McCoy, Rozalina G.

OBJECTIVE To examine whether glucagon-like peptide 1 receptor agonists (GLP-1RA) and sodium–glucose cotransporter 2 inhibitors (SGLT2i) are preferentially initiated among patients with cardiovascular disease, heart failure (HF), or nephropathy, where these drug classes have established benefit, compared with dipeptidyl peptidase 4 inhibitors (DPP-4i), for which corresponding benefits have not been demonstrated. RESEARCH DESIGN AND METHODS We retrospectively analyzed claims of adults with type 2 diabetes included in OptumLabs Data Warehouse, a deidentified database of commercially insured and Medicare Advantage beneficiaries, who first started GLP-1RA, SGLT2i, or DPP-4i therapy between 2016 and 2019. Using multinomial logistic regression, we examined the relative risk ratios (RRR) of starting GLP-1RA and SGLT2i compared with DPP-4i for those with a history of myocardial infarction (MI), cerebrovascular disease, HF, and nephropathy after adjusting for demographic and other clinical factors. RESULTS We identified 75,395 patients who started GLP-1RA, 58,234 who started SGLT2i, and 91,884 who started DPP-4i. Patients with prior MI, cerebrovascular disease, or nephropathy were less likely to start GLP-1RA rather than DPP-4i compared with patients without these conditions (RRR 0.83 [95% CI 0.78–0.88] for MI, RRR 0.77 [0.74–0.81] for cerebrovascular disease, and RRR 0.87 [0.84–0.91] for nephropathy). Patients with HF or nephropathy were less likely to start SGLT2i (RRR 0.83 [0.80–0.87] for HF and RRR 0.57 [0.55–0.60] for nephropathy). Both medication classes were less likely to be started by non-White and older patients. CONCLUSIONS Patients with cardiovascular disease, HF, and nephropathy, for whom evidence suggests a greater likelihood of benefiting from GLP-1RA and/or SGLT2i therapy, were less likely to start these drugs. Addressing this treatment/benefit paradox, which was most pronounced in non-White and older patients, may help reduce the morbidity associated with these conditions.

Diabetes mellitus is considered to be a coronary heart disease (CHD) equivalent, with heart disease and stroke accounting for the majority of diabetes-related deaths. As a result, patients with diabetes require aggressive treatment of CHD risk factors, including dyslipidemia. In addition to targeted reduction of LDL cholesterol, current guidelines recommend addition of a fibrate (gemfibrozil, fenofibrate, or clofibrate) in patients with established CHD and atherogenic dyslipidemia: triglycerides (TG) 200-499 mg/dL and HDL cholesterol (HDL-C) ≤40 mg/dL. Fibrates have also been recommended for patients with TG ≥500 mg/dL to reduce risk of acute pancreatitis. Yet, data supporting the use of fibrates in these settings remains variable and inconclusive. We therefore sought to provide an in-depth analysis of patterns of fibrate use among patients with type 2 diabetes between 2001 and 2010. Using Ingenix administrative claims, we identified 71,161 patients age ≥18 years old with an established diagnosis of type 2 diabetes (ICD-9 250.XX) and ≥3 years of continuous enrollment who were newly initiated on a fibrate between 2001 and 2010. Lab results were available for a subset of 18,863 (26.5%) patients, who were included in final analysis. During each 2-year period, between 77.6% - 84.1% of patients had a lipid test performed within the preceding 12 months (p=0.59 for change in testing over time). The prevalence of atherogenic dyslipidemia increased over time, from 20.8% (2001-2002) to 41.2% (2009-2010); 4.84% rise per 2-year period (p=0.002). The prevalence of severe atherogenic dyslipidemia (HDL-C ≤40 mg/dL and TG ≥500 mg/dL), also increased over time, from 9.3% in 2001-2002 to 13.6% in 2009-2010; 1.17% rise per 2-year period (p=0.002). In contrast, percent of patients with TG ≥500 mg/dL decreased over time, from 20.5% in 2001-2002 to 16.7% in 2009-2010; 1.19% decline per 2-year period (p=0.03). Initiation of new fibrate therapy in treatment naïve patients with diabetes remained constant; 2.0% in 2001-2002 and 1.6% in 2009-2010 (p=0.93). Subgroup analysis of patients with atherogenic dyslipidemia also showed no significant change in fibrate initiation over time; 11.4% in 2001-2002 and 15.7% in 2009-2010 (p=0.3). Similarly, while there was a trend toward increased initiation of fibrates among patients with TG ≥500 mg/dL, this trend was not statistically significant (27.4% in 2001-2002 and 41.6% in 2009-2010; 3.34% change per 2-year period (p=0.09)). In conclusion, the prevalence of atherogenic dyslipidemia among patients with type 2 diabetes has increased significantly over the past decade. However, fibrate use in all patients with type 2 diabetes, including those specifically with atherogenic dyslipidemia, has remained constant throughout the observation period, despite lack of conclusive evidence supporting its use.

