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28.08.2020 | Original article

Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia

verfasst von: Takashi Wada, Akinori Hara, Eri Muso, Shoichi Maruyama, Sawako Kato, Kengo Furuichi, Kenichi Yoshimura, Tadashi Toyama, Norihiko Sakai, Hiroyuki Suzuki, Tatsuo Tsukamoto, Mariko Miyazaki, Eiichi Sato, Masanori Abe, Yugo Shibagaki, Ichiei Narita, Shin Goto, Yuichi Sakamaki, Hitoshi Yokoyama, Noriko Mori, Satoshi Tanaka, Yukio Yuzawa, Midori Hasegawa, Takeshi Matsubara, Jun Wada, Katsuyuki Tanabe, Kosuke Masutani, Yasuhiro Abe, Kazuhiko Tsuruya, Shouichi Fujimoto, Shuji Iwatsubo, Akihiro Tsuda, Hitoshi Suzuki, Kenji Kasuno, Yoshio Terada, Takeshi Nakata, Noriaki Iino, Tadashi Sofue, Hitomi Miyata, Toshiaki Nakano, Takayasu Ohtake, Shuzo Kobayashi, LICENSE study Group

Erschienen in: Clinical and Experimental Nephrology | Ausgabe 1/2021

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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.

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Titel: Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia
verfasst von: Takashi Wada
Akinori Hara
Eri Muso
Shoichi Maruyama
Sawako Kato
Kengo Furuichi
Kenichi Yoshimura
Tadashi Toyama
Norihiko Sakai
Hiroyuki Suzuki
Tatsuo Tsukamoto
Mariko Miyazaki
Eiichi Sato
Masanori Abe
Yugo Shibagaki
Ichiei Narita
Shin Goto
Yuichi Sakamaki
Hitoshi Yokoyama
Noriko Mori
Satoshi Tanaka
Yukio Yuzawa
Midori Hasegawa
Takeshi Matsubara
Jun Wada
Katsuyuki Tanabe
Kosuke Masutani
Yasuhiro Abe
Kazuhiko Tsuruya
Shouichi Fujimoto
Shuji Iwatsubo
Akihiro Tsuda
Hitoshi Suzuki
Kenji Kasuno
Yoshio Terada
Takeshi Nakata
Noriaki Iino
Tadashi Sofue
Hitomi Miyata
Toshiaki Nakano
Takayasu Ohtake
Shuzo Kobayashi
LICENSE study Group
Publikationsdatum: 28.08.2020
Verlag: Springer Singapore
Erschienen in: Clinical and Experimental Nephrology / Ausgabe 1/2021
Print ISSN: 1342-1751
Elektronische ISSN: 1437-7799
DOI: https://doi.org/10.1007/s10157-020-01959-9

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Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia