Abstract
The purpose of this trial was to evaluate the effects of fluvastatin on the lipid profile and on renal function, as measured by creatinine clearance, in dyslipidemic patients with chronic renal failure. In this 8-month prospective, open-label, randomized, parallel-group trial, 130 patients (70 men and 60 women), after a 2-month washout period following previous lipid-lowering treatments, were randomly assigned to fluvastatin XL 80 mg given once daily (80 patients) or to standard treatment (50 patients). Mean total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglyceride values after 3 and 6 months of treatment with fluvastatin showed statistically significant improvement compared with standard treatment. Improved renal function, as measured by creatinine clearance, was observed at the end of the 6-month treatment period in approximately 65% of patients treated with fluvastatin. The increase in creatinine clearance consistently reached 10% to 15% of baseline values. A statistically significant reduction in C-reactive protein (CRP) over baseline values was observed in approximately 75% of patients treated with fluvastatin. Furthermore, mean values of CRP for the fluvastatin standard treatment groups, respectively, were 6.78 and 10.19 at 3 months and 4.47 and 11 at 6 months. Both treatments were well tolerated. No major adverse events were noted. Results of this study suggest that fluvastatin treatment in patients with chronic renal failure is effective in improving the lipid profile, and it demonstrates good safety and tolerability. Furthermore, fluvastatin may contribute to improved nephroprotection in this patient population.
Similar content being viewed by others
References
Pekkanen J, Linn S, Heiss G, et al. Ten-year mortality from cardiovascular disease in relation to cholesterol level among men with and without pre-existing cardiovascular disease.N Engl J Med. 1990;322:700–707.
Gordon DJ, Probstfield JL, Garrison RJ, et al. High-density lipoprotein cholesterol and cardiovascular disease: four prospective American studies.Circulation. 1989;79:8–15.
Kannel WB. Range of serum cholesterol values in the population developing coronary artery disease.Am J Cardiol. 1995;76:69C-77C.
Ballantyne CM, Herd JA, Ferlic LL, et al. Influence of low HDL on progression of coronary artery disease and response to fluvastatin therapy.Circulation. 1999;99:736–743.
Sahadevan M, Kasiske BL. Hyperlipidemia in kidney disease: causes and consequences.Curr Opin Nephrol Hypertens. 2002;11:323–329.
Lintott CJ, Scott RS, Bremer JM, Shand BI. Fluvastatin for dyslipoproteinemia, with or without concomitant chronic renal insufficiency.Am J Cardiol. 1995;76:97A-101A.
Keane WF, Brenner BM, Mazzu A, et al. The CHORUS (Cerivastatin in Heart Outcomes in Renal Disease: Understanding Survival) protocol: a double-blind, placebo controlled trial in patients with ESRD.Am J Kidney Dis. 2001;37:S48-S53.
Attman PO, Sameulsson O, Alaupovic P. Lipoprotein metabolism and renal failure.Am J Kidney Dis. 1993;21:573–592.
Attman PO, Alaupovic P, Sameulsson O. Lipoprotein abnormalities as a risk factor for progressive nondiabetic renal disease.Kidney Int. 1999;56(suppl 71):S14-S17.
Sica DA, Gehr TWB. 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and rhabdomyolysis: considerations in the renal failure patient.Curr Opin Nephrol Hypertens. 2002; 11:123–133.
Samuelsson O, Attman PO, Knight-Gibson C, et al. Fluvastatin improves lipid abnormalities in patients with moderate to advanced chronic renal insufficiency.Am J Kid Dis. 2002;39:67–75.
Gheith OA, Sobh MA, Mohamad K-S, et al. Impact of treatment of dyslipidemia on renal function, fat deposits and scarring in patients with persistent nephrotic syndrome.Nephron. 2002;91:612–619.
Locsey L, Asztalos L, Kincses Z, Balazs G. Fluavastatin (Lescol) treatment of hyperlipidemia in patients with renal transplants.Int Urol Nephrol. 1997;29:95–106.
Scripture CD, Pieper JA. Clinical pharmacokinetics of fluvastatin.Clin Pharmacol. 2001;40:263–281.
