Ferreira, Antonio; Schönenberger, Katja; Potoczna, Natascha; Vogt, Andreas; Gerber, Philipp; Zehetner, Jörg; Giachino, Daniel; Nett, Philipp; Gawinecka, Joanna; Cossu, Luca; Fuster, Daniel; Dalla Man, Chiara; Facchinetti, Andrea; Melmer, Andreas; Nakas, Christos T; Hepprich, Matthias; Donath, Marc; Herzig, David; Bally, Lia (2023). Randomized, double-blind, placebo-controlled crossover trial of once daily empagliflozin 25 mg for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass. Diabetes technology & therapeutics, 25(7), pp. 467-475. Mary Ann Liebert 10.1089/dia.2023.0036
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Aims To investigate the effect of empagliflozin on glucose dynamics in individuals suffering from postbariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass (RYGB). Methods Twenty-two adults with PBH after RYGB were randomized to empagliflozin 25 mg or placebo once daily over 20 days in a randomized, double-blind, placebo-controlled, crossover trial. The primary efficacy outcome was the amplitude of plasma glucose excursion (peak to nadir) during a mixed meal tolerance test (MMTT). Outcomes of the outpatient period were assessed using continuous glucose monitoring (CGM) and an event-tracking app. Results The amplitude of glucose excursion during the MMTT was 8.1±2.4 mmol/L with empagliflozin vs 8.1±2.6 mmol/L with placebo (mean±SD, p=0.807). CGM-based mean amplitude of glucose excursion (MAGE) during the 20 day-period was lower with empagliflozin than placebo (4.8±1.3 vs 5.2±1.6. p=0.028). Empagliflozin reduced the time spent with CGM values >10.0 mmol/L (3.8±3.5 % vs. 4.7±3.8 %, p =0.009), but not the time spent with CGM values <3.0 mmol/L (1.7±1.6 % vs. 1.5±1.5 %, p=0.457). No significant difference was observed in the quantity and quality of recorded symptoms. Eleven adverse events occurred with empagliflozin (three drug-related) and six with placebo. Conclusions Empagliflozin 25 mg reduces glucose excursions but not hypoglycaemia in individuals with PBH.
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