Introduction Observational studies constitute an important evidence base for hypoglycemia in diabetes management. This requires consistent and reliable ascertainment and reporting methodology, particularly in studies of type 2 diabetes where hypoglycemia risk is heterogeneous. Therefore, we aimed to examine the definitions of hypoglycemia used by observational studies of patients with type 2 diabetes. Research design and methods We conducted a meta-epidemiological review of observational studies reporting on hypoglycemia or evaluating glucose-lowering medications in adults with type 2 diabetes. MEDLINE and Google Scholar were searched from January 1970 to May 2018. The definitions of non-severe, severe and nocturnal hypoglycemia were examined. Results We reviewed 243 studies: 47.7% reported on non-severe hypoglycemia, 77.8% on severe hypoglycemia and 16.9% on nocturnal hypoglycemia; 5.8% did not specify. Among 116 studies reporting non-severe hypoglycemia, 18.1% provided no definition, 23.3% used glucose values, 38.8% relied on patient-reported symptoms, 17.2% accepted either glucose values or patient-reported symptoms and 2.6% relied on International Classification of Disease (ICD) codes. Among 189 studies reporting severe hypoglycemia, 11.1% provided no definition, 53.4% required symptoms needing assistance, 3.7% relied on glucose values, 14.8% relied on ICD codes, 2.6% relied on ICD codes or glucose values and 15.9% required both symptoms needing assistance and glucose values. Overall, 38.2% of non-severe and 67.7% of severe hypoglycemia definitions were consistent with the International Hypoglycemia Study Group. Conclusions The marked heterogeneity in how hypoglycemia is defined in observational studies may contribute to the inadequate understanding and correction of hypoglycemia risk factors among patients with type 2 diabetes.

Objective Diagnostic error is a key healthcare concern and can result in substantial morbidity and mortality. Yet no study has investigated the relationship between adverse outcomes resulting from diagnostic errors and one potentially large contributor to these errors: deficiencies in diagnostic knowledge. Our objective was to measure that associations between diagnostic knowledge and adverse outcomes after visits to primary care physicians that were at risk for diagnostic errors. Setting/participants 1410 US general internists who recently took their American Board of Internal Medicine Maintenance of Certification (ABIM-IM-MOC) exam treating 42 407 Medicare beneficiaries who experienced 48 632 ‘index’ outpatient visits for new problems at risk for diagnostic error because the presenting problem (eg, dizziness) was related to prespecified diagnostic error sensitive conditions (eg, stroke). Outcome measures 90-day risk of all-cause death, and, for outcome conditions related to the index visits diagnosis, emergency department (ED) visits and hospitalisations. Design Using retrospective cohort study design, we related physician performance on ABIM-IM-MOC diagnostic exam questions to patient outcomes during the 90-day period following an index visit at risk for diagnostic error after controlling for practice characteristics, patient sociodemographic and baseline clinical characteristics. Results Rates of 90-day adverse outcomes per 1000 index visits were 7 for death, 11 for hospitalisations and 14 for ED visits. Being seen by a physician in the top versus bottom third of diagnostic knowledge during an index visit for a new problem at risk for diagnostic error was associated with 2.9 fewer all-cause deaths (95% CI −5.0 to −0.7, p=0.008), 4.1 fewer hospitalisations (95% CI −6.9 to −1.2, p=0.006) and 4.9 fewer ED visits (95% CI −8.1% to −1.6%, p=0.003) per 1000 visits. Conclusion Higher diagnostic knowledge was associated with lower risk of adverse outcomes after visits for problems at heightened risk for diagnostic error.

Introduction Current diabetes quality measures are agnostic to patient clinical complexity and type of treatment required to achieve it. Our objective was to introduce a patient-centered indicator of appropriate diabetes therapy indicator (ADTI), designed for patients with type 2 diabetes, which is based on hemoglobin A1c (HbA1c) but is also contextualized by patient complexity and treatment intensity. Research design and methods A draft indicator was iteratively refined by a multidisciplinary Delphi panel using existing quality measures, guidelines, and published literature. ADTI performance was then assessed using OptumLabs Data Warehouse data for 2015. Included adults (n=206 279) with type 2 diabetes were categorized as clinically complex based on comorbidities, then categorized as treated appropriately, overtreated, or undertreated based on a matrix of clinical complexity, HbA1c level, and medications used. Associations between ADTI and emergency department/hospital visits for hypoglycemia and hyperglycemia were assessed by calculating event rates for each treatment intensity subset. Results Overall, 7.4% of patients with type 2 diabetes were overtreated and 21.1% were undertreated. Patients with high complexity were more likely to be overtreated (OR 5.60, 95% CI 5.37 to 5.83) and less likely to be undertreated (OR 0.65, 95% CI 0.62 to 0.68) than patients with low complexity. Overtreated patients had higher rates of hypoglycemia than appropriately treated patients (22.0 vs 6.2 per 1000 people/year), whereas undertreated patients had higher rates of hyperglycemia (8.4 vs 1.9 per 1000 people/year). Conclusions The ADTI may facilitate timely, patient-centered treatment intensification/deintensification with the goal of achieving safer evidence-based care.