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  • 菅波　秀規
役　職 興和株式会社 臨床解析部 部長
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、Drug Information Association、International Biometrics Society
その他 日本製薬工業協会 データサイエンス部会 推進委員 / ICH E9(R1) expert / SASユーザー会世話人 / 認定責任試験統計家 / 日本計量生物学会 理事 / 東京理科大学 非常勤講師 / 東京大学登録研究員
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 部長
実　績（論文 / 書籍 / 受賞など）

    ■ 論　文 ■

  1. 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.2018,12(5),1267-1279,e4.
  2. 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.2018,20(8),2041-2042.
  3. 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.2018,25(6),521-538.
  4. 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.
  5. 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.2018,44(2),135-142.
  6. 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.2018,41(3),538-546.
  7. 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.2018,12(1),173-184.
  8. 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.2018,25(5),422-429.
  9. 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.2018,20(4),1061-1065.
  10. 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.2018,44(2),172-174.
  11. 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.2018,9(4),862-869.
  12. 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.2017,261,144-152
  13. 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.2016,50(6),846-852.
  14. 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.2016,249,36-43.
  15. 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.2015,36,102-7.
  16. 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.2015,10(9),e0136802.
  17. 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.2016,94(1),e26-34.
  18. 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.
  19. 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.2015,133(7),755-61.
  20. 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.2015,93(4),e254-60.
  21. 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.2014,48(6),717-723.
  22. 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.2014,13,65.
  23. 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.2014,15(6),749-66.
  24. 佐藤恵子,岩崎学,菅波秀規,佐藤俊哉,椿広計.統計家の行動基準の策定－背景と今後の課題－.計量生物学.2014,35,37-53.
  25. 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. 2009,8,46.
  26. Hideki Suganami,Kiyoshi Kano,Yasuaki Kuwayama,Chikuma Hamada,Isao Yoshimura.Comparison of Methods for Parameter Estimation in a Circular Linear Mixed Effect Model Incorporating the Diurnal Variation for Evaluating the Treatment Effects of Glaucoma Therapy.Japanese Journal of Biometrics.2007,28(1),1-17
  27. 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.
  28. 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),523-529.
  29. 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),513-522.
  30. 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),439-447.
  31. 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.2005,128(1),185-93.
  32. 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.
  33. 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.2004,6(6),596-603.
  34. 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),138-144.
  35. 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),215-219.

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