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Atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality and morbidity, is associated with a substantial healthcare and economic burden. Reduction of low-density lipoprotein cholesterol (LDL-C) to guideline-recommended goals is crucial in the prevention or management of ASCVD, particularly in those at high risk. Despite the availability of several effective lipid-lowering therapies (LLTs), up to 80% of patients with ASCVD do not reach evidence-based LDL-C goals. This nonattainment may be due to poor adherence to, and lack of timely utilization of, LLTs driven by a range of variables, including polypharmacy, side effects, clinical inertia, costs, and access issues. Inclisiran was approved by the US Food and Drug Administration in 2021 as a novel, twice-yearly, healthcare provider (HCP)-administered LLT. In-office administration allows HCPs more control of drug acquisition, administration, and reimbursement, and may allow for more timely care and increased patient monitoring. In the USA, in-office administered drugs are considered a Medical Benefit and can be acquired and reimbursed using the "buy-and-bill" process. Buy-and-bill is a standard system for medication administration already established in multiple therapeutic areas, including oncology, vaccines, and allergy/immunology. Initiating in-office administration will involve new considerations for clinicians in the cardiovascular specialty, such as the implementation of new infrastructure and processes; however, it could ultimately increase treatment adherence and improve cardiovascular outcomes for patients with ASCVD. This article discusses the potential implications of buy-and-bill for the cardiology specialty and provides a practical guide to implementing HCP-administered specialty drugs in US clinical practice. [ABSTRACT FROM AUTHOR]

Summary: Background: Up to 50% of adolescents who undergo metabolic and bariatric surgery (MBS) have obesity 3 years post‐MBS, placing them at continued risk for the consequences of obesity. Objectives: We conducted an open‐label, 16‐week pilot study of liraglutide in adolescents with obesity after sleeve gastrectomy (SG) to investigate liraglutide effects on weight and body mass index (BMI) post‐SG. Methods: Adolescents aged 12–20.99 years with obesity and a history of SG ≥1 year prior were enrolled. Liraglutide was initiated at 0.6 mg/day, escalated weekly to a maximum of 3 mg/day, with treatment duration 16 weeks. Fasting laboratory assessments and an oral glucose tolerance test were performed at baseline and end‐treatment. Results: A total of 43 participants were screened, 34 initiated liraglutide (baseline BMI 41.2 ± 7.7 kg/m2), and 31 (91%) attended the end‐treatment visit. BMI decreased by 4.3% (p < 0.001) with liraglutide. Adolescents who had poor initial response to SG (<20% BMI reduction at BMI nadir) had less weight loss with liraglutide. Fasting glucose and haemoglobin A1C concentrations significantly decreased. There were no serious treatment‐emergent adverse events reported. Conclusions: Liraglutide treatment was feasible and associated with a BMI reduction of 4.3% in adolescents who had previously undergone SG, quantitatively similar to results obtained in adolescents with obesity who have not undergone MBS. [ABSTRACT FROM AUTHOR]

Despite recent therapeutic advances, diabetes remains the seventh leading cause of death in the United States. Clinicians caring for people with diabetes often find that low health literacy interferes with diabetes care. The aim of this cross-sectional study was to determine which diabetes-related misunderstandings or potentially maladaptive health beliefs were present among people at a low-income community clinic in Harris County, TX, and to determine the effect of such misconceptions on A1C values. [ABSTRACT FROM AUTHOR]

Background: To investigate the characteristics and trends of therapeutic errors that occur outside of healthcare facilities involving diabetes medications reported to US poison centers. Methods: National Poison Data System data from 2000 to 2021 were retrospectively analyzed. Results: There were 157,623 exposure cases of non-healthcare facility-related therapeutic errors associated with diabetes medications as the primary substance reported to US poison centers from 2000 to 2021. The rate of all therapeutic errors involving diabetes medications increased by 279.8% from 2000 to 2011, followed by a slower 15.0% increase to 2021. Half (50.1%) of the exposure cases were treated/evaluated and released and 44.1% did not receive treatment in a healthcare facility; however, 9.9% experienced a serious medical outcome, including 17 fatalities, and 1.0% were admitted to a critical care unit and 2.2% to a non-critical care unit. Insulin had the highest rates of therapeutic errors and serious medical outcomes, while sulfonylureas and insulin had the highest medical hospital admission rates. Metformin accounted for 59% (n = 10) of fatalities. Conclusions: Although most cases of therapeutic errors involving diabetes medications had no or minimal clinical consequences, an important minority were associated with a serious medical outcome or medical hospital admission. Increased efforts to prevent therapeutic errors involving diabetes medications are warranted. [ABSTRACT FROM AUTHOR]

The American Diabetes Association (ADA) guidelines prioritize Sodicum-glucose transporter-2-inhibitors (SGLT2i) given cardio-renal and glycemic benefits. This study was conducted to observe clinical factors associated with initial SGLT2i prescription in type 2 diabetes patients eligible for SGLT2i by the ADA. Methods. A retrospective case-control study was performed in a safety-net clinic and consisted of the initial SGLT2i prescriptions group and the group without. The data from the electronic medical records between July 2021 and December 2022 were analyzed in the regressional models. Results. There was a significant association between A1c ≥8% (OR 3.7, p=.01), heart failure (OR 19.3, p<.0001), a history of hypotension (OR 11.9, p=.01), and sulfonylureas (OR 6.5, p=.003) with the SGLT2i prescription. Conclusion. Patients with high A1c levels, heart failure, a history of hypotension, and sulfonylureas were more likely than their counterparts to receive SGLT2i prescriptions. Future research should investigate adherence and provider prescribing behaviors related to SGLT2i to further assess optimal drug use. [ABSTRACT FROM AUTHOR]

This mixed-methods study sought to identify pharmacotherapy preferences among 40 noninsulin-treated adults with type 2 diabetes receiving care at two U.S. health care systems. Participants ranked by relative importance various health outcomes and medication attributes and then contextualized their rankings. Most participants ranked blindness (63%), death (60%), heart attack (48%), and heart failure (48%) as the most important health outcomes and glucose-lowering efficacy (68%) as the most important medication attribute, followed by oral administration (45%) and lack of gastrointestinal side effects (38%). [ABSTRACT FROM AUTHOR]

Summary: Background: Paediatric obesity disproportionately impacts individuals from minoritized racial and ethnic backgrounds. Recent guidelines support use of anti‐obesity pharmacotherapy for adolescents with obesity, but the potential impact on disparities in obesity prevalence has not been evaluated. Objectives: To model changes in obesity prevalence with increasing utilization of anti‐obesity pharmacotherapy among adolescents. Methods: Data representative of American adolescents ages 12–17 years were obtained from the National Health and Nutrition Examination Survey, cycles 2011 through pre‐pandemic 2020. A body mass index (BMI) reduction of 16.7% was applied to each participant based on clinical trial results of weekly subcutaneous semaglutide 2.4 mg among adolescents. Utilization disparities were based on utilization of the same medication class among adults. Obesity prevalence was calculated assuming utilization of 10%–100%, stratified by race and ethnicity. Results: Among 4442 adolescents representing 26 247 384 American adolescents, projected overall obesity prevalence decreased from 22.2% to 8.4% with 100% utilization. However, disparities increased relative to Non‐Hispanic White youth, with prevalence among Non‐Hispanic Black and Mexican American youth ranging from 40%–60% higher to 90%–120% higher, respectively. Conclusions: Increasing utilization of anti‐obesity pharmacotherapy may widen relative disparities in obesity, particularly if utilization is unequal. Advocacy for equitable access is needed to minimize worsening of obesity‐related disparities. [ABSTRACT FROM AUTHOR]

The article focuses on analyzing industry payments to endocrinologists in the U.S. between 2014 and 2022, revealing trends and proportions of payments for research and non-research purposes. Topics discussed include the substantial financial collaborations between endocrinologists and healthcare companies, the decline in general payments over time, and the significant investment in research payments despite a decrease in the number of endocrinologists receiving them.

