a single AA (1/1/2010-11/30/2011; index date), were aged 18-64 years, had insurance enrolment for 12 months pre- (baseline) and 1 month post-index, and had ≥1 medical claim with an ICD-9-CM diagnosis of SCZ, BD, or MDD during baseline. A comprehensive list of AE risk factors, including potential DDIs, was developed based on AA package inserts. Administrative claims-based identification algorithms flagged the presence of each medical risk factor during baseline and identified concomitant prescribing of medications (90 days pre- to 30 days post-index) potentially causing DDIs with AAs. RESULTS Of 97,010 patients identified, mean age was 41.2 years and 66.7% were female. Among patients initiating AA treatment, prevalence of pre-existing AE risk factors were aripiprazole 32.2%; olanzapine 51.6%; ziprasidone 75.6%; quetiapine 77.4%; risperidone 82.5%. CONCLUSION Despite the availability of several AAs to treat psychiatric conditions, pre-existing AE risk factors can limit patient treatment options. Given inter-AA variability in risk factors, open access to AA may help to optimize appropriate prescribing.

Delays in treatment intensification with oral antidiabetic drugs and risk of microvascular and macrovascular events in patients with poor glycaemic control: An individual patient simulation study

To use the Archimedes model to estimate the consequences of delays in oral antidiabetic drug (OAD) treatment intensification on glycaemic control and long‐term outcomes at 5 and 20 years.

Comparison of adherence and persistence among adults with type 2 diabetes mellitus initiating saxagliptin or linagliptin.

Background Adherence and persistence to antidiabetes medications are important to control blood glucose levels among individuals with type 2 diabetes mellitus (T2D). Objectives The objective of this study was to compare adherence and persistence over a 12-month period between patients initiating saxagliptin and patients initiating linagliptin, two dipeptidyl peptidase-4 inhibitors. Methods This retrospective cohort study was conducted in MarketScan® Commercial and Medicare Supplemental claims databases. Patients with T2D initiating saxagliptin or linagliptin between January 1, 2009, and June 30, 2013, were selected. Patients were required to be at least 18 years old and have 12 months of continuous enrollment prior to and following initiation. Adherence and persistence to initiated medication were measured over the 12 months after initiation using outpatient pharmacy claims. Patients were considered adherent if the proportion of days covered was ≥0.80. Patients were considered nonpersistent (or to have discontinued) if there was a gap of >60 days without initiated medication on hand. Multivariable logistic regression and multivariable Cox proportional hazard models were fit to compare adherence and persistence, respectively, between the two cohorts. Results There were 21,599 saxagliptin initiators (mean age 55 years; 53% male) and 5,786 linagliptin initiators (mean age 57 years; 54% male) included in the study sample. Over the 12-month follow-up, 46% of saxagliptin initiators and 42% of linagliptin initiators were considered adherent and 47% of saxagliptin initiators and 51% of linagliptin initiators discontinued their initiated medication. After controlling for patient characteristics, saxagliptin initiation was associated with significantly greater odds of being adherent (adjusted odds ratio =1.212, 95% CI 1.140–1.289) and significantly lower hazards of discontinuation (adjusted hazard ratio =0.887, 95% CI 0.850–0.926) compared with linagliptin initiation. Conclusion Compared with patients with T2D who initiated linagliptin, patients with T2D who initiated saxagliptin had significantly better adherence and persistence.

Cardiovascular event costs in patients with Type 2 diabetes mellitus

Abstract Objective: To quantify the cost of acute major adverse cardiac events (MACE; myocardial infarction [MI] and stroke) stratified by cardiovascular disease (CVD) risk factors in commercially, Medicare Supplemental-, and Medicaid-insured patients with type 2 diabetes mellitus (T2DM). Methods: US administrative claims data were used to identify patients with T2DM aged ≥18 and continuously enrolled with insurance benefits from July 1, 2009–June 30, 2010 (baseline). Patients were classified into three baseline CVD risk groups (highest, medium, and lowest) and followed from July 1, 2010 until 1 year or censoring (follow-up) to measure per-patient per-month (PPPM) all-cause healthcare costs. Multivariable regression compared costs between patients with/without MACE during follow-up. Patients with MACE were further followed for up to 1 year after initial event to quantify longitudinal event costs. Results: Sample comprised 1,415,598 T2DM patients. Over average follow-up ranging from 301–343 days across CVD risk groups, 10,399 patients experienced MACE. Expected multivariable-adjusted mean PPPM costs of MACE per 100 covered patients within each CVD risk group varied by payer and generally increased with CVD risk (range = 

Use of Augmentation Agents for Treating Depression: Analysis of a Psychiatric Electronic Medical Record Data Set

1555 in lowest-risk commercially insured patients to