Empagliflozin as adjunctive to insulin therapy in type 1 diabetes: The EASE Trials
Diabetes Care Nov 22, 2018
Rosenstock J, et al. - In patients with type 1 diabetes (T1D), researchers assessed the safety and effectiveness of empagliflozin 10 mg and 25 mg in addition to a unique lower dose (2.5 mg) as adjunct to intensified insulin. The Empagliflozin as Adjunctive to inSulin thErapy (EASE) program (N=1,707) consisted of two double-blind, placebo-controlled phase 3 trials: EASE-2 with empagliflozin 10 mg (n=243), 25 mg (n=244), and placebo (n=243), 52-week treatment; and EASE-3 with empagliflozin 2.5 mg (n=241), 10 mg (n=248), 25 mg (n=245), and placebo (n=241), 26-week treatment. The investigators found that empagliflozin improved T1D glycemic control and weight without hypoglycemia increase. Furthermore, the ketoacidosis rate was similar between empagliflozin 2.5 mg and placebo, but it increased with the 10- and 25-mg doses. The authors suggested that ketone monitoring for early ketoacidosis detection and intervention and lower doses of empagliflozin can reduce this risk. They found that genital infections occurred more frequently on empagliflozin.
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