Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes
| Autor: | Tomoo Okamura, Atsutaka Yasui, Stefan Kaspers, Tatsuroh Kaneko, Tetsuaki Hirase, Maximilian von Eynatten, Ganghyuck Lee |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism Empagliflozin Urology Diuresis 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Placebo 03 medical and health sciences 0302 clinical medicine Diabetes mellitus Urine volume Internal Medicine medicine Body fluid Kidney Dehydration business.industry Brief Report medicine.disease Japanese patients medicine.anatomical_structure SGLT2 Inhibitor business SGLT2 inhibitors |
| Zdroj: | Diabetes Therapy |
| ISSN: | 1869-6961 1869-6953 0088-5118 |
| Popis: | Introduction Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, ameliorates hyperglycemia in patients with type 2 diabetes (T2D) by inducing sustained glucosuria. Empagliflozin treatment was previously associated with a transient increase in 24-h urine volume in Caucasian patients with T2D, however comparable evidence in Japanese T2D individuals is scarce. We therefore assessed acute and chronic changes in 24-h urine volume and fluid intake with empagliflozin in Japanese patients with T2D. Methods In this randomized, double-blind, placebo-controlled, parallel-group, multiple-dose, 4-week trial, 100 Japanese patients with T2D were randomized to receive either 1, 5, 10, or 25 mg empagliflozin or placebo once-daily. Changes from baseline in 24-h urine volume and fluid intake were assessed at days 1, 27, and 28 after the initiation of empagliflozin. Results The 24-h urine volume and fluid intake were comparable across all treatment groups at baseline. Patients treated with either 10 or 25 mg empagliflozin (i.e., the licensed doses in Japan) showed a significant increase in 24-h urine volume compared to placebo at day 1 (mean change from baseline: + 0.83, + 1.08, and + 0.29 L/day in the empagliflozin 10 and 25 mg groups and the placebo group, respectively; both p 0.05). The 24-h fluid intake was comparable across all study groups throughout the entire study period. No events consistent with dehydration were reported during empagliflozin treatment. Conclusion Treatment initiation with empagliflozin in Japanese patients with T2D was associated with transient diuresis; however, overall urine volume returned towards baseline levels within 4 weeks of treatment. These findings are consistent with a physiological, adaptive mechanism of the kidney to maintain overall body fluid balance in response to treatment initiation with a SGLT2 inhibitor. Trial Registration Number NCT00885118. Funding Nippon Boehringer Ingelheim Co., Ltd. |
| Databáze: | OpenAIRE |
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