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Volumn 38, Issue 1, 2016, Pages 66-88.e20

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

Author keywords

Japanese; Key words glomerular filtration rate; luseogliflozin; renal impairment; sodium glucose cotransporter 2 inhibitor; type 2 diabetes mellitus

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ADIPONECTIN; ALANINE AMINOTRANSFERASE; ALBUMIN; ASPARTATE AMINOTRANSFERASE; BETA 2 MICROGLOBULIN; C PEPTIDE; CREATININE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLIMEPIRIDE; GLUCOSE; GLYCOALBUMIN; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LEPTIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; LUSEOGLIFLOZIN; METFORMIN; PLACEBO; SULFONYLUREA; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; URIC ACID; 1,5-ANHYDRO-1-(5-(4-ETHOXYBENZYL)-2-METHOXY-4-METHYLPHENYL)-1-THIOGLUCITOL; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; SODIUM GLUCOSE COTRANSPORTER; SORBITOL;

EID: 84954388588     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2015.10.025     Document Type: Article
Times cited : (61)

References (40)
  • 1
    • 77951089891 scopus 로고    scopus 로고
    • International Diabetes Federation Accessed January 20
    • International Diabetes Federation. IDF Diabetes Atlas (6th edition). http://www.idf.org/sites/default/files/Atlas-poster-2014-EN.pdf. Accessed January 20, 2015.
    • (2015) IDF Diabetes Atlas (6th Edition)
  • 2
    • 35748967622 scopus 로고    scopus 로고
    • Ministry of Health, Labor and Welfare Accessed January 20, 2015
    • Ministry of Health, Labor and Welfare. The National Health and Nutrition Survey in Japan, 2012. http://www.mhlw.go.jp/bunya/kenkou/eiyou/dl/h24-houkoku.pdf. Accessed January 20, 2015.
    • (2012) The National Health and Nutrition Survey in Japan
  • 4
    • 0034641568 scopus 로고    scopus 로고
    • Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study
    • I.M. Stratton, A.I. Adler, H.A. Neil, and et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study BMJ 321 2000 405 412
    • (2000) BMJ , vol.321 , pp. 405-412
    • Stratton, I.M.1    Adler, A.I.2    Neil, H.A.3
  • 5
    • 0142087597 scopus 로고    scopus 로고
    • Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: The Epidemiology of Diabetes Interventions and Complications (EDIC) study
    • Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study JAMA 290 2003 2159 2167
    • (2003) JAMA , vol.290 , pp. 2159-2167
  • 6
    • 84888214461 scopus 로고    scopus 로고
    • Association between remission of macroalbuminuria and preservation of renal function in patients with type 2 diabetes with overt proteinuria
    • H. Yokoyama, S. Araki, J. Honjo, and et al. Association between remission of macroalbuminuria and preservation of renal function in patients with type 2 diabetes with overt proteinuria Diabetes Care 36 2013 3227 3233
    • (2013) Diabetes Care , vol.36 , pp. 3227-3233
    • Yokoyama, H.1    Araki, S.2    Honjo, J.3
  • 7
    • 84878598114 scopus 로고    scopus 로고
    • KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Chapter 4: Other complications of CKD: CVD, medication dosage, patient safety, infections, hospitalizations, and caveats for investigating complications of CKD
    • Kidney disease improving global outcomes KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Chapter 4: Other complications of CKD: CVD, medication dosage, patient safety, infections, hospitalizations, and caveats for investigating complications of CKD Kidney Int 3 suppl 2013 91 111
    • (2013) Kidney Int , vol.3 , pp. 91-111
  • 9
    • 84954405080 scopus 로고    scopus 로고
    • Committee on the Proper Use of Biguanides revision at March 28, 2014. Accessed April 1
    • Committee on the Proper Use of Biguanides. Recommendation on the proper use of biguanides, revision at March 28, 2014. http://www.jds.or.jp/common/fckeditor/editor/filemanager/connectors/php/transfer.php?file=/uid000025-7265636F6D6D656E646174696F6E5F62696775616E6964652E706466. Accessed April 1, 2015.
    • (2015) Recommendation on the Proper Use of Biguanides
  • 10