Aims: The objective of this umbrella review and meta‐analysis was to evaluate the effect of diabetes on risk of dementia, as well as the mitigating effect of antidiabetic treatments. Materials and Methods: We conducted a systematic umbrella review on diabetes and its treatment, and a meta‐analysis focusing on treatment. We searched MEDLINE/PubMed, Embase, PsycINFO, CINAHL and the Cochrane Library for systematic reviews and meta‐analyses assessing the risk of cognitive decline/dementia in individuals with diabetes until 2 July 2023. We conducted random‐effects meta‐analyses to obtain risk ratios and 95% confidence intervals estimating the association of metformin, thiazolidinediones, pioglitazone, dipeptidyl peptidase‐4 inhibitors, α‐glucosidase inhibitors, meglitinides, insulin, sulphonylureas, glucagon‐like peptide‐1 receptor agonists (GLP1RAs) and sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) with risk of dementia from cohort/case‐control studies. The subgroups analysed included country and world region. Risk of bias was assessed with the AMSTAR tool and Newcastle‐Ottawa Scale. Results: We included 100 reviews and 27 cohort/case‐control studies (N = 3 046 661). Metformin, thiazolidinediones, pioglitazone, GLP1RAs and SGLT2is were associated with significant reduction in risk of dementia. When studies examining metformin were divided by country, the only significant effect was for the United States. Moreover, the effect of metformin was significant in Western but not Eastern populations. No significant effect was observed for dipeptidyl peptidase‐4 inhibitors, α‐glucosidase inhibitors, or insulin, while meglitinides and sulphonylureas were associated with increased risk. Conclusions: Metformin, thiazolidinediones, pioglitazone, GLP1RAs and SGLT2is were associated with reduced risk of dementia. More longitudinal studies aimed at determining their relative benefit in different populations should be conducted. [ABSTRACT FROM AUTHOR]

We developed and validated a claims-based algorithm that classifies patients into obesity categories. Using Medicare (2007–2017) and Medicaid (2000–2014) claims data linked to 2 electronic health record (EHR) systems in Boston, Massachusetts, we identified a cohort of patients with an EHR-based body mass index (BMI) measurement (calculated as weight (kg)/height (m)2). We used regularized regression to select from 137 variables and built generalized linear models to classify patients with BMIs of ≥25, ≥30, and ≥40. We developed the prediction model using EHR system 1 (training set) and validated it in EHR system 2 (validation set). The cohort contained 123,432 patients in the Medicare population and 40,736 patients in the Medicaid population. The model comprised 97 variables in the Medicare set and 95 in the Medicaid set, including BMI-related diagnosis codes, cardiovascular and antidiabetic drugs, and obesity-related comorbidities. The areas under the receiver-operating-characteristic curve in the validation set were 0.72, 0.75, and 0.83 (Medicare) and 0.66, 0.66, and 0.70 (Medicaid) for BMIs of ≥25, ≥30, and ≥40, respectively. The positive predictive values were 81.5%, 80.6%, and 64.7% (Medicare) and 81.6%, 77.5%, and 62.5% (Medicaid), for BMIs of ≥25, ≥30, and ≥40, respectively. The proposed model can identify obesity categories in claims databases when BMI measurements are missing and can be used for confounding adjustment, defining subgroups, or probabilistic bias analysis. [ABSTRACT FROM AUTHOR]

The t:slim X2 insulin pump with Control-IQ technology (Control-IQ) advanced hybrid closed-loop automated insulin delivery system was evaluated in this prospective single-arm trial. Thirty adults with type 2 diabetes using the Control-IQ system showed substantial glycemic improvement with no increase in hypoglycemia. Mean time in range (70–180 mg/dL) improved 15%, representing an increase of 3.6 hours/day, and mean glucose decreased by 22 mg/dL. [ABSTRACT FROM AUTHOR]

Background: Sodium‐glucose cotransporter‐2 inhibitor (SGLT2I) use has increased among community‐dwelling populations, but little is known about how clinicians have prescribed them for US nursing home (NH) residents. We described the adoption of SGLT2Is by prescribers caring for long‐stay NH residents by clinician specialty and over time, compared with sulfonylureas, an older diabetes medication class. Methods: We conducted a retrospective cohort study of prescribers of SGLT2Is and sulfonylureas for all long‐stay US NH residents aged 65 years or older (2017–2019). Using 100% of Medicare Part D claims linked to prescriber characteristics data, we identified all dispensings of SGLT2Is and sulfonylureas for long‐stay NH residents and their associated prescribers. We described the distribution of prescriber specialties for each drug class over time as well as the number of NH residents prescribed SGLT2s versus sulfonylureas. We estimated the proportions of prescribers who prescribed both drug classes versus only sulfonylureas or only SGLT2Is. Results: We identified 36,427 unique prescribers (SGLT2I: N = 5811; sulfonylureas: N = 35,443) for 117,667 NH residents between 2017 and 2019. For both classes, family medicine and internal medicine physicians accounted for most prescriptions (75%–81%). Most clinicians (87%) prescribed only sulfonylureas, 2% prescribed SGLT2Is only, and 11% prescribed both. Geriatricians were least likely to prescribe only SGLT2Is. We observed an increase in the number of residents with SGLT2I use from n = 2344 in 2017 to n = 5748 in 2019. Conclusions: Among NH residents, most clinicians have not incorporated SGLT2Is into their prescribing for diabetes, but the extent of use is increasing. Family medicine and internal medicine physicians prescribed the majority of diabetes medications for NH residents, and geriatricians were the least likely to prescribe only SGLT2Is. Future research should explore provider concerns regarding SGLT2I prescribing, particularly adverse events. [ABSTRACT FROM AUTHOR]

See related Editorial by Tang et al. in this issue. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To evaluate the effect of nonadherence to American Diabetes Association (ADA) guidelines on health care expenditures for patients with type 2 diabetes (T2D). STUDY DESIGN: Retrospective cross-sectional cohort design, utilizing 2016-2018 Medical Expenditure Panel Survey data. METHODS: Patients with a diagnosis of T2D who completed the supplemental T2D care survey were included in the study. Participants were categorized based on adherence to the 10 processes in the ADA guidelines into adherent (≥ 9 processes) and nonadherent (≤ 6 processes) categories. Propensity score matching was employed using a logistic regression model. After matching, total annual health care expenditure change from baseline year was compared using a t test. Further, imbalanced variables were controlled for in a multivariable linear regression model. RESULTS: A total of 1619 patients representing 15,781,346 (SE = 438,832) individuals met the inclusion criteria, among whom 12.17% received nonadherent care. After propensity matching, those who received nonadherent care had $4031 higher total annual health care expenditures compared with their baseline year, whereas patients who received adherent care had $128 lower total annual health care expenditures compared with their baseline year. Further, multivariable linear regression adjusted for the imbalanced variables indicated that nonadherent care was associated with a mean (SE) $3470 ($1588) increase in the change from baseline health care expenditure. CONCLUSIONS: Nonadherence to the ADA guidelines results in a significant increase in health care expenditures among patients with diabetes. The economic impact of nonadherent care for T2D is a significant and extensive issue that needs to be addressed. These findings emphasize the importance of providing care based on ADA guidelines. [ABSTRACT FROM AUTHOR]

