Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice

Expert Opinion on Pharmacotherapy

Volumn 17, Issue 15, 2016, Pages 1985-1994

  Maegawa, Hiroshi ^a   Tobe, Kazuyuki ^b   Tabuchi, Hiromi ^c   Nakamura, Ichiro ^c  

^a SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^b UNIVERSITY OF TOYAMA   (Japan)

^c ASTELLAS PHARMA INC   (Japan)

Author keywords

Ipragliflozin; Japan; post marketing surveillance; safety; sodium glucose cotransporter 2 inhibitor; type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA GLUCOSIDASE INHIBITOR; ANTIDIABETIC AGENT; ANTIHYPERTENSIVE AGENT; ANTITHROMBOCYTIC AGENT; ASPARTATE AMINOTRANSFERASE; CREATININE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DIURETIC AGENT; GAMMA GLUTAMYLTRANSFERASE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; IPRAGLIFLOZIN; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; PRESCRIPTION DRUG; SULFONYLUREA; TRIACYLGLYCEROL; URIC ACID; URICOSURIC AGENT; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; THIOPHENE DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIHYPERTENSIVE THERAPY; APPLICATION SITE REACTION; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BENIGN TUMOR; BLOOD PRESSURE; BREAST DISEASE; CHOLESTEROL BLOOD LEVEL; CHRONOPHARMACOLOGY; CLINICAL EVALUATION; CLINICAL LABORATORY; CLINICAL PRACTICE; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYST; DIABETIC PATIENT; DIET RESTRICTION; DIURETIC THERAPY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL DISEASE; GENITAL SYSTEM DISEASE; GLYCEMIC CONTROL; HEART DISEASE; HEART RATE; HEMATOCRIT; HEPATOBILIARY DISEASE; HUMAN; INCIDENCE; INJURY; INSULIN TREATMENT; INTOXICATION; JAPANESE (PEOPLE); KIDNEY DISEASE; KIDNEY FUNCTION; LIVER FUNCTION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDICATION COMPLIANCE; METABOLIC DISORDER; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; NUTRITIONAL DISORDER; PATIENT COMPLIANCE; POLYP; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PROCEDURAL SITE REACTION; PROSPECTIVE STUDY; SIDE EFFECT; SKIN DISEASE; SOFT TISSUE DISEASE; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; URIC ACID BLOOD LEVEL; URINARY TRACT DISEASE; VITAL SIGN; ADOLESCENT; ANALYSIS; DIABETES MELLITUS, TYPE 2; GLUCOSE BLOOD LEVEL; MIDDLE AGED; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; BLOOD PRESSURE; DIABETES MELLITUS, TYPE 2; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INCIDENCE; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES; THIOPHENES; YOUNG ADULT;

EID: 84981717952     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1080/14656566.2016.1217994     Document Type: Article

References (40)

