Objective To test
whether treatment with enalapril and folic acid is more effective in
slowing renal function decline than enalapril alone across a spectrum
of renal function…
Design, Setting, and
Participants In this substudy of eligible China Stroke Primary
Prevention Trial (CSPPT), 15 104 participants with an estimated
glomerular filtration rate (eGFR) 30 mL/min/1.73 m2 or greater,
including 1671 patients with CKD, were recruited from 20 communities
in Jiangsu province in China.
Interventions
Participants were randomized to receive a single tablet daily
containing 10 mg enalapril and 0.8 mg folic acid (n = 7545) or 10
mg enalapril alone (n = 7559).
Main Outcomes and
Measures The primary outcome was the progression of CKD, defined as
a decrease in eGFR of 30% or more and to a level of less than 60
mL/min/1.73 m2 if the baseline eGFR was 60 mL/min/1.73 m2 or more, or
a decrease in eGFR of 50% or more if the baseline eGFR was less than
60 mL/min/1.73 m2; or end-stage renal disease….
Results Overall,
15 104 Chinese adults with a mean (range) age of 60 (45-75) years
were recruited; median follow-up was 4.4 years. There were 164 and
132 primary events in the enalapril group and the enalapril–folic
acid group, respectively. Compared with the enalapril group, the
enalapril–folic acid group had a 21% reduction in the odds of the
primary event (odds ratio [OR], 0.79; 95% CI, 0.62-1.00) and a slower
rate of eGFR decline (1.28% vs 1.42% per year; P = .02). Among
the participants with CKD at baseline, folic acid therapy resulted in
a significant reduction in the risks for the primary event (OR, 0.44;
95% CI, 0.26-0.75), rapid decline in renal function (OR, 0.67; 95%
CI, 0.47-0.96) and the composite event (OR, 0.62; 95% CI, 0.43-0.90),
and a 44% slower decline in renal function (0.96% vs 1.72% per year,
P less than .001). Among those without CKD at baseline, there was
no between-group difference in the primary end point.
Conclusions and
Relevance Enalapril–folic acid therapy, compared with enalapril
alone, can significantly delay the progression of CKD among patients
with mild-to-moderate CKD.
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