[The Bahía 2008 Study: hydration barometer in the Spanish population]. / Estudio Bahía 2008: barómetro de la hidratación de la población española.

BACKGROUND: Vital functions require a balance between the loss and ingestion of liquids. There are no studies about hydration on Spanish population. MATERIAL AND METHODS: 6,508 questionnaires were applied to a randomly selected Spanish population, together with a 24-hour recall in order to measure liquid consumption and variables related to it. RESULTS: The average consumption of liquids was 2,089.5 +/- 771.4 and 6.05 drinking times/day. 3,423 persons (52.6% of the studied people, CI 95% 51.3%-53.8%) were well-hydrated when considering their individual intake. The frequency and volume of drinking decreased with age. 61% (CI 95% 58.64%-64.01%) of the population older than 65 years were badly hydrated. The greatest bottled water consumption corresponded to the youngest population (18-29 years). The greater the physical activity, the greater the beverages consumption (1,987.6 +/- 705.5 ml vs 2,345.8 +/- 928.1 ml, low vs. intense physical activity, respectively). With regard to the intake frequency and volume, mineral and tap water were the most consumed. Those who drank mineral water exceeded the 2 l-recommendation in order to maintain a good hydration status. 59.8% (CI 95% 57.83%-61.76%) of those who preferred mineral water drank more than 2 l/day and drank more times/day and in greater amounts. There was a greater frequency and amount of beverage consumption when people lived in the same house, and particularly more in houses where children were living (2,197.4 +/- 767.8 ml vs 2,055.7 +/- 769.86 ml and 6.4 +/- 2.2 times vs 5.9 +/- 1,9 times, in homes with or without children, respectively). Bottled water was preferred at home (79.07%) and at work (15.61%). CONCLUSIONS: Only half of the Spanish population is well hydrated. Sixty-one percent of people over the age of 65 years were poorly hydrated, consequence it is imperative to promote its consumption.

[Acetate-free on-line PHF: how to improve hyperacetatemia and haemodynamic tolerance]. / PHF on-line sin acetato: cómo mejorar la hiperacetatemia y la tolerancia hemodinámica.

SUMMARY BACKGROUND: The small quantity of acetate present in the dialysis fluid exposes patient's blood to an acetate concentration 30-40 times the physiological levels. This amount is even greater in hemodiafiltration on-line. Our purpose was to evaluate the clinical-analytical effects using three different dialysis techniques in the same patient. METHODS: 35 patients on hemodialysis were included. All patients were treated with conventional bicarbonate dialysate for 3 months, after randomization were switched to first be treated with PHF online with standard bicarbonate dialysate for 6 months and then switched to PHF on-line acetate-free dialysate for the other 6 months or to invert the two last periods. Blood samples were drawn monthly throughout the study and clinical data were obtained. RESULTS: Postdialysis blood acetate levels were higher in patients treated with conventional bicarbonate dialysate with respect to the period of PHF with free-acetate dialysate. Moreover, the percentage of patients with postdialysis blood acetate levels in the pathologic range was higher in patients treated with conventional bicarbonate dialysate respect to PHF on-line acetate-free dialysate period (61% vs. 30%). Serum concentrations of chloride postdialysis were higher and serum concentrations of bicarbonate pre and posthemodialysis were lower in the PHF free-acetate period. The incidence of hypotensive episodes was significantly lower in the PHF on-line with conventional dialysate. CONCLUSIONS: PHF on-line with free-acetate dialysate allows that most of patients finished hemodialysis with blood acetate levels in the physiologic ranges. PHF on-line is a predilutional hemodiafiltration treatment with better tolerance than hemodialysis with standard bicarbonate dialysate.

[Metabolic syndrome and kidney disease]. / Sindrome metabolico y nefropatia.

