Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis

Journal of Diabetes Investigation

Volumn 7, Issue 5, 2016, Pages 755-763

  Utsunomiya, Kazunori ^a   Shimmoto, Naoki ^b   Senda, Masayuki ^c   Kurihara, Yuji ^b   Gunji, Ryoji ^b   Kameda, Hiroyuki ^c   Tamura, Masahiro ^c   Mihara, Hanako ^c   Kaku, Kohei ^d  

^a JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b KOWA COMPANY LTD   (Japan)

^c Sanofi KK ^*  (Japan)

^d KAWASAKI MEDICAL SCHOOL   (Japan)

Author keywords

Elderly; Sodium glucose transporter 2; Type 2 diabetes mellitus

Indexed keywords

HEMOGLOBIN A1C; TOFOGLIFLOZIN;

ABSCESS; AGED; ARTICLE; ATRIAL FIBRILLATION; BALANOPOSTHITIS; BODY MASS; BRAIN INFARCTION; CHRONIC KIDNEY DISEASE; CLINICAL EFFECTIVENESS; CONNECTIVE TISSUE DISEASE; CONSCIOUSNESS DISORDER; CONSTIPATION; CYSTITIS; DEHYDRATION; DEMOGRAPHY; DRUG ERUPTION; DRUG SAFETY; ECZEMA; ERYTHEMA; FEMALE; GENITAL PRURITUS; GENITAL TRACT INFECTION; GERIATRIC PATIENT; GLOMERULUS FILTRATION RATE; HEAT STROKE; HEMORRHAGIC CYSTITIS; HUMAN; HYPOGLYCEMIA; HYPONATREMIA; INCIDENCE; INFECTION; INFESTATION; JAPANESE (PEOPLE); KIDNEY DISEASE; LACUNAR STROKE; MAJOR CLINICAL STUDY; MALE; MUSCLE WEAKNESS; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NOCTURIA; NON INSULIN DEPENDENT DIABETES MELLITUS; NUTRITIONAL DISORDER; OBSERVATIONAL STUDY; PAPULE; PNEUMONIA; POLLAKISURIA; POLYDIPSIA; POLYURIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; PYELONEPHRITIS; RASH; SKIN DISEASE; SKIN EXFOLIATION; SWEAT GLAND DISEASE; TREATMENT DURATION; TREATMENT WITHDRAWAL; URINARY TRACT DISEASE; URINARY TRACT INFECTION; URTICARIA; VAGINA CANDIDIASIS; VAGINITIS; VULVITIS;

EID: 84991111380     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12513     Document Type: Article

References (17)

1. Ministry of Health, Labour and Welfare Japan. The National Health and Nutrition Survey Japan 2012. Available from: http://www.mhlw.go.jp/stf/houdou/0000032074.html Accessed October 17, 2015 (in Japanese).
2. Japan Diabetic Society. Treatment Guide for Diabetes 2014–2015. Tokyo: Bunkodo, 2014 (in Japanese).
3. DeFronzo RA, Davidson JA, del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab 2012; 14: 5–14.
4. List JF, Whaley JM. Glucose dynamics and mechanistic implications of SGLT2 inhibitors in animals and humans. Kidney Int Suppl 2011; 120: S20–S27.
5. Poole RM, Prossler JE. Tofogliflozin: first global approval. Drugs 2014; 74: 939–944.
6. Committee on Proper Use of SGLT2 Inhibitors. Recommendations on the proper use of SGLT2 inhibitors. 2014 (in Japanese).
7. Rosenwasser RF, Rosenwasser JN, Sutton D, et al. Tofogliflozin: a highly selective SGLT2 inhibitor for the treatment of type 2 diabetes. Drugs Today 2014; 50: 739–745.
8. Japan Pharmaceutical Manufacturers Association. A guide for preparing risk management plans for drug products (provisional). August 2014 (in Japanese).
9. Kowa Company, Ltd. Risk management plan for Deberza 20 mg Tablet. June 2015 (in Japanese).
10. Sanofi KK. Risk management plan for Apleway 20 mg Tablet. June 2015 (in Japanese).
11. Ministry of Health, Labour and Welfare Japan. Summary of Patient Survey 2011. Available from: http://www.mhlw.go.jp/english/database/db-hss/sps_2011.html. Accessed October 17, 2015.
12. Kowa Company, Ltd. Package insert for Deberza 20 mg Tablet (in Japanese)
13. Sanofi KK Package insert for Apleway 20 mg Tablet (in Japanese).
14. Tanizawa Y, Kaku K, Araki E, et al. Long-term safety and efficacy of tofogliflozin, a selective inhibitor of sodium glucose cotransporter 2, as monotherapy or in combination with other oral antidiabetic agents in Japanese patients with type 2 diabetes mellitus: multicenter, open-label, randomized controlled trials. Expert Opin Pharmacother 2014; 15: 749–766.
15. Kasichayanula S, Chang M, Hasegawa M, et al. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab 2011; 13: 357–365.
16. Khurana M, Vaidyanathan J, Marathe A, et al. Canagliflozin use in patients with renal impairment-Utility of quantitative clinical pharmacology analyses in dose optimization. J Clin Pharmacol 2015; 55: 647–656.
17. Kohan DE, Fioretto P, Tang W, et al. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int 2014; 85: 962–971.