Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study.

Autor:	Iizuka T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Iemitsu K; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Takihata M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Takai M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Nakajima S; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Minami N; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Umezawa S; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kanamori A; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Takeda H; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kawata T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Ito S; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kikuchi T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Amemiya H; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kaneshiro M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Mokubo A; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Takuma T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Machimura H; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Tanaka K; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Asakura T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kubota A; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Aoyagi S; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Hoshino K; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Ishikawa M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Matsuzawa Y; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Obana M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Sasai N; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Kaneshige H; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Minagawa F; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Saito T; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Shinoda K; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Miyakawa M; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan., Tanaka Y; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan; Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan., Terauchi Y; Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Kanagawa, Japan., Matsuba I; Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Jazyk:	angličtina
Zdroj:	Journal of clinical medicine research [J Clin Med Res] 2016 Feb; Vol. 8 (2), pp. 116-25. Date of Electronic Publication: 2015 Dec 28.
DOI:	10.14740/jocmr2417w
Abstrakt:	Background: Ipragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment. Methods: This was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks. Results: Two hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects. Conclusions: In patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water.
Databáze:	MEDLINE
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