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  • 菅波　秀規
役　職 興和株式会社 常務執行役員 医薬事業部 データサイエンスセンター センター長
東北大学大学院 医学系研究科・医学部 医学統計学分野 非常勤講師
専門分野 医学統計学、医学情報管理学、医学研究方法論、医薬品開発論
所属学会 日本計量生物学会、応用統計学会、日本緑内障学会、日本臨床試験学会、日本薬剤疫学会、日本循環器学会、Drug Information Association、International Biometrics Society、Society for clinical data management
その他 日本製薬工業協会 データサイエンス部会 副部会長 / ICH E9(R1) expert, E20 topic leader / SASユーザー会世話人 / 日本計量生物学会 評議員 / 東京理科大学 非常勤講師 / 東京大学客員研究員/ 慶應義塾大学 客員教授 / 日本臨床試験学会 将来構想委員・学術委員 / SCDM Editor / 日本支部 publication committee leader / 東北大学臨床研究審査委員会 技術評価委員
略　歴
    • 1995年 興和株式会社 開発管理部統計解析課
    • 2006年 興和株式会社 統計解析課 課長
    • 2007年 興和株式会社 臨床薬理課 課長兼任
    • 2011年 興和株式会社 臨床解析部 部長
    • 2020年 興和株式会社 執行役員 臨床解析部 部長
    • 2022年 Kowa Co., Ltd. Head, Global Data Science Center
    • 2022年 Kowa Research Institute, Inc. Member of the board
    • 2023年 興和株式会社 常務執行役員 データサイエンスセンター センター長
実　績（論文 / 書籍 / 受賞など）

    ■ 論　文 ■

  1. Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Furukawa D, Suganami H, Ishibashi S.Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. J Atheroscler Thromb. 2025 Feb 7.
  2. Uchinuma H, Matsushita M, Tanahashi M, Suganami H, Utsunomiya K, Kaku K, Tsuchiya K.Post-hoc analysis of the tofogliflozin post-marketing surveillance study (J-STEP/LT): Tofogliflozin improves liver function in type 2 diabetes patients regardless of BMI. J Diabetes Investig. 2025 Jan 17.
  3. JPMA MIDD Task force; Sasaki T, Katsube T, Hayato S, Yamaguchi S, Tanaka J, Yoshimatsu H, Nakanishi Y, Kitamura A, Watase H, Suganami H, Matsuoka N, Hasegawa C.Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan. J Pharmacokinet Pharmacodyn. 2025 Jan 6;52(1):10.
  4. Tanigawa R, Nakajima A, Eguchi Y, Takahashi H, Loomba R, Suganami H, Tanahashi M, Saito A, Iida Y, Yamashita S.Effects of Pemafibrate on LDL-C and Related Lipid Markers in Patients with MASLD: A Sub-Analysis of the PEMA-FL Study. J Atheroscler Thromb. 2024 Dec 18.
  5. Yamashita S, Araki E, Arai H, Yokote K, Tanigawa R, Saito A, Suganami H, Minamikawa S, Ishibashi S.Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study.J Atheroscler Thromb. 2025 Mar 1;32(3):367-384.
  6. Ishibashi S, Arai H, Yokote K, Araki E, Watanabe M, Nakanishi M, Makinose Y, Suganami H, Kurihara Y, Yamashita S.Pharmacokinetics and Safety of Pemafibrate in Patients with both Dyslipidemia and Severe Renal Impairment: A Phase 4 Study.J Atheroscler Thromb. 2025 Feb 1;32(2):210-225.
  7. Dai W, Lv Q, Li Q, Fu L, Zhang Y, Zhang Y, Liu L, Tanigawa R, Kunitomi K, Kamei R, Suganami H, Ma C.Efficacy and Safety of Pemafibrate, a Novel Selective PPARα Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial. J Atheroscler Thromb. 2025 Feb 1;32(2):125-140.
  8. Kamimura T, Hounslow N, Suganami H, Tanigawa R.Drug-drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open-label, randomized, 6-sequence, 3-period crossover studies. Clin Transl Sci. 2024 Aug;17(8):e13900.
  9. Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S.Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538.
