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Mario Negri Institute for Pharmacological Research, Clinical Research
Center for Rare Diseases "Aldo e Cele
Daccò" Villa Camozzi, Ranica,
Italy.
Unità di Nefrologia, Ospedali Riuniti,
Azienda Ospedaliera, Bergamo, Italy.
Divisione di Nefrologia Centro di Fisiologia Clinica del CNR, Reggio
Calabria, Italy.
§
Divisione di Nefrologia e Dialisi, USL Zona 10H, Bagno a Ripoli, Firenze,
Italy.
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Divisione di Nefrologia, Ospedale "Careggi Monna Tessa",
Firenze, Italy
Correspondence to Dr. Piero Ruggenenti, Clinical Research Center "Aldo e Cele Daccò" Villa Camozzi, "Mario Negri" Institute for Pharmacological Research, Via Gavazzeni 11, 24125 Bergamo, Italy. Phone: 39 035 319.888; Fax: 39 035 319.331; E-mail: gremuzzi{at}cyberg.it
Abstract. The Ramipril Efficacy in Nephropathy Core and Follow-Up
Study found that 
36 mo of continued ramipril therapy decreased
substantially the risk of end-stage renal failure (ESRF) in patients with
chronic nephropathies and a urinary protein excretion rate 3 g/24 h. This
study investigates the time-dependent changes in GFR in these patients and in
control subjects who were randomized to conventional therapy during the Core
period and switched to ramipril during the Follow-Up study. Analyses included
150 patients (continued ramipril: n = 74; switched to ramipril:
n = 76) who had at least three GFR measurements (including baseline)
during the whole observation period and a subgroup of 43 patients (continued
ramipril: n = 26; switched to ramipril: n = 17) who had at
least six GFR measurements, including at least three on the Core and at least
three on the Follow-Up study. Ramipril (1.25 to 5 mg/d) and conventional
therapy were targeted at achieving a diastolic BP below 90 mmHg. The main
efficacy variables were GFR and ESRF (need for dialysis). Analysis was by
intention to treat. Throughout the study, the mean ± SEM rate of GFR
decline (
GFR) was significantly lower in patients continued on ramipril
compared to those switched to ramipril (0.51 ± 0.09 versus
0.76 ± 0.10 ml/min per 1.73 m2 per mo, P <
0.03). In patients on continued ramipril who had at least six GFR
measured—but not in control subjects—GFR progressively
improved with time and, in the cohort with the longest follow-up, decreased
from (in ml/min per 1.73 m2 per mo): 0.16 ± 0.12 (at 18 mo)
to 0.10 ± 0.05 (at 60 mo). This rate was about 10-fold slower compared
to patients on conventional therapy during the REIN Core study. Analyses of
the individual slopes found that at the end of the follow-up, 10 of 26
patients on continued ramipril therapy had a positive GFR and another
10 patients had an improvement of GFR while on ramipril therapy.
GFR significantly improved in parallel with a significant reduction in
proteinuria. Changes in GFR (P = 0.0001) and proteinuria
(P = 0.04) were significantly different in the two groups. Baseline
characteristics and changes in systolic and diastolic BP and 24-h urine urea
and sodium excretion were comparable. The present results offer evidence that
in chronic nephropathies, the tendency of GFR to decline with time can be
effectively halted, even in patients with remarkably severe disease.
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