腎臓疾患と2型糖尿病の併存症に対するフェネレノンの臨床効果

新型コロナウィルスの世界的な流行に伴って
自宅にいるケースが増えています。
仕事もテレワークなど通勤での歩行の機会も失われています。
従って、運動不足となっている人は
世界的に多いと推測されます。
また家にいる事によって食生活が乱れる事も考えられます。
長引くコロナ禍と活動制限から
ストレスも生じやすくなっています。
このような事は生活習慣病につながり、
2型糖尿病のリスクを高めると考えられます。
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この2型糖尿病ではインスリン抵抗性が生まれる事により
血糖値の制御に不全が生じます。
高血糖の状態が長く続くと
腎臓の中のろ過の役割を果たす糸球体の機能が低下して
タンパク尿がでることがあります。
従って、糖尿病になると腎障害のリスクも高まるとされています。
また慢性腎臓病が2型糖尿病を悪化させる事もあります(2)。
---
慢性腎臓病には腎不全、心臓血管不全のリスクに対する
重症度の分類があります。
それらは糸球体のろ過機能(GFR)と
アルブミン/クレアチニン比の両方で行列的に分類されます。
今までステージ3,4など重症度の高い患者さんにおいて
鉱質コルチコイド受容体拮抗薬であるフィネレノンが
高カリウム血症や腎機能低下を増加させることなく、
用量依存的にアルブミン尿を減少させ
心臓血管のダメージ軽減にも効果があることが示されています(5-9)。
これは、鉱質コルチコイド受容体の過剰活性が
腎臓病や心臓血管病と関連がある事が示されているからです(3-5)。
従って、その活性を抑える拮抗薬フェネレノンが
臨床においても効果を発揮するということです。
---
B. Pitt, G. Filippatos(敬称略)ら
ヨーロッパを中心とする国際的な医療研究グループは
比較的軽症な腎障害の人も含めて
フェネレノンの心臓血管などに対する臨床効果を
プラセボと比較しています(1)。
7437人という大規模な調査において
腎障害の分類を見ると糸球体のろ過機能である
GFRが60ml/min/1.73m2以上ある人が62%であり
この指標からすれば軽度か、正常の範囲内、
一方、アルブミン/クレアチニン比
30以上が46.8%、300以上が50.2%と
A2,A3ランクで高くなっています。
この条件においてフェネレノンの臨床効果を評価しています(1)。
またグルコース低下治療を受けている人が
97.9%で糖尿病治療を受けている人がほとんどです。
---
特に心不全による入院のケースが
プラセボに対して低くなっています(ハザード比0.71)。
また腎臓障害の症状の悪化も防がれています。
従って、腎臓の機能の維持や
それに付随する心臓血管の悪化において
比較的軽度な腎障害の患者さんにおいても
効果がある事が示されました。
---
フェネレノンの副作用は
全体的な有害事象はプラセボに比べて
少なくとも高くはありません。
一方、高カリウム血症になる人は
治療を受けた人において高くなっています。

B. Pitt, G. Filippatos, R. Agarwal, S.D. Anker, G.L. Bakris, P. Rossing,  
A. Joseph, P. Kolkhof, C. Nowack, P. Schloemer, and L.M. Ruilope,  
(敬称略)からなる医療研究グループの結論では
従来より広い症状の程度においてフェネレノンは
心臓血管の臨床効果が偽薬に対してあったとされています。

//Support for Ref.(1)//---
Supported by Bayer.

//Special message from me//---
This brier letter is uploaded in line with my charity or/and philanthropy.
However, the financial support is urgently needed in my prosocial acitivity.

//Participating Countries and Investigators//---
Argentina: Diego Aizenberg, Inés Bartolacci, Diego Besada, Julio Bittar, Mariano Chahin,
Alicia Elbert, Elizabeth Gelersztein, Alberto Liberman, Laura Maffei, Federico Pérez Manghi,
Hugo Sanabria, Augusto Vallejos, Gloria Viñes, and Alfredo Wassermann.
