scholarly journals Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus: Results of 24‐month interim analysis of a long‐term post‐marketing study (J‐STEP/LT)

2020 ◽  
Vol 11 (4) ◽  
pp. 906-916 ◽  
Author(s):  
Kazunori Utsunomiya ◽  
Seigo Kakiuchi ◽  
Masayuki Senda ◽  
Shoko Fujii ◽  
Yuji Kurihara ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Interim Analysis ◽  
Japanese Patients ◽  
Post Marketing

scholarly journals Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

2021 ◽  
Vol 24 (2) ◽  
pp. 141-155
Author(s):  
K. Tobe ◽  
H. Maegawa ◽  
I. Nakamura ◽  
S. Uno
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Renal Impairment ◽  
Japanese Patients ◽  
Surveillance Study ◽  
Post Marketing Surveillance ◽  
Post Marketing

STELLA-LONG TERM, a 3-year post-marketing surveillance study, evaluated the safety and effectiveness of the sodiumglucose cotransporter 2 inhibitor ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients. Final results in the safety (n = 6697) and effectiveness populations (n = 5625) were analyzed by stratifying patients by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) into four subgroups (≥90, 60 to <90, 45 to <60, and <45) and two subgroups (≥60 and <60). Adverse drug reaction (ADR) incidence, and changes from baseline in glycosylated hemoglobin (HbA1c), bodyweight, and eGFR were assessed. The percentage of patients experiencing ADRs and serious ADRs was similar across most eGFR subgroups. Polyuria/pollakiuria was the most common ADR. Renal disorders and volume depletion ADRs were more frequent in the subgroups with more severe renal impairment at baseline than in those with an eGFR of 60 to <90 or ≥90 mL/min/1.73 m2. Bodyweight and HbA1c decreased in all subgroups, the latter by − 0.91% to − 0.40% (P <0.05 vs. baseline). eGFR increased in the 45 to <60 mL/min/1.73 m2 subgroup (+ 1.42 ± 8.77 mL/min/1.73 m2; P = 0.006). It decreased in the ≥90 and 60 to <90 mL/min/1.73 m2 subgroups (− 8.27 ± 13.73 and − 1.22 ± 10.34 mL/min/1.73 m2; P <0.001), but not to <60 mL/min/1.73 m2. In conclusion, there were no new or unexpected safety findings in Japanese patients treated with ipragliflozin for T2DM, and long-term sustained improvements in HbA1c and bodyweight were observed regardless of the presence of renal impairment.

scholarly journals Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan

2015 ◽  
Vol 29 (8) ◽  
pp. 1304-1309 ◽  
Author(s):  
Yutaka Seino ◽  
Daisuke Yabe ◽  
Akane Takami ◽  
Elisabeth Niemoeller ◽  
Hiroki Takagi
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Japanese Patients ◽  
Once Daily
Sign in / Sign up

Export Citation Format

Share Document