Chronic Kidney Disease Eligible for SGLT2 Inhibitors Through the Integration of Italian Administrative and Primary Care Data


Background. Patients with chronic kidney disease (CKD) can be successfully treated with sodium-glucose cotransporter-2 inhibitors (SGLT2-Is), regardless of diabetes. Fondazione Ricerca e Salute’s (ReSD) administrative and Health Search’s (HSD) primary care databases were combined in the Database Consortium ReS-HS to quantify and describe patients with CKD potentially eligible for SGLT2-Is and assess costs charged to the Italian National Health Service (SSN).
Methods. Patients aged ≥18 with CKD and estimated glomerular filtration rate (eGFR) <60 ml/min in 2018, without dialysis and/or renal transplantation, were included. HSD was used to develop and validate algorithms for estimating eGFR, based on covariates, within the ReSD. Comorbidities, dispensed drugs, and direct healthcare costs were assessed.
Results. In 2018, 66,297 (5.0% of HSD population) and 211,494 (4.4% of ReSD population) patients with CKD potentially eligible for SGLT2-Is were identified (females ≥58%). Prevalence increased with age with a peak at 75-84 years. Within HSD and ReSD cohorts, respectively: 31.0% and 41.5% had diabetes; in the observation periods, >82% and >96% received ≥1 pharmacological treatment, of which ≥50% and ≥25% received cardiovascular/blood agents and antidiabetics, respectively. From ReSD, mean per capita direct SSN cost was € 3,825 (CI 95%, € 3,655-€ 4,000): 50.1% due to hospitalizations, and 40.2% to pharmaceuticals (31.6% to cardiovascular drugs and 10.1% to antidiabetics).
Conclusion. The Database Consortium ReS-HS methodology found 5% of adult SSN beneficiaries with CKD potentially eligible for SGLT2-Is bringing with them a high cardio-metabolic burden which increases the risk of CKD progression.

Keywords: Sodium-Glucose Transporter 2 Inhibitors, Chronic Kidney Diseases, Primary Care, Health Care Costs, National Healthcare System

This work was supported by an unconditional grant from Astra Zeneca Italy SpA. The financial support for this study was provided with a funding agreement ensuring maintenance of author independence in study design, data interpretation, writing, and decision to publish.

Competing interests: APM received personal fees for the participation in clinical studies supported by Bayer, Novartis, Sanofi and Astra Zeneca, outside the present work. FL and EM and provided consultancies in protocol preparation for epidemiological studies and data analyses for AstraZeneca and Mundipharma. DP, CC, GP and GM provided clinical consultancies for AstraZeneca. RP received honoraria for lectures from Lilly, Boehringer, AstraZeneca, Novo-Nordisk, Vifor, Alfa-Sigma, and Bayer, outside the present work. CP, LD, SC, GR and NM are employees of Fondazione Ricerca e Salute (ReS). AP is consultant for Fondazione Ricerca e Salute (ReS).  


Sodium-glucose cotransporter-2 inhibitors (SGLT2-Is) have shown positive outcomes on the reduction of glycated hemoglobin (Hb1cA) levels, the protection from cardiovascular events in high-risk patients with type 2 diabetes mellitus (T2DM), the prevention of cardiovascular death and heart failure regardless of T2DM, and of the progression of chronic kidney disease (CKD) [1, 3]. The latter is likely to be independent from the glucose-lowering effects and favored by the glucose-related natriuresis and osmotic diuresis that reduce intraglomerular pressure; the DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease) trial was based on this hypothesis and aimed at assessing the long-term efficacy and safety of dapagliflozin in patients with CKD, regardless of T2DM [4]. This trial has shown that patients with CKD assessed by an estimated glomerular filtration rate (eGFR) ranging from 25 to 75 ml/min, regardless of T2DM, have benefited from dapagliflozin through a significant reduction of the risk of sustained decline in eGFR of at least 50%, end-stage kidney disease (ESKD) and renal- or cardiovascular-related death [4]. 

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