BACKGROUND AND OBJECTIVES: This open, prospective, randomized trial aimed to assess the effects of statins in chronic kidney disease patients on optimized antiproteinuric treatment with combined angiotensin-converting enzyme inhibition and angiotensin receptor blockade. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: After 1-month benazepril therapy followed by 1-month benazepril-valsartan combined therapy (run-in), 186 consenting patients with residual proteinuria >0.5 g/24 h were randomized to 6-month benazepril-valsartan therapy alone or combined with fluvastatin. Between-groups changes in proteinuria (primary outcome), serum lipids, and GFR were compared by ANCOVA. Analyses were blinded and by intention to treat. RESULTS: During the run-in, proteinuria decreased more on benazepril-valsartan than on benazepril alone. Proteinuria reduction correlated with concomitant reduction in total, LDL, and HDL cholesterol, and apolipoprotein B and apolipoprotein A levels. After randomization, median proteinuria similarly decreased from 1.2 (0.6 to 2.2) to 1.1 (0.5 to 1.7) g/24 h on fluvastatin and from 1.5 (0.8 to 2.7) to 1.0 (0.5 to 2.4) g/24 h on benazapril-valsartan therapy alone. Fluvastatin further reduced total and LDL cholesterol and apolipoprotein B versus benazepril-valsartan alone, but did not affect serum triglycerides and GFR. Treatment was well tolerated. CONCLUSIONS: In chronic kidney disease patients with residual proteinuria despite combined angiotensin-converting enzyme inhibitor and angiotensin receptor blockade therapy, add-on fluvastatin does not affect urinary proteins, but further reduces serum lipids and is safe. Whether combined angiotensin-converting enzyme inhibitor, angiotensin receptor blockade, and statin therapy may improve cardiovascular outcomes in this high-risk population is worth investigating.

EFFECTS OF ADD-ON FLUVASTATIN THERAPY IN PATIENTS WITH CHRONIC PROTEINURIC NEPHROPATHY ON DUAL RENIN-ANGIOTENSIN SYSTEM BLOCKADE: THE ESPLANADE TRIAL / P., Ruggenenti; A., Perna; M., Tonelli; G., Loriga; N., Motterlini; N., Rubis; F., Ledda; S., Rota Jr; A., Satta; A., Granata; G., Battaglia; F., Cambareri; David, Salvatore; F., Gaspari; N., Stucchi; S., Carminati; B., Ene Iordache; P., Cravedi; G., Remuzzi. - In: CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY. - ISSN 1555-905X. - 5:(2010), pp. 1928-1938. [10.2215/CJN.03380410]

EFFECTS OF ADD-ON FLUVASTATIN THERAPY IN PATIENTS WITH CHRONIC PROTEINURIC NEPHROPATHY ON DUAL RENIN-ANGIOTENSIN SYSTEM BLOCKADE: THE ESPLANADE TRIAL

DAVID, Salvatore;
2010-01-01

Abstract

BACKGROUND AND OBJECTIVES: This open, prospective, randomized trial aimed to assess the effects of statins in chronic kidney disease patients on optimized antiproteinuric treatment with combined angiotensin-converting enzyme inhibition and angiotensin receptor blockade. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: After 1-month benazepril therapy followed by 1-month benazepril-valsartan combined therapy (run-in), 186 consenting patients with residual proteinuria >0.5 g/24 h were randomized to 6-month benazepril-valsartan therapy alone or combined with fluvastatin. Between-groups changes in proteinuria (primary outcome), serum lipids, and GFR were compared by ANCOVA. Analyses were blinded and by intention to treat. RESULTS: During the run-in, proteinuria decreased more on benazepril-valsartan than on benazepril alone. Proteinuria reduction correlated with concomitant reduction in total, LDL, and HDL cholesterol, and apolipoprotein B and apolipoprotein A levels. After randomization, median proteinuria similarly decreased from 1.2 (0.6 to 2.2) to 1.1 (0.5 to 1.7) g/24 h on fluvastatin and from 1.5 (0.8 to 2.7) to 1.0 (0.5 to 2.4) g/24 h on benazapril-valsartan therapy alone. Fluvastatin further reduced total and LDL cholesterol and apolipoprotein B versus benazepril-valsartan alone, but did not affect serum triglycerides and GFR. Treatment was well tolerated. CONCLUSIONS: In chronic kidney disease patients with residual proteinuria despite combined angiotensin-converting enzyme inhibitor and angiotensin receptor blockade therapy, add-on fluvastatin does not affect urinary proteins, but further reduces serum lipids and is safe. Whether combined angiotensin-converting enzyme inhibitor, angiotensin receptor blockade, and statin therapy may improve cardiovascular outcomes in this high-risk population is worth investigating.
2010
EFFECTS OF ADD-ON FLUVASTATIN THERAPY IN PATIENTS WITH CHRONIC PROTEINURIC NEPHROPATHY ON DUAL RENIN-ANGIOTENSIN SYSTEM BLOCKADE: THE ESPLANADE TRIAL / P., Ruggenenti; A., Perna; M., Tonelli; G., Loriga; N., Motterlini; N., Rubis; F., Ledda; S., Rota Jr; A., Satta; A., Granata; G., Battaglia; F., Cambareri; David, Salvatore; F., Gaspari; N., Stucchi; S., Carminati; B., Ene Iordache; P., Cravedi; G., Remuzzi. - In: CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY. - ISSN 1555-905X. - 5:(2010), pp. 1928-1938. [10.2215/CJN.03380410]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2403538
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