Background: The comparative safety of sulfonylureas (SUs) in nursing home (NH) residents remains understudied despite widespread use. We compared the effects of three SU medications and initial SU doses on adverse glycemic and cardiovascular events among NH residents. Methods: This national retrospective cohort study linked Medicare claims with Minimum Data Set 2.0 assessments for long‐stay NH residents aged ≥65 years between January 2008 and September 2010. Exposures were the SU medication initiated (glimepiride, glipizide, or glyburide) and doses (standard or reduced). One‐year outcomes were hospitalizations or emergency department visits for severe hypoglycemia, heart failure (HF), stroke, and acute myocardial infarction (AMI). After the inverse probability of treatment and inverse probability of censoring by death weighting, we estimated hazard ratios (HR) using Cox regression models with robust 95% confidence intervals (CI). Results: The cohort (N = 6821) included 3698 new glipizide, 1754 glimepiride, and 1369 glyburide users. Overall, the mean (standard deviation) age was 81.4 (8.2) years, 4816 (70.6%) were female, and 5164 (75.7%) were White non‐Hispanic residents. The rates of severe hypoglycemia were 30.3 (95% CI 22.3–40.1), 49.0 (95% CI 34.5–67.5), and 35.9 (95% CI 22.2–54.9) events per 1000 person‐years among new glipizide, glimepiride, and glyburide users, respectively (glimepiride versus glipizide HR 1.6, 95% CI 1.0–2.4, p = 0.04; glyburide versus glipizide HR 1.2, 95% CI 0.7–1.9, p = 0.59). The rates of severe hypoglycemia were 27.1 (95% CI 18.6–38.0) and 42.8 (95% CI 33.6–53.8) events per 1000 person‐years among new users of reduced and standard SU doses, respectively (HR 2.2, 95% CI 1.4–3.5, p < 0.01). Rates of HF, stroke, and AMI were similar between medications and doses. Conclusions: Among long‐stay NH residents, new use of glimepiride and standard SU doses resulted in higher rates of severe hypoglycemic events. Cardiovascular outcomes may not be affected by the choice of SU medication or dose. [ABSTRACT FROM AUTHOR]

This editorial comments on the article by Wu et al. in this issue. [ABSTRACT FROM AUTHOR]

Background: Palliative care (PC) pharmacists can play an important role in optimizing medications for patients with serious illnesses by aligning patients' goals with their treatment regimens. Objectives: The objectives of this study were to (1) quantify successful pharmacist deprescribing interventions incorporated in the hospital discharge plan and (2) describe deprescribing interventions by medication class, reason for discontinuation, and perception of patient/caregiver understanding and acceptance. Methods: This pilot study included 45 inpatient PC consultations and collected data on deprescribing interventions performed by PC clinical pharmacists in Maryland and Washington, D.C., U.S. Descriptive statistics were used to analyze outcomes. Results: Eighty-two percent of recommendations were successfully implemented during hospitalization and included in the discharge plan. Medication classes recommended for discontinuation included vitamins/supplements (20%), antidiabetics (13%), antiplatelets (10%), anticoagulants (10%), statins (10%), antihypertensives (7%), proton pump inhibitors/H2 blockers (7%), antibiotics (5%), dementia medications (1%), and antidepressants (1%). Top reasons for discontinuation included pill burden, unacceptable treatment burden, and potential harm outweighs potential benefit. Conclusions: Results of this study demonstrate PC pharmacists' deprescribing recommendations have a high rate of successful implementation by the primary inpatient care team. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes (T2DM) results in significant morbidity and mortality and is associated with disparities in prevalence, treatment, and outcomes. GIS can identify geographically based disparities. In the focused Rapid Assessment Process (fRAP)—a novel mixed-method study design—GIS is combined with qualitative inquiry to inform practice interventions and policy changes. Methods: Using fRAP, areas with poor T2DM outcomes (priority areas) as well as areas with positive T2DM outcomes (bright spots) were identified, focus groups were conducted, and responses analyzed for intervention opportunities. Focus group participants were English- and Spanish-speaking patients with T2DM living in one of the identified areas. Qualitative analysis consisted of initial coding with a priori themes from the focus group question guide, followed by identification of emergent themes within each defined category. Results: The a priori categories included Facilitators, Barriers, Strategies, and Impact of Diabetes Diagnosis. Emerging recurrent themes were Interactions with Medical Professionals, Medications, Lifestyle Management, Family Motivators and Support, Self-Efficacy, and Social Needs and Community Resources. Conclusions: Thematic results from focus groups can be used by practices to improve T2DM care through educating patients about chronic disease and nutrition, connecting them to diabetes-specific services, learning how diabetes fits in the context of patient lives, and eliciting patient values and motivations to improve diabetes self-management. Findings also may be used by health care professionals to inform community-based advocacy efforts, interventions, and future research. [ABSTRACT FROM AUTHOR]

Background: The Tandem Control-IQ (CIQ) system has demonstrated significant glycemic improvements in large randomized controlled and real-world trials. Use of this system is lower in people with type 1 diabetes (T1D) government-sponsored insurance and those with type 2 diabetes (T2D). This analysis aimed to evaluate the performance of CIQ in these groups. Methods and Materials: A retrospective analysis of CIQ users was performed. Users age ≥6 years with a t:slim X2 Pump and >30 days of continuous glucose monitoring (CGM) data pre-CIQ and >30 days post-CIQ technology initiation were included. Results: A total of 4243 Medicare and 1332 Medicaid CIQ users were analyzed among whom 5075 had T1D and 500 had T2D. After starting CIQ, the Medicare beneficiaries group saw significant improvement in time in target range 70-180 mg/dL (TIR; 64% vs. 74%; P < 0.0001), glucose management index (GMI; 7.3% vs. 7.0%; P < 0.0001), and the percentage of users meeting American Diabetes Association (ADA) CGM Glucometrics Guidelines (12.8% vs. 26.3%; P < 0.0001). The Medicaid group also saw significant improvement in TIR (46% vs. 60%; P < 0.0001), GMI (7.9% vs. 7.5%; P < 0.0001), and percentage meeting ADA guidelines (5.7% vs. 13.4%; P < 0.0001). Patients with T2D and either insurance saw significant glycemic improvements. Conclusions: The CIQ system was effective in the Medicare and Medicaid groups in improving glycemic control. The T2D subgroup also demonstrated improved glycemic control with CIQ use. Glucometrics achieved in this analysis are comparable with those seen in previous randomized controlled clinical trials with the CIQ system. [ABSTRACT FROM AUTHOR]

Background: Information about how newspapers portray antidiabetic medicines to readers is lacking. This study investigated the reporting on antidiabetic medicines in the most widely circulated newspapers published in the United Kingdom (UK) and the United States (US) over a 10-year period. Methods: The Nexis UK database was used to identify and select relevant articles. Systematic content analysis of the articles which met the inclusion criteria (articles of any format that contained reference to antidiabetic medicines) within the highest circulated newspapers in the UK and US between 2009 and 2018 was conducted. Inter-rater reliability of coding was established using a 10% sample of the identified articles. Results: A total of 560 (369 UK and 191 US) relevant newspaper articles were retrieved. In the UK, the number of relevant articles showed a slightly increasing trend over the study period, while in the US, article numbers declined over the study period. Safety/risk of antidiabetic medicines was the most frequent theme covered by the articles (34.6%). Over one-third of the newspaper articles were written from a clinical perspective (37.7%). Insulin was the most commonly discussed class of antidiabetic medicine (23.1%). Control of blood sugar levels (53.1%) and side effects/toxicity (92.7%) were the most frequently reported benefit and risk of antidiabetic medicines, respectively. The most frequently reported organ systems harmed by antidiabetic medicines were the cardiovascular, endocrine and gastrointestinal systems. The UK newspapers were more likely to report the benefits of antidiabetic medicines (p = 0.005), while the US articles were more likely to report on harms/risks (p = 0.001). The majority of relevant articles (91.8%) were judged as having a balanced judgement, while 8.2% of the articles were rated as exaggerated. Conclusions: This study has revealed that antidiabetic medicines are indeed reported on by UK and US newspapers. As media portrayal has the potential to negatively or positively influence patients' views of their medication for diabetes, healthcare professionals should check on patients' beliefs and knowledge about their medication and proactively provide objective and balanced information (including promotion of medication adherence). [ABSTRACT FROM AUTHOR]

