Nephrol Dial Transplant (2001) 16: 961-966
© 2001 European Renal Association-European Dialysis and Transplant Association
Effect of Lisinopril on the progression of renal insufficiency in mild proteinuric non-diabetic nephropathies
on behalf of the collaborative study group*
Division of Nephrology, University of Roma ‘La Sapienza’, Rome and Department of Nephrology S. Orsola-Malpighi Hospital, Bologna, Italy
Background. The aim of the study was to determine whether Lisinopril, an ACE-inhibitor (ACEi), was more effective than other antihypertensive agents in slowing the progression of non-diabetic chronic renal diseases in patients with baseline proteinuria 
1.0 g/day.
Methods. In an open, multicentre study all eligible patients entered a 3 months run-in phase during which antihypertensive therapy (with exclusion of ACEi) was adjusted in order to obtain a supine diastolic blood pressure 90 mmHg and urinary protein excretion and renal function stability were verified. One hundred and thirty-one patients with chronic renal insufficiency (Clcr between 20–50 ml/min) because of primary renoparenchymal diseases and proteinuria 1.0 g/day, were randomized to Lisinopril (L=66) or alternative antihypertensive therapy (C=65). Changes in renal function were assessed by inulin (Clin) clearance.
Results. During the follow-up period of 22.5±5.6 months, Clin did not change significantly in group L (-1.31±0.6 ml/min/1.73 m2) differing significantly from group C in which it declined markedly (-6.71±3.6 ml/min/1.73 m2) (P<0.04). Seven patients experienced adverse events that prompted discontinuation of treatment: four in group L and three in group C; in addition seven patients showed severe deterioration in renal function requiring dialysis: two in group L and five in group C. The overall risk of the combined end-points: need for dialysis or halving of GFR was significantly higher in group C versus group L. During the study the mean value for systolic blood pressure was 137.8±14.6 SD mmHg in group L and 140.8±14.1 SD mmHg in group C; the mean difference between groups, during and at the end of the study, was 2 mmHg (NS). The mean diastolic blood pressure during the study was 83.8±8.6 SD mmHg in group L and 84.3±7.56 SD mmHg in group C; during and at the end of the study the mean diastolic difference between groups was 1 mmHg.
Conclusion. This study, employing a sensitive measurement of renal function and with similar blood pressure in both groups, provides support to the hypothesis that ACEi have a specific renoprotective effect, in addition to blood pressure control, also in patients with mild proteinuria.
Keywords: ACE-inhibitors; antihypertensive therapy; non-diabetic renal diseases; renal failure; reno-protection
Correspondence and offprint requests to: *Study Group: A. Albertazzi (Chieti), G. Baldari (Livorno), G. Bazzato (Mestre), A. Borghetti (Parma), A. Castellani (Brescia), L. Cioffi (Salerno), M. Fusaroli (Ravenna), C. Giordano (Napoli), G. Mioni (Udine), P.T. Scarpelli (Firenze), M. Surian (Desio-Mi), G. Verzetti (Novara).
Correspondence and offprint requests to: Giulio A. Cinotti, Division of Nephrology, Dipartimento di Scienze Cliniche, Policlinico Umberto I, R-00161 Roma, Italy.
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