Chronic kidney disease in Spain: Prevalence and impact of accumulation of cardiovascular risk factors. / Prevalencia de enfermedad renal crónica en España: impacto de la acumulación de factores de riesgo cardiovascular.

BACKGROUND: Chronic kidney disease (CKD) is a public health problem worldwide. We aimed to estimate the CKD prevalence in Spain and to examine the impact of the accumulation of cardiovascular risk factors (CVRF). MATERIAL AND METHODS: We performed a nationwide, population-based survey evaluating 11,505 individuals representative of the Spanish adult population. Information was collected through standardised questionnaires, physical examination, and analysis of blood and urine samples in a central laboratory. CKD was graded according to current KDIGO definitions. The relationship between CKD and 10CVRF was assessed (age, hypertension, general obesity, abdominal obesity, smoking, high LDL-cholesterol, low HDL-cholesterol, hypertriglyceridaemia, diabetes and sedentary lifestyle). RESULTS: Prevalence of CKD was 15.1% (95%CI: 14.3-16.0%). CKD was more common in men (23.1% vs 7.3% in women), increased with age (4.8% in 18-44 age group, 17.4% in 45-64 age group, and 37.3% in ≥65), and was more common in those with than those without cardiovascular disease (39.8% vs 14.6%); all P<.001. CKD affected 4.5% of subjects with 0-1CVRF, and then progressively increased from 10.4% to 52.3% in subjects with 2 to 8-10CVRF (P trend <.001). CONCLUSIONS: CKD affects one in seven adults in Spain. The prevalence is higher than previously reported and similar to that in the United States. CKD was particularly prevalent in men, older people and people with cardiovascular disease. Prevalence of CKD increased considerably with the accumulation of CVRF, suggesting that CKD could be considered as a cardiovascular condition.

Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial.

PURPOSE: Stenosis is the main cause of arteriovenous fistula (AVF) failure. It is still unclear whether surveillance based on vascular access blood flow (QA) enhances AVF function and longevity. METHODS: We conducted a three-year follow-up randomized, controlled, multicenter, open-label trial to compare QA-based surveillance and pre-emptive repair of subclinical stenosis with standard monitoring/surveillance techniques in prevalent mature AVFs. AVFs were randomized to either the control group (surveillance based on classic alarm criteria; n = 104) or to the QA group (QA measured quarterly using Doppler ultrasound [M-Turbo®] and ultrasound dilution [Transonic®] added to classic surveillance; n = 103).The criteria for intervention in the QA group were: 25% reduction in QA, QA<500 mL/min or significant stenosis with hemodynamic repercussion (peak systolic velocity [PSV] more than 400 cm/sc or PSV pre-stenosis/stenosis higher than 3). RESULTS: At the end of follow-up we observed a significant reduction in the thrombosis rate in the QA group (0.025 thrombosis/patient/year in the QA group vs. 0.086 thrombosis/patient/year in the control group [p = 0.007]). There was a significant improvement in the thrombosis-free patency rate (HR, 0.30; 95% CI, 0.11-0.82; p = 0.011) and in the secondary patency rate in the QA group (HR, 0.49; 95% CI, 0.26-0.93; p = 0.030), with no differences in the primary patency rate between the groups (HR, 0.98; 95% CI, 0.57-1.61; p = 0.935).There was greater need for a central venous catheter and more hospitalizations associated with vascular access in the control group (p = 0.034/p = 0.029).Total vascular access-related costs were higher in the control group (€227.194 vs. €133.807; p = 0.029). CONCLUSIONS: QA-based surveillance combining Doppler ultrasound and ultrasound dilution reduces the frequency of thrombosis, is cost effective, and improves thrombosis free and secondary patency in autologous AVF.

A Case Report and Literature Review of Eculizumab Withdrawal in Atypical Hemolytic-Uremic Syndrome.