Introduction: This study assesses the proportion of New York City Medicaid participants diagnosed with type 2 diabetes who did not have any claims for diabetes medication for an entire year and the association between nonuse of diabetes medication and subsequent hospitalizations.Methods: The 2014‒2016 New York State Medicaid claims data were used for this cohort study. Two types of hospitalizations were examined: all-cause hospitalizations and preventable diabetes hospitalizations. A potential association between medication nonuse and the number of hospitalizations in the following year was assessed using the negative binomial regression model, adjusting for individual- and neighborhood-level factors. The study was conducted in 2019‒2020.Results: Among the 117,183 individuals included in this study, 27.5% did not use any diabetes medication for an entire year. Compared with individuals using oral hypoglycemic medication only, the crude rate of all-cause hospitalizations among individuals who used no medication was approximately twice as high (37,111 vs 19,209 per 100,000 population), and the crude rate of preventable diabetes hospitalizations was almost 3 times as high (1,488 vs 537 per 100,000 population). Adjusting for individual- and neighborhood-level characteristics, medication nonuse was still associated with higher levels of all-cause hospitalizations (incidence rate ratio=1.26; 95% CI=1.21, 1.31) and preventable diabetes hospitalizations (incidence rate ratio=1.66; 95% CI=1.39, 1.99).Conclusions: Medication use and adherence are important for managing diabetes. However, almost 30% of New York City Medicaid participants with type 2 diabetes had no claims for diabetes medication for an entire year. Significantly higher hospitalization rates among this group warrant attention from providers and policy makers. [ABSTRACT FROM AUTHOR]

The article discusses the rising of annual incidence of youth-onset type 2 diabetes (YO-T2D) is in the United States and other countries worldwide. Topics include the Clinical trials related to the disease conducted in U.S.; challenges in obtaining the evidence based treatment data for YO-T2D; case for a progressive approach to treatment, and new medications demonstrated to be efficacious in adult.

OBJECTIVES: Recent trials of glucose-lowering drugs (GLDs) have drawn attention to renal outcomes. Our goal was to understand how patients with diabetic kidney disease (DKD) are treated in general practices in the United States. STUDY DESIGN: Retrospective cohort study using a national-level claims data set and electronic health records. METHODS: Patients (≥ 18 years) with type 2 diabetes, whose estimated glomerular filtration rates (eGFRs) were between 15 and 89 mL/min/1.73 m² between 2016 and 2018, were selected. Use of different GLDs during a 12-month period was examined across all eGFR levels. RESULTS: Of the 25,486 sample patients, 69.2%, 18.9%, 9.6%, and 2.3% had an eGFR in the ranges of 60 to 89, 45 to 59, 30 to 44, and 15 to 29 mL/min/1.73 m², respectively. Metformin was used by nearly 33% of patients with an eGFR of 30 to 44 mL/min/1.73 m² and by 10% of patients with an eGFR less than 30 mL/min/1.73 m². Less than 10% (across all eGFR levels) of patients used glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors. Use of insulin was more frequent among patients with a lower eGFR (P < .05). The findings were similar in subgroups with different hemoglobin A1c levels (< 7% and ≥ 7%). CONCLUSIONS: Real-world treatment of DKD in the United States is suboptimal. Inappropriate use of some GLD classes, especially in advanced DKD stages, was found along with lower than expected use of modern agents that are considered safe and effective to treat glycemic outcomes. Efforts may be needed to improve understanding of safety, glycemic efficacy, and overall clinical value of GLDs across DKD stages. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a medication assistance program and the addition of pharmacist management on clinical outcomes in patients with hypertension and diabetes through an Advanced Pharmaceutical Care program. Methods: This was a prospective quality improvement study on patients with hypertension and/or diabetes resistant to usual care. The primary outcomes were change in A1C, blood glucose, and blood pressure between 3 phases: usual care, free medications, and free medications plus pharmacist management. Secondary outcomes included achievement of A1C, blood glucose, and blood pressure goals as well as pharmacist interventions. Results: Seven patients were included in the study. The mean A1C decreased from 11.3% to 8.3% with free medications (p = 0.28) and from 8.3% to 6.4% with pharmacist management (p = 0.119). Mean blood pressure during usual care, free medications, and pharmacist intervention was 150/87 mm Hg, 148/85 mm Hg, and 125/78 mm Hg, respectively. After pharmacist management, 75% of patients with type 2 diabetes were able to achieve A1C and blood glucose goals, and 71% of patients with hypertension achieved blood pressure <130/80 mm Hg. Conclusions: The Advanced Pharmaceutical Care program allowed pharmacists to identify and overcome patient-specific barriers to care, provide individualized disease state education, and optimize medication management. Medication assistance led to improvements in A1C and blood pressure, but did not affect achievement of disease state goals. Pharmacist involvement in hypertension and diabetes care led to clinically significant reductions in blood pressure and A1C and enabled patients to reach guideline-recommended blood pressure and glycemic goals. [ABSTRACT FROM AUTHOR]

Background: Evidence on the risk for cardiovascular events associated with use of first-line sodium-glucose cotransporter-2 inhibitors (SGLT-2i) compared with metformin is limited.Objective: To assess cardiovascular outcomes among adults with type 2 diabetes (T2D) who initiated first-line treatment with SGLT-2i versus metformin.Design: Population-based cohort study.Setting: Claims data from 2 large U.S. commercial and Medicare databases (April 2013 to March 2020).Participants: Patients with T2D aged 18 years and older (>65 years in Medicare) initiating treatment with SGLT-2i or metformin during April 2013 to March 2020, without any use of antidiabetic medications before cohort entry, were identified. After 1:2 propensity score matching in each database, pooled hazard ratios (HRs) and 95% CIs were reported.Intervention: First-line SGLT-2i (canagliflozin, empagliflozin, or dapagliflozin) or metformin.Measurements: Primary outcomes were a composite of hospitalization for myocardial infarction (MI), hospitalization for ischemic or hemorrhagic stroke or all-cause mortality (MI/stroke/mortality), and a composite of hospitalization for heart failure (HHF) or all-cause mortality (HHF/mortality). Safety outcomes including genital infections were assessed.Results: Among 8613 first-line SGLT-2i initiators matched to 17 226 metformin initiators, SGLT-2i initiators had a similar risk for MI/stroke/mortality (HR, 0.96; 95% CI, 0.77 to 1.19) and a lower risk for HHF/mortality (HR, 0.80; CI, 0.66 to 0.97) during a mean follow-up of 12 months. Initiators receiving SGLT-2i showed a lower risk for HHF (HR, 0.78; CI, 0.63 to 0.97), a numerically lower risk for MI (HR, 0.70; CI, 0.48 to 1.00), and similar risk for stroke, mortality, and MI/stroke/HHF/mortality compared with metformin. Initiators receiving SGLT-2i had a higher risk for genital infections (HR, 2.19; CI, 1.91 to 2.51) and otherwise similar safety as those receiving metformin.Limitation: Treatment selection was not randomized.Conclusion: As first-line T2D treatment, initiators receiving SGLT-2i showed a similar risk for MI/stroke/mortality, lower risk for HHF/mortality and HHF, and a similar safety profile except for an increased risk for genital infections compared with those receiving metformin.Primary Funding Source: Brigham and Women's Hospital and Harvard Medical School. [ABSTRACT FROM AUTHOR]

Objective: Medicare Advantage (MA), Medicare's managed care program, is quickly expanding, yet little is known about diabetes care quality delivered under MA compared with traditional fee-for-service (FFS) Medicare.Research Design and Methods: This was a retrospective cohort study of Medicare beneficiaries ≥65 years old enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. Quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns were compared between Medicare plan groups, adjusted for sociodemographic and clinical factors.Results: Among 345,911 Medicare beneficiaries, 229,598 (66%) were enrolled in FFS and 116,313 (34%) in MA plans (for ≥1 month). MA beneficiaries were more likely to receive ACE inhibitors/angiotensin receptor blockers for coronary artery disease, tobacco cessation counseling, and screening for retinopathy, foot care, and kidney disease (adjusted P ≤ 0.001 for all). MA beneficiaries had modestly but significantly higher systolic blood pressure (+0.2 mmHg), LDL cholesterol (+2.6 mg/dL), and HbA1c (+0.1%) (adjusted P < 0.01 for all). MA beneficiaries were independently less likely to receive glucagon-like peptide 1 receptor agonists (6.9% vs. 9.0%; adjusted odds ratio 0.80, 95% CI 0.77-0.84) and sodium-glucose cotransporter 2 inhibitors (5.4% vs. 6.7%; adjusted odds ratio 0.91, 95% CI 0.87-0.95). When integrating Centers for Medicare and Medicaid Services-linked data from 2014 to 2017 and more recent unlinked data from the Diabetes Collaborative Registry through 2019 (total N = 411,465), these therapeutic differences persisted, including among subgroups with established cardiovascular and kidney disease.Conclusions: While MA plans enable greater access to preventive care, this may not translate to improved intermediate health outcomes. MA beneficiaries are also less likely to receive newer antihyperglycemic therapies with proven outcome benefits in high-risk individuals. Long-term health outcomes under various Medicare plans requires surveillance. [ABSTRACT FROM AUTHOR]

