PMID- 31455298
OWN - NLM
STAT- MEDLINE
DCOM- 20200511
LR  - 20221207
IS  - 1475-2840 (Electronic)
IS  - 1475-2840 (Linking)
VI  - 18
IP  - 1
DP  - 2019 Aug 27
TI  - Improved home BP profile with dapagliflozin is associated with amelioration of 
      albuminuria in Japanese patients with diabetic nephropathy: the Yokohama add-on 
      inhibitory efficacy of dapagliflozin on albuminuria in Japanese patients with 
      type 2 diabetes study (Y-AIDA study).
PG  - 110
LID - 10.1186/s12933-019-0912-3 [doi]
LID - 110
AB  - BACKGROUND: The Y-AIDA study was designed to investigate the renal- and home 
      blood pressure (BP)-modulating effects of add-on dapagliflozin treatment in 
      Japanese individuals with type 2 diabetes mellitus (T2DM) and albuminuria. 
      METHODS: We conducted a prospective, multicenter, single-arm study. Eighty-six 
      patients with T2DM, HbA1c 7.0-10.0%, estimated glomerular filtration rate 
      (eGFR) >/= 45 mL/min/1.73 m(2), and urine albumin-to-creatinine ratio 
      (UACR) >/= 30 mg/g creatinine (gCr) were enrolled, and 85 of these patients were 
      administered add-on dapagliflozin for 24 weeks. The primary and key secondary 
      endpoints were change from baseline in the natural logarithm of UACR over 
      24 weeks and change in home BP profile at week 24. RESULTS: Baseline median UACR 
      was 181.5 mg/gCr (interquartile range 47.85, 638.0). Baseline morning, evening, 
      and nocturnal home systolic/diastolic BP was 137.6/82.7 mmHg, 136.1/79.3 mmHg, 
      and 125.4/74.1 mmHg, respectively. After 24 weeks, the logarithm of UACR 
      decreased by 0.37 +/- 0.73 (P < 0.001). In addition, changes in morning, evening, 
      and nocturnal home BP from baseline were as follows: morning systolic/diastolic 
      BP - 8.32 +/- 11.42/- 4.18 +/- 5.91 mmHg (both P < 0.001), evening systolic/diastolic 
      BP - 9.57 +/- 12.08/- 4.48 +/- 6.45 mmHg (both P < 0.001), and nocturnal 
      systolic/diastolic BP - 2.38 +/- 7.82/- 1.17 +/- 5.39 mmHg (P = 0.0079 for systolic 
      BP, P = 0.0415 for diastolic BP). Furthermore, the reduction in UACR after 
      24 weeks significantly correlated with an improvement in home BP profile, but not 
      with changes in other variables, including office BP. Multivariate linear 
      regression analysis also revealed that the change in morning home systolic BP was 
      a significant contributor to the change in log-UACR. CONCLUSIONS: In Japanese 
      patients with T2DM and diabetic nephropathy, dapagliflozin significantly improved 
      albuminuria levels and the home BP profile. Improved morning home systolic BP was 
      associated with albuminuria reduction. Trial registration The study is registered 
      at the UMIN Clinical Trials Registry (UMIN000018930; 
      http://www.umin.ac.jp/ctr/index-j.htm ). The study was conducted from July 1, 
      2015 to August 1, 2018.
FAU - Kinguchi, Sho
AU  - Kinguchi S
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Wakui, Hiromichi
AU  - Wakui H
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. 
      hiro1234@yokohama-cu.ac.jp.
FAU - Ito, Yuzuru
AU  - Ito Y
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Kondo, Yoshinobu
AU  - Kondo Y
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Azushima, Kengo
AU  - Azushima K
AD  - Cardiovascular and Metabolic Disorders Program, Duke-NUS Medical School, 
      Singapore, Singapore.
FAU - Osada, Uru
AU  - Osada U
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Yamakawa, Tadashi
AU  - Yamakawa T
AD  - Department of Endocrinology and Diabetes, Yokohama City University Center 
      Hospital, Yokohama, Japan.
FAU - Iwamoto, Tamio
AU  - Iwamoto T
AD  - Department of Nephrology and Hypertension, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Yutoh, Jun
AU  - Yutoh J
AD  - Department of Nephrology and Hypertension, Yokohama Minami Kyousai Hospital, 
      Yokohama, Japan.
FAU - Misumi, Toshihiro
AU  - Misumi T
AD  - Department of Biostatistics and Epidemiology, Yokohama City University Graduate 
      School of Medicine, Yokohama, Japan.
FAU - Aoki, Kazutaka
AU  - Aoki K
AD  - Department of Internal Medicine, Kanagawa Dental University, Yokosuka, Japan.
FAU - Yasuda, Gen
AU  - Yasuda G
AD  - Department of Nephrology and Hypertension, Yokohama City University Center 
      Hospital, Yokohama, Japan.