Metabolic syndrome (MS) encompasses a series of diseases which, when combined, increase vascular risk more than the sum of their individual risks. Insulin resistance (IR) is one of the basic components of MS. - Abdominal fat distribution is an IR marker and is associated to factors increasing vascular risk such as dyslipidemia, high blood pressure, and hyperglycemia, components of the so-called metabolic syndrome. - IR is related to glomerular sclerosis and renal failure through several mechanisms, Including genetic and environmental factors, and stimulation of the renin-angiotensin-aldosterone system. - IR usually precedes development of DM, and therefore contributes to its early identification. MS increases the risk of chronic complications from DM and is associated to an increased prevalence of cardiovascular disease, particularly coronary heart disease, increasing mortality from this cause. - The presence of MS in DM2 is usually associated to a greater prevalence of microalbuminuria or proteinuria and peripheral polyneuropathy.

[Advances in diabetes mellitus, diabetic nephropathy, metabolic syndrome and cardio-vascular-renal risk]. / Avances en diabetes mellitus, nefropatía diabética, síndrome metabólico y riesgo cardio-vasculo-renal.

1. Epidemiological aspects: There is evidence that the pandemic of DM is entering a stabilization phase, with a slight downturn in the rates of ESRD attributed to DM in the United States. 2. New pathogenic and progression mechanisms of renal disease are proposed: 1) Intraglomerular hyperpressure with phenotypical cell changes, inducing TGF-beta activation; 2) Genetic polymorphisms, with candidate genes in chromosomes 18q, 3q, 7p and others; 3) Endothelial dysfunction as an injury initiating mechanism, demonstrated in the eNOS knockout rat; 4) Isoforms of PKC molecules that favor progression of nephropathy. 3. Importance of metabolic syndrome as a progression factor of chronic renal disease. 4. Increased CV risk in patients treated with thiazolidinediones (glitazones) -Hydrosaline retention and heart failure. 5. Recent studies: ADVANCE study: Combined treatment with an ACE inhibitor (perindropil) and a diuretic (indapamide) in fixed doses helps to reduce CV risk and overall mortality.DREAM study: Ramipril does not reduce the occurrence of DM2, but does improve reversion to normoglycemia. AVOID study: Direct renin inhibitors add greater antihypertensive and antiproteinuric efficacy. 6. New therapeutic targets: Antifibrotic, anti-inflammatory and antiproteinuric effects of sulodexide, isosorbide mononitrate, PKC inhibitors and others. 7. The most effective strategy continues to be intensive, multifactorial and multidisciplinary management of the type 2 diabetic patient, as shown by long-term follow-up in the Steno-2 study.

[Informed consent]. / Consentimiento informado.

- Basic law 41/2002 on patient autonomy regulates the rights and obligations of patients, users and professionals, as well as those of public and private health care centers and services. This regulation refers to patient autonomy, the right to information and essential clinical documentation. - This law establishes the minimum requirements for the information the patient should receive and the decision making in which the patient should take part. Diagnostic tests are performed and therapeutic decisions are taken in the ACKD unit in which patient information is an essential and mandatory requirement according to this law.

Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients: a combined analysis of eight multicenter trials.

AIM: Darbepoetin alfa has a longer half-life than epoetin-(EPO) alfa or beta, allowing administration at less frequent intervals for the treatment of renal anemia. The aim of the present analysis was to evaluate the efficacy and tolerability of an every-2-week (Q2W) schedule of darbepoetin alfa in a large cohort of dialysis patients. METHODS: Data were combined from eight similarly designed 24-week phase 3b European studies, in which patients receiving EPO alfa or beta once-weekly were converted to Q2W darbepoetin alfa. Darbepoetin alfa dosage was titrated to maintain hemoglobin (Hb) between 10 and 13 g/dl and efficacy was evaluated during a 4-week evaluation period. RESULTS: In the 1,101 patients assigned to Q2W darbepoetin alfa (i.v., n = 196, s.c., n = 905), mean (SD) Hb levels were 11.53 (0.77) g/dl at baseline and 11.35 (1.04) g/dl at evaluation (mean change in Hb -0.27 g/dl, 95% confidence interval 0.34, -0.20). Hb levels were maintained between 10 and 13 g/dl during evaluation in 85% of patients. Darbepoetin alfa doses were similar at baseline and evaluation, and the i.v. and s.c. routes were associated with similar efficacy and dose requirements. Darbepoetin alfa was well-tolerated. CONCLUSIONS: Q2W darbepoetin alfa is effective in maintaining Hb levels in dialysis patients switched from weekly rHuEPO, regardless of the route of administration and with no notable increase in the weekly equivalent dose.

