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Long-term effects of esaxerenone in patients with type 2 diabetes, diabetic kidney disease, and hypertension (JDDM77)

  • Daigaku Uchida,
  • Yasunori Sato,
  • Azuma Kanatsuka,
  • Nobuichi Kuribayashi,
  • Susumu Nakamura,
  • Shigetake Ko,
  • Hiroshi Maegawa,
  • Atsushi Hasegawa,
  • Daishiro Yamada,
  • Haruhiko Yoshimura,
  • Hiroki Yokoyama,
  • Kentaro Sakai,
  • Kenichi Kimura,
  • Mikihiko Kudo,
  • Yasushi Ishigaki,
  • Hiroshi Yamaguchi,
  • Fuminobu Okuguchi,
  • Nobuki Yano,
  • Hiroaki Seino,
  • Takashi Ajihara,
  • Katsuya Yamazaki,
  • Yasuko Chiba,
  • Hiroshi Takamura,
  • Mitsutoshi Kato,
  • Naoyuki Yamamoto,
  • Hajime Maeda,
  • Hiroshi Takeda,
  • Keiko Arai,
  • Kotaro Iemitsu,
  • Masahiko Takai,
  • Masato Takaki,
  • Yuki Kono,
  • Sumio Kato,
  • Osamu Sekine,
  • Mariko Oishi,
  • Akiko Hosokawa,
  • Koichi Iwasaki,
  • Akira Okada,
  • Hidekatsu Sugimoto,
  • Kokichi Tanaka,
  • Masae Minami,
  • Katsushige Abe,
  • Noriharu Yagi

摘要

Objectives

This clinical study assessed the three-year, long-term effects of esaxerenone, a non-steroidal aldosterone receptor blocker, on Japanese patients with type 2 diabetes, diabetic kidney disease, and hypertension who were receiving renin-angiotensin system inhibitors.

Materials and methods

Data from a computerized diabetic care database were used to retrospectively compare esaxerenone users (Group A) with non-esaxerenone users (Group B). Propensity score weighting was applied to Group B. The study primarily focused on percent changes in the Urine Albumin-Creatinine Ratio (UACR) from baseline and also examined the estimated Glomerular Filtration Rate (eGFR), blood pressure, serum potassium levels, and HbA1c.

Results

There were 199 patients in Group A and 199 in Group B, matched 1:1 using propensity scores. UACR and blood pressure were significantly lower in Group A than in Group B. Geometric mean percent changes in UACR from baseline between the two groups were as follows: − 62.7% at 1 year (95% Confidence Interval (CI): − 91.0 to − 34.1%), − 48.9% at 2 years (95% CI: − 79.4 to − 19.3%), and − 63.8% at 3 years (95% CI: − 107.4 to − 20.2%). Additionally, the present study examined the impact of combining esaxerenone with SGLT2 inhibitors and GLP-1 receptor agonists and showed consistent effects on UACR irrespective of these medications. Esaxerenone slightly lowered eGFR with a low risk of hyperkalemia but did not adversely impact glucose metabolism.

Conclusions

Esaxerenone exerted antihypertensive and antialbuminuric effects in patients with type 2 diabetes, diabetic kidney disease, and hypertension.