Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia
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ORIGINAL ARTICLE
Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia Takashi Wada1,2 · Akinori Hara2 · Eri Muso3 · Shoichi Maruyama4 · Sawako Kato4 · Kengo Furuichi5 · Kenichi Yoshimura6 · Tadashi Toyama6 · Norihiko Sakai1,2 · Hiroyuki Suzuki3 · Tatsuo Tsukamoto3 · Mariko Miyazaki7 · Eiichi Sato8 · Masanori Abe9 · Yugo Shibagaki10 · Ichiei Narita11 · Shin Goto11 · Yuichi Sakamaki11 · Hitoshi Yokoyama5 · Noriko Mori12 · Satoshi Tanaka12 · Yukio Yuzawa13 · Midori Hasegawa13 · Takeshi Matsubara14 · Jun Wada15 · Katsuyuki Tanabe15 · Kosuke Masutani16 · Yasuhiro Abe16 · Kazuhiko Tsuruya17 · Shouichi Fujimoto18 · Shuji Iwatsubo18 · Akihiro Tsuda19 · Hitoshi Suzuki20 · Kenji Kasuno21 · Yoshio Terada22 · Takeshi Nakata23 · Noriaki Iino24 · Tadashi Sofue25 · Hitomi Miyata26 · Toshiaki Nakano27 · Takayasu Ohtake28 · Shuzo Kobayashi28 · LICENSE study Group Received: 22 February 2020 / Accepted: 11 August 2020 © Japanese Society of Nephrology 2020
Abstract Background Patients with diabetes mellitus and severe proteinuria present with poor renal prognoses, despite improvements in diabetes and kidney disease therapies. In this study, we designed a low-density lipoprotein (LDL)-cholesterol apheresis treatment for patients with diabetic nephropathy (DN)/diabetic kidney disease and severe proteinuria. This was a multicenter prospective LICENSE study to confirm the impact of LDL apheresis on proteinuria that exhibited hyporesponsiveness to treatment. In addition, we sought to determine the efficacy and safety of LDL apheresis by comparing the outcomes to those of historical controls in patients with diabetes, refractory hypercholesterolemia, and severe proteinuria. Methods This was a prospective, multicenter study, including 40 patients with diabetes, severe proteinuria, and dyslipidemia. LDL apheresis was performed 6–12 times over a 12-week period. The primary endpoint was the proportion of patients with a decrease in proteinuria excretion of at least 30% in the 6 months after starting therapy. The secondary endpoints included serum creatinine levels and laboratory variables, which were evaluated 4, 6, 12, 18, and 24 months after therapy initiation. Results LDL apheresis was performed on 40 registered patients with diabetes. The proportion of cases in which proteinuria decreased by 30% or more after 6 months of LDL apheresis was 25%, which was similar to that of historical controls. The overall survival and end-stage kidney disease-free survival rates were significantly higher in the LICENSE group compared to those in historical controls. Conclusion Our results suggest that LDL apheresis may be effective and safe for patients with diabetes, proteinuria, and dyslipidemia. Trial registration Trial registration number: jRCTs042180076. Keywords Diabetic nephropathy · LDL · Apheresis · Proteinuria · Diabetic kidney disease
Introduction Takashi Wada and Akinori Hara contributed equally to this work. Electronic supplementary material The online version of this articl
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