[Prevalence of kidney insufficiency in primary care population in Spain: EROCAP study]. / Prevalencia de insuficiencia renal en Centros de Atención Primaria en España: Estudio EROCAP.

This cross-sectional, multicenter study investigated the prevalence of chronic kidney disease and associated disorders, in an adult population sample (> 18 years old) attending Primary Care services in Spain. Estimated glomerular filtration rate (Modification Diet in Renal Disease equation) was used for analysis of kidney disease prevalence according to NFK-KDOQI (The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) stages. Data were collected on serum creatinine, other laboratory parameters blood pressure, and medical history of cardiovascular risk factors or disease (hypertension, dislypidemia, diabetes, congestive heart failure, coronary artery disease, stroke or peripheral arteriopathy) in 7,202 patients attending Primary Care Centers. 47.3% were males, mean age 60,6 +/- 14,3 years, BMI 28.2 +/- 5.3, with 27,6% overweight (27-30 kg/m2) and 32,1% obese (BMI>or=30 kg/m2), The prevalence of cardiovascular risks factors were: absence in 17.3%, one factor 26.9% two 31.2%, and 23.6% presented three or more The frequency of CV risk factors was: hypertension (66.7%), dyslipidemia (48%) and diabetes (31.5%). Congestive heart failure, coronary artery disease, stroke or peripheral vascular disease frequency was lower than 10% The prevalence of eGFR < 60 ml/min x 1.73 m2 was: stage 3 (30-59 ml/min/1.73 m2) 19.7%; stage 4 (15-29 ml/min/1.73 m2) 1.2%; stage 5 no dialysis (GFR < 15 ml/min) 0.4%. This prevalence increased with age in both sexes and 33,7% of patients attending Primary Care services over 70 years presented a eGFR < 60 ml/min. Of the total patients with eGFR < 60 ml/min 37.3% had normal serum creatinine levels. This study documents the substantial prevalence of significantly abnormal renal function among patients at Primary Care level. Early identification and appropriate nephrological management of these patients with renal disease is an important opportunity for an adequate prescription of drugs that interfere with renal function, to delay the progression of renal disease and modify CV risk factors.

Arterial elasticity measurement in renal transplant patients under anticalcineurin immunosuppression.

