Glycemic and Cost Outcomes among Hispanic/Latino People with Type 2 Diabetes in the USA Initiating Dulaglutide versus Basal Insulin: a Real-World Study.

INTRODUCTION: Optimal glycemic management after diabetes onset remains a challenge in Hispanic/Latino adults with type 2 diabetes (T2D), often resulting in poor health outcomes and higher rates of diabetes-related complications. The aim of this study was to examine and compare demographic and clinical characteristics, glycemic outcomes, health care resource utilization (HCRU), and costs among injection-naïve Hispanic/Latino adults with T2D initiating dulaglutide or basal insulin. METHODS: This retrospective, observational study used administrative claims data from the Optum Research Database. Hispanic/Latino adults with T2D were assigned to dulaglutide or basal insulin cohorts on the basis of pharmacy claims and were propensity-score matched on demographic and baseline characteristics. Measures of glycemic management included 12 month follow-up glycated hemoglobin (HbA1c) and change in HbA1c from baseline. Follow-up all-cause and diabetes-related HCRU and costs, including costs per 1% change in HbA1c, were compared between cohorts. RESULTS: The final propensity-score matched sample included 2872 patients: 1436 patients in each cohort. Mean (SD) reduction in HbA1c from baseline to 12 month follow-up was greater in the dulaglutide cohort compared with the basal insulin cohort [-1.40% (1.88) versus -0.92% (2.07); p < 0.001]. The dulaglutide cohort had significantly lower proportions of patients with ≥ 1 all-cause and diabetes-related outpatient visits, emergency room visits, and inpatient stays compared with the basal insulin cohort (p < 0.05). The dulaglutide cohort had significantly lower all-cause total costs per 1% HbA1c reduction than the basal insulin cohort ($13,768 versus $19,128; p < 0.001). Diabetes-related costs per 1% reduction were numerically lower for the dulaglutide cohort, but the difference was not statistically significant ($9737 versus $11,403; p = 0.081). CONCLUSIONS: Dulaglutide demonstrated better glycemic outcomes and lower all-cause costs per 1% HbA1c reduction among Hispanic/Latino adults compared with those initiating basal insulin. Our real-world findings in the Hispanic/Latino population were consistent with results obtained from the overall population and confirm the glycemic benefits of dulaglutide observed in clinical settings.

Glycemic and Economic Outcomes in Elderly Patients with Type 2 Diabetes Initiating Dulaglutide Versus Basal Insulin in a Real-World Setting in the United States: The DISPEL-Advance Study.

INTRODUCTION: Treatments like glucagon-like peptide-1 receptor agonists carry low hypoglycemia risk and are recommended for elderly patients with type 2 diabetes (T2D), while some routine treatments, like insulin, increase hypoglycemia risk. The DISPEL-Advance (Dulaglutide vs Basal InSulin in Injection Naïve Patients with Type 2 Diabetes: Effectiveness in ReaL World) study compared glycemic outcomes, healthcare resource utilization, and costs in elderly patients with T2D who initiated treatment with dulaglutide versus those initiating treatment with basal insulin. METHODS: This observational, retrospective cohort study used data from the Optum Research Database. Medicare Advantage patients (≥ 65 years) with T2D were assigned to dulaglutide or basal insulin cohorts based on pharmacy claims and propensity score matched on demographic and baseline characteristics. Change in HbA1c, 12-months follow-up HbA1c, and follow-up all-cause and diabetes-related healthcare resource utilization and costs were compared. RESULTS: Propensity score matching yielded well-balanced cohorts with 1891 patients each (mean age: dulaglutide, 72.09 years; basal insulin, 72.56 years). The dulaglutide cohort had significantly greater mean HbA1c reduction from baseline to follow-up than basal insulin cohort (- 0.95% vs - 0.69%; p < 0.001). The dulaglutide cohort had significantly lower mean all-cause and diabetes-related medical costs (all-cause: $8306 vs $12,176; diabetes-related: $4681 vs $7582 respectively; p < 0.001) and lower mean all-cause total costs ($18,646 vs $20,972, respectively; p = 0.007) than basal insulin cohort. The dulaglutide cohort had significantly lower all-cause and diabetes-related total costs per 1% change in HbA1c than basal insulin cohort (all-cause: $19,729 vs $30,334; diabetes-related: $12,842 vs $17,288, respectively; p < 0.001). CONCLUSIONS: Elderly patients with T2D initiating dulaglutide had greater HbA1c reduction, lower mean all-cause medical and total costs, lower diabetes-related medical costs, and lower total all-cause and diabetes-related costs per 1% change in HbA1c than patients initiating basal insulin. Future studies assessing medications that do not increase hypoglycemia risk could help inform therapeutic strategies in elderly patients.

