Development of predictive risk models for major adverse cardiovascular events among patients with type 2 diabetes mellitus using health insurance claims data.

BACKGROUND: There exist several predictive risk models for cardiovascular disease (CVD), including some developed specifically for patients with type 2 diabetes mellitus (T2DM). However, the models developed for a diabetic population are based on information derived from medical records or laboratory results, which are not typically available to entities like payers or quality of care organizations. The objective of this study is to develop and validate models predicting the risk of cardiovascular events in patients with T2DM based on medical insurance claims data. METHODS: Patients with T2DM aged 50 years or older were identified from the Optum™ Integrated Real World Evidence Electronic Health Records and Claims de-identified database (10/01/2006-09/30/2016). Risk factors were assessed over a 12-month baseline period and cardiovascular events were monitored from the end of the baseline period until end of data availability, continuous enrollment, or death. Risk models were developed using logistic regressions separately for patients with and without prior CVD, and for each outcome: (1) major adverse cardiovascular events (MACE; i.e., non-fatal myocardial infarction, non-fatal stroke, CVD-related death); (2) any MACE, hospitalization for unstable angina, or hospitalization for congestive heart failure; (3) CVD-related death. Models were developed and validated on 70% and 30% of the sample, respectively. Model performance was assessed using C-statistics. RESULTS: A total of 181,619 patients were identified, including 136,544 (75.2%) without prior CVD and 45,075 (24.8%) with a history of CVD. Age, diabetes-related hospitalizations, prior CVD diagnoses and chronic pulmonary disease were the most important predictors across all models. C-statistics ranged from 0.70 to 0.81, indicating that the models performed well. The additional inclusion of risk factors derived from pharmacy claims (e.g., use of antihypertensive, and use of antihyperglycemic) or from medical records and laboratory measures (e.g., hemoglobin A1c, urine albumin to creatinine ratio) only marginally improved the performance of the models. CONCLUSION: The claims-based models developed could reliably predict the risk of cardiovascular events in T2DM patients, without requiring pharmacy claims or laboratory measures. These models could be relevant for providers and payers and help implement approaches to prevent cardiovascular events in high-risk diabetic patients.

A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures.

BACKGROUND: The randomized, double-blind CANTATA-SU (CANagliflozin Treatment And Trial Analysis Sulfonyl Urea) clinical trial compared the use of canagliflozin (100 mg or 300 mg) and maximally tolerated glimepiride (6-8 mg) over 104 weeks as add-on therapy for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Compared with glimepiride, canagliflozin use was associated with durable reductions in glycated hemoglobin (A1C), blood pressure (BP), and body weight. The aim of this post-hoc analysis of the CANTATA-SU trial was to assess the comparative efficacy of canagliflozin and glimepiride in the attainment of recently updated diabetes-related quality measures (QMs) for up to 104 weeks of treatment. METHODS: This post-hoc analysis evaluated the proportions of patients achieving individual diabetes-related QMs using data from the randomized, double-blind, Phase 3 CANTATA-SU trial. Change in A1C from baseline, and proportions of the study population achieving QMs: A1C <7.0 %, <8.0 %, and >9.0 % were assessed. Secondary endpoints included change in BP from baseline, and the proportions of the study population achieving QMs related to BP and body weight. RESULTS: The proportions of patients in the canagliflozin 100 mg, canagliflozin 300 mg, and glimepiride groups meeting criteria for all QMs were similar at baseline. At 52 and 104 weeks of treatment, canagliflozin 100 mg and canagliflozin 300 mg provided better or similar reductions in A1C from baseline and achievement of glycemic control QMs compared with glimepiride. At 52 and 104 weeks of treatment, the attainment of QMs related to reductions in body weight and BP all favored canagliflozin compared with glimepiride. Canagliflozin was associated with lower incidence of documented hypoglycemia and severe hypoglycemia compared with glimepiride. CONCLUSIONS: Using the recently adjusted and currently accepted diabetes-related QMs, this analysis observed superior glycemic control with canagliflozin compared with maximally tolerated glimepiride in patients with T2DM who were previously poorly controlled on metformin monotherapy. Compared with maximally tolerated glimepiride, canagliflozin resulted in better achievement of diabetes-related QMs related to weight loss and BP, and was associated with lower incidences of hypoglycemic events. TRIAL REGISTRATION: Clinical trial registry name: CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride. CLINICAL TRIAL REGISTRATION NUMBER: NCT00968812 , registered August 28, 2009.

Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict.

BACKGROUND: Patients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. The American Diabetes Association recommends patient-centered, evidence-based tools supporting shared decision-making between patients and clinicians. We developed a patient decision aid (PDA) targeting decisions about treatment intensification for T2DM. Our objective was to determine the effectiveness of this PDA for patients with T2DM on metformin who require treatment intensification. METHODS: This study was a pragmatic randomized controlled trial conducted in 27 US primary care and endocrinology clinics. Subjects were English-speaking adults with T2DM receiving metformin with persistent hyperglycemia who were recommended to consider medication intensification. Subjects were randomized to receive either the PDA or usual care (UC). Main outcome measures were change in knowledge, decisional self-efficacy, and decisional conflict. RESULTS: Of 225 subjects enrolled, 114 were randomized to the PDA and 111 to UC. Mean [SD] age was 52 [1] years, time since T2DM diagnosis was 6 [+/-6] years, 45.3% were male, and most (55.5%) were non-Caucasian. Compared to UC, PDA users had significantly larger knowledge gains (35.0% [22.3] vs 9.9% [22.2]; P < 0.0001) and larger improvements in self-efficacy (3.7 [16.7] vs-3.9 [19.2]; P < 0.0001) and decisional conflict (-22.2 [20.6] vs-7.5 [16.6]; P < 0.0001). CONCLUSIONS: The PDA resulted in substantial and significant improvements in knowledge, decisional conflict and decisional self-efficacy. Decisional conflict scores after PDA use were within the range that correlates with effective decision-making. This PDA has the potential to facilitate shared-decision-making for patients with T2DM. TRIAL REGISTRATION: NCT02110979.