  10. Tanihara H, Yamamoto T, Aihara M, Koizumi N, Fukushima A, Kawakita K, Kojima S, Nakamura T, Suganami H; K-232 Clinical Study Group.Long-term intraocular pressure-lowering efficacy and safety of ripasudil-brimonidine fixed-dose combination for glaucoma and ocular hypertension: a multicentre, open-label, phase 3 study. Graefes Arch Clin Exp Ophthalmol. 2024 Aug;262(8):2579-2591.
  11. Mikamo H, Takahashi S, Yamagishi Y, Hirakawa A, Harada T, Nagashima H, Noguchi C, Masuko K, Maekawa H, Kashii T, Ohbayashi H, Hosokawa S, Maejima K, Yamato M, Manosuthi W, Paiboonpol S, Suganami H, Tanigawa R, Kawamura H; IVERMILCO Study Group.Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand. J Infect Chemother. 2024 Jun;30(6):536-543.
  12. Takamura T, Kaku K, Yoshida A, Kusakabe H, Nakamura H, Suganami H. Reductions in liver enzymes are associated with anti-hyperglycaemic and anti-obesity effects of tofogliflozin in people with type 2 diabetes: Post-hoc analyses.Endocrinol Diabetes Metab. 2024 Jan;7(1):e461.
  13. Ako J, Yokote K, Tsujita K, Tanigawa R, Kamei R, Suganami H.Long-term Efficacy and Safety of K-924 Pitavastatin/Ezetimibe Fixed-dose Combination in Patients with Hypercholesterolemia: A Phase III, Multi-center, Open-label Trial. J Atheroscler Thromb. 2024 Mar 1;31(3):288-305.
  14. Tanihara H, Yamamoto T, Aihara M, Koizumi N, Minami H, Kojima S, Isobe T, Kanazawa M, Suganami H; K-232 Clinical Study Group.Crossover Randomized Study of Pharmacologic Effects of Ripasudil-Brimonidine Fixed-Dose Combination Versus Ripasudil or Brimonidine.Adv Ther. 2023 Aug;40(8):3559-3573.
  15. Tsujita K, Yokote K, Ako J, Tanigawa R, Tajima S, Suganami H.Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial.J Atheroscler Thromb. 2023 Nov 1;30(11):1580-1600.
  16. Tanihara H, Yamamoto T, Aihara M, Kawakita K, Kojima S, Kanazawa M, Nojima T, Suganami H; K-232 Clinical Study Group.Ripasudil-Brimonidine Fixed-Dose Combination vs Ripasudil or Brimonidine: Two Phase 3 Randomized Clinical Trials. Am J Ophthalmol. 2023 Apr;248:35-44.
  17. Das Pradhan A, Glynn RJ, Fruchart JC, MacFadyen JG, Zaharris ES, Everett BM, Campbell SE, Oshima R, Amarenco P, Blom DJ, Brinton EA, Eckel RH, Elam MB, Felicio JS, Ginsberg HN, Goudev A, Ishibashi S, Joseph J, Kodama T, Koenig W, Leiter LA, Lorenzatti AJ, Mankovsky B, Marx N, Nordestgaard BG, Páll D, Ray KK, Santos RD, Soran H, Susekov A, Tendera M, Yokote K, Paynter NP, Buring JE, Libby P, Ridker PM; PROMINENT Investigators.Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.N Engl J Med. 2022 Nov 24;387(21):1923-1934.
  18. Matsubayashi Y, Yoshida A, Suganami H, Oe M, Sato T, Yaguchi Y, Fujihara K, Yamada T, Tanaka S, Kaku K, Sone H.Predictors of haemoglobin levels and of changes in these levels, focusing on anaemia and polycythaemia after administration of the sodium-glucose cotransporter-2 inhibitor tofogliflozin.Diabetes Obes Metab. 2022 Dec;24(12):2469-2473.
  19. Ginsberg HN, Hounslow NJ, Senko Y, Suganami H, Bogdanski P, Ceska R, Kalina A, Libis RA, Supryadkina TV, Hovingh GK.Efficacy and Safety of K-877 (Pemafibrate), a Selective PPARα Modulator, in European Patients on Statin Therapy.Diabetes Care. 2022 Apr 1;45(4):898-908.
  20. Nakajima A, Eguchi Y, Yoneda M, Imajo K, Tamaki N, Suganami H, Nojima T, Tanigawa R, Iizuka M, Iida Y, Loomba R.Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), versus placebo in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2021 Nov;54(10):1263-1277.