Determinants of aflatoxin exposures in Kenyan School-aged children.

Aflatoxins are naturally occurring food toxins known to contaminate cereals with a carry-over effect in milk and meat products from farm animals raised on contaminated feed. In children, continuous consumption of aflatoxin-contaminated food is linked to immune suppression, vaccine interference and growth faltering while in adult populations, carcinogenesis in the liver has been established. We evaluate the main determinants of aflatoxin exposures among children recruited from primary schools in Makueni and Siaya Counties. A five-part questionnaire was administered to collect information from randomly selected participants. AflatoxinB1-lysine adducts in children's sera and total aflatoxins in food samples were analyzed by High-Performance Liquid Chromatography with Fluorescence detection. Using Chi-squared tests and Kruskal-Wallis tests, children from low-income households had the highest aflatoxin exposure, p-value = 0.0029. Smaller family size, greater food diversity, and good farming practices were associated with low aflatoxin exposures p < 0.001. Individual households living under severe levels of poverty were evidently exposed to higher levels of aflatoxins.

Molecular toxicology and carcinogenesis of fumonisins: a review.

Fumonisins, discovered in 1988 are a group of naturally occurring toxins produced by fusarium pathogenic fungi. Besides their presence in animal feeds, contamination of human foods such as corn, millet, oats, rye, barley, wheat and their products are widespread. Exposure to fumonisins results in species and organ specific toxicities including neurological disorders among equids, pulmonary edema in swine, esophageal cancer in humans and both kidney and liver related toxicities in rodents. This review seeks to consolidate groundbreaking research on the science of fumonisins toxicity, highlight recent progress on fumonisins research, and provide an overview of plausible mechanistic biomarkers for fumonisins exposure assessment.

Nutrition and growth outcomes are affected by aflatoxin exposures in Kenyan children.

Aflatoxin exposure, malnutrition and growth impairment in children present significant public health problems in low- and middle-income countries. Recent epidemiology studies show that exposure to aflatoxins through dietary sources in early life contributes to growth retardation among children. However, the findings remain inconclusive due to limited comparative studies in high versus low aflatoxin exposure regions. This cross-sectional study presents aflatoxin exposure levels among children aged 6 to 12 years, and further evaluates the association between aflatoxin exposure levels, malnutrition and growth impairment in Kenya, East Africa. AFB1-lysine adducts are validated biomarkers of exposure and were quantified using HPLC with fluorescence detection. All children (n = 746) had detectable levels of AFB1-lysine adducts in serum, range 0.65-518.9 pg/mg albumin with a geometric mean (GM) of 10.5 (95%CI 9.4-11.7) pg/mg albumin. The Geometric Means (GM) of AFB1-lysine adducts were 14.0 (95%CI 12.5, 15.7) pg/mg albumin and 8.2 (95%CI 7.6, 8.8) pg/mg albumin (p-value < 0.001), among children recruited from Makueni and Siaya Counties, respectively. While the study confirms higher human exposure levels in Makueni county, it provides an initial data set for aflatoxin exposure levels among children recruited from Siaya County. In multivariate analysis, after adjusting for socio-economic indicators, farming practices, and household dietary patterns, increasing one unit of log AFB1-lysine was associated with decreasing Weight-for-age z-score (WAZ) by -0.13, p-value = 0.019 among all children aged 6-12 years. Among children 6 to 9 years, WAZ decreases by -0.11 (-0.54, -0.01), p-value = 0.049. Additional growth parameters Height-for-age z-score (HAZ) and Weight-for-height z-score (WHZ) do not reach statistical significance. HAZ decreases by -0.08, p-value = 0.337 and WHZ decreases by -0.17, p-value = 0.437 with every increase in log AFB1-lysine. These data suggest that efforts must be put in place to control for aflatoxin exposure in order to achieve better growth outcomes.