INTRODUCTION: Calcineurin inhibitors may be associated with decreased arterial elasticity and increased vascular risk. We measured pulse wave velocity (PWV) in large or small arteries as an index of elasticity. The aim of our study was to determine aortic and radial arterial elasticity in 30 stable kidney transplant patients treated with calcineurin inhibitor immunosuppression. PATIENTS AND METHODS: In stable kidney transplant patients we determined the usual biochemical parameters as well as lipid profiles, 24-hour blood pressure (BP) monitoring (CBPM) using a chronobiological program (Garapa), and PWV with a HDI-PWV CR-2000 monitor. RESULTS: Sixteen patients received cyclosporine (CsA, G-1) and 14 tacrolimus (G-2) immunosuppression. There were no baseline differences regarding age (G-1: 56 +/- 12 years, G-2: 56 +/- 14 years), renal transplant follow-up (G-1: 7 +/- 3 years, G-2: 7.5 +/- 3 years), Systolic BP, pulse pressure or plasma creatinine (G-1: 163 +/- 35 umol/L, G-2: 173 +/- 26 umol/L). Patients in the G-1 showed higher diastolic BP (79 +/- 11 vs 74 +/- 8 mm Hg), greater proteinuria (1.26 +/- 0.4 vs 0.6 +/- 0.2 g/d, P < .05), total cholesterol (5.51 +/- 1.2 mmol/L) and low-density lipoprotein (3.08 +/- 0.3 vs 2.99 +/- 0.3 mmol/L, P = NS). Aortic arterial elasticity was decreased in G-1 patients (10.4 +/- 6 vs 14.3 +/- 2 mL/mm Hg x10, P < .05) as well as that in the radial artery (G-1: 5.52 +/- 1 vs 5.57 +/- 1.2 mL/mm Hg x100, P = NS). Almost 100% of the patients presented normal diurnal BP with high nocturnal BP in a nondipper pattern in both groups. CONCLUSION: Calcineurin immunosuppression may contribute to arterial stiffness in kidney transplant patients. No differences between CsA or tacrolimus were observed in our study. CBPM and PWV are useful tools to evaluate subclinical atherosclerosis in renal transplant patients.

Detection and treatment of post kidney transplant hyperglycemia: a Spanish multicenter cross-sectional study.

INTRODUCTION: The prevalence of diabetes mellitus (DM) is greater among patients with solid organ transplants than in the general population, although the factors associated with posttransplant DM (PTDM) are unknown. OBJECTIVES: The objective of this study was to estimate the prevalence of and assess the risk factors for PTDM. PATIENTS AND METHODS: We included outpatients with functioning isolated solid organ allografts (kidney, liver, heart, and lung). We collected demographic and posttransplant clinical data that included DM diagnostic ADA criteria, DM treatment, DM family history, presence of hepatitis C virus (HCV), immunosuppression treatment, hypertension, and dyslipidemia. RESULTS: A total of 2178 patients included, 1410 kidney recipients, 489 liver transplants, 207 heart transplants, and 72 lung recipients. Seventeen and four-tenths percent of the patients who did not have DM prior to transplantation, developed PTDM (median time: 79 days). A greater prevalence was observed among patients with a family history, HCV, and tacrolimus treatment (with or without steroids P < .05). By logistic regression analyses, OR for these factors were 1.51, 1.65, and 1.38, respectively. Of those patients who did not suffer PTDM, 55.2% showed basal blood glucose values under 100 mg/dL; only 68% presented with a hemoglobin Alc under 6. CONCLUSIONS: The prevalence of PTDM among kidney recipients was higher than that in the general population. DM family history, HCV positive, and tacrolimus were risk factors associated with this entity.

[Lipoprotein oxidation profile in end stage renal disease patients. Role of vitamin C supplementation]. / Estrés oxidativo de las lipoproteínas y efecto antioxidante de la vitamina C un año después de iniciar hemodiálisis.

BACKGROUND: The aim of the study was to analyze the lipid and lipoprotein oxidation profile in patients with end stage renal disease who started haemodialysis and also to evaluate the possible effect of haemodialysis and vitamin C supplementation on lipoprotein oxidation one year after the initiation of the therapy. METHODS: Forty-one end stage renal disease patients who started haemodialysis between January 1999 and January 2000 were enrolled in the study. The patients were randomised to receive 1,000 mg/day of vitamin C or placebo and then hemodialysis was initiated. We measured the lipid profile and the susceptibility of LDL and HDL to oxidation using cooper ions, at the moment of inclusion and one-year after the treatment. RESULTS: No significant differences were observed among the vitamin-C treated patients and those who received placebo. Our results show that haemodialysis by itself did not induce deletereous effects on the lipid profile, which was slightly improved. A small decrease in total cholesterol--183 to 164 mg/dl (group A), 170 to 144 mg/dl (group B); in LDL cholesterol (100 mg/dl to 79 mg/dl (group A), 88 mg/dl to 73 mg/dl (Group B); and in phospholipids [198 to 188 mg/dl, group A (Group A), 195 mg/dl to 178 mg/dl (Group B)], was observed in all the patients one year after starting haemodialysis. When considering oxidation-derivative products, the lag phase of LDL-cholesterol and HDL-cholesterol was enlarged but without statistical significance. A tendency to increase the vitamin E generation in HDL and LDL lipoproteins was observed in vitamin-C treated patients, but the difference still remained not significant. CONCLUSIONS: Haemodialysis by itself could improve lipid profile in patients with a previous pro-oxidative state such as uraemia. Although our results have failed to demonstrate significant differences between vitamin C-treated and not treated patients, the tendency to decrease oxidation products by supplementation of vitamin C could mean a beneficial effect on oxidation parameters. In order to improve oxidative stress, the use of lipophylic more than hydrophilic vitamins could be evaluated in randomized studies with a more important number of patients.

