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Long-term Effect of Losartan on Kidney Disease in American Indians With Type 2
Diabetes: A Follow-up Analysis of a Randomized Clinical Trial
#MMPMID27612501
Tanamas SK
; Saulnier PJ
; Fufaa GD
; Wheelock KM
; Weil EJ
; Hanson RL
; Knowler WC
; Bennett PH
; Nelson RG
Diabetes Care
2016[Nov]; 39
(11
): 2004-2010
PMID27612501
show ga
OBJECTIVE: To determine whether early administration of losartan slows
progression of diabetic kidney disease over an extended period. RESEARCH DESIGN
AND METHODS: We conducted a 6-year clinical trial in 169 American Indians with
type 2 diabetes and urine albumin/creatinine ratio <300 mg/g; 84 participants
were randomly assigned to receive losartan and 85 to placebo. Primary outcome was
a decline in glomerular filtration rate (GFR; iothalamate) to ?60 mL/min or to
half the baseline value in persons who entered with GFR <120 mL/min. At
enrollment, GFR averaged 165 mL/min (interquartile range 49-313 mL/min). During
the trial, nine persons reached the primary outcome with a hazard ratio (HR;
losartan vs. placebo) of 0.50 (95% CI 0.12-1.99). Participants were then followed
posttrial for up to 12 years, with treatment managed outside the study. The
effect of losartan on the primary GFR outcome was then reanalyzed for the entire
study period, including the clinical trial and posttrial follow-up. RESULTS:
After completion of the clinical trial, treatment with renin-angiotensin system
inhibitors was equivalent in both groups. During a median of 13.5 years following
randomization, 29 participants originally assigned to losartan and 35 to placebo
reached the primary GFR outcome with an HR of 0.72 (95% CI 0.44-1.18).
CONCLUSIONS: Long-term risk of GFR decline was not significantly different
between persons randomized to early treatment with losartan and those randomized
to placebo. Accordingly, we found no evidence of an extended benefit of early
losartan treatment on slowing GFR decline in persons with type 2 diabetes.
|*Indians, North American
[MESH]
|Adult
[MESH]
|Albumins/metabolism
[MESH]
|Creatinine/urine
[MESH]
|Diabetes Mellitus, Type 2/*drug therapy/ethnology
[MESH]
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