Australia: Walter Abhayaratna, Peter Colman, David Colquhoun, Elif Ekinci, Chris Ellis,
Kim Joshua, Richard MacIsaac, Peak Mann, Craig Nelson, David Packham, Alexia Pape,
Eugenia Pedagogos, Paul Regal, Simon Roger, Hugo Stephenson, Michael Suranyi,
Duncan Topliss, James Vandeleur, Johan Verjans, Gary Wittert, and Katie-Jane Wynne.
Austria: Martin Clodi, Heinz Drexel, Christoph Ebenbichler, Evelyn Fliesser-Görzer,
Ursula Hanusch, Bernhard Ludvik, Gert Mayer, Peter Neudorfer, Rainer Oberbauer,
Bernhard Paulweber, Rudolf Prager, Friedrich Prischl, Gerit-Holger Schernthaner,
Hans‑Robert Schönherr, and Harald Sourij.
Belgium: Peter Doubel, Francis Duyck, Pieter Gillard, Jean-Michel Hougardy,
André Scheen, Marijn Speeckaert, Luc van Gaal, and Hilde Vanbelleghem.
Brazil: Daniela Antunes, Marcelo Bacci, Roberto Botelho, Claudia Brito, Luis Canani,
Maria Eugenia Canziani, Maria Cerqueira, Rogerio de Paula, Freddy Eliaschewitz,
Carlos Eduardo Figueiredo, Adriana Forti, Miguel Hissa, Maurilo Leite Jr, Lilia Maia,
Irene Noronha, Bruno Paolino, Roberto Pecoits Filho, Marcio Pereira, Evandro Portes,
Dalton Precoma, Rosangela Rea, Miguel Riella, Joao Eduardo Salles,
Eduardo Vasconcellos, Sergio Vencio, and Aline Villacorta.
Bulgaria: Radostina Boshnyashka, Ghassan Farah, Dimitar Georgiev,
Valentina Gushterova, Neli Klyuchkova, Mariya Lucheva, Petya Manova, Angel Marinchev,
Dotska Minkova, Mariya Miteva, Boyan Nonchev, Mariyana Pichmanova, Zhulieta Prakova,
Rangel Rangelov, Rosen Rashkov, Pavel Stanchev, Bilyana Stoyanovska-Elencheva,
Zhivko Tagarev, Theodora Temelkova-Kurktschieva, Svetla Vasileva, and
Mariana Yoncheva-Mihaylova.
Canada: Brian Carlson, James Conway, Serge Cournoyer, Richard Dumas, Fadia El Boreky,
Sameh Fikry, Richard Goluch, Pavel Hamet, Randolph Hart, Sam Henein, Alan Kelly,
Lawrence Leiter, Joanne Liutkus, Francois Madore, Valdemar Martinho, Giuseppe Mazza,
Philip McFarlane, Dennis O’Keefe, Sean Peterson, Daniel Schwartz, Daniel Shu,
Andrew Steele, Ivor Teitelbaum, Guy Tellier, Karthik Tennankore, Sheldon Tobe,
George Tsoukas, Richard Tytus, Louise Vitou, Michael Walsh, Stanley Weisnagel,
Igor Wilderman, and Jean-Francois Yale.
Chile: Jorge Cobos, Fernando González, Marcelo Medina, Juan Carlos Prieto Dominguez,
Eliana Reyes, Carmen Romero, Victor Saavedra, and Paola Varleta.