SR-121463. Sanofi-Synthélabo.

Sanofi-Synthélabo (formerly Sanofi) is developing SR-121463, a vasopressin V, receptor antagonist, as a potential treatment for cardiovascular indications such as congestive heart failure (CHF) and hypertension [330073], [341858]. By September 2001, it had entered phase IIa trials for these indications [421268]. SR-121463 was in phase I clinical trials for CHF and hypertension in June 2001 [359231], [413342]. It was also being evaluated for the potential treatment of glaucoma but its development has been discontinued for this indication [367094]. In October 1999, Lehman Brothers predicted a 5% chance of the compound reaching market, with a launch anticipated in 2004 and potential peak sales of $100 million in 2012 [346267].

Lixivaptan (American Home Products).

Lixivaptan is a non-peptide, orally-active vasopressin antagonist under development by American Home Products for the potential treatment of hyponatremia associated with diseases such as heart failure, liver cirrhosis and nephrotic syndrome. By 1997, it was in phase II trials in the US and elsewhere for hyponatremia [2424051. It selectively prevents vasopressin-dependent water resorption, increasing water excretion with low electrolyte loss [266993] and is selective towards the human V2 versus V1 receptors [295987].

Treatment of hypertension after renal transplantation: long-term efficacy of verapamil, enalapril, and doxazosin.

Normal blood pressure is a good marker of graft survival after renal transplantation, and effective antihypertensive treatment reduces the progression of graft damage. We conducted a long-term follow-up study of 88 hypertensive renal transplant recipients, all of whom were taking sustained cyclosporine A (CsA) immunosuppression. The patients were treated for at least three years, and initially received 240 mg/day of verapamil (N = 24, group I), 5 mg/day of enalapril (N = 24, group II) or 1 mg/day of doxazosin (N = 40, group III). Baseline creatinine did not differ in the three groups, but proteinuria was higher in the enalapril group (7 patients had proteinuria > 1.5 g/day). Treatment was withdrawn in 5 patients in the verapamil group, 5 in the enalapril group and 2 in the doxazosin group due to drug-related side effects. Blood pressure (BP) control at three years was equivalent in the three groups (systolic BP, group I 157 +/- 12; group II 149 +/- 19; group III 154 +/- 21; diastolic BP, group I 90 +/- 8.7, group II 84 +/- 9.8, group III 90.5 +/- 16; mean BP, group I 113 +/- 7, group II 106 +/- 10, group III 106 +/- 29). Two patients in group I, 3 in group II and 15 in group III required additional antihypertensive drugs. CsA levels increased in the verapamil-treated patients, allowing for an early decrease in CsA doses (1 year doses, 3.3 +/- 1 mg/kg body wt/day in group I, 4.3 +/- 1.6 in group II, 3.7 +/- 1.6 in group III). Six cardiovascular events occurred, 3 in group I, 1 in group II, and 2 in group III patients. One patient died in the enalapril group and another in the doxazosin group. Eight verapamil-treated patients, 8 enalapril-treated patients and 4 doxazosin-treated patients lost their grafts due to biopsy-proven chronic transplant nephropathy. In conclusion, the three antihypertensive agents are effective in reducing blood pressure, with no clear advantage of one above any other. Verapamil allows the CsA dose to be reduced, thus decreasing the cost of immunosupression. Enalapril can be a more effective antiproteinuric agent, but hyperkalemia or impaired allograft function may occur in patients with non-optimal allograft function. Doxazosin offers an excellent safety and efficacy profile, and when not efficient by itself in controlling blood pressure, is an ideal concomitant agent in hypertensive renal transplant patients.