  21. Yokote K, Yamashita S, Arai H, Araki E, Matsushita M, Nojima T, Suganami H, Ishibashi S.Effects of pemafibrate on glucose metabolism markers and liver function tests in patients with hypertriglyceridemia: a pooled analysis of six phase 2 and phase 3 randomized double-blind placebo-controlled clinical trials. Cardiovasc Diabetol. 2021 May 4;20(1):96.
  22. Kondo H, Kamiyoshihara T, Fujisawa K, Nojima T, Tanigawa R, Fujiwara H, Suganami H, Hayashi Y, Yamaguchi T.Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment. Ther Innov Regul Sci. 2021 Jul;55(4):841-849.
  23. Matsubayashi Y, Yoshida A, Suganami H, Oe M, Sato T, Yaguchi Y, Fujihara K, Yamada T, Tanaka S, Kaku K, Sone H.Association of estimated plasma volume and weight loss after long-term administration and subsequent discontinuation of the sodium-glucose cotransporter-2 inhibitor tofogliflozin. Diabetes Obes Metab. 2021 Jul;23(7):1660-1665.
  24. Abe T, Matsubayashi Y, Muragishi S, Yoshida A, Suganami H, Furusawa K, Fujihara K, Tanaka S, Kaku K, Sone H.Dipeptidyl peptidase-4 inhibitor, anagliptin, alters hepatic insulin clearance in relation to the glycemic status in Japanese individuals with type 2 diabetes. J Diabetes Investig. 2021 Oct;12(10):1805-1815.
  25. Sakamaki K, Yoshida S, Morita Y, Kamiura T, Iba K, Ogawa N, Suganami H, Tsuchiya S, Fukimbara S.Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan. Ther Innov Regul Sci. 2020 May;54(3):528-533.
  26. Nojima T, Matsubayashi Y, Yoshida A, Suganami H, Abe T, Ishizawa M, Fujihara K, Tanaka S, Kaku K, Sone H.Influence of an SGLT2 inhibitor, tofogliflozin, on the resting heart rate in relation to adipose tissue insulin resistance. Diabet Med. 2020 Aug;37(8):1316-1325.
  27. Hasegawa T, Misawa S, Nakagawa S, Tanaka S, Tanase T, Ugai H, Wakana A, Yodo Y, Tsuchiya S, Suganami H; JPMA Task Force Members.Restricted mean survival time as a summary measure of time-to-event outcome.Pharm Stat. 2020 Jul;19(4):436-453.
  28. Sakamaki K, Morita Y, Iba K, Kamiura T, Yoshida S, Ogawa N, Suganami H, Tsuchiya S, Fukimbara S.Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan. Ther Innov Regul Sci. 2020 Sep;54(5):1097-1105.
  29. Matsubayashi Y, Yoshida A, Suganami H, Osawa T, Furukawa K, Suzuki H, Fujihara K, Tanaka S, Kaku K, Sone H.Association of increased hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration via the sodium/glucose-cotransporter 2 inhibitor tofogliflozin. Diabetes Obes Metab. 2020 Jun;22(6):947-956.
  30. Yamashita S, Arai H, Yokote K, Araki E, Matsushita M, Nojima T, Suganami H, Ishibashi S.Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor α Modulator (SPPARMα): Pooled Analysis of Phase 2 and 3 Studies in Dyslipidemic Patients with or without Statin Combination. Int J Mol Sci. 2019 Nov 6;20(22):5537.
  31. Sato Y, Nunoi K, Kaku K, Yoshida A, Suganami H.Basal insulin secretion capacity predicts the initial response and maximum levels of beta-hydroxybutyrate during therapy with the sodium-glucose co-transporter-2 inhibitor tofogliflozin, in relation to weight loss. Diabetes Obes Metab. 2020 Feb;22(2):222-230.
  32. Sakamaki K, Yoshida S, Morita Y, Kamiura T, Iba K, Ogawa N, Suganami H, Tsuchiya S, Fukimbara S.Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan. Ther Innov Regul Sci. 2019 Jun 18:2168479019855994.
  33. Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K.Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526.
