Evaluation of the safety and efficacy of SGLT2 inhibitor luseogliflozin in elderly patients with type 2 diabetes mellitus -Post-marketing surveillance in elderly patients (Final Report)

Japanese Pharmacology and Therapeutics

Volumn 45, Issue 4, 2017, Pages 559-569

  Kurose, Takeshi ^a   Inagati, Nobuya ^b   Fukatsu, Atsushi ^c   Sasaki, Takashi ^d   Kitajima, Soichi ^e   Seino, Yutaka ^f  

^a Electric Power Hospital   (Japan)

^b KYOTO UNIVERSITY   (Japan)

^c Department of Surgery   (Japan)

^d JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e TAISHO PHARMACEUTICAL CO LTD   (Japan)

^f KANSAI ELECTRIC POWER CO   (Japan)

Author keywords

Adverse drug reaction; Elderly patient with type 2 diabetes mellitus; Luseogliflozin; Post marketing surveillance; Sglt2 inhibitor

Indexed keywords

HEMOGLOBIN A1C; LUSEOGLIFLOZIN;

ADULT; AGED; ARTICLE; BODY WEIGHT; COHORT ANALYSIS; DIABETIC PATIENT; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; GERIATRIC PATIENT; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS;

EID: 85021171874     PISSN: 03863603     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. Ferrannini E, Solini A. SGLT2 inhibition in diabetes mel- litus: rationale and clinical prospects. Nat Rev Endocrinol 2012; 8: 495-502.
2. Abdul-Ghani MA, Norton L, DeFronzo RA. Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus. Curr Diab Rep 2012; 12: 230-8.
3. Lathief S, Inzucchi SE. Approach to diabetes management in patients with CVD. Trends Cardiovasc Med 2016; 26: 165-79.
4. Inzucchi SE, Zinman B, Wanner C, Ferrari R, Fitchett D, Hantel S, et al. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vase Dis Res 2015; 12: 90-100.
5. Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, et al. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol 2014; 13: 102.
6. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med 2015; 373:2117-28.
7. Kirkman MS, Briscoe VJ, Clark N, Florez H, Haas LB, Halter JB, et al. Diabetes in older adults: a consensus report. J Am Geriatr Soc 2012; 60: 2342-56.
8. Yamamoto K, Uchida S, Kitano K, Fukuhara N, Okumura- Kitajima L, Gunji E, et al. TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity. Br J Pharmacol 2011; 164: 181-91.
9. Uchida S, Mitani A, Gunji E, Takahashi T, Yamamoto K. In vitro characterization of luseogliflozin, a potent and competitive sodium glucose co-transporter 2 inhibitor: inhibition kinetics and binding studies. J Pharmacol Sci 2015; 128: 54-7.
10. Seino Y, Sasaki T, Fukatsu A, Ubukata M, Sakai S, Samu-kawa Y. Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 study. Curr Med Res Opin 2014; 30: 1245-55.
11. Seino Y, Kaku K, Inagaki N, Haneda M, Sasaki T, Fukatsu A, et al. Fifty-two-week long-term clinical study of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Endocr J 2015; 62: 593-603.
12. Seino Y, Inagaki N, Haneda M, Kaku K, Sasaki T, Fukatsu A, et al. Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig 2015; 6: 443-53.
13. http://www.jds.or.jp/modules/important/index.php?page=article&storyid=48.
14. Seino Y. Luseogliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother 2014; 15: 2741-9.
15. Haneda M, Seino Y, Inagaki N, Kaku K, Sasaki T, Fukatsu A, et al. Influence of Renal Function on the 52-Week Efficacy and Safety of the Sodium Glucose Cotransporter 2 Inhibitor Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Clin Ther 2016; 38: 66-88.