Fluvastatin and low-density lipoprotein oxidation in hypercholesterolemic renal transplant patients.

BACKGROUND: Hyperlipidemia contributes to the development and progression of vascular disease in organ transplant patients. Oxidative modification of low-density lipoproteins (LDLs) has been suggested as a key event in early atherogenesis. METHODS: We conducted a pilot study in renal transplanted patients with persistent hypercholesterolemia above 6.5 mmol/liter. We studied the LDL oxidation before and after one year of fluvastatin treatment. Twenty patients (12 males and 8 females, 46 +/- 10 years old) who received a kidney transplant 24 +/- 18 months before the study were treated with fluvastatin (20 mg/day for 12 weeks). Patients with a total cholesterol under 6.3 mmol/liter continued to receive 20 mg/day for another 40 weeks (group I, N = 10). Nine patients with a total cholesterol above 6.3 mmol/liter received 40 mg/day for a further 40 weeks (group II). RESULTS: Cyclosporine levels did not experience a significant variation. Total and LDL cholesterol decreased significantly in both groups (21.7 and 27.9% in group I, 18.3 and 27.2% in group II, respectively). The lag-phase time, which was significantly enlarged before fluvastatin treatment in the patients with respect to the controls (N = 18, 82 +/- 45 vs. 50 +/- 8 min) was shortened after one year of fluvastatin treatment (64 +/- 24 vs. 50 +/- 8 min, P = 0.04). Fluvastatin was stopped in only one patient because of nausea and vomiting. Transaminases and creatin-phospho-kinase were not altered. All of the patients maintained a functioning graft during the study period. CONCLUSIONS: Fluvastatin significantly reduced total and LDL cholesterol, without interferences with cyclosporine A through levels. Fluvastatin has not demonstrated an antioxidant effect in our renal hypercholesterolemic transplant patients.

Staphylococcus aureus nasal carriage in patients on haemodialysis: role of cutaneous colonization.

We performed a prospective study of Staphylococcus aureus nasal carriage in patients on chronic haemodialysis to determine the role of cutaneous colonization in the aetiology of recurrent nasal colonization. From February 2000 to September 2001, 71 patients on chronic haemodialysis in the dialysis unit at a university hospital were screened monthly for S. aureus nasal carriage. Carriers received nasal mupirocin for five days and were tested for nasal and cutaneous carriage two days later and monthly thereafter. Using genotyping results, recurrence was defined as relapse if pretreatment and subsequent nasal isolates were clonally identical; if the isolates were different, it was considered recolonization. Thirty-nine patients (55%) were nasal carriers: 11 initially and 28 during follow-up. Among the mupirocin-treated patients, the eradication of S. aureus nasal carriage rate was 88.5%. Nasal recurrence was documented in 17 patients (43.5%), and S. aureus nasal strains were available for molecular typing in 14 patients with a total of 23 recurrence episodes. On the basis of pulsed-field gel electrophoresis analysis, 16 (70%) recurrence episodes were considered relapses and seven were considered (30%) recolonizations. Among the episodes of relapse, prior cutaneous colonization was detected in only three cases. In haemodialysis patients, the majority of nasal carriage recurrences after mupirocin therapy were due to relapses. Cutaneous colonization does not appear to be relevant in the development of these relapses.