  34. Nunoi K, Sato Y, Kaku K, Yoshida A, Suganami H.Renal effects of a sodium-glucose cotransporter 2 inhibitor, tofogliflozin, in relation to sodium intake and glycaemic status. Diabetes Obes Metab. 2019 Jul;21(7):1715-1724.
  35. Araki E, Yamashita S, Arai H, Yokote K, Satoh J, Inoguchi T, Nakamura J, Maegawa H, Yoshioka N, Tanizawa Y, Watada H, Suganami H, Ishibashi S.Efficacy and safety of pemafibrate in people with type 2 diabetes and elevated triglyceride levels: 52-week data from the PROVIDE study. Diabetes Obes Metab. 2019 Jul;21(7):1737-1744.
  36. Nunoi K, Sato Y, Kaku K, Yoshida A, Suganami H.Effects of sodium-glucose cotransporter 2 inhibitor, tofogliflozin, on the indices of renal tubular function in patients with type 2 diabetes. Endocrinol Diabetes Metab. 2018 Mar 26;1(2):e00015.
  37. Yoshida A, Matsubayashi Y, Nojima T, Suganami H, Abe T, Ishizawa M, Fujihara K, Tanaka S, Kaku K, Sone H.Attenuation of Weight Loss Through Improved Antilipolytic Effect in Adipose Tissue Via the SGLT2 Inhibitor Tofogliflozin. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3647-3660.
  38. Yokote K, Yamashita S, Arai H, Araki E, Suganami H, Ishibashi S, Of The K-Study Group OB.Long-Term Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor-α Modulator (SPPARMα), in Dyslipidemic Patients with Renal Impairment. Int J Mol Sci. 2019 Feb 6;20(3):706.
  39. Yamashita S, Arai H, Yokote K, Araki E, Suganami H, Ishibashi S; K-877 Study Group.Effects of pemafibrate (K-877) on cholesterol efflux capacity and postprandial hyperlipidemia in patients with atherogenic dyslipidemia. J Clin Lipidol. 2018 Sep-Oct;12(5):1267-1279.e4.
  40. Ouchi M, Oba K, Suganami H, Yoshida A, Fujita T, Suzuki T, Yasutake M, Kaku K.This is in reply to the Letter by Kahathuduwa et al. titled "Unaccounted for regression to the mean renders conclusion of article titled 'Uric acid lowering in relation to HbA1c reductions with the SGLT2 inhibitor Tofogliflozin' unsubstantiated". Diabetes Obes Metab. 2018 Aug;20(8):2041-2042.
  41. Arai H, Yamashita S, Yokote K, Araki E, Suganami H, Ishibashi S; K-877 Study Group.Efficacy and Safety of Pemafibrate Versus Fenofibrate in Patients with High Triglyceride and Low HDL Cholesterol Levels: A Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial. J Atheroscler Thromb. 2018 Jun 1;25(6):521-538.
  42. Matsuba I, Matsuba R, Ishibashi S, Yamashita S, Arai H, Yokote K, Suganami H, Araki E.Effects of a novel selective peroxisome proliferator-activated receptor-α modulator, pemafibrate, on hepatic and peripheral glucose uptake in patients with hypertriglyceridemia and insulin resistance. J Diabetes Investig. 2018 Nov;9(6):1323-1332.
  43. Matsubayashi Y, Yoshida A, Suganami H, Ishiguro H, Yamamoto M, Fujihara K, Kodama S, Tanaka S, Kaku K, Sone H.Role of fatty liver in the association between obesity and reduced hepatic insulin clearance. Diabetes Metab. 2018 Mar;44(2):135-142.
  44. Araki E, Yamashita S, Arai H, Yokote K, Satoh J, Inoguchi T, Nakamura J, Maegawa H, Yoshioka N, Tanizawa Y, Watada H, Suganami H, Ishibashi S.Effects of Pemafibrate, a Novel Selective PPARα Modulator, on Lipid and Glucose Metabolism in Patients With Type 2 Diabetes and Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. Diabetes Care. 2018 Mar;41(3):538-546.
  45. Ishibashi S, Arai H, Yokote K, Araki E, Suganami H, Yamashita S; K-877 Study Group.Efficacy and safety of pemafibrate (K-877), a selective peroxisome proliferator-activated receptor α modulator, in patients with dyslipidemia: Results from a 24-week, randomized, double blind, active-controlled, phase 3 trial. J Clin Lipidol. 2018 Jan-Feb;12(1):173-184.
