A Retrospective Observational Study Examining the Generalizability of Glucagon-Like Peptide 1 Receptor Agonist Cardiovascular Outcome Trials to the Real-World Population with Type 2 Diabetes in Spain: The REPRESENT Study.

INTRODUCTION: The REPRESENT study aims to examine whether participants enrolled in glucagon-like peptide 1 receptor agonist cardiovascular outcome trials (CVOTs) LEADER (liraglutide), REWIND (dulaglutide), and SUSTAIN-6 (injectable semaglutide) are representative of the Spanish population with type 2 diabetes (T2D). METHODS: This retrospective observational study used the IQVIA Electronic Medical Records database in Spain to identify adults aged 18 years and older with T2D diagnosed before/between January 2013 and December 2015. Demographic and clinical characteristics were analyzed descriptively. The proportions of individuals in the Spanish cohort who met the key selection criteria of each CVOT were calculated from individuals with available database entries for estimated glomerular filtration rate and body mass index using proxies. RESULTS: A total of 24,268 adults with T2D were identified from the IQVIA database. The Spanish cohort was predominantly male (55.5%) and had a mean (± SD) age of 66.8 ± 12.5 years and HbA1c of 7.2 ± 1.5%, with 14.0% having established cardiovascular disease and 2.9% having prior myocardial infarction. The characteristics of the Spanish cohort were more similar to that of REWIND than LEADER or SUSTAIN-6. The proportions of subjects in the Spanish cohort who met the CVOTs key selection criteria were 10.1% for LEADER, 53.6% for REWIND, and 10.4% for SUSTAIN-6. CONCLUSIONS: Although none of the CVOTs was fully representative of the Spanish cohort, the REWIND population was found to be more representative of the real-world Spanish population with T2D than those of LEADER and SUSTAIN-6. These findings reinforce the applicability of the results of REWIND in clinical practice.

Cardiovascular Profile of Patients with Type 2 Diabetes in France Based on REWIND CVOT Inclusion Criteria: A Real-World Retrospective Study.

INTRODUCTION: The REWIND study demonstrated a cardiovascular (CV) benefit of dulaglutide treatment in patients with type 2 diabetes (T2D) with or without established cardiovascular disease (CVD). The current study aims to describe similarities and differences between characteristics of patients with T2D in France and the REWIND population. METHODS: A retrospective, observational study was conducted in France using primary care IQVIA electronic medical records. Patients aged ≥ 18 years with at least one clinical visit and/or glucose-lowering agent prescription in 2019 were identified. The percentages of patients aged ≥ 50 years with established CVD, aged ≥ 55 years with subclinical CVD or aged ≥ 60 years with multiple CV risk factors based on REWIND definitions were calculated. RESULTS: A total of 63,927 patients with T2D were included. Mean age was 67 years, 93% were aged ≥ 50 years and 58% were male. The median time since T2D diagnosis was 5.6 years, mean glycated hemoglobin was 7.1% and mean body mass index was 30.4 kg/m2. Of the patients included in the current study, 59.4% fulfilled REWIND CV criteria; 12.4% of patients were ≥ 50 years old with established CVD; 9.7% of patients were aged ≥ 55 years with subclinical vascular disease and 44.7% were aged ≥ 60 years with ≥ 2 CV risk factors. CONCLUSION: Almost 60% of this primary care French cohort with T2D fulfilled key REWIND CV criteria, with a lower percentage of patients having established CVD than REWIND participants.

The impact of volume overload on technique failure in incident peritoneal dialysis patients.

BACKGROUND: Technique failure in peritoneal dialysis (PD) can be due to patient- and procedure-related factors. With this analysis, we investigated the association of volume overload at the start and during the early phase of PD and technique failure. METHODS: In this observational, international cohort study with longitudinal follow-up of incident PD patients, technique failure was defined as either transfer to haemodialysis or death, and transplantation was considered as a competing risk. We explored parameters at baseline or within the first 6 months and the association with technique failure between 6 and 18 months, using a competing risk model. RESULTS: Out of 1092 patients of the complete cohort, 719 met specific inclusion and exclusion criteria for this analysis. Being volume overloaded, either at baseline or Month 6, or at both time points, was associated with an increased risk of technique failure compared with the patient group that was euvolaemic at both time points. Undergoing treatment at a centre with a high proportion of PD patients was associated with a lower risk of technique failure. CONCLUSIONS: Volume overload at start of PD and/or at 6 months was associated with a higher risk of technique failure in the subsequent year. The risk was modified by centre characteristics, which varied among regions.

Evolution Over Time of Volume Status and PD-Related Practice Patterns in an Incident Peritoneal Dialysis Cohort.

BACKGROUND AND OBJECTIVES: Volume overload is frequent in prevalent patients on kidney replacement therapies and is associated with outcome. This study was devised to follow-up volume status of an incident population on peritoneal dialysis (PD) and to relate this to patient-relevant outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This prospective cohort study was implemented in 135 study centers from 28 countries. Incident participants on PD were enrolled just before the actual PD treatment was started. Volume status was measured using bioimpedance spectroscopy before start of PD and thereafter in 3-month intervals, together with clinical and laboratory parameters, and PD prescription. The association of volume overload with time to death was tested using a competing risk Cox model. RESULTS: In this population of 1054 participants incident on PD, volume overload before start of PD amounted to 1.9±2.3 L, and decreased to 1.2±1.8 L during the first year. At all time points, men and participants with diabetes were at higher risk to be volume overloaded. Dropout from PD during 3 years of observation by transfer to hemodialysis or transplantation (23% and 22%) was more prevalent than death (13%). Relative volume overload >17.3% was independently associated with higher risk of death (adjusted hazard ratio, 1.59; 95% confidence interval, 1.08 to 2.33) compared with relative volume overload ≤17.3%. Different practice patterns were observed between regions with respect to proportion of patients on PD versus hemodialysis, selection of PD modality, and prescription of hypertonic solutions. CONCLUSIONS: In this large cohort of incident participants on PD, with different treatment practices across centers and regions, we found substantial volume overload already at start of dialysis. Volume overload improved over time, and was associated with survival.