Propensity score matched assessment of treatment patterns and cost of erythropoiesis stimulating agent treatment in patients with cancer receiving myelosuppressive chemotherapy.

OBJECTIVE: To examine epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment patterns and erythropoiesis stimulating agent (ESA) costs in patients with cancer receiving chemotherapy (CRC), and to compare the results observed in the pre-matched total study population (TSP) with a propensity score matched population (PSMP). METHODS: A medical claims analysis was conducted from 1 January 2004 through 31 July 2009 using the HealthCore Integrated Research Database. Patients were at least 18 years old, newly initiated on EPO or DARB, received ≥ 2 ESA doses, and had ≥ 1 claim for cancer and chemotherapy proximate to ESA treatment. Patients were matched using propensity scores. January 2010 Wholesale Acquisition Cost was used to calculate drug cost. Mean cumulative ESA dose and drug costs were evaluated in the TSP and PSMP. RESULTS: 4921 EPO and 9173 DARB patients with CRC were identified. In the TSP, mean cumulative ESA doses were EPO: 398,770 units and DARB: 1508 mcg, with similar treatment durations for each. Mean cumulative drug costs were EPO: $6041 and DARB: $7861 (30% higher for DARB). The cumulative dose ratio (EPO units: DARB mcg) was 264:1. The PSMP analysis identified 4831 ESA treated CRC patients in each group. Mean drug costs were EPO: $6055 and DARB: $7863 (30% higher for DARB). The observed dose ratio (EPO units: DARB mcg) was 265:1. CONCLUSION: In both analyses, the costs of DARB were higher, even after accounting for baseline differences in the PSMP. Similar trends in dose ratios were also observed in both groups.

Association of anemia with worsened activities of daily living and health-related quality of life scores derived from the Minimum Data Set in long-term care residents.

BACKGROUND: Among long-term care (LTC) residents, we explored the association between anemia status and hemoglobin (Hb) level with Activities of Daily Living (ADL) functioning and health-related quality of life (HRQOL). METHODS: Data were derived from the AnalytiCare database, containing laboratory and Minimum Data Set (MDS) reports for 27 LTC facilities in Colorado. Study timeframe was 1/1/07-9/15/08. Patients were selected based on: residence in LTC >90 days, Hb and serum creatinine value within 90 days of the earliest non-admission (index) MDS. From the index MDS, the method of 1) Carpenter et al. [BMC Geriatrics 6:7(2006)] was used to derive a summary measure of ADL performance (the MDS-ADL score) and 2) Wodchis et al. [IJTAHC 19:3(2003)] was used to assign HRQOL scores (MDS items were mapped to the Health Utilities Index Mark 2 (HUI2) scoring function to create the MDS-HSI score). Anemia was defined as Hb <12 g/dL females and <13 g/dL males. Adjusted linear regression was used to evaluate the independent association of anemia and hemoglobin level on MDS-ADL and MDS-HSI scores. RESULTS: 838 residents met all inclusion criteria; 46% of residents were anemic. Mean (SD) MDS-ADL score was 14.9 (7.5) [0-28 scale, where higher score indicates worse functioning]. In the adjusted model, anemia was associated with a significantly worse MDS-ADL score (+1.62 points, P=.001). Residents with Hb levels 10 to <11 g/dL had significantly worse ADL score (+2.06 points, P=.005) than the >13 g/dL reference. The mean MDS-HSI score was 0.431 (0.169) [range, where 0=dead to 1=perfect health]. Compared with non-anemic residents, in this adjusted model, residents with anemia had significantly worse MDS-HSI scores (-0.034 points, P=.005). Residents with hemoglobin levels <10 g/dL had significantly worse MDS-HSI scores (-0.058 points, P=.016) than the >13 g/dL reference. CONCLUSIONS: After adjusting for several covariates, LTC residents with anemia, and many of those with moderate to severe declines in Hb level, had significantly poorer outcomes in both ADL functioning and HRQOL. The association between Hb level and the HRQOL measure of MDS-HSI appears to be largely explained by the mobility domain of the HRQOL measure.

The prevalence and recognition of chronic kidney disease and anemia in long-term care residents.

