THE BENEFICIAL EFFECT OF ANGIOTENSIN-CONVERTING ENZYME-INHIBITION WITH CAPTOPRIL ON DIABETIC NEPHROPATHY IN NORMOTENSIVE IDDM PATIENTS WITHMICROALBUMINURIA
Lmb. Laffel et al., THE BENEFICIAL EFFECT OF ANGIOTENSIN-CONVERTING ENZYME-INHIBITION WITH CAPTOPRIL ON DIABETIC NEPHROPATHY IN NORMOTENSIVE IDDM PATIENTS WITHMICROALBUMINURIA, The American journal of medicine, 99(5), 1995, pp. 497-504
PURPOSE: To determine whether angiotens-inconverting enzyme (ACE) inhi
bition with captopril reduces the progression of microalbuminuria to o
vert proteinuria in normotensive patients with insulin-dependent diabe
tes mellitus (IDDM). PATIENTS AND METHODS: This study was a prospectiv
e randomized, double-blind, placebo-controlled trial involving 26 cent
ers in the United States and Canada. One hundred forty-three subjects,
14 to 57 years of age, with IDDM for 4 to 33 years, blood pressure <1
40/90 mm Hg in the absence of antihypertensive therapy, and persistent
albumin excretion 20 to 200 mu g/min were randomized to double-blind
treatment with captopril 50 mg or placebo BID. Albumin excretion rate
(AER), blood pressure, and glycohemoglobin were determined every 3 mon
ths, and creatinine clearance (CrCl) and urea excretion were measured
every 6 months.RESULTS: Within 24 months, 6.0% (4/67) of captopril-tre
ated subjects and 18.6% (13/70) of placebo-treated subjects progressed
to clinical proteinuria, defined as AER >200 pg/min and at least 30%
above baseline (risk reduction = 67.8%, P = 0.037). AER increased-at a
n annual rate of 11.8% (95% confidence interval [CI] -3.3% to 29.1%) i
n the placebo group, while it declined by 17.9% (CI -29.6% to -4.3%) i
n the captopril group (P = 0.004). CrCl decreased by 4.9 mL/min per 1.
73 m(2) per year in the placebo group, while it remained stable in the
captopril group (0.9 mL/min per 1.73 m(2) per year, P = 0.039 between
groups). Ten subjects required treatment for hypertension; 8 in the p
lacebo group and 2 in the captopril group.