・Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial.
Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538. DOI: 10.5551/jat.64677
・RENOIR Trial - RSVpreF Vaccine Efficacy over Two Seasons.
Walsh EE, Pérez Marc G, Falsey AR, Jiang Q, Eiras D, Patton M, Polack FP, Llapur C, Doreski PA, Zareba AM, Ilangovan K, Rämet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gruber WC, Schmoele-Thoma B, Gurtman A.N Engl J Med. 2024 Oct 17;391(15):1459-1460. DOI: 10.1056/NEJMc2311560.
・Daridorexant in Japanese patients with insomnia disorder: A phase 3, randomized, double-blind, placebo-controlled study.
Uchimura N, Taniguchi M, Ariyoshi Y, Oka Y, Togo O, Uchiyama M.Sleep Med. 2024 Oct;122:27-34. DOI: 10.1016/j.sleep.2024.07.037.
・Burden of respiratory syncytial virus infections in older adults with acute respiratory infection in Japan: An epidemiological study among outpatients.
Ohbayashi H, Sakurai T, Himeji D, Fukushima Y, Takahashi H, Kiyosue A, Sabater Cabrera E, Matsuki T, Molnar D, Preckler Moreno V, Damaso S, Pirçon JY, Moitinho de Almeida M. Respir Investig. 2024 Sep;62(5):914-921. DOI: 10.1016/j.resinv.2024.06.003.
・Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment.
Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Gonçalves L; QWINT-2 Investigators. N Engl J Med. 2024 Sep 10. DOI: 10.1056/NEJMoa2403953.
・Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial.
Deanfield J, Verma S, Scirica BM, Kahn SE, Emerson SS, Ryan D, Lingvay I, Colhoun HM, Plutzky J, Kosiborod MN, Hovingh GK, Hardt-Lindberg S, Frenkel O, Weeke PE, Rasmussen S, Goudev A, Lang CC, Urina-Triana M, Pietilä M, Lincoff AM; SELECT Trial Investigators. Lancet. 2024 Aug 24;404(10454):773-786. DOI: 10.1016/S0140-6736(24)01498-3.
・Effect of Semaglutide on Regression and Progression of Glycemia in People With Overweight or Obesity but Without Diabetes in the SELECT Trial.
Kahn SE, Deanfield JE, Jeppesen OK, Emerson SS, Boesgaard TW, Colhoun HM, Kushner RF, Lingvay I, Burguera B, Gajos G, Horn DB, Hramiak IM, Jastreboff AM, Kokkinos A, Maeng M, Matos ALSA, Tinahones FJ, Lincoff AM, Ryan DH; SELECT Trial Investigators. Diabetes Care. 2024 Aug 1;47(8):1350-1359. DOI: 10.2337/dc24-0491.
・Semaglutide and Cardiovascular Outcomes by Baseline HbA1c and Change in HbA1c in People With Overweight or Obesity but Without Diabetes in SELECT.
Lingvay I, Deanfield J, Kahn SE, Weeke PE, Toplak H, Scirica BM, Rydén L, Rathor N, Plutzky J, Morales C, Lincoff AM, Lehrke M, Jeppesen OK, Gajos G, Colhoun HM, Cariou B, Ryan D; SELECT Trial Investigators. Diabetes Care. 2024 Aug 1;47(8):1360-1369. DOI: 10.2337/dc24-0764.
・Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.
Ryan DH, Lingvay I, Deanfield J, Kahn SE, Barros E, Burguera B, Colhoun HM, Cercato C, Dicker D, Horn DB, Hovingh GK, Jeppesen OK, Kokkinos A, Lincoff AM, Meyhöfer SM, Oral TK, Plutzky J, van Beek AP, Wilding JPH, Kushner RF. Nat Med. 2024 Jul;30(7):2049-2057. DOI: 10.1038/s41591-024-02996-7.
・Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.
Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators.N Engl J Med. 2024 Jul 11;391(2):109-121. DOI: 10.1056/NEJMoa2403347.
・A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults ≥ 60 years of age in Japan, South Korea, and Taiwan.
Haranaka M, Young Song J, Huang KC, de Solom R, Yamaji M, McElwee K, Kline M, Aizawa M, Peng Y, Scully I, Kogawara O, Gruber WC, Scott DA, Watson W. Vaccine. 2024 Feb 15;42(5):1071-1077. DOI: 10.1016/j.vaccine.2024.01.004.
