Robert A. Bailey

Impact of hypoglycemia on patients with type 2 diabetes mellitus and their quality of life, work productivity, and medication adherence.

Background The purpose of this study was to determine the characteristics of adults with type 2 diabetes mellitus (T2DM) that correlate with greater risk of hypoglycemia and determine the impact of hypoglycemia on health-related quality of life, work productivity, and medication adherence from a patient perspective. Methods Data from a large web-based survey were retrospectively analyzed. Adults with a diagnosis of T2DM taking antihyperglycemic agents were included in the analysis. Participants with knowledge of their hypoglycemic history were divided into three groups: those experiencing recent hypoglycemia (previous 3 months), those experiencing nonrecent hypoglycemia, and those never experiencing hypoglycemia. Results Of the participants with T2DM taking antihyperglycemic agents who were knowledgeable of their hypoglycemia history, 55.7% had ever experienced hypoglycemia. Of those, 52.7% had recent hypoglycemia. Compared with those who never experienced hypoglycemia, those who experienced hypoglycemia tended to: be younger; be more aware of their glycated hemoglobin (HbA1c) levels; have higher HbA1c levels; have a higher body mass index; have higher Charlson Comorbidity Index scores; be on insulin, sulfonylureas, and/or glucagon-like peptide-1 agonists; and be less adherent to their antihyperglycemic agents. Hypoglycemia interfered with social activities, caused more missed work (absenteeism), more impairment while at work (presenteeism), and decreased overall work productivity compared with patients who had never experienced hypoglycemia. Overall health-related quality of life, as determined by the Short Form-36 health questionnaire, was negatively impacted by hypoglycemia. Both Physical and Mental Summary scores were significantly lower for the recent hypoglycemia and nonrecent hypoglycemia groups compared with the never hypoglycemia group. Conclusion Hypoglycemia can negatively impact many aspects of life. Greater awareness of those who are at risk for developing hypoglycemia can lead to the development of measures (eg, patient and physician education) to prevent future hypoglycemia episodes.

Characterization of type 2 diabetes mellitus burden by age and ethnic groups based on a nationwide survey.

BACKGROUND Type 2 diabetes mellitus (T2DM) is the most common form of diabetes. Risk factors for its development include older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. OBJECTIVE The purpose of this study was to characterize T2DM burden, from a patient perspective, with respect to age and race/ethnicity. METHODS Adults aged ≥18 years with T2DM from a large, Internet-based, nationwide survey were retrospectively analyzed. Demographic and clinical characteristics (glycemic control, body mass index [BMI], comorbidities, and diabetes-related complications), hypoglycemic episodes, and medication adherence were used to assess diabetes burden. Degree of burden was compared across age (18-64, 65-74, and ≥75 years) and racial/ethnic (white, African American, Hispanic, Asian, and American Indian) groups. RESULTS An apparent association was found between glycemic control and medication adherence. Hispanics had the lowest percentage of participants with a hemoglobin A1c (HbA1c) level <7.0% (24.4%) and the highest percentage of those not knowing their HbA1c levels (55.4%) but also had the poorest medication adherence among racial/ethnic groups. Conversely, American Indians and whites had the best glycemic control, HbA1c knowledge, and medication adherence. The 18- to 64-year age group had the poorest glycemic control (28.8%), the most with unknown HbA1c levels (46.3%), and the poorest medication adherence of the age groups. Mean BMIs were high (>30 mg/kg(2)) for all racial/ethnic groups other than the Asian group (28.9 mg/kg(2)). Approximately 71% of Asians were obese or overweight compared with ≥90% in the other racial/ethnic groups. Mean BMIs decreased with increasing age group (34.5, 32.6, and 29.8 kg/m(2) for the age groups of 18-64, 65-74, and ≥75 years, respectively). Regarding diabetes-related comorbidities, the Asian group had the lowest percentages of those with hypertension (39.1%) and hypercholesterolemia (46.6%). The Asian group had the lowest mean Charlson Comorbidity Index (CCI) score (score of 1.4); the American Indian group had the highest CCI score (score of 1.8). Of the age groups, the 65- to 74-year group had the highest percentages of those with hypertension (69.0%) and hypercholesterolemia (67.4%). The mean CCI scores in the 65- to 74-year and ≥75-year age groups (scores of 1.8 for both) were significantly higher than in the 18- to 64-year age group. The Asian group had the lowest percentage of participants reporting hypoglycemia (37.3%). The 18- to 64-year age group had the highest percentage of participants reporting hypoglycemia (52.7%). Limitations of this study include selection bias (Internet-based survey), recall bias, missing values, and descriptive analyses without adjustment for multiplicity. CONCLUSION There are many factors that contribute to diabetes burden and the complexity of diabetes management. The results of this study provide insight from a patient perspective regarding how these factors vary across age and race/ethnicity to aid in the individualization of diabetes treatment.

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

BackgroundAmong 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).MethodsData 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.Results838 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.ConclusionsAfter 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.