BACKGROUND Recent advances in the treatment of atypical hemolytic-uremic syndrome (aHUS) have resulted to better long-term survival rates for patients with this life-threatening disease. However, many questions remain such as whether or not long-term treatment is necessary in some patients and what are the risks of prolonged therapy. CASE REPORT Here, we discuss the case of a 37-year-old woman with CFH and CD46 genetic abnormalities who developed aHUS with severe renal failure. She was successfully treated with three doses of rituximab and a three month treatment with eculizumab. After eculizumab withdrawal, symptoms of thrombotic micro-angiopathy (TMA) recurred, therefore eculizumab treatment was restarted. The patient exhibited normal renal function and no symptoms of aHUS at one-year follow-up with further eculizumab treatment. CONCLUSIONS This case highlights the clinical challenges of the diagnosis and management of patient with aHUS with complement-mediated TMA involvement. Attention was paid to the consequences of the treatment withdrawal. Exact information regarding genetic abnormalities and renal function associated with aHUS, as well as estimations of the relapse risk and monitoring of complement tests may provide insights into the efficacy of aHUS treatment, which will enable the prediction of therapeutic responses and testing of new treatment options. Improvements in our understanding of aHUS and its causes may facilitate the identification of patients in whom anti-complement therapies can be withdrawn without risk.

The impact of access blood flow surveillance on reduction of thrombosis in native arteriovenous fistula: a randomized clinical trial.

PURPOSE: The usefulness of access blood flow (QA) measurement is an ongoing controversy. Although all vascular access (VA) clinical guidelines recommend monitoring and surveillance protocols to prevent VA thrombosis, randomized clinical trials (RCTs) have failed to consistently show the benefits of QA-based surveillance protocols. We present a 3-year follow-up multicenter, prospective, open-label, controlled RCT, to evaluate the usefulness of QA measurement using Doppler ultrasound (DU) and ultrasound dilution method (UDM), in a prevalent hemodialysis population with native arteriovenous fistula (AVF). METHODS: Classical monitoring and surveillance methods are applied in all patients, the control group (n = 98) and the QA group (n = 98). Besides this, DU and UDM are performed in the QA group every three months. When QA is under 500 ml/min or there is a >25% decrease in QA the patient goes for fistulography, surgery or close clinical/surveillance observation. Thrombosis rate, assisted primary patency rate, primary patency rate and secondary patency rate are measured. RESULTS: After one-year follow-up we found a significant reduction in thrombosis rate (0.022 thrombosis/patient/year at risk in the QA group compared to 0.099 thrombosis/patient/year at risk in the control group [p = 0.030]). Assisted primary patency rate was significantly higher in the QA group than in control AVF (hazard ratio [HR] 0.23, 95% confidence interval [CI] 0.05-0.99; p = 0.030). In the QA group, the numbers unddergoing angioplasty and surgery were higher but with no significant difference in non-assisted primary patency rate (HR 1.41, 95% CI 0.72-2.84; p = 0.293). There was a non-significant improvement in secondary patency rate in the QA group (HR 0.510, 95% CI 0.17-1.50; p = 0.207). CONCLUSIONS: The measurement of QA combining DU and UDM shows a reduction in thrombosis rate and an increased assisted primary patency rate in AVF after one-year follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02111655.

The Concept and the Epidemiology of Diabetic Nephropathy Have Changed in Recent Years.

Diabetes Mellitus (DM) is a growing worldwide epidemic. It was estimated that more than 366 million people would be affected. DM has spread its presence over the world due to lifestyle changes, increasing obesity and ethnicities, among others. Diabetic nephropathy (DN) is one of the most important DM complications. A changing concept has been introduced from the classical DN to diabetic chronic kidney disease (DCKD), taking into account that histological kidney lesions may vary from the nodular or diffuse glomerulosclerosis to tubulointerstitial and/or vascular lesions. Recent data showed how primary and secondary prevention were the key to reduce cardiovascular episodes and improve life expectancy in diabetic patients. A stabilization in the rate of end stage kidney disease has been observed in some countries, probably due to the increased awareness by primary care physicians about the prognostic importance of chronic kidney disease (CKD), better control of blood pressure and glycaemia and the implementation of protocols and clinical practice recommendations about the detection, prevention and treatment of CKD in a coordinated and multidisciplinary management of the DM patient. Early detection of DM and DCKD is crucial to reduce morbidity, mortality and the social and economic impact of DM burden in this population.

The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease.