Purpose Despite high type 2 diabetes mellitus (T2DM) prevalence in Medicare enrollees, newer therapeutic options, and revised treatment guidelines, little is known about US antihyperglycemic prescribing trends after 2015. This research describes recent monthly antihyperglycemic prescribing trends in a large, diverse population of Medicare enrollees from the US Mid-Atlantic region. Methods Encounter data (July 2018-July 2020) for Medicare enrollees 65 years of age or older with T2DM were extracted from electronic health records of a large integrated health system. Descriptive time-series regression models were estimated to describe monthly prescribing rates (ie, prescription orders per 100 eligible plan members with T2DM) overall and by medication subgroups for all-eligible and continuously-eligible samples. Trends in monthly prescription orders per 100 eligible plan members with T2DM were reported. Results The monthly all-eligible member sample (n > 22,000) exhibited an overall positive baseline monthly prescribing rate of 23.88 T2DM medication orders per 100 members with T2DM and a significant positive monthly prescribing rate trend (ie, change) of 0.12 T2DM medication orders per 100 members with T2DM (P < 0.05). Subgroup T2DM medication order rates per 100 members with T2DM at baseline were 16.28 for first-generation medications, 3.87 for human insulins, 3.04 for insulin analogs, 0.58 for second-generation medications, and 0.11 for combination medications. Human insulins, insulin analogs, and second-generation medications had positive monthly trends (P < 0.05). Among second-generation medications, sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) agonists had positive monthly trends (P < 0.05). Continuously eligible members with T2DM (n = 19,185) had no significant overall monthly prescribing trend; however, human insulins, insulin analogs, and second-generation medications and the SGLT-2 inhibitor class had positive monthly prescribing trends (P < 0.05). Conclusion In a diverse Medicare sample, this study observed increasing monthly trends for second-generation medications, human insulins, and insulin analogs consistent with emerging evidence. Among second-generation medications, SGLT-2 inhibitors became the most commonly prescribed over time. [ABSTRACT FROM AUTHOR]

Semaglutide belongs to a class of medications known as glucagon‐like peptide‐1 (GLP‐1) receptor agonists. It mimics the GLP‐1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP‐1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP‐1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness. [ABSTRACT FROM AUTHOR]

Objective: To assess trends in HbA1c and appropriateness of diabetes medication use by patient health status.Research Design and Methods: We conducted cross-sectional analysis of 2001-2018 National Health and Nutrition Examination Survey (NHANES). We included older adults age ≥65 years who had ever been told they had diabetes, had HbA1c >6.4%, or had fasting plasma glucose >125 mg/dL. Health status was categorized as good, intermediate, or poor. Being below goal was defined as taking medication despite having HbA1c ≥1% below the glycemic goals of the American Diabetes Association (ADA), which varied by patient health status and time period. Drugs associated with hypoglycemia included sulfonylureas, insulin, and meglitinides.Results: We included 3,539 patients. Mean HbA1c increased over time and did not differ by health status. Medication use increased from 59% to 74% with metformin being the most common drug in patients with good or intermediate health and sulfonylureas and insulin most often prescribed to patients with poor health. Among patients taking medications, prevalence of patients below goal increased while prevalence of those above goal decreased from 2001 to 2018. One-half of patients with poor health and taking medications had below-goal HbA1c; two-thirds received drugs associated with hypoglycemia. Patients with poor health who were below goal had 4.9 (95% CI 2.3-10.4) times the adjusted odds of receiving drugs associated with hypoglycemia than healthy patients.Conclusions: In accordance with ADA's newer Standards of Medical Care in Diabetes, HbA1c goals were relaxed but did not differ by health status. Below-goal HbA1c was common among patients with poor health; many were prescribed medications associated with a higher risk of hypoglycemia. [ABSTRACT FROM AUTHOR]

Racial/ethnic differences cover clinical, biological, genetic, or epigenetic factors associated with disease risk, outcome, and treatment that are not related to socio-economic factors. The presence of these in type 2 diabetes mellitus produces a different perspective to the understanding and care in different races and ethnic groups. This becomes very important with individualized care that is not applied alongside these differences. Newer antidiabetic drugs with great promises do not have comparable efficacies across the races. New drug developments using genomics are similarly affected, so also their pharmacogenetic and pharmacogenomic applications. Racial/ethnic differences are found among the subgroups of type 2 diabetes mellitus in the aspects of epidemiology, pathogenesis, and diagnosis. These differences are, however, different and independent of the differences found in drug treatment, diabetic chronic kidney disease, and diabetic retinopathy. For the African Americans and other Blacks, the type 2 diabetes with its different manifestations has not been adequately studied. Even when data exist, they are not taken into cognizance in formulating guidelines. There is, therefore, a need for a call to action. Literature search was in PubMed, Medline, and Google, for search terms race, ethnic, differences, and type 2 diabetes. [ABSTRACT FROM AUTHOR]

Context: Early initiation of continuous glucose monitoring (CGM) is advocated for youth with type 1 diabetes (T1D). Data to guide CGM use on time-in-range (TIR), hypoglycemia, and the role of partial clinical remission (PCR) are limited.Objective: Our aims were to assess whether 1) an association between increased TIR and hypoglycemia exists, and 2) how time in hypoglycemia varies by PCR status.Methods: We analyzed 80 youth who were started on CGM shortly after T1D diagnosis and were followed for up to 1-year post diagnosis. TIR and hypoglycemia rates were determined by CGM data and retrospectively analyzed. PCR was defined as (visit glycated hemoglobin A1c) + (4*units/kg/day) less than 9.Results: Youth were started on CGM 8.0 (interquartile range, 6.0-13.0) days post diagnosis. Time spent at less than 70 mg/dL remained low despite changes in TIR (highest TIR 74.6 ± 16.7%, 2.4 ± 2.4% hypoglycemia at 1 month post diagnosis; lowest TIR 61.3 ± 20.3%, 2.1 ± 2.7% hypoglycemia at 12 months post diagnosis). No events of severe hypoglycemia occurred. Hypoglycemia was rare and there was minimal difference for PCR vs non-PCR youth (54-70 mg/dL: 1.8% vs 1.2%, P = .04; < 54mg/dL: 0.3% vs 0.3%, P = .55). Approximately 50% of the time spent in hypoglycemia was in the 65 to 70 mg/dL range.Conclusion: As TIR gradually decreased over 12 months post diagnosis, hypoglycemia was limited with no episodes of severe hypoglycemia. Hypoglycemia rates did not vary in a clinically meaningful manner by PCR status. With CGM being started earlier, consideration needs to be given to modifying CGM hypoglycemia education, including alarm settings. These data support a trial in the year post diagnosis to determine alarm thresholds for youth who wear CGM. [ABSTRACT FROM AUTHOR]