OBJECTIVE: To evaluate the prevalence of chronic kidney disease (CKD) and anemia in the long-term care facility, the rate of recognition of these conditions, and the specific interventions used to treat anemia. DESIGN: Retrospective cross-sectional analysis. SETTING: Twenty-seven long-term care facilities in Colorado. PATIENTS, PARTICIPANTS: Had > 90-day residency in the long-term care facility; had index serum creatinine and hemoglobin (Hb) values ± 90 days of the earliest (index) Minimum Data Set (MDS). Data were derived from the AnalytiCare(sm) database (January 1, 2007-September 15, 2008) containing laboratory results, MDS reports, and pharmacy fills. Residents with laboratory-defined CKD had estimated glomerular filtration rates < 60 mL/min/1.73 m(2). Those with laboratory-defined anemia had < 12 g/dL Hb females, < 13 g/dL Hb males. MDS reports indicated recognition of CKD and anemia. Prescription records identified anemia-related pharmacotherapy for anemic residents. MAIN OUTCOME MEASUREMENTS: Prevalence rates of laboratory-defined CKD and anemia, recognition rates of anemia and CKD, and rates of use of specific anemia pharmacotherapies. RESULTS: For 838 eligible residents, laboratory findings showed a prevalence rate of 43% for CKD and 46% for anemia. Only 2.8% and 14.6% of residents with laboratory defined CKD had CKD recognized on the index, or any index or postindex MDS, respectively. Anemia recognition rates were 9.6% and 39.9%, respectively. No single anemia prescription therapy class (erythropoiesis stimulating agents, iron, vitamin B(12), or folic acid) was used for more than 10% of all residents with laboratory- or MDS-defined anemia. CONCLUSION: For CKD and anemia, the lack of concordance between laboratory- and MDS-identified disease should alert health care professionals of potential under-recognition within the long-term care facility.

Chronic Kidney Disease Testing Among Primary Care Patients With Type 2 Diabetes Across 24 U.S. Health Care Organizations.

OBJECTIVE: Clinical guidelines for people with diabetes recommend chronic kidney disease (CKD) testing at least annually using estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (uACR). We aimed to understand CKD testing among people with type 2 diabetes in the U.S. RESEARCH DESIGN AND METHODS: Electronic health record data were analyzed from 513,165 adults with type 2 diabetes receiving primary care from 24 health care organizations and 1,164 clinical practice sites. We assessed the percentage of patients with both one or more eGFRs and one or more uACRs and each test individually in the 1, 2, and 3 years ending September 2019 by health care organization and clinical practice site. Elevated albuminuria was defined as uACR ≥30 mg/g. RESULTS: The 1-year median testing rate across organizations was 51.6% for both uACR and eGFR, 89.5% for eGFR, and 52.9% for uACR. uACR testing varied (10th-90th percentile) from 44.7 to 63.3% across organizations and from 13.3 to 75.4% across sites. Over 3 years, the median testing rate for uACR across organizations was 73.7%. Overall, the prevalence of detected elevated albuminuria was 15%. The average prevalence of detected elevated albuminuria increased linearly with uACR testing rates at sites, with estimated prevalence of 6%, 15%, and 30% at uACR testing rates of 20%, 50%, and 100%, respectively. CONCLUSIONS: While eGFR testing rates are uniformly high among people with type 2 diabetes, testing rates for uACR are suboptimal and highly variable across and within the organizations examined. Guideline-recommended uACR testing should increase detection of CKD.

Real-World Diagnosis and Treatment of Diabetic Kidney Disease.

INTRODUCTION: People with type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD) have increased morbidity and mortality risk. Angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) are recommended to slow kidney function decline in DKD. This representative, real-world data analysis of patients with T2DM was performed to detect onset of DKD and determine methods and timing of DKD diagnosis and time to initiation of ACEi/ARB therapy. METHODS: Patients diagnosed with T2DM before January 1, 2016 who developed DKD between January 1, 2017 and June 30, 2019 were identified from a longitudinal ambulatory electronic health record (EHR) dataset (Veradigm Inc). Each record was analyzed using the CLinical INTelligence engine (CLINT™, HealthPals, Inc.) to identify delays and gaps in diagnosing DKD. DKD was diagnosed through two reduced estimated glomerular filtration rate (eGFR; < 60 mL/min/1.73 m2) measurements at least 90 days apart, a single elevated urine albumin-to-creatinine ratio (UACR; > 30 mg/g) measurement, or ICD-9/10 diagnosis codes for DKD and/or albuminuria. Time to diagnose (TTD), time to treat (TTT), and diagnosis to treatment time were assessed. RESULTS: Of 6,499,409 patients with T2DM before January 2016, 245,978 developed DKD between January 1, 2017 and June 30, 2019. In this DKD cohort, ca. 50% were first identified through EHR diagnosis and ca. 50% by UACR or eGFR lab-based diagnosis. In patients who had UACR/eGFR assessed, more than 90% exhibited DKD-level results on the first diagnostic test. Average TTD after eGFR labs was 2 years; average TTT with ACEi/ARB was 6-9 months after DKD lab evidence. The majority of patients who developed DKD received ACEi/ARB therapy 6-7 months after diagnosis. CONCLUSION: In a contemporary, large national cohort of patients with T2DM, progression to DKD was common but likely underrepresented. The low rate of DKD-screening labs, along with sizable delays in diagnosis of DKD and initiation of ACEi/ARB therapy, indicates that many patients who progress to DKD are not being properly treated.