・Obesity, Cardiovascular Disease, and the Promising Role of Semaglutide: Insights from the SELECT Trial.
Irfan H.Curr Probl Cardiol. 2024 Jan;49(1 Pt A):102060. DOI: 10.1016/j.cpcardiol.2023.102060.
・Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.
Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornøe CW, Ryan DH; SELECT Trial Investigators.N Engl J Med. 2023 Dec 14;389(24):2221-2232. DOI: 10.1056/NEJMoa2307563.
・Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High Neutralizing Titers in Older Adults
Fukushima Y, Cardona JF, Zareba A, Jiang Q, Eiras DP, Patton M, Ilangovan K, DeHaan EN, Mikati T, Kalinina E, Cooper D, Koury K, Anderson AS, Swanson KA, Gruber WC, Gurtman AC, Schmoele-Thoma B Open Forum Infect Dis 2023 Nov 27;10(Suppl 2):ofad500.1466. DOI: 10.1093/ofid/ofad500.1466
・The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease.
Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. DOI: 10.1093/ndt/gfad009
・Safety and efficacy analyses across age and body mass index subgroups in East Asian participants with type 2 diabetes in the phase 3 tirzepatide studies (SURPASS programme).
Kiyosue A, Dunn JP, Cui X, Hickey A, Hirase T, Imaoka T, Heine RJ. Diabetes Obes Metab. 2023 Apr;25(4):1056-1067. DOI: 10.1111/dom.14952.
・Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.
Walsh EE, Pérez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Rämet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. N Engl J Med. 2023 Apr 5. DOI: 10.1056/NEJMoa2213836
・Safety and efficacy analyses across age and body mass index subgroups in East Asian participants with type 2 diabetes in the phase 3 tirzepatide studies (SURPASS programme).
Kiyosue A, Dunn JP, Cui X, Hickey A, Hirase T, Imaoka T, Heine RJ. Diabetes Obes Metab. 2023 Apr;25(4):1056-1067. DOI: 10.1111/dom.14952
・One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study.
Shinkai M, Ebisawa M, Fukushima Y, Takeuchi S, Okada H, Tokiyo T, Hayashi N, Takikawa M, Colice G, Almqvist G.J Asthma. 2023 Mar;60(3):616-624. DOI: 10.1080/02770903.2022.2082309
・Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes.
Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. DOI: 10.1111/jdv.17792
・Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study.
Katoh N, Ohya Y, Murota H, Ikeda M, Hu X, Ikeda K, Liu J, Sasaki T, Raymundo EM, Teixeira HD, Saeki H. Dermatol Ther (Heidelb). 2023 Jan;13(1):221-234. DOI: 10.1007/s13555-022-00842-7
・Efficacy and safety of tezepelumab in patients recruited in Japan who participated in the phase 3 NAVIGATOR study.
Ishizuka T, Menzies-Gow A, Okada H, Fukushima Y, Hayashi N, Colice G, Ponnarambil S, Hunter G, Odajima H, Ebisawa M. Allergol Int. 2023 Jan;72(1):82-88. DOI: 10.1016/j.alit.2022.07.004
・Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics.
Lingvay I, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lincoff AM, Marso SP, Fries TM, Plutzky J, Ryan DH; SELECT Study Group. Obesity (Silver Spring). 2023 Jan;31(1):111-122. DOI: 10.1002/oby.23621.
・Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis.
Reich K, Lio PA, Bissonnette R, Alexis AF, Lebwohl MG, Pink AE, Kabashima K, Boguniewicz M, Nowicki RJ, Valdez H, Zhang F, DiBonaventura M, Cameron MC, Clibborn C. J Allergy Clin Immunol Pract. 2022 Dec;10(12):3228-3237.e2. DOI: 10.1016/j.jaip.2022.08.042
・Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.
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. N Engl J Med. 2022 Nov 24;387(21):1923-1934. DOI: 10.1056/NEJMoa2210645
・Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up).
Tanaka T, Sasaki T, Ikeda K, Liu J, Tenorio AR, Ohya Y. World Allergy Organ J. 2022 Sep 13;15(9):100678. DOI: 10.1016/j.waojou.2022.100678
・Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.