1. R.M.Poole, R.T.Dungo Ipragliflozin:first global approval. Drugs. 2014;74:611–617.
2. A.Kashiwagi, N.Akiyama, T.Shiga, et al. Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes:results of the randomized, placebo-controlled, double-blind, phase III EMIT study. Diabetol Int. 2015;6:125–138.
3. A.Kashiwagi, K.Kazuta, K.Goto, et al. Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes:ILLUMINATE, a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2015;17:304–308.
4. A.Kashiwagi, K.Kazuta, Y.Takinami, et al. Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus:the BRIGHTEN study. Diabetol Int. 2015;6:8–18.
5. T.Kadokura, N.Akiyama, A.Kashiwagi, et al. Pharmacokinetic and pharmacodynamic study of ipragliflozin in Japanese patients with type 2 diabetes mellitus:A randomized, double-blind, placebo-controlled study. Diabetes Res Clin Pract. 2014;106:50–56.
6. A.Kashiwagi, T.Shiga, N.Akiyama, et al. Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes:a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study). Diabetol Int. 2015;6:104–116.
7. A.Kashiwagi, H.Takahashi, H.Ishikawa, et al. A randomized, double-blind, placebo-controlled study on long-term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment:results of the long-term ASP1941 safety evaluation in patients with type 2 diabetes with renal impairment (LANTERN) study. Diabetes Obes Metab. 2015;17:152–160.
8. Y.Terauchi, K.Yokote, I.Nakamura, et al. Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER):interim results of a post-marketing surveillance study. Expert Opin Pharmacother. 2016;17:463–471.• This survey, conducted in an older population, provided comparable findings to the present survey in real-world clinical practice.
9. Ministry of Health, Labour and Welfare. Classification criteria for seriousness of adverse drug reactions of pharmaceuticals. PAB/SD notification no. 80. Tokyo:Ministry of Health, Labour and Welfare; 1992 Jun 29.
10. International Council for Harmonisation of technical requirements for registration of pharmaceuticals for human use. Medical Dictionary for Regulatory Activities Version 18.0. Geneva:International Council for Harmonisation of technical requirements for registration of pharmaceuticals for human use; 2015.
11. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. On release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents. PSSB/ELD notification no. 0709-1. Tokyo:Ministry of Health, Labour and Welfare; 2010 Jul 9.
12. A.Kashiwagi, S.Yoshida, I.Nakamura, et al. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index:a subgroup analysis of five randomized clinical trials. J Diabetes Investig. 2015. doi:10.1111/jdi.12471.
13. T.Iizuka, K.Iemitsu, M.Takihata, et al. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes:interim outcome of the ASSIGN-K study. J Clin Med Res. 2016;8:116–125. Correction J Clin Med Res 2016;8:267
14. S.Sakai, K.Kaku, Y.Seino, et al. Efficacy and safety of the SGLT2 inhibitor luseogliflozin in Japanese patients with type 2 diabetes mellitus stratified according to baseline body mass index:pooled analysis of data from 52-week phase III trials. Clin Ther. 2016;38:843–62.e9.
15. Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals LP. FARXIGA® (dapagliflozin) tablets, for oral use. United States Prescribing Information. London:Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals LP; Revised:08/2014.
16. Janssen Pharmaceuticals, Inc. INVOKANA® (canagliflozin) tablets, for oral use. United States Prescribing Information. Beerse:Janssen Pharmaceuticals, Inc.; Revised:05/2016.
17. Boehringer Ingelheim International GmbH. JARDIANCE® (empagliflozin) tablets, for oral use. United States Prescribing Information. Ingelheim am Rhein:Boehringer Ingelheim International GmbH; Revised:03/2016.
18. S.Matthaei, K.Bowering, K.Rohwedder, et al. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea:a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015;38:365–372.
19. S.Matthaei, K.Bowering, K.Rohwedder, et al. Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. Diabetes Obes Metab. 2015;17:1075–1084.
20. K.Stenlöf, W.T.Cefalu, K.A.Kim, et al. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise:findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014;30:163–175.
21. E.Araki, Y.Tanizawa, Y.Tanaka, et al. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015;17:665–674.
22. S.Ikeda, Y.Takano, O.Cynshi, et al. A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015;17:984–993.
23. N.Inagaki, K.Kondo, T.Yoshinari, et al. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes:a 52-week open-label study. J Diabetes Investig. 2015;6:210–218.
24. N.Inagaki, K.Kondo, T.Yoshinari, et al. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes:a randomized, double-blind, placebo-controlled, 12-week study. Diabetes Obes Metab. 2013;15:1136–1145.
25. N.Inagaki, K.Kondo, T.Yoshinari, et al. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise:a 24-week, randomized, double-blind, placebo-controlled, phase III study. Expert Opin Pharmacother. 2014;15:1501–1515.
26. T.Kadowaki, M.Haneda, N.Inagaki, et al. Empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus:a randomized, 12-week, double-blind, placebo-controlled, phase II trial. Adv Ther. 2014;31:621–638.
27. T.Kadowaki, M.Haneda, N.Inagaki, et al. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes:a randomized, double-blind, parallel-group study. Adv Ther. 2015;32:306–318.
28. K.Kaku, S.Inoue, O.Matsuoka, et al. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control:a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2013;15:432–440.
29. K.Kaku, A.Kiyosue, S.Inoue, et al. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014;16:1102–1110.
30. K.Kaku, H.Maegawa, Y.Tanizawa, et al. Dapagliflozin as monotherapy or combination therapy in Japanese patients with type 2 diabetes:an open-label study. Diabetes Ther. 2014;5:415–433.
31. K.Kaku, H.Watada, Y.Iwamoto, et al. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus:a combined phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study. Cardiovasc Diabetol. 2014;13:65.
32. Y.Seino, N.Inagaki, M.Haneda, 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;6:443–453.
33. Y.Seino, K.Kaku, N.Inagaki, 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.
34. Y.Seino, T.Sasaki, A.Fukatsu, et al. Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus:a 12-week, randomized, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30:1219–1230.
35. Y.Seino, T.Sasaki, A.Fukatsu, et al. 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;30:1245–1255.
36. Y.Seino, T.Sasaki, A.Fukatsu, et al. Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus:a 12-week, randomized, double-blind, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30:1231–1244.
37. Y.Tanizawa, K.Kaku, E.Araki, 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.
38. F.Briand, E.Mayoux, E.Brousseau, et al. Empagliflozin, via switching metabolism toward lipid utilization, moderately increases LDL cholesterol levels through reduced LDL catabolism. Diabetes. 2016;65:2032–2038.
39. H.J.Lambers Heerspink, D.de Zeeuw, L.Wie, et al. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013;15:853–862.
40. B.Zinman, C.Wanner, J.M.Lachin, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–2128.•• This large-scale, well-designed trial provided convincing evidence that empagliflozin was associated with reduced cardiovascular morbidity and mortality compared with placebo.