China: Ruifang Bu, Hanqing Cai, Nan Chen, Qinkai Chen, Dejun Chen, Jinluo Cheng,
Junwu Dong, Youping Dong, Yuming Du, Yi Fang, Tianjun Guan, Weiying Guo,
Chuanming Hao, Fangfang Jiang, Sheng Jiang, Jian Kuang, Minxiang Lei, Dongmei Li,
Hongmei Li, Jingmei Li, Ling Li, Yan Li, Yinan Li, Yuxiu Li, Zhonghe Li, Fang Liu, Jian Liu,
Yinghong Liu, Yu Liu, Zhihong Liu, Yuantao Liu, Gang Long, Guoyuan Lu, Weiping Lu,
Yibing Lu, Jianhua Ma, Heng Miao, Zhaohui Mo, Jianying Niu, Ai Peng, Wen Peng,
Feixia Shen, Jiansong Shen, Bingyin Shi, Qing Su, Zhuxing Sun, Shuifu Tang, Nanwei Tong,
Guixia Wang, Hao Wang, Jianqin Wang, Li Wang, Lihua Wang, Xinjun Wang, Jiali Wei,
Chaoqing Wu, Tianfeng Wu, Changying Xing, Fei Xiong, Mingtong Xu, Ning Xu, Xudong Xu,
Jinkui Yang, Aiping Yin, Longyi Zeng, Hao Zhang, Yanlin Zhang, Ying Zhang, Zhiquan Zhao,
Hongguang Zheng, Ling Zhong, Liyong Zhong, Dalong Zhu, and Jun Zhu.
Colombia: Clara Arango, Edgar Arcos, Gustavo Aroca, Sandra Barrera, Germán Barreto,
Nelly Beltrán López, Diego Benitez, Andres Bermudez, Guillermo Blanco, Rodrigo Botero,
Tatiana Cárdenas, Julian Coronel, Carlos Cure, Carlos Durán, Wilmer Figueroa, Luis García,
Gustavo Guzmán, Eric Hernández, Jaime Ibarra, Carlos Jaramillo, Mónica Jaramillo,
Nicolás Jaramillo, William Kattah, Manuel Liévano, Mónica López, Dora Molina,
Ricardo Rosero, Gregorio Sánchez, Mónica Terront, Pedro Trillos, Freddy Trujillo,
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Czech Republic: Dino Alferi, Michal Brada, Petr Bucek, Tomas Edelsberger,
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Italy: Carlo Antonio Bossi, Enzo Bonora, Paolo Calabrò, Davide Carlo, Roberto Cimino,
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Japan: Hideo Araki, Yukihiro Bando, Osamu Ebisui, Naruhiro Fujita, Hirotaka Fukasawa,
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Lithuania: Dovile Kriauciuniene, Jurate Lasiene, Antanas Navickas, Lina Radzeviciene,
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Malaysia: Norhaliza Mohd Ali, Nor Azizah Aziz, Nik Nur Fatnoon Nik Ahmad, Wan Hasnul,
Rizmy Najme Khir, Li Yuan Lee, Chek Loong Loh, Masni Mohamad,
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Mexico: Melchor Alpizar Salazar, Sandro Avila Pardo, Miriam Bastidas Adrian,
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Ramiro Gutiérrez Ochoa, José Lazcano Soto, Magdalena Madero Rovalo,
Gustavo Méndez Machado, Luis Nevarez Ruiz, Gabriel Ramos López,
Arturo Saldaña Mendoza, Sergio Irizar Santana, Leobardo Sauque Reyna,
Gustavo Solache Ortiz, Rafael Valdez Ortiz, Elvira González Vilchis, and
Juan Villagordoa Mesa.
Netherlands: Rene Bakker, Jos Barendregt, Arnold Boonstra, Catherine Brouwer,
Ron Gansevoort, Adriaan Kooy, Marielle Krekels, Aloysius Lieverse, Peter Luik, Lars Penne,
Bert-Jan van den Born, Marjolijn van Buren, and Ruud van Leendert.
New Zealand: John Baker, Veronica Crawford, Rick Cutfield, Peter Dunn, Jeremy Krebs,
Kingsley Nirmalaraj, Russell Scott, Nine Smuts, and Janet Titchener.
