Geographic variation and racial disparities in adoption of newer glucose-lowering drugs with cardiovascular benefits among US Medicare beneficiaries with type 2 diabetes.

BACKGROUND: Prior studies have shown disparities in the uptake of cardioprotective newer glucose-lowering drugs (GLDs), including sodium-glucose cotranwsporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1a). This study aimed to characterize geographic variation in the initiation of newer GLDs and the geographic variation in the disparities in initiating these medications. METHODS: Using 2017-2018 claims data from a 15% random nationwide sample of Medicare Part D beneficiaries, we identified individuals diagnosed with type 2 diabetes (T2D), who had ≥1 GLD prescriptions, and did not use SGLT2i or GLP1a in the year prior to the index date,1/1/2018. Patients were followed up for a year. The cohort was spatiotemporally linked to Dartmouth hospital-referral regions (HRRs), with each patient assigned to 1 of 306 HRRs. We performed multivariable Poisson regression to estimate adjusted initiation rates, and multivariable logistic regression to assess racial disparities in each HRR. RESULTS: Among 795,469 individuals with T2D included in the analyses, the mean (SD) age was 73 (10) y, 53.3% were women, 12.2% were non-Hispanic Black, and 7.2% initiated a newer GLD in the follow-up year. In the adjusted model including clinical factors, compared to non-Hispanic White patients, non-Hispanic Black (initiation rate ratio, IRR [95% CI]: 0.66 [0.64-0.68]), American Indian/Alaska Native (0.74 [0.66-0.82]), Hispanic (0.85 [0.82-0.87]), and Asian/Pacific islander (0.94 [0.89-0.98]) patients were less likely to initiate newer GLDs. Significant geographic variation was observed across HRRs, with an initiation rate spanning 2.7%-13.6%. CONCLUSIONS: This study uncovered substantial geographic variation and the racial disparities in initiating newer GLDs.

Individual and social determinants of adherence to sodium-glucose cotransporter 2 inhibitor therapy: A trajectory analysis.

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) are known to improve cardiovascular and renal outcomes in patients with type 2 diabetes (T2D). Understanding the longitudinal patterns of adherence and the associated predictors is critical to addressing the suboptimal use of this outcome-improving treatment. OBJECTIVE: To characterize the distinct trajectories of adherence to SGLT2is in patients with T2D and to identify patient characteristics and social determinants of health (SDOHs) associated with SGLT2i adherence. METHODS: In this retrospective cohort study, we identified patients with T2D who initiated and filled at least 1 SGLT2i prescription according to 2012-2016 national Medicare claims data. The monthly proportion of days covered with SGLT2is for each patient was incorporated into group-based trajectory models to identify groups with similar adherence patterns. A multinomial logistic regression model was constructed to examine the association between patient characteristics and group membership. In addition, the association between context-specific SDOHs (eg, neighborhood median income and neighborhood employment rate) and adherence to an SGLT2i regimen was explored in both the overall cohort and the racial and ethnic subgroups. RESULTS: The final sample comprised 6,719 patients with T2D. Four trajectories of SGLT2i adherence were identified: continuously adherent users (49.6%), early discontinuers (27.5%), late discontinuers (14.5%), and intermediately adherent users (8.4%). Patient age, sex, race, diabetes duration, and Medicaid eligibility were significantly associated with trajectory group membership. Areas with a higher unemployment rate, lower income level, lower high school education rate, worse nutrition environment, fewer health care facilities, and greater Area Deprivation Index scores were found to be associated with low adherence to SGLT2is. CONCLUSIONS: Four distinct trajectories of adherence to SGLT2is were identified, with only half of the patients remaining continuously adherent to their treatment regimen during the first year after initiation. Several contextual SDOHs were associated with suboptimal adherence to SGLT2is.

Tear film interferometry assessment after intense pulsed light in dry eye disease: A randomized, single masked, sham-controlled study.

BACKGROUND: Inadequate meibomian glands (MGs) secretion can lead to dry eye signs and symptoms. Tear film lipid layer (TFLL) secreted by MGs protects and prevents rapid evaporation of tear film. The purpose was to assess TFLL alteration and function in patients with evaporative dry eye (EDE) using tear interferometry after optimal pulse light technology (OPT) intense pulsed light (IPL). METHODS: This prospective randomized examiner-masked sham- controlled study included 86 participants (142 eyes) with DED. IPL or sham procedure was performed on day 0, 21, and 42. Ocular Surface Disease Index (OSDI), non-invasive breakup time (NITBUT), interferometric fringe pattern determined TFLL quality, fluorescein staining (FS), and meibum gland (MG) were assessed at day 0, 21, 42 and 3-month. RESULTS: At 3-month, TFLL, NITBUT, MG drop-out, MG quality, MG expressibility, FS and OSDI improved significantly (P < 0.05) in the IPL group, while the sham group had no significant improvements. Except for Meibo-score and FS, all parameters significantly correlated with the improvement in TFLL following IPL treatment. Additionally, artificial tears usage was significantly less in the IPL group from D-42 onwards. CONCLUSION: IPL treatment demonstrated the ability to improve TFLL quality and clinically reduced sign and symptoms of DED thereby reducing the frequency of artificial tears use.

Primary care provider payment models and adherence to anticoagulation in patients with atrial fibrillation.