Kadowaki T, Chin R, Ozeki A, Imaoka T, Ogawa Y. Lancet Diabetes Endocrinol. 2022 Sep;10(9):634-644. DOI: 10.1016/S2213-8587(22)00187-5.
・Effect of glucagon-like peptide-1 receptor agonists on cardiovascular events in overweight or obese adults without diabetes: A meta-analysis of placebo-controlled randomized trials.
Leite AR, Angélico-Gonçalves A, Vasques-Nóvoa F, Borges-Canha M, Leite-Moreira A, Neves JS, Ferreira JP. Diabetes Obes Metab. 2022 Aug;24(8):1676-1680. DOI: 10.1111/dom.14707.
・Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity.
Mares AC, Chatterjee S, Mukherjee D. Curr Opin Cardiol. 2022 Jul 1;37(4):350-355. DOI: 10.1097/HCO.0000000000000955.
・Tirzepatide Once Weekly for the Treatment of Obesity.
Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. N Engl J Med. 2022 Jul 21;387(3):205-216. DOI: 10.1056/NEJMoa2206038
・Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials.
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Diabetes Care. 2022 Jun 2;45(6):1445-1452. DOI: 10.2337/dc21-2034
・Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study.
Alexis A, de Bruin-Weller M, Weidinger S, Soong W, Barbarot S, Ionita I, Zhang F, Valdez H, Clibborn C, Yin N. Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. DOI: 10.1007/s13555-022-00694-1
・Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial.
Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodríguez Á. JAMA. 2022 Feb 8;327(6):534-545. DOI: 10.1001/jama.2022.0078
・Comparing abrocitinib and dupilumab in the treatment of atopic dermatitis: a plain language summary.
Bieber T, Simpson EL, Silverberg JI, Thaçi D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H. Immunotherapy. 2022 Jan;14(1):5-14. DOI: 0.2217/imt-2021-0224
・Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Nat Med. 2022 Mar;28(3):591-598. DOI: 10.1038/s41591-022-01707-4
・A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function.
Heerspink HJL, Cherney D, Postmus D, Stefánsson BV, Chertow GM, Dwyer JP, Greene T, Kosiborod M, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjöström CD, Toto RD, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Kidney Int. 2022 Jan;101(1):174-184. DOI: 10.1016/j.kint.2021.09.005
・Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), versus placebo in patients with non-alcoholic fatty liver disease.
Nakajima A, Eguchi Y, Yoneda M, Imajo K, Tamaki N, Suganami H, Nojima T, Tanigawa R, Iizuka M, Iida Y, Loomba R. Aliment Pharmacol Ther. 2021 Nov;54(10):1263-1277. DOI: 10.1111/apt.16596.
・Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial.
Eichenfield LF, Flohr C, Sidbury R, Siegfried E, Szalai Z, Galus R, Yao Z, Takahashi H, Barbarot S, Feeney C, Zhang F, DiBonaventura M, Rojo R, Valdez H, Chan G. JAMA Dermatol. 2021 Oct 1;157(10):1165-1173. DOI: 10.1001/jamadermatol.2021.2830.
・Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis.
Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. DOI: 10.1002/14651858.
・Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program.
Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Am J Clin Dermatol. 2021 Sep;22(5):693-707. DOI: 10.1007/s40257-021-00618-3.
・Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial.
Frías JP, Auerbach P, Bajaj HS, Fukushima Y, Lingvay I, Macura S, Søndergaard AL, Tankova TI, Tentolouris N, Buse JB. Lancet Diabetes Endocrinol. 2021 Sep;9(9):563-574. DOI: 10.1016/S2213-8587(21)00174-1
・Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma.
Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Clin Exp Allergy. 2021 Apr;51(4):546-555. DOI: 10.1111/cea.13790.
・Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD randomized controlled trial.
Heerspink HJL, Sjöström CD, Jongs N, Chertow GM, Kosiborod M, Hou FF, McMurray JJV, Rossing P, Correa-Rotter R, Kurlyandskaya R, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Eur Heart J. 2021 Mar 31;42(13):1216-1227. DOI: 10.1093/eurheartj/ehab094
・Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis.
Bieber T, Simpson EL, Silverberg JI, Thaçi D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H; JADE COMPARE Investigators. N Engl J Med. 2021 Mar 25;384(12):1101-1112. DOI: 10.1056/NEJMoa2019380.
・Once-Weekly Semaglutide in Adults with Overweight or Obesity.
Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. N Engl J Med. 2021 Mar 18;384(11):989-1002. DOI: 10.1056/NEJMoa2032183
・Selective Peroxisome Proliferator-Activated Receptor Alpha Modulators (SPPARMα) in the Metabolic Syndrome: Is Pemafibrate Light at the End of the Tunnel?
Fruchart JC, Hermans MP, Fruchart-Najib J, Kodama T Curr Atheroscler Rep. 2021 Jan 3;23(1):3. DOI: 10.1007/s11883-020-00897-x.
・Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design.
Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM.Am Heart J. 2020 Nov;229:61-69. DOI: 10.1016/j.ahj.2020.07.008.
・Dapagliflozin in Patients with Chronic Kidney Disease.
Heerspink HJL, Stefánsson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjöström CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. N Engl J Med. 2020 Oct 8;383(15):1436-1446. DOI: 10.1056/NEJMoa2024816
・Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.
Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. DOI: 10.1016/S2213-8587(20)30074-7
・Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial.
Yamada Y, Katagiri H, Hamamoto Y, Deenadayalan S, Navarria A, Nishijima K, Seino Y; PIONEER 9 investigators. Lancet Diabetes Endocrinol. 2020 May;8(5):377-391. DOI: 10.1016/S2213-8587(20)30075-9
・Long-Term Safety and Efficacy of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD.
Ichinose M, Fukushima Y, Inoue Y, Hataji O, Ferguson GT, Rabe KF, Hayashi N, Okada H, Takikawa M, Bourne E, Ballal S, DeAngelis K, Aurivillius M, Reisner C, Dorinsky P.Int J Chron Obstruct Pulmon Dis. 2019 Dec 23;14:2993-3002. DOI: 10.2147/COPD.S220861
・Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD: A Subgroup Analysis of the KRONOS Study.
Ichinose M, Fukushima Y, Inoue Y, Hataji O, Ferguson GT, Rabe KF, Hayashi N, Okada H, Takikawa M, Bourne E, Ballal S, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Int J Chron Obstruct Pulmon Dis. 2019 Dec 23;14:2979-2991. DOI: 10.2147/COPD.S220850
・Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.
Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Diabetes Care. 2019 Dec;42(12):2262-2271. DOI: 10.2337/dc19-0898
・Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma.
N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. DOI: 10.1136/bmjresp-2019-000406.
・Benralizumab for the Prevention of COPD Exacerbations.
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramírez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. N Engl J Med. 2019 Sep 12;381(11):1023-1034. DOI: 10.1056/NEJMoa1905248
・PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.
Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzík M; PIONEER 1 Investigators. Diabetes Care. 2019 Sep;42(9):1724-1732. DOI: 10.2337/dc19-0749
・Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study.
Terauchi Y, Utsunomiya K, Yasui A, Seki T, Cheng G, Shiki K, Lee J. Diabetes Ther. 2019 Jun;10(3):951-963. DOI: 10.1007/s13300-019-0604-8.
・Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial.
Nomura A, Tanigawa T, Muto T, Oga T, Fukushima Y, Kiyosue A, Miyazaki M, Hida E, Satake K.J Med Internet Res. 2019 Apr 26;21(4):e13520. DOI: 10.2196/13520
・Linagliptin as add-on to empagliflozin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a two-part, randomized, placebo-controlled trial.
Kaku K, Haneda M, Tanaka Y, Lee G, Shiki K, Miyamoto Y, Solimando F, Lee J, Lee C, George J. Diabetes Obes Metab. 2019 Jan;21(1):136-145. DOI: 10.1111/dom.13496
・Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study.
Pradhan AD, Paynter NP, Everett BM, Glynn RJ, Amarenco P, Elam M, Ginsberg H, Hiatt WR, Ishibashi S, Koenig W, Nordestgaard BG, Fruchart JC, Libby P, Ridker PM. Am Heart J. 2018 Dec;206:80-93. DOI: 10.1016/j.ahj.2018.09.011.
・Empagliflozin as add-on to linagliptin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52-week, randomized, placebo-controlled trial.
Kawamori R, Haneda M, Suzaki K, Cheng G, Shiki K, Miyamoto Y, Solimando F, Lee C, Lee J, George J. Diabetes Obes Metab. 2018 Sep;20(9):2200-2209. DOI: 10.1111/dom.13352.
・Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents.
Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. N Engl J Med. 2018 Sep 6;379(10):913-923. DOI: 10.1056/NEJMoa1716197
・Efficacy and safety of twice-daily rabeprazole maintenance therapy for patients with reflux esophagitis refractory to standard once-daily proton pump inhibitor: the Japan-based EXTEND study.
Kinoshita Y, Kato M, Fujishiro M, Masuyama H, Nakata R, Abe H, Kumagai S, Fukushima Y, Okubo Y, Hojo S, Kusano M.J Gastroenterol. 2018 Jul;53(7):834-844. DOI: 10.1007/s00535-017-1417-z
・Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.
Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K. J Diabetes Investig. 2018 Jul;9(4):831-839. DOI: 10.1111/jdi.12759
・Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.
Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Diabetes Obes Metab. 2018 May;20(5):1202-1212. DOI: 10.1111/dom.13218
・Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD.
Fukushima Y, Nakatani Y, Ide Y, Sekino H, St Rose E, Siddiqui S, Maes A, Reisner C. Int J Chron Obstruct Pulmon Dis. 2018 Apr 13;13:1187-1194. DOI: 10.2147/COPD.S159246
・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.
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.
Diabetes Care. 2018 Mar;41(3):538-546. DOI: 10.2337/dc17-1589.
・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.
Ishibashi S, Arai H, Yokote K, Araki E, Suganami H, Yamashita S; K-877 Study Group.
J Clin Lipidol. 2018 Jan-Feb;12(1):173-184. DOI: 10.1016/j.jacl.2017.10.006.
・Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials.
Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Lancet Respir Med. 2016 Oct;4(10):781-796. DOI: 10.1016/S2213-2600(16)30265-X
・Association of baseline plasma des-acyl ghrelin level with the response to rikkunshito in patients with functional dyspepsia.
Togawa K, Matsuzaki J, Kobayakawa M, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, Naito Y, Hayakawa T, Kamiya T, Andoh T, Yoshida H, Tokura Y, Nagata H, Mori M, Kato K, Hosoda H, Takebayashi T, Miura S, Uemura N, Joh T, Hibi T, Suzuki H.J Gastroenterol Hepatol. 2016 Feb;31(2):334-41. DOI: 10.1111/jgh.13074
・Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial.
Kaku K, Kiyosue A, Ono Y, Shiraiwa T, Kaneko S, Nishijima K, Bosch-Traberg H, Seino Y.J Diabetes Investig. 2016 Jan;7(1):76-84. DOI: 10.1111/jdi.12367
・Mepolizumab treatment in patients with severe eosinophilic asthma.
Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. N Engl J Med. 2014 Sep 25;371(13):1198-207. DOI: 10.1056/NEJMoa1403290
・Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia--a multicenter, double-blind, randomized, placebo-controlled study.
Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, Naito Y, Hayakawa T, Kamiya T, Andoh T, Yoshida H, Tokura Y, Nagata H, Kobayakawa M, Mori M, Kato K, Hosoda H, Takebayashi T, Miura S, Uemura N, Joh T, Hibi T, Tack J; Rikkunshito study group. Neurogastroenterol Motil. 2014 Jul;26(7):950-61. DOI: 10.1111/jgh.13074
・Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study.
Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Gut. 2014 Jul;63(7):1061-8. DOI: 10.1136/gutjnl-2013-304722
・High frequency of overlap between functional dyspepsia and overactive bladder.
Matsuzaki J, Suzuki H, Fukushima Y, Hirata K, Fukuhara S, Okada S, Hibi T. Neurogastroenterol Motil. 2012 Sep;24(9):821-7. DOI: 10.1111/j.1365-2982.2012.01939.x
・Efficacy of Solifenacin on Irritable Bowel Syndrome With Diarrhea: Open-label Prospective Pilot Trial.
Fukushima Y, Suzuki H, Matsuzaki J, Kiyosue A, Hibi T. J Neurogastroenterol Motil. 2012 Jul;18(3):317-23. DOI: 10.5056/jnm.2012.18.3.317
・日本人成人気管支喘息患者におけるテルブタリンとサルブタモールの単回投与の有用性の比較
福嶋康之、本間哲也、大田和枝、纐纈優子、清末有宏 アレルギー・免疫 2011 Sep;18 (9):1360-1368
注：下から6本の論文は、東京駅センタービルクリニックで責任医師として参加したもの