Norway: Emil Asprusten, Erik Eriksen, Trine Finnes, Robert Hagemeier, Hans Høivik,
Kjetil Høye, Thomas Karlsson, Peter Scott Munk, Knut Risberg, Jan Rocke, Hilde Selsås,
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Philippines: Albert Bautista, Elizabeth Catindig, Carlo Manalo, Roberto Mirasol,
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Lithuania: Dovile Kriauciuniene, Jurate Lasiene, Antanas Navickas, Lina Radzeviciene,
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Malaysia: Norhaliza Mohd Ali, Nor Azizah Aziz, Nik Nur Fatnoon Nik Ahmad, Wan Hasnul,
Rizmy Najme Khir, Li Yuan Lee, Chek Loong Loh, Masni Mohamad,
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Mexico: Melchor Alpizar Salazar, Sandro Avila Pardo, Miriam Bastidas Adrian,
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Netherlands: Rene Bakker, Jos Barendregt, Arnold Boonstra, Catherine Brouwer,
Ron Gansevoort, Adriaan Kooy, Marielle Krekels, Aloysius Lieverse, Peter Luik, Lars Penne,
Bert-Jan van den Born, Marjolijn van Buren, and Ruud van Leendert.
New Zealand: John Baker, Veronica Crawford, Rick Cutfield, Peter Dunn, Jeremy Krebs,
Kingsley Nirmalaraj, Russell Scott, Nine Smuts, and Janet Titchener.
Norway: Emil Asprusten, Erik Eriksen, Trine Finnes, Robert Hagemeier, Hans Høivik,
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Philippines: Albert Bautista, Elizabeth Catindig, Carlo Manalo, Roberto Mirasol,
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Poland: Patrycja Butrymowicz, Kazimierz Ciechanowski, Grazyna Cieslik, Edward Franek,
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Oksana Rymar, Ruslan Sardinov, Olga Semenova, Alexander Sherenkov, 
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Bancha Satirapoj, and Piyamitr Sritara.
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Abdulbaki Kumbasar, Aytekin Oguz, Oner Ozdogan, Idris Sahin, Ibrahim Sari,
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Huseyin Yilmaz, and Mehmet Yilmaz.
Ukraine: Iryna Bondarets, Volodymyr Botsyurko, Viktoriia Chernikova, Oleksandra Donets,
Ivan Fushtey, Mariia Grachova, Ganna Isayeva, Dmytro Kogut, Julia Komisarenko,
Nonna Kravchun, Oleksandr Larin, Kateryna Malyar, Borys Mankovsky, Liliya Martynyuk,
Vitaliy Maslyanko, Halyna Myshanych, Larysa Pererva, Nataliia Pertseva,
Oleksandr Serhiyenko, Ivan Smirnov, Liubov Sokolova, and Maryna Vlasenko.
United Kingdom: Rudy Bilous, Cuong Dang, Andrew Johnson, Hassan Kahal,
Dhanya Kalathil, Anne Kilvert, Christina Kyriakidou, Amit Mathew, Kieran McCafferty,
Rasha Mukhtar, Imrozia Munsoor, Sui Phi Kon, Anton Poterajlo, Sam Rice, Pauline Swift,
Arutchelvam Vijayaraman, and Yuk-ki Wong.
United States: Emaad Abdel-Rahman, Edel Abreu, Idalia Acosta, Atoya Adams,
Sharon Adler, Dilawar Ajani, Slamat Ali, Radica Alicic, Amer Al-Karadsheh, Sreedhara Alla,
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Nader Bahri, Shweta Bansal, Steven Barag, Mark Barney, Khalid Bashir, Jose Bautista,
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Jose Birriel, David Bleich, Jonathan Bornfreund, Harjeet Brar, Susan Brian,
Stephen Brietzke, Cynthia Brinson, Humberto Bruschetta, Osvaldo Brusco, Anna Burgner,
Robert Busch, Rafael Canadas, Maria Caramori, Jose Cardona, Jose Carpio,
Christopher Case, Steven Cohen, John Cosby, Humberto Cruz, Ramprasad Dandillaya,
Dalia Dawoud, Soni Dhanireddy, Jorge Diaz, Zia Din, Bradley Dixon, Ankur Doshi,
Fredrick Dunn, Mahfouz El Shahawy, Mohammed El-Shahawy, Sabitha Eppanapally, 
Damaris Vega, Peter Weissman, Adam Whaley-Connell, Don Williamson, Jonathan Winston,
Jonathan Wise, Catherine Womack, Hala Yamout, Michael Yuryev, and Steven Zeig.