    • 77951143723 scopus 로고    scopus 로고
    • (1S)-1,5-anhydro-1- [45-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment
    • H. Kakinuma, T. Oi, Y. Hashimoto-Tsuchiya, and et al. (1S)-1,5-anhydro-1- [45-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment J Med Chem 53 2010 3247 3261
    • (2010) J Med Chem , vol.53 , pp. 3247-3261
    • Kakinuma, H.1    Oi, T.2    Hashimoto-Tsuchiya, Y.3
  • 11
    • 79961228970 scopus 로고    scopus 로고
    • TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity
    • K. Yamamoto, S. Uchida, K. Kitano, and et al. TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity Br J Pharmacol 164 2011 181 191
    • (2011) Br J Pharmacol , vol.164 , pp. 181-191
    • Yamamoto, K.1    Uchida, S.2    Kitano, K.3
  • 12
    • 84911028030 scopus 로고    scopus 로고
    • Sodium glucose transporter protein 2 inhibitors: Focusing on the kidney to treat type 2 diabetes
    • B. Peene, and K. Benhalima Sodium glucose transporter protein 2 inhibitors: focusing on the kidney to treat type 2 diabetes Ther Adv Endocrinol Metab 5 2014 124 136
    • (2014) Ther Adv Endocrinol Metab , vol.5 , pp. 124-136
    • Peene, B.1    Benhalima, K.2
  • 13
    • 84902245089 scopus 로고    scopus 로고
    • Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A 12-week, randomized, placebo-controlled, phase II study
    • Y. Seino, T. Sasaki, A. Fukatsu, and 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 30 2014 1219 1230
    • (2014) Curr Med Res Opin , vol.30 , pp. 1219-1230
    • Seino, Y.1    Sasaki, T.2    Fukatsu, A.3
  • 14
    • 84902242668 scopus 로고    scopus 로고
    • Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus: A 12-week, randomized, double-blind, placebo-controlled, phase II study
    • Y. Seino, T. Sasaki, A. Fukatsu, and 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 30 2014 1231 1244
    • (2014) Curr Med Res Opin , vol.30 , pp. 1231-1244
    • Seino, Y.1    Sasaki, T.2    Fukatsu, A.3
  • 15
    • 84903557735 scopus 로고    scopus 로고
    • Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled, phase 3 study
    • Y. Seino, T. Sasaki, A. Fukatsu, and 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 30 2014 1245 1255
    • (2014) Curr Med Res Opin , vol.30 , pp. 1245-1255
    • Seino, Y.1    Sasaki, T.2    Fukatsu, A.3
  • 16
    • 84933675778 scopus 로고    scopus 로고
    • Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus
    • Y. Seino, N. Inagaki, M. Haneda, and et al. Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus J Diabetes Invest 6 2015 443 453
    • (2015) J Diabetes Invest , vol.6 , pp. 443-453
    • Seino, Y.1    Inagaki, N.2    Haneda, M.3
  • 17
    • 84938319426 scopus 로고    scopus 로고
    • 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
    • Y. Seino, K. Kaku, N. Inagaki, and 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 62 2015 593 603
    • (2015) Endocr J , vol.62 , pp. 593-603
    • Seino, Y.1    Kaku, K.2    Inagaki, N.3
  • 18
    • 84882591638 scopus 로고    scopus 로고
    • The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus
    • S. Kasichayanula, X. Liu, M. Pe Benito, and et al. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus Br J Clin Pharmacol 76 2013 432 444
    • (2013) Br J Clin Pharmacol , vol.76 , pp. 432-444
    • Kasichayanula, S.1    Liu, X.2    Pe Benito, M.3
  • 19
    • 84919333505 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic profiles of canagliflozin in Japanese patients with type 2 diabetes mellitus and moderate renal impairment
    • N. Inagaki, K. Kondo, T. Yoshinari, and et al. Pharmacokinetic and pharmacodynamic profiles of canagliflozin in Japanese patients with type 2 diabetes mellitus and moderate renal impairment Clin Drug Investig 34 2014 731 742
    • (2014) Clin Drug Investig , vol.34 , pp. 731-742
    • Inagaki, N.1    Kondo, K.2    Yoshinari, T.3
  • 20
    • 84911874621 scopus 로고    scopus 로고
    • Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus
    • A. Sarashina, K. Ueki, T. Sasaki, and et al. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus Clin Ther 36 2014 1606 1615
