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Aims: To characterize survival in relation to achieved glycated haemoglobin (HbA1c) level within alternative glucose-lowering regimens with differing risks of hypoglycaemia., Methods: Data were extracted from the UK Clinical Practice Research Datalink and the corresponding Hospital Episode Statistics. Patients with type 2 diabetes prescribed glucose-lowering therapy in monotherapy or dual therapy with metformin between 2004 and 2013 were identified. Risk of all-cause mortality within treatment cohorts was evaluated using the Cox proportional hazards model, introducing mean HbA1c as a quarterly updated, time-dependent covariable., Results: There were 6646 deaths in a total follow-up period of 374 591 years. Survival for lower (<7%) vs moderate HbA1c levels (≥7%, <8.5%) differed by cohort: metformin, adjusted hazard ratio (aHR) 1.03 (95% confidence interval [CI] 0.95-1.12); sulphonylurea, aHR 1.11 (95% CI 0.99-1.25); insulin, aHR 1.47 (95% CI 1.25-1.72); combined regimens with low hypoglycaemia risk, aHR 1.02 (95% CI 0.94-1.10); and combined regimens with higher hypoglycaemia risk excluding insulin, aHR 1.24 (95% CI 1.13-1.35) and including insulin, aHR 1.28 (95% CI 1.18-1.37). Higher HbA1c levels were associated with increased mortality in regimens with low hypoglycaemia risk. Post hoc analysis by HbA1c deciles revealed an elevated risk of all-cause mortality for the lowest deciles across all cohorts, but particularly in those regimens associated with hypoglycaemia. High HbA1c was associated with no difference, or a small increase in mortality risk in regimens with increased risk of hypoglycaemia., Conclusions: The pattern of mortality risk across the range of HbA1c differed by glucose-lowering regimen. Lower HbA1c was associated with increased mortality risk compared with moderate control, especially in those regimens associated with hypoglycaemia. High levels of HbA1c were associated with the expected elevated mortality risk in regimens with low hypoglycaemia risk., (© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Aims: To investigate the discontinuation of oral antihyperglycemic agents (OHA), and examine factors associated with OHA discontinuation, and the effect of OHA discontinuation on glycemic control and healthcare utilization among diabetes patients prescribed dual OHA therapy., Methods: We identified 23,612 adult patients aged >18years with a diagnosis of type 2 diabetes who initiated dual OHA therapy between 1/1/2005 and 6/30/2010. The date of initiation of the second OHA was defined as the index date. Discontinuation was defined as a gap >1.5 times the last days' supply without subsequent reinitiation., Results: Over 24months, 16.9% discontinued 1 OHA and 9.2% discontinued both. Patients who discontinued were more likely to be female, younger, Black or of Hispanic ethnicity, have more comorbidities, higher medication co-pays, start both OHAs together, have higher healthcare utilization before the index date and less likely to use prescription mail order compared with patients who did not discontinue. In multivariable regression models, patients who discontinued were more likely to be hospitalized or have emergency department visits during follow-up., Conclusions: Discontinuation of OHAs is common among patients with diabetes and is associated with several patient factors and increased healthcare utilization. Future research should further examine reasons for OHA discontinuation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Hospital inpatient care for patients with diabetes was estimated to cost $76 billion in 2012. Substantial expense resulted from those patients having multiple hospitalizations. The objective was to compare the risk for diabetes-related hospital readmission in patients with type 2 diabetes treated with sulfonylureas (SUs) compared to those treated with other oral antihyperglycemic agents (AHAs)., Methods: A retrospective cohort analysis was conducted using two-year panels, from 1999 to 2010, from the Medical Expenditure Panel Survey. The study included patients with type 2 diabetes taking an oral AHA who experienced a diabetes-related hospitalization. A Cox proportional hazard regression predicting time to readmission was used to estimate and compare the risks of readmission for SU-monotherapy versus other-AHA-monotherapy patients. Covariates included age, gender, marital status, cardiovascular disease, kidney disease, and eye disease, along with a propensity score to control for selection bias. The lack of clinical data on disease severity and progression limited our ability to estimate causal relationships between drug use and risk of hospital readmission., Results: From 1999 to 2010, an estimated 13.5 million patients experienced a diabetes-related hospital admission and subsequent AHA treatment. While 23.2 % (n = 746,579) of patients in the SU monotherapy cohort had a readmission, only 16.1 % (n = 881,984) in the other-AHA monotherapy group were readmitted. Average readmission expenditure for readmitted SU users (in 2010 dollars) was $11,148 (±$1,558) compared to $7,673 (±$763) for users of other oral AHAs. The estimated readmission hazard ratio was 1.29 (95 % CI: 1.01-1.65; p-value = 0.04) for SU monotherapy users. If a patient's first hospital admission was during the time period 2008-2010, a readmission was significantly less likely (HR 0.49, 95 % CI: 0.31-0.78; p = 0.003) relative to 2004-2007., Conclusions: Among patients with type 2 diabetes, SU use was associated with an approximately 30 % increased risk for readmission compared to other-AHA use, while each readmission for an SU user cost on average 45 % more than one for an other-AHA patient. Because of the rapidly rising prevalence of diabetes in the U.S. and the large number of patients with prediabetes, preventing hospital readmissions will continue to be an important cost-saving strategy in the future.