BACKGROUND: Oral anticoagulation (OAC) is recommended for the prevention of stroke in atrial fibrillation (AF). However, only 50%-60% of AF patients in the United States are treated with OAC, and 60% of them adhere to OAC therapy over time. OBJECTIVES: To (1) compare adherent use of OAC between AF patients who received primary care from practices involved in shared-savings models and patients who received care from practices not involved in shared savings and (2) examine the trend of adherence to OAC over time. Because OAC can save downstream medical costs associated with averted stroke events, we hypothesized that OAC adherence would be higher among patients receiving care from practices involved in shared savings. METHODS: Using 2014-2019 claims data from a health insurer in western Pennsylvania, we identified 20,637 AF patients from 2015-2018. Patients were followed from the first AF diagnosis (index date) for 12 months or until disenrollment. We categorized patients according to the payment model of the practice from which they received primary care: shared savings (n = 8,844) and no shared savings (n = 11,793). The primary outcome was adherent use of OAC therapy, which was defined as having at least 80% of the followup period covered with OAC. Secondary outcomes included adherent use of direct oral anticoagulants (DOACs) and adherent use of warfarin. We constructed logistic regression models to assess the association between involvement in shared savings and adherent use of OAC, while controlling for demographics, clinical characteristics, and index year. RESULTS: 34% of patients in the shared-savings group adhered to OAC, compared with 32.7% in the no shared-savings group (P = 0.04). After adjustment, adherence was higher for the shared-savings group for OAC (adjusted odds ratio [aOR] = 1.07, 95% CI = 1.01-1.14) and warfarin (aOR = 1.11, 95% CI = 1.02-1.20) compared with the no shared-savings group. However, the odds of adherent use of DOACs did not statistically differ between shared savings and no shared savings (aOR = 0.99, 95% CI = 0.91-1.08). The odds of adherent OAC use increased over time: the aOR of adherent use of OAC was 1.21 (95% CI = 1.09-1.34) for index year 2016; 1.50 (95% CI = 1.36-1.67) for 2017; and 1.78 (95% CI 1.60-1.98) for 2018, all compared with 2015. CONCLUSIONS: Receipt of primary care from a practice involved in shared savings was associated with a higher adherent use of OAC and warfarin for patients with atrial fibrillation. Furthermore, adherent use of OAC improved over time for both treatment groups. Our research demonstrates that the alignment of financial incentives between providers and insurers may improve the use of therapies with downstream cost-saving potential. DISCLOSURES: This project was funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). Hernandez has received consulting fees from Pfizer and BMS, outside of the submitted work. The other authors have nothing to disclose.

Using machine learning to identify diabetes patients with canagliflozin prescriptions at high-risk of lower extremity amputation using real-world data.

AIMS: Canagliflozin, a sodium-glucose cotransporter 2 inhibitor indicated for lowering glucose, has been increasingly used in diabetes patients because of its beneficial effects on cardiovascular and renal outcomes. However, clinical trials have documented an increased risk of lower extremity amputations (LEA) associated with canagliflozin. We applied machine learning methods to predict LEA among diabetes patients treated with canagliflozin. METHODS: Using claims data from a 5% random sample of Medicare beneficiaries, we identified 13 904 diabetes individuals initiating canagliflozin between April 2013 and December 2016. The samples were randomly and equally split into training and testing sets. We identified 41 predictor candidates using information from the year prior to canagliflozin initiation, and applied four machine learning approaches (elastic net, least absolute shrinkage and selection operator [LASSO], gradient boosting machine and random forests) to predict LEA risk after canagliflozin initiation. RESULTS: The incidence rate of LEA was 0.57% over a median 1.5 years follow-up. LASSO produced the best prediction, yielding a C-statistic of 0.81 (95% CI: 0.76, 0.86). Among individuals categorized in the top 5% of the risk score, the actual incidence rate of LEA was 3.74%. Among the 16 factors selected by LASSO, history of LEA [adjusted odds ratio (aOR): 33.6 (13.8, 81.9)] and loop diuretic use [aOR: 3.6 (1.8,7.3)] had the strongest associations with LEA incidence. CONCLUSIONS: Our machine learning model efficiently predicted the risk of LEA among diabetes patients undergoing canagliflozin treatment. The risk score may support optimized treatment decisions and thus improve health outcomes of diabetes patients.

Real-World Direct Comparison of the Effectiveness and Safety of Apixaban, Dabigatran, Rivaroxaban, and Warfarin in Medicare Beneficiaries With Atrial Fibrillation.

It remains unknown whether the comparative effectiveness of direct oral anticoagulants (DOACs) and warfarin differs between atrial fibrillation patients with and without a history of stroke or transient ischemic attack (TIA). Using 2012 to 2014 Medicare claims data, we identified patients newly diagnosed with AF in 2013 to 2014 who initiated apixaban, dabigatran, rivaroxaban, or warfarin. We categorized patients based on a history of stroke or TIA. We constructed Cox proportional hazard models that included indicator variables for treatment groups, a history of stroke or TIA, and the interaction between them, and controlled for demographics and clinical characteristics. DOACs were generally more effective than warfarin in stroke prevention; however, there were important differences between subgroups defined by a history of ischemic stroke. In particular, the superiority of dabigatran compared with warfarin in ischemic stroke prevention was more pronounced in patients with a history of stroke or TIA (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.48 to 0.85) than in patients with no history of stroke or TIA (HR 0.94; 95% CI 0.75 to 1.16; p value for interaction = 0.034). There was no difference in the risk of stroke between apixaban, dabigatran, and rivaroxaban in patients with no history of stroke or TIA. However, in patients with a history of stroke or TIA, the risk of stroke was lower with dabigatran (HR 0.64; 95% CI 0.48 to 0.85) and rivaroxaban (HR 0.70; 95% CI 0.56 to 0.87), compared with apixaban (p value for both interactions <0.05). In conclusion, the comparative effectiveness of DOACs differs substantially between patients with and without a history of stroke or TIA; specifically, apixaban is less effective in patients with a history of stroke or TIA.