An observational study of glycemic control in canagliflozin treated patients

Abstract Objective: To evaluate changes in glycemic control following the initial canagliflozin pharmacy claim in a real-world population. Research design and methods: A retrospective cohort analysis of adult patients with type 2 diabetes mellitus (T2DM) was conducted using 2013 medical, pharmacy and laboratory claims from the Inovalon MORE2 Registry. Patients with T2DM aged ≥18 years with ≥60 days of canagliflozin supply and HbA1c test results within 120 days before and ≥60 days after initial canagliflozin claim (defined as index date) were included. The differences between HbA1c levels pre- and post-index were assessed. Changes pre- and post-index in Healthcare Effectiveness Data and Information Set (HEDIS) glycemic control criteria of HbA1c <7% and <8% and poor control of HbA1c >9% were evaluated. Subgroup analyses of patients with HbA1c >7% at baseline and patients aged ≥65 were also conducted. Results: Among the 268 patients meeting the study criteria, mean HbA1c pre-index was 8.3% and post-index was 7.6%; the mean reduction in HbA1c pre–post index was 0.7% (95% CI: 0.6%, 0.9%). The proportions of patients meeting the HEDIS glycemic control measures (HbA1c <7%, <8% and poor control of >9%) improved and was significantly different pre- and post-index (all p < 0.001). Of the patients with an HbA1c >7% prior to index (81% of the cohort; mean pre-index HbA1c = 8.8%), HbA1c was reduced by 0.9% (95% CI: 0.8%, 1.1%). The aged ≥65 subgroup consisted of 15% of the cohort, with a pre-index HbA1c of 8.3%. The mean reduction in HbA1c test results pre- and post-canagliflozin index was 0.6% (95% CI: 0.4%, 0.9%). This analysis did not adjust for changes in antihyperglycemic agents during the study period. Conclusion: Patients with T2DM were observed to have improved glycemic control following initial canagliflozin pharmacy claim as measured by HbA1c change and attainment of specific glycemic control criteria.

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.

Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials.

PURPOSE This post hoc analysis evaluated attainment of diabetes-related composite quality measures (CQMs) with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus (T2DM). We used pooled data from two 52-week Phase III clinical trials evaluating the efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg. METHODS CQMs assessed included the combined attainment of glycosylated hemoglobin (HbA1c), blood pressure (BP), and LDL-C. To assess on-treatment differences at 52 weeks, odds ratios (ORs) and associated 95% CIs were calculated based on a logistic regression model. CQM attainment was assessed in the overall population and for patients with a body mass index ≥25 kg/m(2) at baseline. FINDINGS Overall, baseline demographic and disease characteristics were comparable across treatment groups. Proportions of patients with T2DM meeting the CQMs HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL and HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL were similar at baseline. After 52 weeks of treatment, the proportion of patients meeting both CQMs was similar for canagliflozin 100 mg and sitagliptin 100 mg, and favored canagliflozin 300 mg versus sitagliptin 100 mg. For canagliflozin 300 mg, the OR was 1.79 (95% CI, 1.25-2.58) for the CQM HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL; the OR was 1.49 (95% CI, 1.15-1.92) for the CQM HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL. CQM attainments for patients with a body mass index ≥25 kg/m(2) were similar to those for the overall population. IMPLICATIONS At 52 weeks of treatment, this analysis observed comparable CQM attainment for canagliflozin 100 mg, and superior CQM attainment for canagliflozin 300 mg, compared with sitagliptin 100 mg. ClinicalTrials.gov identifiers are NCT01106677 and NCT01137812.

Healthcare costs associated with nephrology care in pre-dialysis chronic kidney disease patients

Abstract Objective: To compare the healthcare costs of pre-dialysis chronic kidney disease (CKD) patients cared for in a nephrology clinic setting versus other care settings. Methods: An analysis of health claims between 01/2002 and 09/2007 from the Ingenix Impact Database was conducted. Inclusion criteria were ≥18 years of age, ≥1 ICD-9 claim for CKD, and ≥1 estimated glomerular filtration rate (eGFR) value of <60 mL/min/1.73 m2. Patients were classified in the nephrology care cohort if they were treated in a nephrology clinic setting at least once during the study period. Univariate and multivariate analyses were conducted to compare average annualized healthcare costs of patients in nephrology care versus other care settings. Results: Among the 20,135 patients identified for analysis, 1,547 patients were cared for in a nephrology clinic setting. Nephrology care was associated with lower healthcare costs with an unadjusted cost savings of

Economic simulation of canagliflozin and sitagliptin treatment outcomes in patients with type 2 diabetes mellitus with inadequate glycemic control

3,049 (

Comparative Multidatabase Analysis of Dosing Patterns and Infusion Intervals for the First 12 Infliximab Infusions in Patients With Rheumatoid Arthritis

11,303 vs.

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

14,352, p = 0.0014) and a cost ratio of 0.8:1 relative to other care settings. After adjusting for covariates, nephrology care remained associated with lower costs (adjusted cost savings: