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Kidney Week

Abstract: TH-PO1143

Results of an Exploratory and Randomized Control Study on DAPagliflozin for the Attenuation of Albuminuria in Patients with HEaRt Failure and Type 2 Diabetes Mellitus: DAPPER Study

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Yoshihara, Fumiki, National Cerebral and Cardiovascular Center, Suita, Japan
  • Imazu, Miki, National Cerebral and Cardiovascular Center, Suita, Japan
  • Sakuma, Ichiro, Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan
  • Hiroi, Yukio, National Center for Global Health and Medicine, Tokyo, Japan
  • Hara, Hisao, National Center for Global Health and Medicine, Tokyo, Japan
  • Okazaki, Osamu, Okazaki Heart Clinic, Tokyo, Japan
  • Ishiguro, Chizuru, Okazaki Heart Clinic, Tokyo, Japan
  • Izumi, Chisato, National Cerebral and Cardiovascular Center, Suita, Japan
  • Noguchi, Teruo, National Cerebral and Cardiovascular Center, Suita, Japan
  • Shiraiwa, Toshihiko, Shiraiwa Medical Clinic, Kashiwara, Japan
  • Nishioka, Norio, Shiraiwa Medical Clinic, Kashiwara, Japan
  • Fujii, Kenshi, Sakurabashi Watanabe Hospital, Osaka, Japan
  • Iwakura, Katsuomi, Sakurabashi Watanabe Hospital, Osaka, Japan
  • Tomonaga, Osamu, Tomonaga Clinic, Tokyo, Japan
  • Kobayashi, Koichi, Toyota Memorial Hospital, Toyota, Japan
  • Takihata, Masahiro, Miura Central Clinic, Miura, Japan
  • Yumoto, Kazuhiko, Yokohama Rosai Hospital, Yokohama, Japan
  • Takase, Hiroyuki, JA Shizuoka Kohseiren Enshu Hospital, Hamamatsu, Japan
  • Himi, Toshiharu, Kimitsu Chuo Hospital, Kisarazu, Japan
  • Asakura, Masanori, Hyogo Medical University Hospital, Nishinomiya, Japan
  • Kawabata, Takanori, National Cerebral and Cardiovascular Center, Suita, Japan
  • Omae, Katsuhiro, National Cerebral and Cardiovascular Center, Suita, Japan
  • Ito, Shin, National Cerebral and Cardiovascular Center, Suita, Japan
  • Kitakaze, Masafumi, Hanwa Memorial Hospital, Osaka, Japan

Group or Team Name

  • DAPPER Investigators
Background

Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the urinary albumin-to-creatinine ratio (UACR) in patients with elevated albuminuria in the presence or absence of heart failure (HF) or type 2 diabetes mellitus (T2D). However, these effects have not yet been reported in the presence of both HF and T2D.

Methods

DAPPER is a multicenter, randomized, open-labeled, standard treatment-controlled trial that enrolled patients at 18 sites in Japan. Eligible participants with both HF and T2D were randomly assigned to a dapagliflozin or control (anti-diabetic drugs other than SGLT 2 inhibitors) with a 1:1 allocation. The primary outcome was the changes in UACR from baseline after a two-year observation, and the secondary endpoints were cardiovascular (CV) events and parameters related to HF.

Results

Between May 2017 and March 2020, 294 patients were randomly assigned to the dapagliflozin-group (n=146) or control-group (n=148). The mean age was 72.1 years and 29% were female. The mean HbA1c was 6.9%, mean NT-proBNP was 429.1 pg/mL, mean estimated GFR was 65.7 ml/min/1.73 m2, and median UACR was 25.0 mg/g Cr in the dapagliflozin-group and 25.6 mg/g Cr in the control-group. In the dapagliflozin-group, when 122 patients completed the study, 107 (87.7%) had been taking 5 mg daily. The primary outcome did not differ between the dapagliflozin and control groups. Among the secondary endpoints, the mean decrease in left ventricular end-diastolic dimensions was greater in the dapagliflozin-group than in the control-group. The composite endpoint, defined as CV death or hospitalization for CV events, hospitalization for HF events, hospitalization for all causes, and an additional change in prescriptions for HF were also suppressed in the dapagliflozin-group.

Conclusion

Although dapagliflozin 5 mg daily, the major dose of the present study, did not reduce urinary albumin excretion in HF patients with T2D compared to the control, dapagliflozin decreased CV events and suppressed left ventricular remodeling.

Funding

  • Commercial Support – AstraZeneca K. K., Ono Pharmaceutical Co., LTD.