Effect of Ramipril vs Amlodipine on Renal Outcomes in Hypertensive Nephrosclerosis: A Randomized Controlled Trial
2001
ContextIncidence of end-stage renal disease due to hypertension has increased
in recent decades, but the optimal strategy for treatment of hypertension
to prevent renal failure is unknown, especially among African Americans.ObjectiveTo compare the effects of an angiotensin-converting enzyme (ACE) inhibitor
(ramipril), a dihydropyridine calcium channel blocker (amlodipine), and a β-blocker
(metoprolol) on hypertensive renal disease progression.Design, Setting, and ParticipantsInterim analysis of a randomized, double-blind, 3 × 2 factorial
trial conducted in 1094 African Americans aged 18 to 70 years with hypertensive
renal disease (glomerular filtration rate [GFR] of 20-65 mL/min per 1.73 m2) enrolled between February 1995 and September 1998. This report compares
the ramipril and amlodipine groups following discontinuation of the amlodipine
intervention in September 2000.InterventionsParticipants were randomly assigned to receive amlodipine, 5 to 10 mg/d
(n = 217), ramipril, 2.5 to 10 mg/d (n = 436), or metoprolol, 50 to 200 mg/d
(n = 441), with other agents added to achieve 1 of 2 blood pressure goals.Main Outcome MeasuresThe primary outcome measure was the rate of change in GFR; the main
secondary outcome was a composite index of the clinical end points of reduction
in GFR of more than 50% or 25 mL/min per 1.73 m2, end-stage renal
disease, or death.ResultsAmong participants with a urinary protein to creatinine ratio of >0.22
(corresponding approximately to proteinuria of more than 300 mg/d), the ramipril
group had a 36% (2.02 [SE, 0.74] mL/min per 1.73 m2/y) slower mean
decline in GFR over 3 years (P = .006) and a 48%
reduced risk of the clinical end points vs the amlodipine group (95% confidence
interval [CI], 20%-66%). In the entire cohort, there was no significant difference
in mean GFR decline from baseline to 3 years between treatment groups (P = .38). However, compared with the amlodipine group,
after adjustment for baseline covariates the ramipril group had a 38% reduced
risk of clinical end points (95% CI, 13%-56%), a 36% slower mean decline in
GFR after 3 months (P = .002), and less proteinuria
(P<.001).ConclusionRamipril, compared with amlodipine, retards renal disease progression
in patients with hypertensive renal disease and proteinuria and may offer
benefit to patients without proteinuria.
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