The European Medicines Agency Committee for Medical Products for Human Use (CHMP) has recently approved dapagliflozin and issued a positive opinion for sotagliflozin, as adjunctive treatments to insulin for adults with type 1 diabetes (T1D). The decisions were made based on the results of randomized clinical trials (RCT) conducted in patients with T1D (DEPICT studies for dapagliflozin and InTANDEM studies for sotagliflozin) [1, 2]. Furthermore, also empagliflozin and canagliflozin have shown positive results as adjunct treatment to insulin in patients with type 1 diabetes (EASE-2 and EASE-3 trials for empagliflozin) [3, 4]. However, there are some safety concerns for the increased risk of diabetic ketoacidosis associated with the use of these drugs in patients with T1D [1,2,3,4]. The CHMP provides a list of conditions to mitigate the risk of diabetic ketoacidosis (DKA), including patient selection (prescription by a specialist, only to patient with a BMI above 27 and excluding those with low insulin requirement), diabetes management (optimization of insulin therapy with lowering of insulin doses only to prevent hypoglycemia) and active prevention of DKA (patient education and commitment to the measurement of blood ketones). Similar recommendations were presented in details in a recent consensus published on Diabetes Care [5]. The increased risk of DKA is indeed the reason why, almost at the same time, the Food and Drug Administration (FDA) rejected sotagliflozin and, more recently, dapagliflozin as adjunct to insulin for the treatment of type 1 diabetes.
Scavini, M., Bertuzzi, F., Girelli, A., Celleno, R., Molinari, C., Tripodi, F.P., et al. (2019). Off-label prescription of SGLT-2 inhibitors to patients with type 1 diabetes: an online survey of diabetes specialists in Italy. ACTA DIABETOLOGICA, 56(11), 1235-1238 [10.1007/s00592-019-01386-7].
Off-label prescription of SGLT-2 inhibitors to patients with type 1 diabetes: an online survey of diabetes specialists in Italy
Di Bartolo P.;
2019
Abstract
The European Medicines Agency Committee for Medical Products for Human Use (CHMP) has recently approved dapagliflozin and issued a positive opinion for sotagliflozin, as adjunctive treatments to insulin for adults with type 1 diabetes (T1D). The decisions were made based on the results of randomized clinical trials (RCT) conducted in patients with T1D (DEPICT studies for dapagliflozin and InTANDEM studies for sotagliflozin) [1, 2]. Furthermore, also empagliflozin and canagliflozin have shown positive results as adjunct treatment to insulin in patients with type 1 diabetes (EASE-2 and EASE-3 trials for empagliflozin) [3, 4]. However, there are some safety concerns for the increased risk of diabetic ketoacidosis associated with the use of these drugs in patients with T1D [1,2,3,4]. The CHMP provides a list of conditions to mitigate the risk of diabetic ketoacidosis (DKA), including patient selection (prescription by a specialist, only to patient with a BMI above 27 and excluding those with low insulin requirement), diabetes management (optimization of insulin therapy with lowering of insulin doses only to prevent hypoglycemia) and active prevention of DKA (patient education and commitment to the measurement of blood ketones). Similar recommendations were presented in details in a recent consensus published on Diabetes Care [5]. The increased risk of DKA is indeed the reason why, almost at the same time, the Food and Drug Administration (FDA) rejected sotagliflozin and, more recently, dapagliflozin as adjunct to insulin for the treatment of type 1 diabetes.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