Doxazosin GITS trough to peak ratio and 24-hour blood pressure monitoring in the management of hypertension in renal transplant patients.

UNLABELLED: We have studied 20 patients, 10 male, 10 female, mean age 52.5+/-10.9 years, who received a cadaver kidney transplant between June 1996 and January 1999. The patients presented with mild or moderate high BP and were treated on a maintained immunosuppression with an anti-calcineurin agent and steroids, associated or not to mycophenolate-mofetil. At baseline, a 24-hour ambulatory BP monitoring was performed. General biochemical parameters were determined and doxazosin GITS (Gastro-Intestinal Therapeutic System) in a single dose of 4 mg/d was started. Doxazosin GITS was titrated four weeks after up to 8 mg/d if the BP was greater than 140/90 mm Hg. At week 12, biochemical analysis were repeated as well as the 24-hour BP monitoring and the T/P ratio was calculated. RESULTS: The patients were divided in responders, T/P index >50%, n=10 or not-responders, T/P index <50%, n=10 patients). No differences in systolic BP (SBP), diastolic BP(DBP), plasma creatinine or proteinuria were seen at base-line. DBP was lower in responders than in non-responders (P=ns). Doxazosin doses were 5.5+/-3 mg/d vs 5.8+/-3 and T/P ratio 0.70+/-0.13 vs 0.17+/-0.14, (P=.001). There were no variations in pl. t. cholesterol, triglycerides, glucose or uric acid. CONCLUSIONS: Treatment was safe and efficient, not increasing metabolic adverse effects. Doxazosin GITS is a safe agent which can reduce cardiovascular risk. In our patients, the good T/P ratio has been associated with a best diastolic BP control. This good profile should be taken into account for 24-hour BP control in hypertensive renal transplant patients.

[Dyslipidemia and cardiovascular risk in type 2 diabetes mellitus patients with associated diabetic nephropathy]. / Dislipemia y riesgo cardiovascular en el paciente diabético tipo 2 con nefropatía diabética asociada.

BACKGROUND: Diabetes patients with concomitant diabetic nephropathy are especially destined to cardiovascular complications due to the presence of microalbuminuria or proteinuria, that are potent inductors of dyslipidaemia. METHODS: We have studied 98 type 2 diabetes mellitus patients, 61 male and 37 female, mean age 63 +/- 13 year old, all of them with overt proteinuria (above 500 mg/day), divided into 4 groups: G-I (n = 13): patients with t. cholesterol > 6.25 mmol/l treated with fibric-acid derivatives; G-II (n = 52): hypercholesterolemic patients treated with statins; G-III (n = 20): hypercholesterolemic patients with no lipid-lowering intervention; G-IV (n = 13): normocholesterolemic patients (control group). Lipidic profile, proteinuria and renal function have being compared after 1, 3 and 5 years. RESULTS: Base-line characteristics of the patients were similar when regarding age, onset of diabetes or nephropathy. Only proteinuria was higher in statins-treated group (p < 0.05). Fibric-acid derivatives were more effective on hypertriglyceridaemia while statins were more effective lowering LDL cholesterol. A gemfibrocyl-treated patient presented a rhabdomyolysis episode. Statins were safe and well tolerated. Nine patients (19%) in G-II, 2 patients (10%) in G-III and 1 patient (7%) in G-IV achieved end-stage renal failure. Five-year cardiovascular mortality and all-cause mortality rate were 23%/23% in G-I, 13%/19% in G-II, 20%/25% in G-III and 31%/31% in G-IV. The difference was statistically significant when comparing normocolesterolemic versus statin-treated patients (p < 0.05). CONCLUSION: Lipid-lowering therapy could probably delay but not avoid the progression of diabetic nephropathy. Since dyslipidaemia is closely related to the progression of cardiovascular disease and mortality, an aggressive lipid-lowering therapy is recommended, irrespectively of its potential effect on diabetic nephropathy.