Diabetic kidney disease is kidney disease that occurs in patients with type 2 diabetes and is associated with greater risk of death and other adverse cardiovascular and kidney outcomes. Unfortunately, diabetic kidney disease is underdiagnosed because of lack of awareness and its early asymptomatic presentation. Early detection and treatment of diabetic kidney disease with medicines such as angiotensin-converting enzyme inhibitors (also known as ACE inhibitors) or angiotensin II receptor blockers (also known as ARBs) is important for the prevention of disease progression and the development of other serious conditions. This real-world analysis evaluated electronic health record data from more than 6 million patients with diabetes to detect the onset of diabetic kidney disease and to determine timing of treatment and gaps in medical care. Results from the study show that there are often significant delays in the diagnosis of diabetic kidney disease, even when laboratory evidence is available. Furthermore, many patients are not undergoing regular renal function testing, thus missing the opportunity for diagnosis (and subsequent treatment) of earlier onset, less severe disease. After diagnosis, patients with diabetic kidney disease experience significant delay until they receive appropriate treatment with an ACE inhibitor or ARB. The low rate of kidney function screening coupled with delays in diagnosis and treatment initiation suggest that many patients who progress to diabetic kidney disease are not being properly treated. The results from this study highlight the need to improve diagnostic and treatment protocols to address these significant gaps in care.

Drug utilization and cost for erythropoiesis-stimulating agents in a long-term care resident population with chronic kidney disease.

OBJECTIVE: To compare drug-utilization patterns and costs in patients with chronic kidney disease (CKD), not on dialysis, yet receiving epoetin alfa (EPO) or darbepoetin alfa (DARB) in a long-term care setting. DESIGN: A retrospective analysis of pharmacy dispensing from January 2007 through March 2009, was conducted using the AnalytiCareSM LTC database. SETTING: Long-term care. PATIENTS, PARTICIPANTS: Patients>or=18 years of age, with >or=1 EPO or DARB dose dispensed, were included. Patients dispensed both agents, diagnosed with cancer, receiving chemotherapy, radiation therapy, or renal dialysis, were excluded. MAIN OUTCOME MEASURES: Mean cumulative erythropoiesis-stimulating agent (ESA) dose was used to calculate drug cost (using April 2009 wholesale acquisition cost) and dose ratio (Units EPO:mcg DARB). Results were also stratified by payer types. RESULTS: A total of 2,259 patients were identified (EPO 1,640; DARB 619). EPO patients were slightly older (76.1 vs. 74.8 years of age, P=0.021), with similar proportion of women, compared with DARB patients. Mean (SD) cumulative dose was 98,420 (122,381) Units for EPO and 360 (428) mcg for DARB, resulting in a dose ratio of 273:1 (Units EPO:mcg DARB). The corresponding drug cost was 42% higher with DARB than with EPO ($1,734 vs. $1,217, P<0.001). Stratified analysis by payer types yielded similar results (dose ratios: 299:1 and 270:1 [Units EPO:mcg DARB]); cost premiums: 30% and 44% for Medicare Part A/Facility and Medicare Part D/Medicaid groups, respectively. CONCLUSIONS: This study of long-term care CKD patients receiving ESAs reported 42% higher drug cost with DARB compared with EPO and a dose ratio of 273:1.

Development of risk models for major adverse chronic renal outcomes among patients with type 2 diabetes mellitus using insurance claims: a retrospective observational study.

Objective: To develop and validate models allowing the prediction of major adverse chronic renal outcomes (MACRO) in patients with type 2 diabetes mellitus (T2DM) using insurance claims data.Methods: The Optum Integrated Real World Evidence Electronic Health Records and Claims de-identified database (10/01/2006-09/30/2016) was used to identify T2DM patients ≥50 years old. Risk factors were assessed over a 12-month baseline period, and MACRO were subsequently assessed until the end of data availability, continuous enrollment, or death. Separate models were built for moderate-to-severe diabetic kidney disease (DKD), end-stage renal disease (ESRD), and renal death. A random split-sample approach was employed, where 70% of the sample served for model development (training set) and the remaining 30% served for validation (testing set). C-statistics were used to assess model performance.Results: A total of 160,031 patients were included. Risk factors associated with MACRO for all models included adapted diabetes complications severity index, heart failure, anemia, diabetic nephropathy, and CKD. C-statistics ranged between 0.70 (moderate-to-severe DKD) and 0.84 (renal death) in the testing set. A substantial proportion (e.g. 88.7% for moderate-to-severe DKD) of patients predicted to be at high-risk of MACRO did not have diabetic nephropathy, proteinuria, or CKD at baseline.Conclusions: The models developed using insurance claims data could reliably predict the risk of MACRO in patients with T2DM and enabled patients at higher-risk of DKD to be identified in the absence of baseline diabetic nephropathy, CKD, or proteinuria. These models could help establish strategies to reduce the risk of MACRO in T2DM patients.

Direct all-cause health care costs associated with chronic kidney disease in patients with diabetes and hypertension: a managed care perspective.