Aim: In elderly Americans with type 2 diabetes, use of insulin and oral antidiabetic drugs (OADs) accounts for almost one-fourth of drug adverse event-related hospitalizations. It is not clear, however, if sulfonylureas (SUs), frequently prescribed OADs known to cause hypoglycemia, increase the risk of emergency room (ER) visits compared to other OADs. The aim of this study was to compare the emergency room utilization between US elderly patients with diabetes on SU monotherapy vs. other non-SU monotherapies., Methods: This retrospective cohort study was conducted using MarketScan(®) database (2009-10) and aimed to evaluate the association between use of SU and ER visits. The analysis included 28,533 patients (aged ≥65 years) receiving SU monotherapy at baseline and 1:1 propensity score (PS)-matched group receiving monotherapy with other OADs. ER utilization was determined during a 1-year follow-up period., Results: The SU and non-SU groups were overall well balanced after PS matching. The mean (SD) number of ER visits during the follow-up was 0.56 among users of SU users compared to 0.49 (P<0.0001) among non-users. In multivariable analysis, the adjusted odds ratios for ≥2 ER visits were 1.21 (95% CI=1.13-1.30) comparing SU users to non-users and 1.31 (95% CI=1.21-1.41) for SU vs. metformin users., Conclusion: Elderly patients with type 2 diabetes on SU monotherapy were more likely to use ER than those on other monotherapies. Further studies are needed to confirm our findings and evaluate other factors associated with ER visits., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Both increased age and type 2 diabetes mellitus are risk factors for developing bone fractures. While recent data in the elderly suggest a link between hypoglycemia and fall-related fractures, the association between sulfonylureas, commonly used hypoglycemic agents, and fracture risk has not been well investigated., Methods: We used patient data from a large commercial health insurer from 2002-2005. Individuals aged ≥65 years receiving oral sulfonylurea treatment (n=13,195) were matched 1:1 to non-users based on propensity for sulfonylurea use. Multivariable conditional logistic regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (CIs)., Results: During an average 4 years of follow-up, sulfonylurea users experienced 226 incident hip fractures (1.7%) and non-users experienced 157 (1.2%). Sulfonylurea use was associated with increased risk of developing hip fracture (aOR 1.46, 95% CI 1.17-1.82), and this association was apparent for men (120 cases; aOR 1.83, 95% CI 1.25-2.66) and women (263 cases; aOR 1.32, 95% CI 1.03-1.69). Patients with documented hypoglycemia in the follow-up period had increased odds of hip fracture relative to those without such diagnosis (aOR 2.42, 95% CI 1.35-4.34)., Conclusion: Sulfonylureas are associated with increased risk of hip fracture in elderly men and women with type 2 diabetes.

