4.7 Article

SGLT2-inhibitors are effective and safe in the elderly: The SOLD study

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PHARMACOLOGICAL RESEARCH
卷 183, 期 -, 页码 -

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ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.phrs.2022.106396

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SGLT2-I; T2D; Safety

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The SOLD study evaluated the effectiveness and safety of SGLT2i in older patients with type 2 diabetes. The results showed significant improvement in glycemic control and weight reduction with SGLT2i treatment in the elderly, with minimal impact on renal function. However, caution is advised in more fragile patients.
Background and aims: Sodium-glucose co-transporter-2 inhibitors (SGLT2i) may have important benefits for the elderly with type 2 diabetes (T2D), however some safety concerns still limit their use in patients over 70 years of age. The SOLD study (SGLT2i in Older Diabetic patients) is a multicenter study, aimed to evaluate the effectiveness and safety of SGLT2i in the older diabetic patients in a real-life setting. Materials and methods: We analyzed a population of 739 adults (mean age 75.4 +/- 3.9 years, M/F 420/319) with T2D, which started a SGLT2i-based treatment after the age of 70, with at least one year of follow-up. Data were collected at baseline, at 6 and 12 months of follow-up. Results: SGLT2i (37.5% Empagliflozin, 35.7% Dapagliflozin, 26.1% Canagliflozin, 0.7% Ertugliflozin) were an add-on therapy to Metformin in 88.6%, to basal insulin in 36.1% and to other antidiabetic drugs in 29.6% of cases. 565 subjects completed the follow up, while 174 (23.5%) discontinued treatment due to adverse events which were SGLT2i related. A statistically significant reduction of glycated hemoglobin (baseline vs 12 months: 7.8 +/- 1.1 vs 7.1 +/- 0.8%, p < 0.001) and body mass index values (baseline vs 12 months: 29.2 +/- 4.7 vs 28.1 +/- 4.5 kg/m(2), p < 0.001) were evident during follow-up. Overall, estimated glomerular filtration rate remained stable over time, with significant reduction of urinary albumin excretion. In the subgroup of patients which were >= 80 years, a significant improvement in glycated hemoglobin values without renal function alterations was evident. Overall discontinuation rate during the follow-up period was different across age groups, being urinary tract infections and worsening of renal function the most common cause. Conclusion: SGLT2i are well-tolerated and safe in the elderly and appear as an effective therapeutic option, though some caution is also suggested, especially in more fragile subjects.

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