Vietnam: Lam Van Hoang, Tran Khanh, Thuy Khuong Le, Boi Ngoc Nguyen,
Pham Nguyen Son, Thao Nguyen, Nguyen Minh Nui, Tran Quang Nam, Lan Phuong Tran,
and Kim Chi Tran.

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Bruce Neal, M.B., Ch.B., Ph.D., Yangfeng Wu, M.D., Ph.D., Xiangxian Feng, Ph.D., Ruijuan Zhang, M.Sc., Yuhong Zhang, M.Med., Jingpu Shi, Ph.D., Jianxin Zhang, Ph.D., Maoyi Tian, Ph.D., Liping Huang, Ph.D., Zhifang Li, M.Sc., Yan Yu, Ph.D., Yi Zhao, Ph.D., Bo Zhou, Ph.D., Jixin Sun, M.Sc., Yishu Liu, M.Sc., Xuejun Yin, M.P.H., Zhixin Hao, M.D., Jie Yu, M.D., Ph.D., Ka-Chun Li, M.Sc., Xinyi Zhang, M.P.H., Peifen Duan, M.Sc., Faxuan Wang, Ph.D., Bing Ma, M.Sc., Weiwei Shi, Ph.D., Gian Luca Di Tanna, Ph.D., Sandrine Stepien, M.Sc., Sana Shan, M.Sc., Sallie-Anne Pearson, Ph.D., Nicole Li, M.D., Ph.D., Lijing L. Yan, Ph.D., Darwin Labarthe, Ph.D., and Paul Elliott, M.B., B.S., Ph.D.
Effect of Salt Substitution on Cardiovascular Events and Death
The New England Journal of Medicine August 29, 2021
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Author Affiliations
From the George Institute for Global Health (B.N., M.T., L.H., Y.L., X.Y., J.Y., K.-C.L., G.L.D.T., S. Stepien, S. Shan) and the Centre for Big Data Research in Health (S.-A.P.), University of New South Wales, and George Clinical (N.L.) — all in Sydney; the School of Public Health (B.N., K.-C.L., P.E.), the U.K. Dementia Research Institute (P.E.), the British Heart Foundation Centre for Research Excellence (P.E.), and the NIHR Imperial Biomedical Research Centre (P.E.), Imperial College London, Health Data Research (P.E.), the NIHR Health Protection Research Unit in Chemical and Radiation Threats and Hazards (P.E.), and the Medical Research Council Centre for Environment and Health (P.E.) — all in London; Peking University Clinical Research Center, Peking University (Y.W.), the George Institute for Global Health at Peking University Health Science Center (Y.W., M.T., Z.H., X.Z., L.L.Y.), and the Department of Cardiology, Peking University Third Hospital (J.Y.), Beijing, the School of Public Health, Changzhi Medical College, Changzhi (X.F., Z.L., P.D.), the School of Public Health, Xi’an Jiaotong University, Xi’an (R.Z., Y.Y.), the School of Public Health and Management, Ningxia Medical University, Yinchuan (Y. Zhang, Y. Zhao, F.W.), the Department of Evidence-Based Medicine, First Hospital of China Medical University, Shenyang (J. Shi, B.Z., B.M.), the Department of Noncommunicable Disease Prevention and Control, Center for Disease Control of Hebei Province, Shijiazhuang (J.Z., J. Sun, W.S.), the School of Public Health, Harbin Medical University, Harbin (M.T.), the Global Health Research Center, Duke Kunshan University, Kunshan (L.L.Y.), and the School of Health Sciences, Wuhan University, Wuhan (L.L.Y.) — all in China; and the Feinberg School of Medicine, Northwestern University, Chicago (D.L.).
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