Objective: To estimate overall rates of adherence, persistence, and discontinuation for patients with type 2 diabetes mellitus (T2DM) prescribed oral antihyperglycemic agents (OAHAs) by combining results of published studies., Research Design and Methods: A systematic literature review was conducted to identify articles published in English over the last 10 years evaluating the use of OAHAs for the treatment of T2DM. Databases searched included PubMed/MEDLINE, EMBASE, and the Cochrane Library. Seventy studies reporting adherence, persistence or discontinuation were identified by two independent reviewers and 40 reported relevant endpoints for the analysis. Outcomes included: (1) mean adherence defined as the average medication possession ratio (MPR); (2) proportion of adherent patients (MPR ≥ 80%); (3) discontinuation; and (4) persistence. Adherence and persistence were reported in observational studies only. Discontinuation was examined separately in randomized controlled trials (RCTs) and observational studies. Meta-analyses were conducted using both fixed and random effects models. When meta-analysis was not appropriate for a given outcome, descriptive statistics were provided., Results: The pooled mean MPR (95% confidence interval [CI]) was 75.3% (68.8%-81.7%; n = 13) and the proportion of adherent patients (95% CI) was 67.9% (59.6%-76.3%; n = 12). The discontinuation rate (95% CI) in RCTs was 31.8% (17.0%-46.7%; n = 7). Persistence and discontinuation were not assessed via meta-analysis for observational studies due to the limited number of available studies and differences in outcome definitions. In these studies, persistence estimates ranged from 41.0% to 81.1%, with a mean (95% CI) of 56.2% (46.1%-66.3%; n = 6), while discontinuation estimates ranged from 9.9% to 60.1%, with a mean (95% CI) of 31.4% (17.6%-45.3%; n = 6)., Limitations: Limitations include (1) the use of MPR as a proxy for adherence, (2) limited number of studies available, and (3) observed heterogeneity., Conclusion: The results of the analysis demonstrate that medication adherence, persistence, and discontinuation rates are suboptimal in patients with T2DM prescribed OAHAs.

Background: Patients with type 2 diabetes on metformin monotherapy frequently require treatment intensification with another anti-hyperglycemic medication over time. Previous studies have indicated that a high proportion of patients with diabetes have a significant delay in the initiation of oral add-on therapy after metformin alone fails to achieve targeted glycemic control. In this study, we evaluated the impact of the timing of treatment intensification with oral add-on drug on glycemic goal attainment among diabetic patients failing metformin monotherapy., Research Design and Methods: Using the General Electric (GE) Centricity Electronic Medical Record database (January 2004 through December 2009), we identified 5,870 patients with type 2 diabetes with treatment failure on metformin monotherapy - defined by a glycosylated hemoglobin (HbA1c) of ≥7.5% (index date). This cut-off of ≥7.5% (trigger HbA1c) was chosen rather than that of >7.0% to ensure that selected patients were more likely to be indicated for treatment intensification with add-on drug. Continuous enrollment of one year prior and two years after index date was required to be included in the study. Add-on treatment was defined as prescription of second oral agent from any available therapeutic classes while continuing metformin. Early treatment intensification was defined as initiation of oral add-on therapy within 3 months (n=1,012) of index date while late intensification was defined as add-on initiation between 10 and 15 months after index date (n=461). The study outcome was defined as glycemic goal attainment (HbA1c<7%), which was evaluated between 18 and 24 months after index date., Results: Our results suggested that at the end of the follow-up period, 47.2% of patients in the early add-on group were at glycemic goal compared to 41.7% in the late add-on group (p=0.039). In a multivariable logistic regression model that accounted for age, gender, trigger HbA1c level, Charlson comorbidity index, anti-hypertensive and anti-hyperlipidemic drug use and history of cardiovascular disease, the adjusted odds ratio (OR) for glycemic goal attainment was 1.36 (95% confidence intervals [CI]: 1.09-1.72) comparing early add-on to late add-on treatment. This association was stronger among patients with higher trigger HbA1c at baseline; ORs of 1.53 (95% CI: 1.08-2.19) for HbA1c ≥8% and 2.63 (95% CI: 1.40-5.27) for HbA1c ≥9%., Conclusion: These results suggest that earlier use of oral add-on drug in treatment regimen helps better achieve glycemic goal attainment in patients with metformin failure. Future studies should evaluate whether earlier treatment intensification is also associated with longer term health outcomes such as risk of microvascular and macrovascular complications., (Copyright © 2014 Elsevier Inc. All rights reserved.)