BACKGROUND: Anemia is a common condition in CKD that has been identified as a cardiovascular (CV) risk factor in end-stage renal disease, constituting a predictor of low survival. The aim of this study was to define the onset of anemia of renal origin and its association with the evolution of kidney disease and clinical outcomes in stage 3 CKD (CKD-3). METHODS: This epidemiological, prospective, multicenter, 3-year study included 439 CKD-3 patients. The origin of nephropathy and comorbidity (Charlson score: 3.2) were recorded. The clinical characteristics of patients that developed anemia according to EBPG guidelines were compared with those that did not, followed by multivariate logistic regression, Kaplan-Meier curves and ROC curves to investigate factors associated with the development of renal anemia. RESULTS: During the 36-month follow-up period, 50% reached CKD-4 or 5, and approximately 35% were diagnosed with anemia (85% of renal origin). The probability of developing renal anemia was 0.12, 0.20 and 0.25 at 1, 2 and 3 years, respectively. Patients that developed anemia were mainly men (72% anemic vs. 69% non-anemic). The mean age was 68 vs. 65.5 years and baseline proteinuria was 0.94 vs. 0.62 g/24h (anemic vs. non anemic, respectively). Baseline MDRD values were 36 vs. 40 mL/min and albumin 4.1 vs. 4.3 g/dL; reduction in MDRD was greater in those that developed anemia (6.8 vs. 1.6 mL/min/1.73 m2/3 years). These patients progressed earlier to CKD-4 or 5 (18 vs. 28 months), with a higher proportion of hospitalizations (31 vs. 16%), major CV events (16 vs. 7%), and higher mortality (10 vs. 6.6%) than those without anemia. Multivariate logistic regression indicated a significant association between baseline hemoglobin (OR=0.35; 95% CI: 0.24-0.28), glomerular filtration rate (OR=0.96; 95% CI: 0.93-0.99), female (OR=0.19; 95% CI: 0.10-0.40) and the development of renal anemia. CONCLUSIONS: Renal anemia is associated with a more rapid evolution to CKD-4, and a higher risk of CV events and hospitalization in non-dialysis-dependent CKD patients. This suggests that special attention should be paid to anemic CKD-3 patients.

Pathophysiological role and therapeutic implications of inflammation in diabetic nephropathy.

Diabetes mellitus and its complications are becoming one of the most important health problems in the world. Diabetic nephropathy is now the main cause of end-stage renal disease. The mechanisms leading to the development and progression of renal injury are not well known. Therefore, it is very important to find new pathogenic pathways to provide opportunities for early diagnosis and targets for novel treatments. At the present time, we know that activation of innate immunity with development of a chronic low grade inflammatory response is a recognized factor in the pathogenesis of diabetic nephropathy. Numerous experimental and clinical studies have shown the participation of different inflammatory molecules and pathways in the pathophysiology of this complication.

Baseline characteristics of patients with chronic kidney disease stage 3 and stage 4 in Spain: the MERENA observational cohort study.

BACKGROUND: To obtain information on cardiovascular morbidity, hypertension control, anemia and mineral metabolism based on the analysis of the baseline characteristics of a large cohort of Spanish patients enrolled in an ongoing prospective, observational, multicenter study of patients with stages 3 and 4 chronic kidney diseases (CKD). METHODS: Multicenter study from Spanish government hospital-based Nephrology outpatient clinics involving 1129 patients with CKD stages 3 (n = 434) and 4 (n = 695) defined by GFR calculated by the MDRD formula. Additional analysis was performed with GFR calculated using the CKD-EPI and Cockcroft-Gault formula. RESULTS: In the cohort as a whole, median age 70.9 years, morbidity from all cardiovascular disease (CVD) was very high (39.1%). In CKD stage 4, CVD prevalence was higher than in stage 3 (42.2 vs 35.6% p < 0.024). Subdividing stage 3 in 3a and 3b and after adjusting for age, CVD increased with declining GFR with the hierarchy (stage 3a < stage 3b < stage 4) when calculated by CKD-EPI (31.8, 35.4, 42.1%, p 0.039) and Cockcroft-Gault formula (30.9, 35.6, 43.4%, p 0.010) and MDRD formula (32.5, 36.2, 42.2%,) but with the latter, it did not reach statistical significance (p 0.882). Hypertension was almost universal among those with stages 3 and 4 CKD (91.2% and 94.1%, respectively) despite the use of more than 3 anti-hypertensive agents including widespread use of RAS blockers. Proteinuria (> 300 mg/day) was present in more than 60% of patients and there was no significant differences between stages 3 and 4 CKD (1.2 ± 1.8 and 1.3 ± 1.8 g/day, respectively). A majority of the patients had hemoglobin levels greater than 11 g/dL (91.1 and 85.5% in stages 3 and 4 CKD respectively p < 0.001) while the use of erythropoiesis-stimulating agents (ESA) was limited to 16 and 34.1% in stages 3 and 4 CKD respectively. Intact parathyroid hormone (i-PTH) was elevated in stage 3 and stage 4 CKD patients (121 ± 99 and 166 ± 125 pg/mL p 0.001) despite good control of calcium-phosphorus levels. CONCLUSION: This study provides an overview of key clinical parameters in patients with CKD Stages 3 and 4 where delivery or care was largely by nephrologists working in a network of hospital-based clinics of the Spanish National Healthcare System.

