ABSTRACT
INTRODUCTION: Second-generation basal insulins like glargine 300 U/mL (Gla-300) have a longer duration of action and less daily fluctuation and interday variability than first-generation ones, such as glargine 100 U/mL (Gla-100). The EF-BI study, a nationwide observational, retrospective study, was designed to compare persistence, acute care complications, and healthcare costs associated with the initiation of such basal insulins (BI) in a real-life setting in France. METHODS: This study was conducted using the French healthcare claims database (SNDS). Adult patients living with type 1 or type 2 diabetes mellitus (T1DM or T2DM) initiating Gla-300 or Gla-100 ± other hypoglycemic medications between January 1, 2016 and December 31, 2020, and without any insulin therapy over the previous 6 months were included. Persistence was defined as remaining on the same insulin therapy until discontinuation defined by a 6 month period without insulin reimbursement. Hospitalized acute complications were identified using ICD-10 codes. Total collective costs were established for patients treated continuously with each basal insulin over 1-3 years. All comparisons were adjusted using a propensity score based on initial patient/treatment characteristics. RESULTS: A total of 235,894 patients with T2DM and 6672 patients with T1DM were included. Patients treated with Gla-300 were 83% (T1DM) and 44% (T2DM) less likely to discontinue their treatment than those treated with Gla-100 after 24 months (p < 0.0001). The annual incidence of acute hospitalized events in patients with T2DM treated with Gla-300 was 12% lower than with Gla-100 (p < 0.0001) but similar in patients with T1DM. Comparison of overall costs showed moderate but statistically significant differences in favor of Gla-300 versus Gla-100 for all patients over the first year, and in T2DM only over a 3-year follow-up. CONCLUSION: Use of Gla-300 resulted in a better persistence, less acute hospitalized events at least in T2DM, and reduced healthcare expenditure. These real-life results confirmed the potential interest of using Gla-300 rather than Gla-100.
ABSTRACT
BACKGROUND: Diagnosis of children with type 1 diabetes (T1D) imposes an unprecedented burden on children and their caregivers. OBJECTIVE: To assess the burden of T1D on children and their informal caregivers, both after a recent diagnosis or after a longer duration of disease. METHODS: A series of systematic literature reviews were performed to explore the burden of T1D on children with the disease and their primary informal caregivers, based on the time of diagnosis. After the extraction of the qualitative and quantitative data from the included studies, two literature-based conceptual frameworks were developed: on the burden of pediatric T1D on children, and on informal caregivers. A third conceptual framework on the shared burden of pediatric T1D on both children and informal caregivers as part of the same family unit was also developed. RESULTS: The review of literature has identified a series of factors that affect the quality of life of children with T1D and their informal caregivers, with a direct impact on physical, emotional, and social outcomes. Generally, female patients and older adolescents experience more worry and stress that affects their quality of life. Other categories of factors affecting the child's and caregiver's burden include social, emotional, and physical factors, treatment-related and disease-related factors, as well as their coping abilities. Anxiety, depression, stress, and worry were commonly found among children and caregivers, starting with the diagnosis of T1D and continuing over time in relation to new challenges pertaining to aging or the disease duration. CONCLUSION: T1D causes a significant burden to affected children and their caregivers, both independently and through transactional interaction within the family unit. Disease burden can be reduced by strengthening individuals for the benefit of the whole family.
ABSTRACT
OBJECTIVE: To characterise uncontrolled severe asthma and compare the disease burden with the general and asthmatic populations. DESIGN: Retrospective observational study using a national sample of a French healthcare database (Echantillon Généraliste des Bénéficiaires (EGB)). SETTING: The EGB, an anonymised permanent sample of health insurance databases, representing 1/97th of the French population. PARTICIPANTS: Patients (≥12 years) were selected in year 2014 and followed 2 years. A cohort of patients with uncontrolled severe asthma was defined using an algorithm based on peer-reviewed literature and Global Initiative for Asthma recommendations. Index date was the occurrence of the first marker of uncontrolled asthma. This cohort was matched with two control cohorts, general population and asthmatic controls, on baseline characteristics. MAIN OUTCOMES MEASURES: Mortality, healthcare use and associated costs were studied in the 2 years of follow-up. RESULTS: Among 467 716 individuals in the EGB, 16 588 patients with asthma were identified, including 739 (4.5%) with uncontrolled severe disease. The survival probability at 2 years for patients with uncontrolled severe asthma (92.0%) was lower than in the general population cohort (96.6%; relative risk of death: 2.35; 95% CI: 1.70 to 3.29; p<0.0001) and tended to be lower than in the control asthmatic cohort (94.3%; p=0.07). Emergency department visits and hospitalisations were higher in patients with uncontrolled severe asthma than in the general population (64.7% vs 34.9%; p<0.0001) and asthmatic controls (64.7% vs 55.2%; p=0.0002). Other components of healthcare use (medical and paramedical visits, medications) were increased in patients with uncontrolled severe asthma compared with control populations. These increases translated into higher costs (p<0.0001 for both comparisons). CONCLUSIONS: This study demonstrates the huge burden of uncontrolled severe asthma in terms of mortality, morbidity and healthcare resource consumption compared with other patients with asthma and with the general population and emphasises the importance of appropriate management in this high-risk population.
