Determinants of glycaemic control in a practice setting: the role of weight loss and treatment adherence (The DELTA Study).

AIMS: Examine the association between weight loss and adherence with glycaemic goal attainment in patients with inadequately controlled T2DM. MATERIALS AND METHODS: Patients ≥ 18 years with T2DM from a US integrated health system starting a new class of diabetes medication between 11/1/10 and 4/30/11 (index date) with baseline HbA1c ≥ 7.0% were included in this cohort study. Target HbA1c and weight change were defined at 6-months as HbA1c < 7.0% and ≥ 3% loss in body weight. Patient-reported medication adherence was assessed per the Medication Adherence Reporting Scale. Structural equation modelling was used to describe simultaneous associations between adherence, weight loss and HbA1c goal attainment. RESULTS: Inclusion criteria were met by 477 patients; mean (SD) age 59.1 (11.6) years; 50.9% were female; 30.4% were treatment naïve; baseline HbA1c 8.6% (1.6); weight 102.0 kg (23.0). Most patients (67.9%) reported being adherent to the index diabetes medication. At 6 months mean weight change was -1.3 (5.1) kg (p = 0.39); 28.1% had weight loss of ≥ 3%. Mean HbA1c change was -1.2% (1.8) (p< 0.001); 42.8% attained HbA1c goal. Adherent patients (OR 1.70; p = 0.02) and diabetes therapies that lead to weight loss (metformin, GLP-1) were associated with weight loss ≥ 3% (OR 2.96; p< 0.001). Weight loss (OR 3.60; p < 0.001) and adherence (OR 1.59; p < 0.001) were associated with HbA1c goal attainment. CONCLUSIONS: Weight loss ≥ 3% and medication adherence were associated with HbA1c goal attainment in T2DM; weight loss was a stronger predictor of goal attainment than medication adherence in this study population. It is important to consider weight-effect properties, in addition to patient-centric adherence counselling, when prescribing diabetes therapy.

Predictors of oral bisphosphonate prescriptions in post-menopausal women with osteoporosis in a real-world setting in the USA.

SUMMARY: We identified factors associated with oral bisphosphonate treatment in 50+-year-old female patients with a first fracture, osteoporosis diagnosis, or BMD < or =-2.5 in the Geisinger Health System electronic health record database. Treatment was positively associated with age, oral corticosteroids, and smoking, and negatively associated with body mass index and bone mineral density scores. INTRODUCTION: To identify factors associated with oral bisphosphonate treatment in patients with an indicator for post-menopausal osteoporosis. METHODS: Females age 50+ years with a first fracture, osteoporosis diagnosis, or bone mineral density (BMD) < or =-2.5 (index date) were identified in the Geisinger Health System electronic health record database. Treatment was defined as an oral bisphosphonate prescription order (risedronate sodium, ibandronate sodium, or alendronate) < or =90 days post-index date. Treatment rates were assessed and a multivariate logistic model was used to identify predictors of treatment separately for patients with fracture (FRAC) and with diagnosis or low BMD (ICD-9-BMD). RESULTS: The FRAC group had 2,003 female patients with a mean (SD) age of 69.0 (+/-11.3) years and the ICD-9-BMD group had 12,976 female patients with a mean (SD) age of 66.9 (+/-10.0) years. Within 90 days of the index date of fracture, diagnosis, or low BMD score, 188 (9.4%) patients in the FRAC group and 5,395 (41.6%) in the ICD-9-BMD group received treatment. Treatment was positively associated with age and oral corticosteroids and negatively associated with body mass index and subsequent BMD in both groups. Smoking currently was positively associated with treatment in the ICD-9-BMD group. CONCLUSION: Certain patient characteristics are predictors of physicians prescribing oral bisphosphonates. However, many patients remain untreated.

Analysis of glycaemic control and weight change in patients initiated with human or analog insulin in an US ambulatory care setting.