BACKGROUND: Diabetes and hypertension are the 2 major causes of endstage renal disease. The rate of chronic kidney disease (CKD) secondary to diabetes and/or hypertension is on the rise, and the related health care costs represent a significant economic burden. OBJECTIVE: To quantify from a health system perspective the incremental direct all-cause health care costs associated with a diagnosis of CKD in patients with diabetes and/or hypertension. METHODS: An analysis was conducted of medical claims and laboratory data with dates of service between January 1, 2000, and February 28, 2006, from a managed care database for approximately 30 million members enrolled in 35 health plans. Each patient's observation period began on the date of the first diabetes or hypertension diagnosis (index date) and ended on the earlier of the health plan disenrollment date or February 28, 2006. Inclusion criteria were continuous insurance coverage in the 6 months prior to the index date and during the observation period, age at least 18 years, and at least 2 claims less than 90 days apart with a primary or secondary diagnosis for diabetes or hypertension. Exclusion criteria were cancer, lupus, or organ transplantation or chemotherapy at any time during the observation period. CKD was defined as at least 1 claim with a primary or secondary diagnosis for CKD and at least 2 glomerular filtration rate values of below 60 milliliters per minute per 1.73 square meters of body surface area (60 mL/min/1.73 m(2)) at any time during the observation period. Bivariate and Tobit regression analyses were conducted to compare patients who developed CKD versus those who did not for annualized (per patient per month [PPPM] multiplied by 12) direct, all-cause, health care costs, defined as standardized net provider payments after subtraction of member cost-share. These costs consisted of outpatient services, inpatient services, and pharmacy claims. A subset analysis of the post-versus pre- CKD medical costs was also conducted for cohorts of patients with at least 60 days of observation before and after the development of CKD; that analysis measured both all-cause costs and costs for services directly related to CKD treatment (i.e., claims with a primary or secondary diagnosis of CKD or claims for dialysis services). RESULTS: 11,531 patients with diabetes, 74,759 patients with hypertension, and 4,779 patients with both conditions were identified, of whom 123 (1.1%), 1,137 (1.5%), and 712 (14.9%), respectively, developed CKD during the observation period. The CKD group was older than the no-CKD group in each cohort (mean ages for CKD vs. no-CKD were, respectively, diabetes only cohort: 60.7 vs. 49.9 years, P < 0.001; hypertension only cohort: 63.6 vs. 53.6 years, P < 0.001; diabetes and hypertension cohort: 63.4 vs. 61.8 years, P < 0.001). CKD was associated with significantly higher total direct all-cause health care costs, with unadjusted annualized per patient mean [median] cost differences of $11,814 [$6,895], $8,412 [$4,115], and $10,625 [$7,203], respectively (diabetes: $18,444 [$11,025] vs. $6,631 [$4,131], P < 0.001; hypertension: $14,638 [$7,817] vs. $6,226 [$3,703], P < 0.001; diabetes and hypertension: $21,452 [$13,840] vs. $10,827 [$6,637], P < 0.001). The largest driver of the all-cause mean cost difference associated with CKD for each cohort was hospitalization cost (diabetes: $6,410, P < 0.001; hypertension: $5,498, P < 0.001; diabetes and hypertension: $6,467, P < 0.001). Among patients developing CKD, all-cause mean [median] annualized costs increased significantly following CKD onset (increases for patients with diabetes: $8,829 [$4,899], P = 0.026; hypertension: $4,175 [$2,741], P = 0.004; diabetes and hypertension: $9,397 [$7,240], P < 0.001). In the post-CKD period, costs directly related to treatment of CKD accounted for 9%--19% of all-cause medical service costs--9.2% for patients with diabetes, 11.6% for patients with hypertension, and 18.8% for patients with both diabetes and hypertension. CONCLUSION: CKD was associated with significantly higher all-cause health care costs in managed care patients with diabetes and/or hypertension.

Factors Associated with Diabetes-Related Clinical Inertia in a Managed Care Population and Its Effect on Hemoglobin A1c Goal Attainment: A Claims-Based Analysis.

BACKGROUND: Despite evidence showing the benefits of treatment intensification following an elevated hemoglobin A1c (A1c), clinical inertia, or failure to establish and/or escalate treatment to achieve treatment goals, is a concern among patients diagnosed with type 2 diabetes (T2DM). Clinical inertia may contribute to increased health care utilization and costs due to poor clinical outcomes in MCOs. OBJECTIVES: To (a) identify factors associated with clinical inertia in T2DM and (b) determine differences in A1c goal attainment between patients who experience clinical inertia versus treatment intensification in a commercially insured population. METHODS: Medical and pharmacy claims data were used to identify commercially insured patients in a regional MCO with a recorded A1c ≥ 8.0% between January 1, 2013, and December 31, 2015. In the 4 months following the first elevated A1c value (index date), patients were classified into 2 groups: treatment intensification or clinical inertia. Treatment intensification was defined as the addition of ≥ 1 new noninsulin antihyperglycemic medication, the addition of insulin, or a dose increase of any current noninsulin antihyperglycemic medication. Patients were required to have ≥ 1 follow-up A1c value 6-12 months after the index date and continuous enrollment in the health plan for 12 months before and after the index date. Patients were excluded if they had a diagnosis for gestational diabetes or type 1 diabetes or if they were on insulin in the pre-index period. The primary outcome of attaining A1c < 7.0% was compared between groups after propensity score matching (PSM). Factors associated with clinical inertia were identified using logistic regression. RESULTS: 3,078 patients, with a mean (SD) age of 54.4 (10.6) years and a mean (SD) baseline A1c of 9.6% (1.7), were included in the study. Of these, 1,093 patients (36%) experienced clinical inertia. After PSM, 1,760 patients remained; 880 in each group. In the clinical inertia group, 23% of patients achieved an A1c < 7.0% in the post-index period, compared with 35% in the treatment intensification group (P < 0.001). A greater likelihood of experiencing clinical inertia was associated with baseline treatment with 2 (OR = 1.51, 95% CI = 1.22-2.86; P < 0.001) or ≥ 3 (OR = 1.78, 95% CI = 1.30-2.42; P < 0.001) antihyperglycemic medications (vs. none), baseline age ≥ 65 years (OR = 2.11, 95% CI = 1.63-2.74; P < 0.001), and diagnosis of coronary heart disease (OR = 1.44, 95% CI = 1.10-1.88; P = 0.007). A baseline A1c ≥ 9.0% (vs. 8.0%-8.9%) was associated with a lower likelihood of experiencing clinical inertia (OR = 0.56, 95% CI = 0.48-0.66; P < 0.001). CONCLUSIONS: More than a third of patients in a commercially insured population with T2DM and a baseline A1c ≥ 8% experienced clinical inertia. Clinical inertia resulted in worse A1c outcomes over the 12-month follow-up period. Results of this study suggest that treatment intensification should be monitored, with efforts made to educate health care providers on strategies aimed at improving glycemic control for high-risk patients. DISCLOSURES: This study was funded by a grant from Janssen Scientific Affairs, which was involved in study design, interpretation of results, and manuscript review. Wander reports consulting fees from Sanofi Aventis outside the submitted work. McAdam-Marx reports grants from Sanofi Aventis and AstraZeneca outside the submitted work. Pesa and Bailey were employees of Janssen Scientific Affairs during the conduct of the study. Bailey also reports stock ownership in Johnson and Johnson. This study was presented as a poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Grapevine, TX.

Changing Patients' Treatment Preferences and Values with a Decision Aid for Type 2 Diabetes Mellitus: Results from the Treatment Arm of a Randomized Controlled Trial.

INTRODUCTION: Failure to intensify treatment for type 2 diabetes mellitus (T2DM) when indicated, or clinical inertia, is a major obstacle to achieving optimal glucose control. This study investigates the impact of a values-focused patient decision aid (PDA) for T2DM antihyperglycemic agent intensification on patient values related to domains important in decision-making and preferred treatments. METHODS: Patients with poorly controlled T2DM who were taking a metformin-containing regimen were recruited through physicians to access a PDA presenting evidence-based information on T2DM and antihyperglycemic agent class options. Participants' preferences for treatment, decision-making, and the relative importance they placed on various values related to treatment options (e.g., dosing, weight gain, side effects) were assessed before and after interacting with the PDA. Changes from baseline were calculated (post-PDA minus pre-PDA difference) and assessed in univariate generalized linear models exploring associations with patients' personal values. RESULTS: Analyses included 114 diverse patients from 27 clinics across the US. The importance of avoiding injections, concern about hypoglycemia, and taking medications only once a day significantly decreased after interacting with the PDA [- 1.1 (p = 0.002), - 1.3 (p < 0.001), - 1.1 (p = 0.004), respectively], while the importance of taking medications that avoided weight gain increased [0.8 (p = 0.004)]. Prior to viewing the PDA, most patients (58.8%) had not begun thinking about the decision of adding a medication, and few (12.3%) indicated that they had already made a decision. Post-PDA, 46.5% could state a medication preference. CONCLUSION: The values-focused PDA for T2DM medication intensification prepared patients to make a shared decision with their clinician and changed patients' values regarding what was important in making that decision. Helping patients understand their options and underlying values can promote shared decision-making and may reduce clinical inertia delaying treatment intensification. FUNDING: Janssen Scientific Affairs, LLC.

Real-world evaluation of Hba1c, blood pressure, and weight loss among patients with type 2 diabetes mellitus treated with canagliflozin: an analysis of electronic medical records from a network of hospitals in Florida.

OBJECTIVE: Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups. METHODS: Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012-February 15, 2017) from a network of hospitals in Florida. Quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected thresholds were HbA1c < 7%, BP < 140/90 mmHg, and weight loss ≥5%. Sub-groups included patients ≥65 years old, with African American race, with CANA dose increase, initiating CANA in an endocrinology setting, and initiating CANA in a primary care setting. RESULTS: Overall, 1,259 patients (mean age = 56.7 years; 51.2% female, 70.4% White) were identified. Among patients with a baseline HbA1c ≥ 7%, 16.1% had an HbA1c < 7% 3 months following CANA initiation, and the mean HbA1c decreased from 8.8% to 8.1%. Among patients with a baseline systolic BP ≥140 mmHg or diastolic BP ≥ 90 mmHg, 59.3% attained a systolic BP < 140 mmHg and 77.3% a diastolic BP < 90 mmHg after 3 months. HbA1c and BP responses were sustained through 12 months. The proportion of patients with a weight loss from baseline ≥5% increased from 17.0% at 3 months to 31.1% at 12 months. Consistent trends were observed for all sub-groups. CONCLUSIONS: In CANA-treated patients and patient sub-groups from a network of Florida hospitals, improvements in quality measures and response durability were similar to clinical trials and other real-world studies.

Real-world Clinical Outcomes Among Patients With Type 2 Diabetes Receiving Canagliflozin at a Specialty Diabetes Clinic: Subgroup Analysis by Baseline HbA1c and Age.