Aims: Studies examining the prevalence of and factors associated with switching from sulphonylureas (SUs) to dipeptidyl peptidase 4 (DPP‐4) inhibitors in real‐world settings are lacking. We assessed the factors associated with switching from SUs to DPP‐4 inhibitors in the United States. Materials and Methods: This retrospective cohort study was conducted using the Optum Clinformatics® Data Mart (2009‐2018). Adults with type 2 diabetes and newly prescribed at least two SUs were included and were followed for 2 years after the initiation of SU (index date). We compared the characteristics of those who switched from SUs to DPP‐4 inhibitors (only; no additional antidiabetic drugs) with those who continued with SUs (without adding other antidiabetic drugs) using multivariate logistic regression. Multinomial regression analyses were also conducted to assess the factors associated with switching to different drug classes versus continuation with SUs. Results: In a sample of 119 107 new SU users, 2.2% (2633) switched to DPP‐4 inhibitors, 3.8% (4542) switched to antidiabetic drugs other than DPP‐4 inhibitors, 68.3% (81 394) discontinued SUs but did not switch to another antidiabetic drug, 12.9% (15 345) continued with SUs and added other antidiabetic drugs, and 12.8% (15 193) continued with SUs only. Multivariate logistic regression showed that those who had significantly higher likelihood of switching were younger, female [vs. males; adjusted odds ratio (AOR) = 0.70], and living in the south; had previous use of DPP‐4 inhibitors (AOR = 1.71); were not using antidiabetic drugs at baseline; had more baseline diabetes‐related emergency room visits (AOR = 1.13), depression (AOR = 1.34), post‐index hypoglycaemia (AOR = 2.20), and an earlier index year; and were glyburide users (vs. glimepiride users; AOR = 1.29). Conclusions: The discontinuation rate for SUs is high. Factors associated with switching from SUs to DPP‐4 inhibitors included age, sex, geographic region, baseline antidiabetic drug use, type of SU, baseline diabetes‐related emergency room visits, hypoglycaemia and depression. [ABSTRACT FROM AUTHOR]

Objective: To describe physicians' variation in de-adopting concurrent statin and fibrate therapy for type 2 diabetic patients following a reversal in clinical evidence.Data Sources: We analyzed 2007-2015 claims data from OptumLabs® Data Warehouse, a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data.Study Design: We modeled fibrate use among Medicare Advantage and commercially insured type 2 diabetic statin users before and after the publication of the ACCORD lipid trial, which found statins and fibrates were no more effective than statins alone in reducing cardiovascular events among type 2 diabetic patients. We modeled fibrate use trends with physician random effects and physician characteristics such as age and specialty.Data Extraction: We identified patient-year-quarters with one year of continuous insurance enrollment, type 2 diabetes diagnoses, and fibrate use. We designated the physician most responsible for patients' diabetes care based on evaluation and management visits and prescriptions of glucose-lowering drugs.Principal Findings: Fibrate use increased by 0.12 percentage points per quarter among commercial patients (95% CI, 0.10 to 0.14) and 0.17 percentage points per quarter among Medicare Advantage patients (95% CI, 0.13 to 0.20) before the trial and then decreased by 0.16 percentage points per quarter among commercial patients (95% CI, -0.18 to -0.15) and 0.05 percentage points per quarter among Medicare Advantage patients (95% CI, -0.06 to -0.03) after the trial. However, 45% of physicians treating commercial patients and 48% of physicians treating Medicare Advantage patients had positive trends in prescribing following the trial. Physicians' characteristics did not explain their variation (pseudo R2  = 0.000).Conclusion: On average, physicians decreased fibrate prescribing following the ACCORD lipid trial. However, many physicians increased prescribing following the trial. Observable physician characteristics did not explain variations in prescribing. Future research should examine whether physicians vary similarly in other de-adoption settings. [ABSTRACT FROM AUTHOR]

The impact of overlapping risk factors on coronavirus disease (COVID-19) severity is unclear. To evaluate the impact of type 2 diabetes (T2D) and obesity on COVID-19 severity, we conducted a cohort study with 28,095 anonymized COVID-19 patients using data from the COVID-19 Research Database from January 1, 2020 to November 30, 2020. The mean age was 50.8 ± 17.5 years, and 11,802 (42%) patients were male. Data on age, race, sex, T2D complications, antidiabetic medication prescription, and body mass index ≥ 30 kg/m2 (obesity) were analysed using Cox proportional hazard models, with hospitalization risk and critical care within 30 days of COVID-19 diagnosis as the main outcomes. The risk scores were 0–4 for age ≥ 65 years, male sex, T2D, and obesity. Among the participants, 11,294 (61.9%) had obesity, and 4445 (15.8%) had T2D. T2D, obesity, and male sex were significantly associated with COVID-19 hospitalization risk. Regarding hospitalization risk scores, compared with those for hospitalization risk score 0 and critical care risk score 0, hazard ratios [95% confidence intervals] were 19.034 [10.470–34.600] and 55.803 [12.761–244.015] (P < 0.001) (P < 0.001), respectively, for risk score 4. Complications from diabetes and obesity increased hospitalization and critical care risks for COVID-19 patients. [ABSTRACT FROM AUTHOR]

Background: The t:slim X2™ insulin pump with Control-IQ® technology from Tandem Diabetes Care is an advanced hybrid closed-loop system that was first commercialized in the United States in January 2020. Longitudinal glycemic outcomes associated with real-world use of this system have yet to be reported. Methods: A retrospective analysis of Control-IQ technology users who uploaded data to Tandem's t:connect® web application as of February 11, 2021 was performed. Users age ≥6 years, with >2 weeks of continuous glucose monitoring (CGM) data pre- and >12 months post-Control-IQ technology initiation were included in the analysis. Results: In total 9451 users met the inclusion criteria, 83% had type 1 diabetes, and the rest had type 2 or other forms of diabetes. The mean age was 42.6 ± 20.8 years, and 52% were female. Median percent time in automation was 94.2% [interquartile range, IQR: 90.1%-96.4%] for the entire 12-month duration of observation, with no significant changes over time. Of these users, 9010 (96.8%) had ≥75% of their CGM data available, that is, sufficient data for reliable computation of CGM-based glycemic outcomes. At baseline, median percent time in range (70-180 mg/dL) was 63.6 (IQR: 49.9%-75.6%) and increased to 73.6% (IQR: 64.4%-81.8%) for the 12 months of Control-IQ technology use with no significant changes over time. Median percent time <70 mg/dL remained consistent at ∼1% (IQR: 0.5%-1.9%). Conclusion: In this real-world use analysis, Control-IQ technology retained, and to some extent exceeded, the results obtained in randomized controlled trials, showing glycemic improvements in a broad age range of people with different types of diabetes. [ABSTRACT FROM AUTHOR]

Introduction: Non‐alcoholic fatty liver disease (NAFLD) has been associated with increased risk of incident diabetes. But such evidence is lacking in the Hispanic/Latino population, which has high prevalence of obesity and NAFLD. Methods: We conducted a prospective cohort study of 6,928 adults of Hispanic/Latino background who had no diabetes, did not report excessive alcohol use, and no hepatitis B and C infection at baseline (2008–2011). We estimated risk ratios (RR) for incident diabetes, identified from visit 2 examination by glucose measurements or antidiabetic medication use, with baseline liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma‐glutamyl transpeptidase (GGT)). Results: A total of 738 adults developed diabetes during 6 years of follow‐up. After adjusting for participant characteristics at baseline, versus the lowest quartile, highest quartiles of ALT and GGT were associated with risks for incident diabetes (RR for ALT: 1.51 [95% CI 1.03–2.22], p‐trend = 0.006; RR for GGT: 2.39 [1.60–3.55], p‐trend = 0.001). Higher GGT levels predicted increased risk of incident diabetes even among those with ALT or AST below the median levels. The associations of ALT and GGT with incident diabetes were similar among most Hispanic background but were not seen among Dominicans (p for interaction <0.05). The association of AST with incident diabetes was found only among light‐to‐moderate alcohol drinkers (RR = 1.50 [1.20–1.86]) but not abstainers (RR = 0.91 [0.69–1.20], p for interaction = 0.006). Conclusion: Higher ALT and GGT levels are associated with increased risk of developing diabetes among Latinos. Liver enzyme tests might aid in diabetes prevention by identifying high‐risk individuals. [ABSTRACT FROM AUTHOR]