  46. Harada-Shiba M, Kastelein JJP, Hovingh GK, Ray KK, Ohtake A, Arisaka O, Ohta T, Okada T, Suganami H, Wiegman A.Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hypercholesterolemia in Japan and Europe. J Atheroscler Thromb. 2018 May 1;25(5):422-429.
  47. Ouchi M, Oba K, Kaku K, Suganami H, Yoshida A, Fukunaka Y, Jutabha P, Morita A, Otani N, Hayashi K, Fujita T, Suzuki T, Yasutake M, Anzai N.Uric acid lowering in relation to HbA1c reductions with the SGLT2 inhibitor tofogliflozin. Diabetes Obes Metab. 2018 Apr;20(4):1061-1065.
  48. Abe T, Matsubayashi Y, Yoshida A, Suganami H, Nojima T, Osawa T, Ishizawa M, Yamamoto M, Fujihara K, Tanaka S, Kaku K, Sone H.Predictors of the response of HbA1c and body weight after SGLT2 inhibition. Diabetes Metab. 2018 Mar;44(2):172-174.
  49. Tobe K, Suganami H, Kaku K.Sodium-glucose cotransporter 2 inhibitor, tofogliflozin, shows better improvements of blood glucose and insulin secretion in patients with high insulin levels at baseline. J Diabetes Investig. 2018 Jul;9(4):862-869.
  50. Arai H, Yamashita S, Yokote K, Araki E, Suganami H, Ishibashi S; K-877 Study Group.Efficacy and safety of K-877, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), in combination with statin treatment: Two randomised, double-blind, placebo-controlled clinical trials in patients with dyslipidaemia. Atherosclerosis. 2017 Jun;261:144-152.
  51. Sakamaki K, Kamiura T, Morita Y, Iba K, Yoshida S, Wakana A, Tsuchiya S, Fukimbara S, Suganami H.Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan. Ther Innov Regul Sci. 2016 Nov;50(6):846-852.
  52. Ishibashi S, Yamashita S, Arai H, Araki E, Yokote K, Suganami H, Fruchart JC, Kodama T; K-877-04 Study Group.Effects of K-877, a novel selective PPARα modulator (SPPARMα), in dyslipidaemic patients: A randomized, double blind, active- and placebo-controlled, phase 2 trial. Atherosclerosis. 2016 Jun;249:36-43.
  53. Ishikawa N, Suganami H, Nishida A, Miyamori D, Kakiuchi Y, Yamada N, Wook-Cheol K, Kubo T, Ikegaya H.Utilization of bone impedance for age estimation in postmortem cases. J Forensic Leg Med. 2015 Nov;36:102-7.
  54. Nakagawa H, Koizumi N, Okumura N, Suganami H, Kinoshita S.Morphological Changes of Human Corneal Endothelial Cells after Rho-Associated Kinase Inhibitor Eye Drop (Ripasudil) Administration: A Prospective Open-Label Clinical Study. PLoS One. 2015 Sep 14;10(9):e0136802.
  55. Tanihara H, Inoue T, Yamamoto T, Kuwayama Y, Abe H, Fukushima A, Suganami H, Araie M; K-115 Clinical Study Group.One-year clinical evaluation of 0.4% ripasudil (K-115) in patients with open-angle glaucoma and ocular hypertension. Acta Ophthalmol. 2016 Feb;94(1):e26-34.
  56. Harada-Shiba M, Arisaka O, Ohtake A, Okada T, Suganami H; NK-104-PH 01 study registration group.Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hypercholesterolemia. J Atheroscler Thromb. 2016;23(1):48-55.
  57. Tanihara H, Inoue T, Yamamoto T, Kuwayama Y, Abe H, Suganami H, Araie M; K-115 Clinical Study Group.Additive Intraocular Pressure-Lowering Effects of the Rho Kinase Inhibitor Ripasudil (K-115) Combined With Timolol or Latanoprost: A Report of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2015 Jul;133(7):755-61.
  58. Tanihara H, Inoue T, Yamamoto T, Kuwayama Y, Abe H, Suganami H, Araie M; K-115 Clinical Study Group.Intra-ocular pressure-lowering effects of a Rho kinase inhibitor, ripasudil (K-115), over 24 hours in primary open-angle glaucoma and ocular hypertension: a randomized, open-label, crossover study.Acta Ophthalmol. 2015 Jun;93(4):e254-60.