PURPOSE: Canagliflozin, a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM), has demonstrated effectiveness in patients with T2DM receiving care at a specialty diabetes clinic. We report the outcomes in these patients in subgroups classified by baseline hemoglobin A1c (HbA1c) and age. METHODS: This subgroup analysis was based on a review of data from the electronic health records of adults with T2DM who were prescribed canagliflozin at a specialty diabetes clinic and who returned for ≥1 follow-up office visit. Mean changes from baseline to the first and second follow-up office visits in HbA1c, body weight, and systolic and diastolic blood pressure (BP) were calculated in each subgroup classified by baseline HbA1c (≥7.0%, ≥8.0%, and >9.0%) and age (<65 and ≥65 years). FINDINGS: Of the 462 patients included in the study, 430, 305, and 169 patients had baseline HbA1c ≥7.0%, ≥8.0%, and >9.0%, respectively; 396 and 66 patients were aged <65 and ≥65 years, respectively. With canagliflozin use, patients across subgroups classified by baseline HbA1c and age experienced clinically and statistically significant reductions from baseline in HbA1c, body weight, and systolic BP that were sustained over 2 office visits; diastolic BP was also reduced across baseline HbA1c and age subgroups. Greater reductions in HbA1c were seen among the canagliflozin-treated patients with higher baseline HbA1c and among younger versus older patients. IMPLICATION: These findings from clinical practice demonstrate real-world effectiveness of canagliflozin in lowering HbA1c, body weight, and systolic BP among patients with T2DM, regardless of baseline HbA1c levels or age.

Glycemic Control Outcomes After Canagliflozin Initiation: Observations in a Medicare and Commercial Managed Care Population in Clinical Practice.

PURPOSE: Although the efficacy of canagliflozin has been well established in clinical trials, research regarding its use and impact on outcomes in clinical practice has been limited by the availability of data on observations up to and beyond 6 months after the initial use of canagliflozin. The purpose of this study was to evaluate changes in glycemic control after the initiation of canagliflozin use in a managed care population. METHODS: A retrospective cohort analysis in adults with type 2 diabetes mellitus was conducted using medical and pharmacy claims data and laboratory results from the Humana Research Database. The differences between hemoglobin (Hb) A1c levels pre- and postindex were assessed. Changes from pre- to postindex in the percentages of patients achieving glycemic control (eg, HbA1c <7% or <8%) were evaluated. HbA1c levels were also observed during days 31 to 90, 91 to 180, 181 to 270, and 271 to 360 postindex relative to preindex to assess the durability of HbA1c change over time. Analyses were conducted in the full cohort and in 3 subgroups: (1) HbA1c ≥7% at baseline; (2) age ≥65 years; (3) and Medicare members age ≥65 years and HbA1c ≥7% at baseline. FINDINGS: Among the 1562 patients meeting the study criteria, the mean HbA1c values pre- and postindex were 8.6% and 7.9%, respectively (P < 0.0001); in the subgroup with HbA1c ≥7% at baseline, these values were 8.9% and 8.0%; in the subgroup aged ≥65 years, 8.5% and 7.9%; and in the subgroup aged ≥65 years with HbA1c ≥7% at baseline, 8.8% and 8.1% (all subgroups, P < 0.001). The percentages of patients meeting glycemic-control thresholds (HbA1c <7%, <8%) were significantly greater at postindex in the full study cohort and in all 3 subgroups (all, P < 0.001). Based on longitudinal HbA1c results in the postindex periods, HbA1c reduction appeared durable across 12 months. IMPLICATIONS: The findings from this study suggest that treatment with canagliflozin is associated with improved glycemic control, as evidenced by HbA1c reduction and glycemic goal attainment. Even though not all patients had valid HbA1c measurements available in each quarter during the follow-up period, the reductions in mean HbA1c appeared durable across the postindex intervals. The observations from this majority Medicare Advantage with Prescription Drug sample and, more specifically, in the subgroups limited to patients aged ≥65 years are particularly informative for payers and providers managing or caring for patients of this age with diabetes.

Real-world Canagliflozin Utilization: Glycemic Control Among Patients With Type 2 Diabetes Mellitus-A Multi-Database Synthesis.

PURPOSE: Randomized controlled trials have found that treatment of type 2 diabetes mellitus with canagliflozin, a sodium glucose co-transporter 2 inhibitor, is associated with significant reductions in glycosylated hemoglobin (HbA1c) levels. However, very few studies have evaluated the effectiveness of sodium glucose co-transporter 2 inhibitors in a real-world context. This data synthesis aims to examine the demographic characteristics and glycemic control among patients treated with canagliflozin in clinical practice, using results obtained from 2 US-specific retrospective administrative claims databases. METHODS: Data included in the synthesis were derived from 2 large claims databases (the Optum Research Database and the Inovalon MORE(2) Registry, Research Edition) and were obtained from 3 recently published retrospective observational studies of adult patients with type 2 diabetes mellitus who were treated with canagliflozin. Two of the studies used the Optum database (3-month and 6-month follow-up) and 1 study used the Inovalon database (mean follow-up of 4 months). Patient demographic characteristics, clinical characteristics, treatment utilization, and achievement of glycemic goals at baseline and after canagliflozin treatment were evaluated across the 3 studies. Results were assessed using univariate descriptive statistics. FINDINGS: Baseline demographic characteristics were generally similar between the Optum and Inovalon cohorts. Mean baseline HbA1c was 8.7% in the Optum and 8.3% in the Inovalon cohort. Seventy-five percent of the Optum (3-month study) cohort and 74% of the Inovalon cohort used 2 or more antihyperglycemic agents. During follow-up, in both cohorts, the proportion of patients who achieved tight glycemic control (HbA1c <7.0%) more than doubled, while the proportion who had poor control (HbA1c ≥9.0%) decreased by approximately 50%. Among patients who had baseline HbA1c ≥7.0%, 21% of the Optum cohort and 24% of the Inovalon cohort achieved tight glycemic control (HbA1c <7.0%), and the proportion of patients achieving HbA1c <8.0% more than doubled in both cohorts (from 30% to 61% in the Optum cohort, and from 33% to 69% in the Inovalon cohort). IMPLICATIONS: This synthesis of real-world data from 2 large patient databases suggests that treatment of type 2 diabetes mellitus with canagliflozin is associated with significant and consistent improvements in glycemic control. Patients with varying HbA1c control and multiple antihyperglycemic agent use were able to lower their HbA1c levels with canagliflozin treatment. Additional studies with longer follow-up would be beneficial to evaluate the durability of the real-world effectiveness of canagliflozin.

