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

Fumiki Yoshihara,

• Imazu, Miki, National Cerebral and Cardiovascular Center, Suita, Japan

Miki Imazu,

• Sakuma, Ichiro, Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan

Ichiro Sakuma,

• Hiroi, Yukio, National Center for Global Health and Medicine, Tokyo, Japan

Yukio Hiroi,

• Hara, Hisao, National Center for Global Health and Medicine, Tokyo, Japan

Hisao Hara,

• Okazaki, Osamu, Okazaki Heart Clinic, Tokyo, Japan

Osamu Okazaki,

• Ishiguro, Chizuru, Okazaki Heart Clinic, Tokyo, Japan

Chizuru Ishiguro,

• Izumi, Chisato, National Cerebral and Cardiovascular Center, Suita, Japan

Chisato Izumi,

• Noguchi, Teruo, National Cerebral and Cardiovascular Center, Suita, Japan

Teruo Noguchi,

• Shiraiwa, Toshihiko, Shiraiwa Medical Clinic, Kashiwara, Japan

Toshihiko Shiraiwa,

• Nishioka, Norio, Shiraiwa Medical Clinic, Kashiwara, Japan

Norio Nishioka,

• Fujii, Kenshi, Sakurabashi Watanabe Hospital, Osaka, Japan

Kenshi Fujii,

• Iwakura, Katsuomi, Sakurabashi Watanabe Hospital, Osaka, Japan

Katsuomi Iwakura,

• Tomonaga, Osamu, Tomonaga Clinic, Tokyo, Japan

Osamu Tomonaga,

• Kobayashi, Koichi, Toyota Memorial Hospital, Toyota, Japan

Koichi Kobayashi,

• Takihata, Masahiro, Miura Central Clinic, Miura, Japan

Masahiro Takihata,

• Yumoto, Kazuhiko, Yokohama Rosai Hospital, Yokohama, Japan

Kazuhiko Yumoto,

• Takase, Hiroyuki, JA Shizuoka Kohseiren Enshu Hospital, Hamamatsu, Japan

Hiroyuki Takase,

• Himi, Toshiharu, Kimitsu Chuo Hospital, Kisarazu, Japan

Toshiharu Himi,

• Asakura, Masanori, Hyogo Medical University Hospital, Nishinomiya, Japan

Masanori Asakura,

• Kawabata, Takanori, National Cerebral and Cardiovascular Center, Suita, Japan

Takanori Kawabata,

• Omae, Katsuhiro, National Cerebral and Cardiovascular Center, Suita, Japan

Katsuhiro Omae,

• Ito, Shin, National Cerebral and Cardiovascular Center, Suita, Japan

Shin Ito,

• Kitakaze, Masafumi, Hanwa Memorial Hospital, Osaka, Japan

Masafumi Kitakaze,

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.