FAU - Yoshii, Taishi
AU  - Yoshii T
AD  - Department of Endocrinology and Metabolism, Yokohama Minami Kyousai Hospital, 
      Yokohama, Japan.
FAU - Yamada, Takayuki
AU  - Yamada T
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Ono, Syuji
AU  - Ono S
AD  - Department of Nephrology and Hypertension, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Shibasaki-Kurita, Tomoko
AU  - Shibasaki-Kurita T
AD  - Department of Nephrology and Hypertension, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Hosokawa, Saho
AU  - Hosokawa S
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Orime, Kazuki
AU  - Orime K
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Hanaoka, Masaaki
AU  - Hanaoka M
AD  - Department of Nephrology and Hypertension, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Sasaki, Hiroto
AU  - Sasaki H
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Inazumi, Kohji
AU  - Inazumi K
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Yamada, Taku
AU  - Yamada T
AD  - Department of Diabetes and Endocrinology, Saiseikai Yokohama South Hospital, 
      Yokohama, Japan.
FAU - Kobayashi, Ryu
AU  - Kobayashi R
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Ohki, Kohji
AU  - Ohki K
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Haruhara, Kotaro
AU  - Haruhara K
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
FAU - Kobayashi, Yusuke
AU  - Kobayashi Y
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
AD  - Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City 
      University, Yokohama, Japan.
FAU - Yamanaka, Takeharu
AU  - Yamanaka T
AD  - Department of Biostatistics and Epidemiology, Yokohama City University Graduate 
      School of Medicine, Yokohama, Japan.
FAU - Terauchi, Yasuo
AU  - Terauchi Y
AD  - Department of Endocrinology and Metabolism, Yokohama City University Graduate 
      School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. 
      terauchi@yokohama-cu.ac.jp.
FAU - Tamura, Kouichi
AU  - Tamura K
AD  - Department of Medical Science and Cardiorenal Medicine, Yokohama City University 
      Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. 
      tamukou@med.yokohama-cu.ac.jp.
LA  - eng
SI  - JPRN/UMIN000018930
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190827
PL  - England
TA  - Cardiovasc Diabetol
JT  - Cardiovascular diabetology
JID - 101147637
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Albuminuria/diagnosis/*drug therapy/epidemiology/physiopathology
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Biomarkers/blood
MH  - Blood Glucose/drug effects/metabolism
MH  - Blood Pressure/*drug effects
MH  - Blood Pressure Monitoring, Ambulatory
MH  - Circadian Rhythm
MH  - Diabetes Mellitus, Type 2/diagnosis/*drug therapy/epidemiology/physiopathology
MH  - Diabetic Nephropathies/diagnosis/*drug therapy/epidemiology/physiopathology
MH  - Female
MH  - Glomerular Filtration Rate/drug effects
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Japan/epidemiology
MH  - Kidney/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Sodium-Glucose Transporter 2 Inhibitors/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6710883
OTO - NOTNLM
OT  - Albuminuria
OT  - Blood pressure
OT  - Diabetic nephropathy
OT  - SGLT2 inhibitor
OT  - Type 2 diabetes mellitus
COIS- UO has received honoraria for speaking from Astra Zeneca and Ono Pharmaceutical 
      Co. Ltd. TY has received research grant support from Astra Zeneca and an 
      honorarium for speaking from Ono Pharmaceutical Co. Ltd. TM has received research 
      grant support from Ono Pharmaceutical Co. Ltd. KA has received research grant 
      support from Astra Zeneca. TY has received honoraria for speaking from Astra 
      Zeneca and Ono Pharmaceutical Co. Ltd. TY has received research grant support 
      from Ono Pharmaceutical Co. Ltd. and honoraria for speaking from Astra Zeneca and 
      Ono Pharmaceutical Co. Ltd. YT has received research support from Ono 
      Pharmaceutical Co. Ltd. and honoraria for speaking from Astra Zeneca and Ono 
      Pharmaceutical Co. Ltd., and has participated in an advisory board for 
      AstraZeneca. KT has received honoraria for speaking from Astra Zeneca and Ono 
      Pharmaceutical Co. Ltd., and has participated in an advisory board for 
      AstraZeneca.
EDAT- 2019/08/29 06:00
MHDA- 2020/05/12 06:00
PMCR- 2019/08/27
CRDT- 2019/08/29 06:00
PHST- 2019/05/17 00:00 [received]
PHST- 2019/08/12 00:00 [accepted]
PHST- 2019/08/29 06:00 [entrez]
PHST- 2019/08/29 06:00 [pubmed]
PHST- 2020/05/12 06:00 [medline]
PHST- 2019/08/27 00:00 [pmc-release]
AID - 10.1186/s12933-019-0912-3 [pii]
AID - 912 [pii]
AID - 10.1186/s12933-019-0912-3 [doi]
PST - epublish
SO  - Cardiovasc Diabetol. 2019 Aug 27;18(1):110. doi: 10.1186/s12933-019-0912-3.