Anemia development and cardiovascular risk management in nonanemic stage 3 chronic kidney disease.

BACKGROUND/AIM: There is little information on the development of anemia in the early stages of chronic kidney disease. The aim of this study was to analyze the onset of renal anemia in a cohort of initially nonanemic chronic kidney disease patients followed up in nephrology clinics. METHODS: This epidemiological, prospective, three-year, multicenter study enrolled patients aged 18-78 years with stage 3 chronic kidney disease without anemia. Interim analysis was performed on the data collected during the first 12 months. RESULTS: The study included 432 patients, average age 63.6 years (range 22-78 years, 70% male). The main etiologies of chronic kidney disease were glomerular (11.6%), interstitial (10.4%), vascular (29.4%), and diabetic (16.9%). The percentages of patients with comorbidities were 33.8% diabetes (2.5% type 1), 69% dyslipidemia, and 93% hypertension. During the first year, 12.4% of patients developed anemia. The chronic kidney disease progression rate was low: proteinuria was 0.46 +/- 0.8 g/24 h at one year versus 0.67 +/- 1.0 g/24 h at baseline. Diabetic patients showed a greater prevalence of previous cardiovascular events (50.0% vs. 24.5%) and worse control of some modifiable cardiovascular risk factors: smoking (13.4% vs. 8.6%), obesity (BMI > 30 kg/m(2), 33.6% vs. 25.3%), target blood pressure (<130/80 mmHg, 21.0% vs. 27.9%), and proteinuria (0.8 +/- 1.1 vs. 0.6 +/- 0.9 g/day). CONCLUSIONS: After one year, 12.4% of patients developed anemia. Diabetic patients had a higher cardiovascular risk and limited blood pressure control. The overall control of cardiovascular risk was unsatisfactory.

[European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. CEIPC 2008 Spanish Adaptation]. / Guía Europea de Prevención Cardiovascular en la Práctica Clínica. Adaptación española del CEIPC 2008.

The present CEIPC Spanish adaptation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice 2008. This guide recommends the SCORE model for risk evaluation. The aim is to prevent premature mortality and morbidity due to CVD by means of dealing with its related risk factors in clinical practice. The guide focuses on primary prevention and emphasizes the role of the nurses and primary care doctors in promoting a healthy life style, based on increasing physical activity, changing dietary habits, and not smoking. The therapeutic goal is to achieve a Blood Pressure<140/90mmHg, but in patients with diabetes, chronic kidney disease, or definite CVD, the objective is<130/80mmHg. Serum cholesterol should be<200mg/dl and cLDL<130mg/dl, although in patients with CVD or diabetes, the objective is<100mg/dl (80mg/dl if feasible in very high-risk patients). Patients with type 2 diabetes and those with metabolic syndrome must lose weight and increase their physical activity, and drugs must be administered whenever applicable, with the objective guided by body mass index and waist circumference. In diabetic type 2 patients, the objective is glycated haemoglobin<7%. Allowing people to know the guides and developing implementation programs, identifying barriers and seeking solutions for them, are priorities for the CEIPC in order to put the recommendations into practice.

C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial.

BACKGROUND AND OBJECTIVES: This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb +/-1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation. RESULTS: Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated. CONCLUSIONS: Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.

Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study.