Appel-Dingemanse S, Smith T, Merz M. Pharmacokinetics of fluvastatin in subjects with renal impairment and nephrotic syndrome.J Clin Pharmacol. 2002;42:312–318.
Ballantyne CM, Pazzucconi F, Pintò X, et al. Efficacy and tolerability of fluvastatin extendedrelease delivery system: a pooled analysis.Clin Ther. 2001;23:177–192.
Corsini A, Jacobson TA, Ballantyne CM. Fluvastatin: clinical and safety profile.Drugs. 2004; 64:1305–1323.
Tanaka M, Itoh K, Matsushita K, et al. Effects of fluvastatin on plasma lipid abnormalities in hemodialysis patients with chronic renal failure.Nippon Jinzo Gakkai Shi. 2002;44:402–408.
Asberg A, Hartmann A, Fjeldsa E, et al. Bilateral pharmacokinetic interaction between cyclosporine A and fluvastatin in renal transplant recipients.Am J Transplant. 2001;1:382–386.
Zoccali C, Benedetto FA, Mallamaci F, et al. Inflammation is associated with carotid atherosclerosis in dialysis patients. Creed Investigators, Cardiovascular Risk Extended Evaluation in Dialysis Patients.J Hypertens. 2000;18:1207–1213.
Tsirpanlis G, Boufidou F, Manganas S, et al. Treatment with fluvastatin rapidly modulates, via different pathways and in dependence on the baseline level, inflammation in hemodialysis patients.Blood Purification. 2004;22:518–524.
Blackburn R, Giral P, Bruckert E, et al. Elevated C-reactive protein constitutes an independent predictor of advanced carotid plaques in dyslipidemic subjects.Arterioscler Thromb Vasc Biol. 2001;21:1962–1968.
Blankenberg S, Rupprecht HJ, Bickel C, et al. Statins and inflammatory markers. The role of inflammation and infection in acute coronary.Curr Atheroscler Rep. 2002;4:42–47.
Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C. Inflammation enhances cardiovascular risk and mortality in hemodialysis patients.Kidney Int. 1999;55:648–658.
Zoccali C, Benedetto FA, Maas R, et al. Asymmetric dimethylarginine, C-reactive protein, and carotid intima-media thickness in end-stage renal disease.J Am Soc Nephrol. 2002;13:490–496.
Alzali B, Bakri RS, Bharma-Ariza P, et al. Raised plasma total sialic acid levels are markers of cardiovascular disease in renal dialysis patients.J Nephrol. 2003;16:540–545.
Chi DS, Jin FX, Yang SG, Su YW, Zhang Y, Liu YL. Effects of fluvastatin on the levels of C-reactive protein and lipids in patients with hyperlipidemia.Di Yi Jun Yi Da Xue Xue Bao. 2002;22:1109–1111.
Van Haelst PL, van Doormaal JJ, May GF, et al. Secondary prevention with fluvastatin decreases levels of adhesion molecules, neopterin and C-reactive protein.Eur J Intern Med. 2001;12:503–509.
Ichihara A, Hayashi M, Ryuzaki M, et al. Fluvastatin prevents development of arterial stiffness in haemodialiysis patients with type 2 diabetes mellitus.Nephrol Dial Transplant. 2002;17:1513–1517.
Baigent C, Landray M, Warren M. Statin therapy in kidney disease populations. Potential benefits beyond lipid lowering and need for clinical trials.Curr Opin Nephrol Hypertens. 2004; 13:601–605.
Holdaas H, Fellström B, Jardine AG, et al, on behalf of the ALERT Study Group. Beneficial effect of early initiation of lipid-lowering therapy following renal transplantation.Nephrol Dial Transplant. 2005;20:974–980.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Di Lullo, L., Addesse, R., Comegna, C. et al. Effects of fluvastatin treatment on lipid profile, C-reactive protein trend, and renal function in dyslipidemic patients with chronic renal failure. Adv Therapy 22, 601–612 (2005). https://doi.org/10.1007/BF02849954
Issue Date:
DOI: https://doi.org/10.1007/BF02849954