TY - JOUR
T1 - Effects of LDL apheresis on proteinuria in patients with diabetes mellitus, severe proteinuria, and dyslipidemia
AU - LICENSE study Group
AU - Wada, Takashi
AU - Hara, Akinori
AU - Muso, Eri
AU - Maruyama, Shoichi
AU - Kato, Sawako
AU - Furuichi, Kengo
AU - Yoshimura, Kenichi
AU - Toyama, Tadashi
AU - Sakai, Norihiko
AU - Suzuki, Hiroyuki
AU - Tsukamoto, Tatsuo
AU - Miyazaki, Mariko
AU - Sato, Eiichi
AU - Abe, Masanori
AU - Shibagaki, Yugo
AU - Narita, Ichiei
AU - Goto, Shin
AU - Sakamaki, Yuichi
AU - Yokoyama, Hitoshi
AU - Mori, Noriko
AU - Tanaka, Satoshi
AU - Yuzawa, Yukio
AU - Hasegawa, Midori
AU - Matsubara, Takeshi
AU - Wada, Jun
AU - Tanabe, Katsuyuki
AU - Masutani, Kosuke
AU - Abe, Yasuhiro
AU - Tsuruya, Kazuhiko
AU - Fujimoto, Shouichi
AU - Iwatsubo, Shuji
AU - Tsuda, Akihiro
AU - Suzuki, Hitoshi
AU - Kasuno, Kenji
AU - Terada, Yoshio
AU - Nakata, Takeshi
AU - Iino, Noriaki
AU - Sofue, Tadashi
AU - Miyata, Hitomi
AU - Nakano, Toshiaki
AU - Ohtake, Takayasu
AU - Kobayashi, Shuzo
N1 - Publisher Copyright:
© 2020, Japanese Society of Nephrology.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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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U2 - 10.1007/s10157-020-01959-9
DO - 10.1007/s10157-020-01959-9
M3 - Article
C2 - 32857255
AN - SCOPUS:85089908469
SN - 1342-1751
VL - 25
SP - 1
EP - 8
JO - Clinical and Experimental Nephrology
JF - Clinical and Experimental Nephrology
IS - 1
ER -