Background: The rapidly increased spending on insulin is a major public health issue in the United States. Industry marketing might be one of the upstream determinants of physicians' prescription of long-acting insulin-the most commonly used and costly type of insulin, but the evidence is lacking. We therefore aimed to investigate the association between industry payments to physicians and subsequent prescriptions of long-acting insulin.Methods and Findings: Using the databases of Open Payments and Medicare Part D, we examined the association between the receipt of industry payments for long-acting insulin in 2016 and (1) the number of claims; (2) the costs paid for all claims; and (3) the costs per claim of long-acting insulin in 2017. We also examined the association between the receipt of payments and the change in these outcomes from 2016 to 2017. We employed propensity score matching to adjust for the physician-level characteristics (sex, years in practice, specialty, and medical school attended). Among 145,587 eligible physicians treating Medicare beneficiaries, 51,851 physicians received industry payments for long-acting insulin worth $22.3 million. In the propensity score-matched analysis including 102,590 physicians, we found that physicians who received the payments prescribed a higher number of claims (adjusted difference, 57.8; 95% CI, 55.8 to 59.7), higher costs for total claims (adjusted difference, +$22,111; 95% CI, $21,387 to $22,836), and higher costs per claim (adjusted difference, +$71.1; 95% CI, $69.0 to $73.2) of long-acting insulin, compared with physicians who did not receive the payments. The association was also found for changes in these outcomes from 2016 to 2017. Limitations to our study include limited generalizability, confounding, and possible reverse causation.Conclusions: Industry marketing payments to physicians for long-acting insulin were associated with the physicians' prescriptions and costs of long-acting insulin in the subsequent year. Future research is needed to assess whether policy interventions on physician-industry financial relationships will help to ensure appropriate prescriptions and limit overall costs of this essential drug for diabetes care. [ABSTRACT FROM AUTHOR]

List prices for brand-name drugs have risen steeply, often despite the introduction of competition from other brand-name drugs in the same therapeutic class. List prices, however, do not reflect any rebates that manufacturers provide payers. To understand how net prices (after rebates and other discounts) respond to competition, we compared changes in inflation-adjusted, revenue-weighted mean list and net prices of a one-month supply of three classes of diabetes drugs: glucagon-like peptide 1 (GLP1) agonists, dipeptidyl peptidase 4 (DPP4) inhibitors, and sodium glucose cotransporter 2 (SGLT2) inhibitors. These drug classes each had several brand-name products enter the market between 2005 and 2017. The annualized change in list price over this period was $75 (15 percent) for GLP1 agonists, $22 (8 percent) for DPP4 inhibitors, and $41 (11 percent) for SGLT2 inhibitors. In contrast, the annualized change in net price was $38 (10 percent) for GLP1 agonists, -$3 (-2 percent) for DPP4 inhibitors, and -$17 (-9 percent) for SGLT2 inhibitors, suggesting a variable impact of brand-name competition on net prices. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is among the most prevalent and dire complications of diabetes mellitus in adults across the world. Diabetes substantially contributes to the burden of kidney disease, such that one third to one half of CKD in the United States and many other countries is attributable to diabetic kidney disease (DKD). As DKD progresses to end-stage renal disease (ESRD), patients are at heightened risk for atypical glycemic complications, including the development of burnt-out diabetes, manifested by hypoglycemic bouts and poor outcomes. Furthermore, even in the absence of diabetes, hypoglycemia is a frequent occurrence in CKD patients that may contribute to their high burden of cardiovascular disease and death. Extrapolation of data from clinical trials in high-cardiovascular-risk populations and observational studies in patients with non-dialysis-dependent (NDD) CKD and ESRD suggest that moderate glycemic targets defined by glycated hemoglobin levels of 6% to 8% and glucose levels of 100 to 150 mg/dL are associated with better survival in DKD patients. However, given the imprecision of glycated hemoglobin levels in kidney disease, further research is needed to determine the optimal glycemic metric and target in diabetic NDD-CKD and ESRD patients. Given their exceedingly high cardiovascular morbidity and mortality, there is a compelling need for further investigation of how to optimally manage dysglycemia in the NDD-CKD and ESRD populations. [ABSTRACT FROM AUTHOR]

Objective: To compare treatment regimens and glycosylated hemoglobin (A1c) levels in Type 1 (T1D) and Type 2 diabetes (T2D) using diabetes registries from two countries—U.S. SEARCH for Diabetes in Youth (SEARCH) and Indian Registry of youth onset diabetes in India (YDR). Methods: The SEARCH and YDR data were harmonized to the structure and terminology in the Observational Medical Outcomes Partnership Common Data Model. Data used were from T1D and T2D youth diagnosed <20 years between 2006‐2012 for YDR, and 2006, 2008, and 2012 for SEARCH. We compared treatment regimens and A1c levels across the two registries. Results: There were 4003 T1D (SEARCH = 1899; YDR = 2104) and 611 T2D (SEARCH = 384; YDR = 227) youth. The mean A1c was higher in YDR compared to SEARCH (T1D:11.0% ± 2.9% vs 7.8% ± 1.7%, P <.001; T2D:9.9% ± 2.8% vs 7.2% ± 2.1%, P <.001). Among T1D youth in SEARCH, 65.1% were on a basal/bolus regimen, whereas in YDR, 52.8% were on once/twice daily insulin regimen. Pumps were used by 16.2% of SEARCH and 1.5% of YDR youth with T1D. Among T2D youth, in SEARCH and YDR, a majority were on metformin only (43.0% vs 30.0%), followed by insulin + any oral hypoglycemic agents (26.3% vs 13.7%) and insulin only (12.8% vs 18.9%), respectively. Conclusion: We found significant differences between SEARCH and YDR in treatment patterns in T1D and T2D. A1c levels were higher in YDR than SEARCH youth, for both T1D and T2D, irrespective of the regimens used. Efforts to achieve better glycemic control for youth are urgently needed to reduce the risk of long‐term complications. [ABSTRACT FROM AUTHOR]

Background: The unintentional prescribing of medications harmful for patients with heart failure (HF) remains an ongoing problem. The American Heart Association published a scientific statement detailing a list of medications that may worsen or exacerbate a patient's HF. The use of potentially harmful medications has not been studied in Medicare patients with HF. Objective: The aim of this study was to assess the prevalence of prescribing these harmful medications in a Medicare-enrolled medication therapy management (MTM)-eligible population with HF and to identify the characteristics associated with this potentially harmful prescribing. Methods: This cross-sectional analysis involved utilization of a national MTM provider's database for the 2018 calendar year. Eligible patients were included if they were Medicare enrolled, MTM eligible, and with International Classification of Disease 9/10 codes for HF. Counts and percentages were used to describe the prevalence of potentially harmful medication use and prescribing, by physician specialty. Exploratory logistic regression assessed the relationship between unique patient characteristics and potentially harmful prescribing. Results: A total of 13,250 patients were included, of whom 7017 (53%) were prescribed at least one potentially harmful medication. The most frequently prescribed medications in this cohort were nonsteroidal anti-inflammatory drugs (NSAIDs; 3357, 25%), dipeptidyl peptidase-4 (DPP4) inhibitors (3117, 24%), and non-dihydropyridine calcium channel blockers (CCBs; 936, 7%). A logistic regression found female sex, increasing polypharmacy, years qualified for MTM, higher poverty level, number of prescribers, and number of pharmacies were associated with potentially harmful medication prescribing. Of 17,548 potentially harmful medications encountered in a 4-month span, 9433 (54%) were prescribed by physician primary care providers. Conclusions: Over one-half of patients with HF were prescribed one or more potentially harmful medication(s). Automated monitoring of prescription claims and implementation of alerts in electronic health records in primary care is warranted to reduce potentially harmful medication use among Medicare MTM-eligible patients. [ABSTRACT FROM AUTHOR]

Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framework developed by the United States Food and Drug Administration; and quantitative approaches such as the numbers needed to treat for benefit and harm, the benefit-risk ratio, and Incremental Net Benefit. We give illustrative examples of benefit-risk evaluations using 4 treatment interventions including sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes; a direct antithrombin agent, dabigatran, for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation; transcatheter aortic valve replacement in patients with symptomatic severe aortic valve stenosis; and antiplatelet agents vorapaxar and prasugrel for reducing cardiovascular events in patients at high cardiovascular risk. Regular applications of structured benefit-risk assessment, whether qualitative, quantitative, or both, enabled by easy-to-understand graphical presentations that capture uncertainties around the benefit-risk metric, may aid shared decision-making and enhance transparency of those decisions. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this systematic review was to assess the literature regarding access to, and utilization of medication for type 2 diabetes (T2D) and pre-post improvements in diabetes outcomes for adults enrolled in clinic- or pharmacy-based medication assistance programs.Data Sources: The databases searched were PubMed, CINAHL, Scopus, Embase, Ovid HealthSTAR, PapersFirst, and OpenGrey.Study Selection: Databases were searched from the beginning of each database to Feburary 29, 2020. Articles were included if (1) the population of interest was adults 18 years of age or older with a T2D diagnosis, (2) the study addressed access to medication for diabetes patients in a clinic- or pharmacy-based setting, and (3) the study was conducted in the United States.Data Extraction: Data extracted from the selected studies included location of study, patient inclusion criteria, sample size, medication assistance program description, and reported diabetes medication access and medication related adherence outcomes.Results: Eleven articles met the inclusion criteria for the study. The mean reduction in glycated hemoglobin level following the use of medication assistance programs ranged from 0.45 to 0.8. Across studies, the mean number of antihyperglycemic medications used by patients in medication assistance programs ranged from 1 to 1.9. Medication adherence was reported at 45% across studies that reported adherence measures.Conclusion: Among the 11 studies identified that assessed access to medication for adults with T2D using clinic- or pharmacy-based medication assistance programs, study findings indicated that many of these programs showed some positive changes in medication access and diabetes-related outcomes. [ABSTRACT FROM AUTHOR]

Objective: We examined changes in glucose-lowering medication spending and quantified the magnitude of factors that are contributing to these changes.Research Design and Methods: Using the Medical Expenditure Panel Survey, we estimated the change in spending on glucose-lowering medications during 2005-2007 and 2015-2017 among adults aged ≥18 years with diabetes. We decomposed the increase in total spending by medication groups: for insulin, by human and analog; and for noninsulin, by metformin, older, newer, and combination medications. For each group, we quantified the contributions by the number of users and cost-per-user. Costs were in 2017 U.S. dollars.Results: National spending on glucose-lowering medications increased by $40.6 billion (240%), of which insulin and noninsulin medications contributed $28.6 billion (169%) and $12.0 billion (71%), respectively. For insulin, the increase was mainly associated with higher expenditures from analogs (156%). For noninsulin, the increase was a net effect of higher cost for newer medications (+88%) and decreased cost for older medications (-34%). Most of the increase in insulin spending came from the increase in cost-per-user. However, the increase in the number of users contributed more than cost-per-user in the rise of most noninsulin groups.Conclusions: The increase in national spending on glucose-lowering medications during the past decade was mostly associated with the increased costs for insulin, analogs in particular, and newer noninsulin medicines, and cost-per-user had a larger effect than the number of users. Understanding the factors contributing to the increase helps identify ways to curb the growth in costs. [ABSTRACT FROM AUTHOR]

Objective: Hypoglycemia has been postulated to contribute to falls risk in older adults with type 2 diabetes. However, few studies have prospectively examined the association between severe hypoglycemia and falls, both important causes of morbidity and mortality.Research Design and Methods: We conducted a prospective cohort analysis of participants from the Atherosclerosis Risk in Communities (ARIC) study with diagnosed diabetes at visit 4 (1996-1998). Episodes of severe hypoglycemia requiring medical treatment were identified using ICD-9 codes from hospitalizations, emergency department visits, and ambulance calls; total falls were identified from medical claims using E-codes from 1996 to 2013. Secondary analyses examined hospitalized falls and falls with fracture. We calculated incidence rates and used Cox regression models to evaluate the independent association of severe hypoglycemia with falls occurring after visit 4 through 2013.Results: Among 1,162 participants with diabetes, 149 ever had a severe hypoglycemic event before baseline or during the median of 13.1 years of follow-up. The crude incidence rate of falls among persons without severe hypoglycemia was 2.17 per 100 person-years (PY) (95% CI 1.93-2.44) compared with 8.81 per 100 PY (6.73-11.53) with severe hypoglycemia. After adjustment, severe hypoglycemia was associated with a more than twofold higher risk of falls (hazard ratio 2.23, 95% CI 1.61-3.07). Associations were consistent in subgroups defined by age, sex, race, BMI, duration of diabetes, or functional difficulty.Conclusions: Severe hypoglycemia was associated with a substantially higher risk of falls in this community-based population of adults with diabetes. Fall risk should be considered when individualizing glycemic treatment in older adults. Assessing hypoglycemia history and future hypoglycemia risk could also improve multifactorial fall prevention interventions for older adults with diabetes. [ABSTRACT FROM AUTHOR]

Objectives. To estimate treatment rates of high cholesterol, hypertension, and diabetes among Hispanic/Latino immigrants by immigration status (i.e., naturalized citizens, documented immigrants, or undocumented immigrants). Methods. We performed a cross-sectional analyses of the Hispanic Community Health Study/Study of Latinos (visit 2, 2014–2017). We restricted our analysis to Hispanic/Latino immigrants with high cholesterol (n = 3974), hypertension (n = 3353), or diabetes (n = 2406); treatment was defined as use of statins, antihypertensives, and antidiabetics, respectively. Results. When compared with naturalized citizens, undocumented and documented immigrants were less likely to receive treatment for high cholesterol (38.4% vs 14.1%; prevalence ratio [PR] = 0.37 [95% confidence interval [CI] = 0.27, 0.51] and 25.7%; PR = 0.67 [95% CI = 0.58, 0.76]), hypertension (77.7% vs 57.7%; PR = 0.74 [95% CI = 0.62, 0.89] and 68.1%; PR = 0.88 [95% CI = 0.82, 0.94]), and diabetes (60.3% vs. 50.4%; PR = 0.84 [95% CI = 0.68, 1.02] and 55.8%; PR = 0.93 [95% CI = 0.83, 1.03]); the latter did not reach statistical significance. Undocumented and documented immigrants had less access to health care, including insurance coverage or a usual health care provider, than naturalized citizens. Therefore, adjusting for health care access largely explained treatment disparities across immigration status. Conclusions. Preventing cardiovascular disease among Hispanic/Latino immigrants should focus on undertreatment of high cholesterol, hypertension, and diabetes by increasing health care access, especially among undocumented immigrants. [ABSTRACT FROM AUTHOR]

Background: Data on trends of diabetes medications use are sparse, outdated, and limited to prescription data. We determined trends in diabetes medication use among US individuals with diabetes during 2008-2015. Methods: We used 2008-2015 Medical Expenditure Panel Survey to examine diabetes medication utilization among individuals aged ≥18 years with diabetes. Prescription medications were classified based on therapeutic class and subclass using Multum Lexicon database. Results: From 2008 to 2015, use of any diabetes medication (81.4% vs. 87%), metformin (47.8% vs. 59.0%), and insulin (23.0% vs. 31.0%) increased, whereas, use of sulfonylurea (36.0% vs. 29.0%) and thiazolidinedione (21% vs. 9.0%) declined. A linear increase was observed in the uptake of dipeptidyl peptidase-4 (DPP-4) inhibitors from 6.2% in 2008 to 12.4% in 2015; glucagon-like peptide-1 (GLP-1) receptor agonists from 2.5% in 2008 to 4.4% in 2015 and sodium glucose transporter-2 (SGLT2) inhibitors from 0.8% in 2014 (the first SGLT2 inhibitors approval year) to 4.4% in 2015. Monotherapy use increased from 50.6% to 56.4% during 2008-2015, while triple therapy use declined. Conclusions: Metformin, insulin and sulfonylureas remained the top-three prescribed classes of diabetes medications. Increased use of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors was offset by decline in TZDs use. [ABSTRACT FROM AUTHOR]