Abstract
OBJECTIVE OF THE STUDY SIDECAR (SGLT2-Inhibitors in Diabetes: Evaluation of metabolic Control and Adverse events in the Real-world), is a monocentric prospective observational study performed to monitoring in clinical practice patients with type 2 diabetes (T2D) treated with SGLT2-i to evaluate metabolic and anthropometric evolution during time, as well as the onset of adverse effects (AEs). Design and methods. Demographic features, T2D duration, and clinical parameters at baseline have been recorded as mean ± Standard Deviation (SD) for continuous variables, and frequency distribution for discrete variables. A repeated measures regression model was utilized for the evolution during time of parameters. AEs prevalence were recorded with stratification for main clinical and demographic features at baseline. RESULTS N=220 patients, with 18 months available follow-up, treated with SGLT2-i (N= 19 canagliflozin, 8.6%; N=91 dapagliflozin, 41.4%; N=110 empagliflozin, 50%) monotherapy or in combination according to AIFA indications). Really effective was the action of SGLT2-i on glucose metabolism, with rapid reduction in HbA1c and fasting plasma glucose after 6 months, as well as after 12 and 18 months (HbA1c: -1,0%; fasting plasma glucose: -34,8mg/dL). Weight and BMI showed a satisfying improvement, while waist circumference was statistically significant only after 12 months. Blood pressure, total cholesterol, and renal function were not modified by the treatment. But, apart from the valuable effects on metabolic parameters, 86 patients (39%) suspended SGLT2-i treatment mainly because ineffectiveness (15,7%) or for Genito-Urinary Tract Infections (GUTIs) appearance (14,3%). CONCLUSIONS Median term follow-up confirms the efficacy of SGLT2-i, but a significant percentage of patients is forced to suspend these drugs especially for GUTIs appearance. Such high prevalence of non-serious AEs limits the potential nephro-cardiovascular benefits related to SGLT2-i utilization. A possible chance to reduce GUTIs should come from single tablet association of SGLT2-i and DPP4-i actually available on the market. KEY WORDS type 2 diabetes; SGLT2 inhibitors; genito-urinary tract infections; real world evaluation; health education
Highlights
Gli Autori hanno utilizzato 2 approcci: innanzitutto hanno valutato gli RCTs presenti in letteratura comparando la frequenza di GUTIs in coloro in trattamento con associazione SGLT2-i/DPP4-i rispetto a coloro in trattamento solo con SGLT2-i rilevando come il rischio di infezioni genitali (GTIs) fosse circa dimezzato nei pazienti in terapia combinata rispetto a coloro che assumevano solo SGLT2-i
Successivamente hanno valutato la frequenza di GUTIs nel sistema di farmacovigilanza e reportistica di eventi avversi della Food and Drug Administration (FDA) (FDA AE Reporting System) rilevando come tale rischio era statisticamente ridotto in pazienti in terapia combinata SGLT2-i + DPP4-i
220 patients (M: 130; F: 90) suffering from type 2 diabetes, median age 60.7 years (SD ±11.3), median duration of the disease 12.4 years (±8.3), in poor metabolic control [median HbA1c 8.9% (±1.7)], treated with SGLT2-i as add-on, with a follow-up duration of 18 months were included in the study
Summary
V. De Mori1, A. Balini1, D. Bertola1, D. Berzi1, F. Forloni1, G. Meregalli1, G. Veronesi2, A.C. Bossi1 1 UOC Malattie Endocrine - Centro Regionale per il Diabete Mellito, ASST Bergamo Ovest, Treviglio (BG). 2 Dipartimentodi Medicina e Chirurgia, Centro di ricerca in Epidemiologia e Medicina Preventiva (EPIMED), Università degli Studi dell’Insubria, Varese.
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