  59. Tanaka S, Fukinbara S, Tsuchiya S, Suganami H, Ito YM.Current Practice in Japan for the Prevention and Treatment of Missing Data in Confirmatory Clinical Trials: A Survey of Japanese and Foreign Pharmaceutical Manufacturers. Ther Innov Regul Sci. 2014 Nov;48(6):717-723.
  60. Kaku K, Watada H, Iwamoto Y, Utsunomiya K, Terauchi Y, Tobe K, Tanizawa Y, Araki E, Ueda M, Suganami H, Watanabe D; Tofogliflozin 003 Study Group.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 Mar 28;13:65.
  61. Tanizawa Y, Kaku K, Araki E, Tobe K, Terauchi Y, Utsunomiya K, Iwamoto Y, Watada H, Ohtsuka W, Watanabe D, Suganami H; Tofogliflozin 004 and 005 Study group.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 Apr;15(6):749-66.
  62. Sato Y, Laird N, Suganami H, Hamada C, Niki N, Yoshimura I, Yoshida T.Statistical screening method for genetic factors influencing susceptibility to common diseases in a two-stage genome-wide association study. Stat Appl Genet Mol Biol. 2009;8:Article 46.
  63. Sato Y, Suganami H, Hamada C, Yoshimura I, Sakamoto H, Yoshida T, Yoshimura K.The confidence interval of allelic odds ratios under the Hardy-Weinberg disequilibrium. J Hum Genet. 2006;51(9):772-780.
  64. Miyazaki H, Watanabe H, Kitayama T, Nishida M, Nishi Y, Sekiya K, Suganami H, Yamamoto K.QT PRODACT: sensitivity and specificity of the canine telemetry assay for detecting drug-induced QT interval prolongation. J Pharmacol Sci. 2005;99(5):523-9.
  65. Sasaki H, Shimizu N, Suganami H, Yamamoto K.QT PRODACT: inter-facility variability in electrocardiographic and hemodynamic parameters in conscious dogs and monkeys. J Pharmacol Sci. 2005;99(5):513-22.
  66. Yamazaki R, Yamada M, Kobayashi K, Kitani S, Shimada C, Shimosato T, Mori T, Suganami H, Yamamoto K.QT PRODACT: inter- and intra-facility variability of the action potential assay using isolated guinea-pig papillary muscles. J Pharmacol Sci. 2005;99(5):439-47.
  67. Ikegaya H, Zheng HY, Saukko PJ, Varesmaa-Korhonen L, Hovi T, Vesikari T, Suganami H, Takasaka T, Sugimoto C, Ohasi Y, Kitamura T, Yogo Y.Genetic diversity of JC virus in the Saami and the Finns: implications for their population history. Am J Phys Anthropol. 2005 Sep;128(1):185-93.
  68. Sato Y, Suganami H, Hamada C, Yoshimura I, Yoshida T, Yoshimura K.Designing a multistage, SNP-based, genome screen for common diseases. J Hum Genet. 2004;49(12):669-676.
  69. Zheng HY, Zhao P, Suganami H, Ohasi Y, Ikegaya H, Kim JC, Sugimoto C, Takasaka T, Kitamura T, Yogo Y.Regional distribution of two related Northeast Asian genotypes of JC virus, CY-a and -b: implications for the dispersal of Northeast Asians. Microbes Infect. 2004 May;6(6):596-603.
  70. Morikawa S, Umetani M, Nakagawa S, Yamazaki H, Suganami H, Inoue K, Kitahara M, Hamakubo T, Kodama T, Saito Y.Relative induction of mRNA for HMG CoA reductase and LDL receptor by five different HMG-CoA reductase inhibitors in cultured human cells. J Atheroscler Thromb. 2000;7(3):138-44.
  71. Wachi H, Seyama Y, Yamashita S, Suganami H, Uemura Y, Okamoto K, Yamada H, Tajima S.Stimulation of cell proliferation and autoregulation of elastin expression by elastin peptide VPGVG in cultured chick vascular smooth muscle cells. FEBS Lett. 1995 Jul 17;368(2):215-9.

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