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2015 ; 19
(6
): 1098-106
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Anti-albuminuric effects of spironolactone in patients with type 2 diabetic
nephropathy: a multicenter, randomized clinical trial
#MMPMID25795029
Kato S
; Maruyama S
; Makino H
; Wada J
; Ogawa D
; Uzu T
; Araki H
; Koya D
; Kanasaki K
; Oiso Y
; Goto M
; Nishiyama A
; Kobori H
; Imai E
; Ando M
; Matsuo S
Clin Exp Nephrol
2015[Dec]; 19
(6
): 1098-106
PMID25795029
show ga
BACKGROUND: Several studies have demonstrated that spironolactone has an
anti-albuminuric property in diabetic nephropathy. As an adverse event,
spironolactone often induces the elevation of creatinine levels with hypotension
and hyperkalemia. Therefore, we aimed to evaluate the efficacy and safety of
spironolactone in Japanese patients with type 2 diabetes treated with either
angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
METHODS: Fifty-two Japanese patients with diabetic nephropathy and albuminuria
(100 mg/gCr-2000 mg/gCr) treated with renin-angiotensin system (RAS) blockade
were enrolled in a prospective, randomized, open-label study. The patients were
subjected to add-on treatment with spironolactone 25 mg once daily and compared
with matched controls for 8 weeks. The primary outcome was a reduction in the
rate of albuminuria at 8 weeks compared with the baseline value. This study was
registered with UMIN Clinical Trials Registry (000008016). RESULTS: Albuminuria
was reduced by 33 % (95 % confidence interval: 22-54; P = 0.0002) at 8 weeks with
spironolactone. In the spironolactone group, blood pressure tended to lower and
the estimated glomerular filtration rate (eGFR) was significantly decreased
compared to those in the control group. When adjusted by systolic blood pressure
and eGFR, spironolactone treatment still showed a significant effect on
albuminuria reduction in a linear mixed model (coefficient ± standard error;
514.4 ± 137.6 mg/gCr, P < 0.0005). No patient was excluded from the study because
of hyperkalemia. CONCLUSIONS: Spironolactone reduced albuminuria along with
conventional RAS inhibitors in patients with diabetic nephropathy. Our study
suggests that spironolactone exerts anti-albuminuric effects independent of
systemic hemodynamic alterations.
|Adult
[MESH]
|Aged
[MESH]
|Albuminuria/complications/*drug therapy
[MESH]
|Aldosterone/blood
[MESH]
|Asian People
[MESH]
|Blood Pressure/drug effects
[MESH]
|Diabetes Mellitus, Type 2/*complications/urine
[MESH]