    • (2014) Clin Ther , vol.36 , pp. 1606-1615
    • Sarashina, A.1    Ueki, K.2    Sasaki, T.3
  • 21
    • 84893727925 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in subjects with renal impairment
    • S. Macha, M. Mattheus, A. Halabi, and et al. Pharmacokinetics, pharmacodynamics and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in subjects with renal impairment Diabetes Obes Metab 16 2014 215 222
    • (2014) Diabetes Obes Metab , vol.16 , pp. 215-222
    • MacHa, S.1    Mattheus, M.2    Halabi, A.3
  • 22
    • 84876803427 scopus 로고    scopus 로고
    • Renal glucose handling: Impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes
    • E. Ferrannini, S.A. Veltkamp, R.A. Smulders, and T. Kadokura Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes Diabetes Care 36 2013 1260 1265
    • (2013) Diabetes Care , vol.36 , pp. 1260-1265
    • Ferrannini, E.1    Veltkamp, S.A.2    Smulders, R.A.3    Kadokura, T.4
  • 23
    • 65549111017 scopus 로고    scopus 로고
    • Collaborators Developing the Japanese Equation for Estimated GFR. GFR estimation using standardized serum cystatin C in Japan
    • S. Matsuo, E. Imai, M. Horio, and et al. Collaborators Developing the Japanese Equation for Estimated GFR. GFR estimation using standardized serum cystatin C in Japan Am J Kidney Dis 53 2009 982 992
    • (2009) Am J Kidney Dis , vol.53 , pp. 982-992
    • Matsuo, S.1    Imai, E.2    Horio, M.3
  • 24
    • 84857217561 scopus 로고    scopus 로고
    • Committee on the Standardization of Diabetes Mellitus-Related Laboratory Testing of Japan Diabetes Society. International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values
    • A. Kashiwagi, M. Kasuga, E. Araki, and et al. Committee on the Standardization of Diabetes Mellitus-Related Laboratory Testing of Japan Diabetes Society. International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values J Diabetes Investig 3 2012 39 40
    • (2012) J Diabetes Investig , vol.3 , pp. 39-40
    • Kashiwagi, A.1    Kasuga, M.2    Araki, E.3
  • 25
    • 84897394040 scopus 로고    scopus 로고
    • 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
    • D.E. Kohan, P. Fioretto, W. Tang, and J.F. List 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 85 2014 962 971
    • (2014) Kidney Int , vol.85 , pp. 962-971
    • Kohan, D.E.1    Fioretto, P.2    Tang, W.3    List, J.F.4
  • 26
    • 84876311251 scopus 로고    scopus 로고
    • Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease
    • J.F. Yale, G. Bakris, B. Cariou, and et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease Diabetes Obes Metab 15 2013 463 473
    • (2013) Diabetes Obes Metab , vol.15 , pp. 463-473
    • Yale, J.F.1    Bakris, G.2    Cariou, B.3
  • 27
    • 84904525477 scopus 로고    scopus 로고
    • Efficacy and safety of canagliflozin in patients with type 2 diabetes and stage 3 nephropathy
    • H. Yamout, V. Perkovic, M. Davies, and et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes and stage 3 nephropathy Am J Nephrol 40 2014 64 74
    • (2014) Am J Nephrol , vol.40 , pp. 64-74
    • Yamout, H.1    Perkovic, V.2    Davies, M.3
  • 28
    • 84899961819 scopus 로고    scopus 로고
    • Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: A randomised, double-blind, placebo-controlled trial
    • A.H. Barnett, A. Mithal, J. Manassie, et al. EMPA-REG RENAL Trial Investigators Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial Lancet Diabetes Endocrinol 2 2014 369 384
    • (2014) Lancet Diabetes Endocrinol , vol.2 , pp. 369-384
    • Barnett, A.H.1    Mithal, A.2    Manassie, J.3
  • 29
    • 33845340507 scopus 로고    scopus 로고
    • Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: A meta-regression analysis
    • Z.T. Bloomgarden, R. Dodis, C.M. Viscoli, and et al. Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: a meta-regression analysis Diabetes Care 29 2006 2137 2139
    • (2006) Diabetes Care , vol.29 , pp. 2137-2139
    • Bloomgarden, Z.T.1    Dodis, R.2    Viscoli, C.M.3
  • 30
    • 80053920805 scopus 로고    scopus 로고
    • Metabolic syndrome and kidney disease: A systematic review and meta-analysis