BACKGROUND: Insulin is a mainstay in the treatment of type 1 diabetes and is a recommended option in patients with type 2 diabetes who fail to maintain glycaemic control on other non-insulin therapies. The purpose of this study was to describe patient characteristics and evaluate changes in glycaemic control and weight in patients treated with insulin in an ambulatory care setting. METHODS: Patients with diabetes were identified from the General Electric electronic medical record (EMR) database (1 September 2004 to 30 April 2008). Patients were > or =18 years, insulin naive, newly treated with monoinsulin therapy (index date). Baseline characteristics were identified overall and stratified by insulin type (basal, mixed, and rapid). Basal insulins were described by human versus analog and for insulin detemir and insulin glargine. Change in haemoglobin A1C (HbA1C) and weight from baseline (45 days pre- to 15 days postindex date) to 6 months (+/-90 days) were compared. Regression analyses were used to evaluate HbA1C outcomes across insulins and for the likelihood of gaining 0.9 kg (2 lbs) for detemir versus glargine controlling for baseline characteristics. RESULTS: A total of 12 136 patients were included. A majority were initiated on a basal insulin (64.7%) followed by mixed (20.8%) and rapid (14.4%). Basal users had significantly higher mean body weight and lower mean baseline HbA1C than mixed users (p < 0.001 for all), and were significantly older, had higher baseline HbA1C and higher baseline body mass index (BMI) than rapid insulin users (p < 0.001 for all). Glargine patients had a significantly higher mean baseline HbA1C (p = 0.003) than detemir patients. The adjusted reduction in HbA1C was greater for rapid insulin than for mixed or basal insulin (p < or = 0.05). The adjusted differences in HbA1C between basal human and basal analog insulins and between detemir and glargine were not statistically significant (p > 0.05). Patients using detemir were 30% less likely to gain 0.9 kg or more than glargine users (p < 0.05). CONCLUSIONS: HbA1C outcomes in the ambulatory care setting were generally not different between insulin classes. The likelihood of weight gain was less with insulin detemir than with insulin glargine. Thus, real-world weight outcomes for basal analog insulin may differ by specific product.

Six-month outcomes on A1C and cardiovascular risk factors in patients with type 2 diabetes treated with exenatide in an ambulatory care setting.

AIM: This study evaluated changes in clinical effectiveness measures of patients with type 2 diabetes initiating exenatide therapy in a real-world setting. METHODS: Eligible patients identified in the General Electric (GE) electronic medical record (EMR) research database from 1 January 2000 through 31 December 2007 were > or =18 years old with type 2 diabetes. Patients had prescription orders in the previous 395 days for metformin, a sulfonylurea, or a thiazolidinedione as monotherapy or in combination, and had at least 6 months of follow-up activity. Baseline clinical measures were documented from 45 days prior up to 15 days after exenatide initiation and follow-up measures documented at 6 months +/- 45 days. RESULTS: A total of 1709 patients were identified for study inclusion. The overall mean A1C reduction (s.e.m.) at 6 months was -0.8% (0.05) (p<0.001), weight loss was -3.2 kg (0.14) (p<0.001), blood pressure (BP) lowering was -1.9 mmHg (0.46) systolic blood pressure (SBP) (p<0.001) and -0.5 mmHg (0.27) diastolic blood pressure (DBP) (p = 0.078). Changes in low-density lipoprotein (LDL), triglycerides and HDL were -7.4 mg/dl (1.7) (p<0.001), -23.2 mg/dl (6.7) (p = 0.001) and -0.8 mg/dl (0.33) (p = 0.012) respectively. In a quartile analysis by weight loss, mean A1C reduction ranged from -1.1 to -0.65% in the highest to lowest weight loss quartiles respectively. CONCLUSIONS: In a real-world setting, exenatide initiation is associated with significant improvements in the measures of clinical effectiveness for type 2 diabetes. These reductions were comparable to those reported in randomized, controlled registration trials after 6 months of therapy.

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes.

OBJECTIVE: To quantify adverse events (AEs) associated with the use of metformin (MET), sulphonylureas (SUs) and thiazolidinediones (TZDs) in a usual care setting, and to assess the relationship of AEs to treatment patterns and glycaemic response in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: An electronic medical record database was used to identify patients with type 2 diabetes age >or=18 years from 1996 to 2005. Patients naïve to oral antidiabetic therapy were followed for 395 days postinitiation of MET, SU or TZD treatment. AEs related to study drugs were evaluated during the follow-up period. Baseline and follow-up A1C levels were compared by drug regimen. Associations between the change in A1C, drug regimen changes and AEs were evaluated. RESULTS: A total of 14,512 patients (mean age 60.8 years, 52.9% female) were identified. During the follow-up period, 12.7% of patients experienced an AE (8.6% MET, 15.9% SU and 19.8% TZD patients). SU and TZD patients were more likely to experience an AE than MET (p < 0.001) patients. AEs did not significantly influence A1C outcomes, although MET and SU patients experiencing an AE were more likely to add-on therapy (odds ratio (OR) = 1.34 and OR = 1.37, respectively; p < 0.05) than those without an AE. MET patients with AEs were more likely to switch therapy (OR = 1.91; p < 0.05) than those without an AE. CONCLUSIONS: The occurrence of AEs did not significantly impact glycaemic response to therapy. However, AEs may lead to greater treatment switches for patients receiving MET and add-on therapy for MET-treated and SU-treated patients.