BACKGROUND: Patients with diabetes and anemia are at high risk of cardiovascular disease. The Anemia CORrection in Diabetes (ACORD) Study aimed to investigate the effect of anemia correction on cardiac structure, function, and outcomes in patients with diabetes with anemia and early diabetic nephropathy. METHODS: One hundred seventy-two patients with type 1 or 2 diabetes mellitus, mild to moderate anemia, and stage 1 to 3 chronic kidney disease were randomly assigned to attain a target hemoglobin (Hb) level of either 13 to 15 g/dL (130 to 150 g/L; group 1) or 10.5 to 11.5 g/dL (105 to 115 g/L; group 2). The primary end point was change in left ventricular mass index (LVMI). Secondary end points included echocardiographic variables, renal function, quality of life, and safety. RESULTS: Median Hb level and LVMI were similar in groups 1 and 2 (Hb, 11.9 and 11.7 g/dL [119 and 117 g/L]; LVMI, 113.5 and 112.3 g/m(2), respectively). At study end, Hb levels were 13.5 g/dL (135 g/L) in group 1 and 12.1 g/dL (121 g/L) in group 2 (P < 0.001). No significant differences were observed in median LVMI at month 15 between study groups (group 1, 112.3 g/m(2); group 2, 116.5 g/m(2)). Multivariate analysis showed a nonsignificant decrease in LVMI (P = 0.15) in group 1 versus group 2. Anemia correction had no effect on the rate of decrease in creatinine clearance, but resulted in significantly improved quality of life in group 1 (P = 0.04). There were no clinically relevant differences in adverse events between study groups. CONCLUSION: In patients with diabetes with mild to moderate anemia and moderate left ventricular hypertrophy, correction to an Hb target level of 13 to 15 g/dL (130 to 150 g/L) does not decrease LVMI. However, normalization of Hb level prevented an additional increase in left ventricular hypertrophy, was safe, and improved quality of life.

Target organ damage and cardiovascular complications in patients with hypertension and type 2 diabetes in Spain: a cross-sectional study.

BACKGROUND: Target organ damage (mainly cardiac and renal damage) is easy to evaluate in outpatient clinics and offers valuable information about patient's cardiovascular risk. The purpose of this study was to evaluate, using simple methods, the prevalence of cardiac and renal damage and its relationship to the presence of established cardiovascular disease (CVD), in patients with hypertension (HT) and type 2 diabetes mellitus (DM). METHODS: The RICARHD study is a multicentre, cross-sectional study made by 293 investigators in Nephrology and Internal Medicine Spanish outpatient clinics, and included patients aged 55 years or more with HT and type 2 DM with more than six months of diagnosis. Demographic, clinical and biochemical data, and CVD were collected from the clinical records. Cardiac damage was defined by the presence of electrocardiographic left ventricular hypertrophy (ECG-LVH), and renal damage by a calculated glomerular filtration rate (GFR) of <60 ml/min/1.73 m2, and/or the presence of an albumin/creatinine ratio > or = 30 mg/g; or an urinary albumin excretion (UAE) > or = 30 mg/24 hours. RESULTS: 2339 patients (mean age 68.9 years, 48.2% females, 51.3% with established CVD) were included. ECG-LVH was present in 22.9% of the sample, GFR <60 ml/min/1.73 m2 in 45.1%, and abnormal UAE in 58.7%. Compared with the reference patients (those without neither cardiac nor renal damage), patients with ECG-LVH alone (OR 2.20, [95%CI 1.43-3.38]), or kidney damage alone (OR 1.41, [1.13-1.75]) showed an increased prevalence of CVD. The presence of both ECG-LVH and renal damage was associated with the higher prevalence (OR 3.12, [2.33-4.19]). After stratifying by gender, this relationship was present for both, men and women. CONCLUSION: In patients with HT and type 2 DM, ECG-LVH or renal damage, evaluated using simple methods, are associated with an increased prevalence of established CVD. The simultaneous presence of both cardiac and renal damage was associated to the higher prevalence of CVD, affording complementary information. A systematic assessment of cardiac and renal damage complements the risk assessment of these patients with HT and type 2 DM.

Effect of doxazosin gastrointestinal therapeutic system on patients with uncontrolled hypertension: the ASOCIA Study.