    • G. Thomas, A.R. Sehgal, S.R. Kashyap, and et al. Metabolic syndrome and kidney disease: a systematic review and meta-analysis Clin J Am Soc Nephrol 6 2011 2364 2373
    • (2011) Clin J Am Soc Nephrol , vol.6 , pp. 2364-2373
    • Thomas, G.1    Sehgal, A.R.2    Kashyap, S.R.3
  • 31
    • 0032511583 scopus 로고    scopus 로고
    • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group
    • UK Prospective Diabetes Study(UKPDS) Group Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group Lancet 352 1998 837 853
    • (1998) Lancet , vol.352 , pp. 837-853
  • 32
    • 77955585592 scopus 로고    scopus 로고
    • Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: An analysis of the ACCORD randomised trial
    • F. Ismail-Beigi, T. Craven, M.A. Banerji, et al. ACCORD Trial Group Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial Lancet 376 2010 419 430
    • (2010) Lancet , vol.376 , pp. 419-430
    • Ismail-Beigi, F.1    Craven, T.2    Banerji, M.A.3
  • 33
    • 45149133036 scopus 로고    scopus 로고
    • Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
    • ADVANCE Collaborative Group A. Patel, S. MacMahon, J. Chalmers, and et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes N Engl J Med 358 2008 2560 2572
    • (2008) N Engl J Med , vol.358 , pp. 2560-2572
    • Patel, A.1    MacMahon, S.2    Chalmers, J.3
  • 34
    • 58149389215 scopus 로고    scopus 로고
    • Glucose control and vascular complications in veterans with type 2 diabetes
    • W. Duckworth, C. Abraira, T. Moritz, et al. VADT Investigators Glucose control and vascular complications in veterans with type 2 diabetes N Engl J Med 360 2009 129 139
    • (2009) N Engl J Med , vol.360 , pp. 129-139
    • Duckworth, W.1    Abraira, C.2    Moritz, T.3
  • 35
    • 79960959816 scopus 로고    scopus 로고
    • Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: Meta-analysis of randomised controlled trials
    • R. Boussageon, T. Bejan-Angoulvant, M. Saadatian-Elahi, and et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials BMJ 343 2011 d4169
    • (2011) BMJ , vol.343 , pp. d4169
    • Boussageon, R.1    Bejan-Angoulvant, T.2    Saadatian-Elahi, M.3
  • 36
    • 80052344301 scopus 로고    scopus 로고
    • Seasonal variation in estimated glomerular filtration rate based on serum creatinine levels in hypertensive patients
    • H. Masugata, S. Senda, M. Inukai, and et al. Seasonal variation in estimated glomerular filtration rate based on serum creatinine levels in hypertensive patients Tohoku J Exp Med 224 2011 137 142
    • (2011) Tohoku J Exp Med , vol.224 , pp. 137-142
    • Masugata, H.1    Senda, S.2    Inukai, M.3
  • 37
    • 0021948044 scopus 로고
    • Control of glomerular hypertension limits glomerular injury in rats with reduced renal mass
    • S. Anderson, T.W. Meyer, H.G. Rennke, and B.M. Brenner Control of glomerular hypertension limits glomerular injury in rats with reduced renal mass J Clin Invest 76 1985 612 619
    • (1985) J Clin Invest , vol.76 , pp. 612-619
    • Anderson, S.1    Meyer, T.W.2    Rennke, H.G.3    Brenner, B.M.4
  • 38
    • 84893214045 scopus 로고    scopus 로고
    • Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus
    • D.Z. Cherney, B.A. Perkins, N. Soleymanlou, and et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus Circulation 129 2014 587 597
    • (2014) Circulation , vol.129 , pp. 587-597
    • Cherney, D.Z.1    Perkins, B.A.2    Soleymanlou, N.3
  • 39
    • 84954370892 scopus 로고    scopus 로고
    • The Japanese Society of Hypertension. Accessed January 20
    • The Japanese Society of Hypertension. http://www.jpnsh.jp/data/jsh2014/jsh2014v1-1.pdf. Accessed January 20, 2015.
    • (2015)
  • 40
    • 78651112164 scopus 로고    scopus 로고
    • Hypertension in diabetic nephropathy: Epidemiology, mechanisms, and management
    • P.N. Van Buren, and R. Toto Hypertension in diabetic nephropathy: epidemiology, mechanisms, and management Adv Chronic Kidney Dis 18 2011 28 41
    • (2011) Adv Chronic Kidney Dis , vol.18 , pp. 28-41
    • Van Buren, P.N.1    Toto, R.2


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