Development of a patient decision aid for type 2 diabetes mellitus for patients not achieving glycemic control on metformin alone.

PURPOSE: To describe the process used to develop an evidence-based patient decision aid (PDA) that facilitates shared decision-making for treatment intensification in inadequately controlled type 2 diabetes mellitus (T2DM) consistent with International Patient Decision Aids Standards. METHODS: A PDA was developed by a multidisciplinary steering committee of clinicians, patient advocate, nurse, certified diabetes educators, and decision scientist, using a systematic development process. The process included defining the PDA scope and purpose, outlining the framework, content creation, and designing for integration into clinical practice. This was accomplished through a review of the literature and publically available educational materials and input from practicing clinicians and patients during development and iteratively refining content based on input. Patients with poorly controlled T2DM on metformin considering additional medication assessed the PDA during a pilot. RESULTS: Testing identified six preference-sensitive domains important for choosing T2DM treatment: degree of glycemic response, avoiding weight gain, hypoglycemia risk and other adverse events, avoiding injections, convenience of dose administration, blood glucose monitoring, and cost of therapy. Patient feedback guided content revision. Treatment options were offered after presenting medication class risk-benefit information and eliciting patient values, goals, and preferences. The PDA received the highest International Patient Decision Aids Standards global score to date, 88/100, with 100% of criteria fully met for the following dimensions: development process, disclosures, evaluation process, evidence quality, guidance for users, information quality, language/readability, testing, and eliciting patient values. CONCLUSION: A PDA was developed to help T2DM patients make decisions regarding medication choice. This approach may be applicable to other chronic conditions.

Demographic Disparities Among Medicare Beneficiaries with Type 2 Diabetes Mellitus in 2011: Diabetes Prevalence, Comorbidities, and Hypoglycemia Events.

This study describes demographic characteristics, comorbidities, and hypoglycemia events in patients with type 2 diabetes mellitus (T2DM) identified using 2011 Medicare 5% Standard Analytical Files. Among 1,913,477 Medicare beneficiaries, 367,602 (19.2%) had T2DM. T2DM prevalence increased with age and was higher in blacks (26.4%) and Hispanics (25.5%) than in whites (18.0%); and in Medicare/Medicaid dual-eligible versus non-dual-eligible patients (28.0% vs 17.2%, respectively). Compared with whites, diagnosed hypertension and diabetic retinopathy were more common in blacks and Hispanics, and lipid metabolism disorders and atrial fibrillation were less common. Hypoglycemia requiring health care services was more common in blacks (4.7%) and Hispanics (3.6%) compared with whites (2.9%). T2DM, related comorbidities, and hypoglycemia are burdensome to the Medicare population. Differences in these endpoints were observed based on race/ethnicity, age, and dual-eligible status, highlighting the importance of demographic factors when determining T2DM management strategies.

Improving access to shared decision-making for Hispanics/Latinos with inadequately controlled type 2 diabetes mellitus.

PURPOSE: To describe the cultural and linguistic adaptation and Spanish translation of an English-language patient decision aid (PDA) for use in supporting shared decision-making in Hispanics/Latinos with type 2 diabetes mellitus (T2DM), a group at a high risk for complications. PATIENTS AND METHODS: A steering committee of endocrinologists, a primary care physician, a certified diabetes educator, and a dietician, each with extensive experience in providing care to Hispanics/Latinos was convened to assess a PDA developed for English-speaking patients with T2DM. English content was reviewed for cultural sensitivity and appropriateness for a Hispanic/Latino population. A consensus-building process and iterative version edits incorporated clinician perspectives. The content was adapted to be consistent with traditional Hispanic/Latino cultural communication precepts (eg, avoidance of hostile confrontation; value for warm interaction; respect for authority; value of family support for decisions). The PDA was translated by native-speaking individuals with diabetes expertise. RESULTS: The PDA underwent testing during cognitive interviews with ten Spanish-speaking Hispanics/Latinos with T2DM to ensure that the content is reflective of the experience, understanding, and language Hispanic/Latino patients use to describe diabetes and treatment. Content edits were made to assure a literacy level appropriate to the audience, and the PDA was produced for online video dissemination. CONCLUSION: High-quality, well-developed tools to facilitate shared decision-making in populations with limited access to culturally sensitive information can narrow gaps and align care with individual patient preferences. A newly developed PDA is available for shared decision-making that provides culturally appropriate treatment information for inadequately controlled Hispanics/Latinos with T2DM. The impact on the overall health of patients and care management of T2DM requires further study.