OBJECTIVE: To evaluate extended-release doxazosin gastrointestinal therapeutic system (GITS) as add-on therapy in patients with treated, but uncontrolled hypertension. METHODS: A 16-week, open, noncomparative, multicenter, prospective study of patients with hypertension (> or = 140/> or = 90 mm Hg). Doxazosin GITS 4 mg/d was added to entry medication and increased to 8 mg/d at Week 4 in cases of inadequate blood pressure (BP) control. RESULTS: A total of 3631 patients (40% women) with mean age of 62.4 +/- 0.2 years were included. Proportion of patients reaching goal (< 140/< 90 mm Hg) after 4 weeks of add-on therapy with doxazosin GITS was 39% and increased to 61% at Week 16. Systolic and diastolic BP (mean +/- SEM) decreased, respectively, from 161.6 +/- 0.2 and 95.1 +/- 0.1 mm Hg at baseline to 142.2 +/- 0.2 and 84.1 +/- 0.1 mm Hg at Week 4 (P < 0.0001) and 136.8 +/- 0.2 and 80.6 +/- 0.2 mm Hg at Week 16 (P < 0.0001). Adverse events occurred in 108 patients (3.0%), with 57 (1.6%) related to the study treatment. In 17 patients (0.5%), serious adverse events were described, but only one was related to the study drug. CONCLUSIONS: Doxazosin GITS as add-on therapy achieved target blood pressure and was well tolerated in patients with hypertension uncontrolled by previous regimens. Doxazosin GITS efficacy and tolerability was achieved in combination with all classes of antihypertensives tested.

Epidemiology of diabetic nephropathy in Spain.

BACKGROUND: The incidence of diabetes mellitus (DM) has increased persistently in recent years and is becoming an epidemic. Some have estimated that 4.4% of the world's population will be diabetic by the year 2030. The increase incidence of DM has been accompanied by an increased incidence in diabetic nephropathy (DN), the main cause of end-stage renal disease. METHODS AND RESULTS: In 1996, a pharmaco-economic study estimated that 162,000 people in Spain had type 1 DM and 1,354,900 had type 2 DM. More recent studies have estimated that 6% to 10% of the Spanish population might be diabetic. This percentage is higher in some autonomous communities, such as Canarias, in which 12% of the population is thought to have DM. Based on these studies, we estimate that more than 33,000 residents of Canarias have DN associated with type 1 DM, and more than 405,000 have DN associated with type 2 DM. The percentage of diabetic patients starting renal replacement therapy each year is currently around 21% in Spain but much higher (35%) in Canarias, which equates to 78 patients per million population (pmp) per year. In Catalonia, the number of DM patients entering renal replacement therapy has increased from 8.6 pmp per year in 1984 to 32.4 pmp per year in 2003. We estimate that the systematic application of converting enzyme inhibitors or angiotensin receptor blockers could save more than 2.690 million over 15 years in Spain. CONCLUSION: This epidemic could be prevented, or its impact reduced, through multifactorial and multidisciplinary early intervention, under the observance of guides, Spanish consensus documents, and clinical practice recommendations, together with an integrated educational program aimed at people with diabetes and the improvement of the standard of medical care.

Independent and additive impact of blood pressure control and angiotensin II receptor blockade on renal outcomes in the irbesartan diabetic nephropathy trial: clinical implications and limitations.

Elevated arterial pressure is a major risk factor for progression to ESRD in diabetic nephropathy. However, the component of arterial pressure and level of BP control for optimal renal outcomes are disputed. Data from 1590 hypertensive patients with type 2 diabetes in the Irbesartan Diabetic Nephropathy Trial (IDNT), a randomized, double-blind, placebo-controlled trial performed in 209 clinics worldwide, were examined, and the effects of baseline and mean follow-up systolic BP (SBP) and diastolic BP and the interaction of assigned study medications (irbesartan, amlodipine, and placebo) on progressive renal failure and all-cause mortality were assessed. Other antihypertensive agents were added to achieve predetermined BP goals. Entry criteria included elevated baseline serum creatinine concentration up to 266 micromol/L (3.0 mg/dl) and urine protein excretion >900 mg/d. Baseline BP averaged 159/87 +/- 20/11 mmHg. Median patient follow-up was 2.6 yr. Follow-up achieved SBP most strongly predicted renal outcomes. SBP >149 mmHg was associated with a 2.2-fold increase in the risk for doubling serum creatinine or ESRD compared with SBP <134 mmHg. Progressive lowering of SBP to 120 mmHg was associated with improved renal and patient survival, an effect independent of baseline renal function. Below this threshold, all-cause mortality increased. An additional renoprotective effect of irbesartan, independent of achieved SBP, was observed down to 120 mmHg. There was no correlation between diastolic BP and renal outcomes. We recommend a SBP target between 120 and 130 mmHg, in conjunction with blockade of the renin-angiotensin system, in patients with type 2 diabetic nephropathy.