Renin–angiotensin–aldosterone system blockers effect in chronic kidney disease progression in hypertensive elderly patients without proteinuria: PROERCAN trial / Efecto de los bloqueantes del sistema renina-angiotensina-aldosterona en la progresión de enfermedad renal crónica en pacientes hipertensos añosos sin proteinuria: ensayo clínico Progresión de Enfermedad Renal Crónica en Ancianos

Introduction: Evidence about nefroprotective effect with RAAS blockers in elderly patients with chronic kidney disease (CKD) without proteinuria is lacking. The primary outcome of our study is to evaluate the impact of RAAS blockers in CKD progression in elderly patients without proteinuria. Materials and methods: Multicenter open-label, randomized controlled clinical trial including patients over 65 year-old with hypertension and CKD stages 3–4 without proteinuria. Patients were randomized in a 1:1 ratio to either receive RAAS blockers or other antihypertensive drugs and were followed up for three years. Primary outcome is estimated glomerular filtration rate (eGFR) decline at 3 years. Secondary outcome measures include BP control, renal and cardiovascular events and mortality. Results: 88 patients were included with a mean age of 77.9±6.1 years and a follow up period of 3 years: 40 were randomized to RAAS group and 48 to standard treatment. Ethiology of CKD was: 53 vascular, 16 interstitial and 19 of unknown ethiology. In the RAAS group eGFR slope during follow up was −4.3±1.1ml/min, whereas in the standard treatment group an increase on eGFR was observed after 3 years (+4.6±0.4ml/min), p=0.024. We found no differences in blood pressure control, number of antihypertensive drugs, albuminuria, potassium serum levels, incidence of cardiovascular events nor mortality during the follow up period. Conclusions: In elderly patients without diabetes nor cardiopathy and with non proteinuric CKD the use of RAAS blockers does not show a reduction in CKD progression. The PROERCAN (PROgresión de Enfermedad Renal Crónica en ANcianos) trial (trial registration: NCT03195023). (AU)

Introducción: Actualmente no existe suficiente evidencia sobre el efecto nefroprotector de los bloqueantes del sistema renina-angiotensina-aldosterona (BSRAA) en pacientes añosos con enfermedad renal crónica (ERC) sin proteinuria y sin cardiopatía. El objetivo es evaluar el efecto de los BSRAA en la progresión de la ERC en este grupo poblacional. Métodos: Se trata de un estudio prospectivo, aleatorizado, que compara la eficacia de los BSRAA vs. otros tratamientos antihipertensivos en la progresión renal en personas mayores de 65 años con ERC estadios 3 y 4 e índice albúmina/creatinina<30mg/g. Aleatorización 1:1 BSRAA o tratamiento antihipertensivo estándar. Se recogieron cifras tensionales y parámetros analíticos de un año previo a la aleatorización y durante el seguimiento. Resultados: Se incluyeron 88 pacientes seguidos durante tres años con edad media de 77,9±6,1 años. De estos, se aleatorizaron 40 al grupo BSRAA y 48 al estándar. La etiología de ERC fue: 53 vascular, 16 intersticial y 19 no filiada. En el primer grupo se observó una progresión de la ERC con una caída del filtrado glomerular estimado (FGe) de -4,3±1,1mL/min, mientras que en el grupo estándar un aumento del FGe durante el seguimiento de 4,6±0,4mL/min, p=0,024. No se apreciaron diferencias entre ambos en el control tensional, el número de antihipertensivos, la albuminuria, los niveles de potasio, la incidencia de eventos cardiovasculares ni la mortalidad durante el seguimiento. Conclusiones: En pacientes añosos no diabéticos con ERC no proteinúrica y sin cardiopatía el uso de BSRAA no añade beneficio en la progresión de la ERC. Ensayo clínico Progresión de Enfermedad Renal Crónica en Ancianos (PROERCAN) (NCT03195023). (AU)

Renin-angiotensin-aldosterone system blockers effect in chronic kidney disease progression in hypertensive elderly patients without proteinuria: PROERCAN trial.

INTRODUCTION: Evidence about nefroprotective effect with RAAS blockers in elderly patients with chronic kidney disease (CKD) without proteinuria is lacking. The primary outcome of our study is to evaluate the impact of RAAS blockers in CKD progression in elderly patients without proteinuria. MATERIALS AND METHODS: Multicenter open-label, randomized controlled clinical trial including patients over 65 year-old with hypertension and CKD stages 3-4 without proteinuria. Patients were randomized in a 1:1 ratio to either receive RAAS blockers or other antihypertensive drugs and were followed up for three years. Primary outcome is estimated glomerular filtration rate (eGFR) decline at 3 years. Secondary outcome measures include BP control, renal and cardiovascular events and mortality. RESULTS: 88 patients were included with a mean age of 77.9±6.1 years and a follow up period of 3 years: 40 were randomized to RAAS group and 48 to standard treatment. Ethiology of CKD was: 53 vascular, 16 interstitial and 19 of unknown ethiology. In the RAAS group eGFR slope during follow up was -4.3±1.1ml/min, whereas in the standard treatment group an increase on eGFR was observed after 3 years (+4.6±0.4ml/min), p=0.024. We found no differences in blood pressure control, number of antihypertensive drugs, albuminuria, potassium serum levels, incidence of cardiovascular events nor mortality during the follow up period. CONCLUSIONS: In elderly patients without diabetes nor cardiopathy and with non proteinuric CKD the use of RAAS blockers does not show a reduction in CKD progression. The PROERCAN (PROgresión de Enfermedad Renal Crónica en ANcianos) trial (trial registration: NCT03195023).

The effect of renin–angiotensin–aldosterone system blockers on the progression of chronic kidney disease in hypertensive elderly patients without proteinuria: PROERCAN study. Rationale and design / Efecto de los bloqueantes del sistema renina-angiotensina-aldosterona en la progresión de la enfermedad renal crónica en pacientes añosos sin proteinuria: ensayo clínico PROERCAN. Diseño y justificación del estudio

INTRODUCTION: Blood pressure (BP) control is fundamental to the care of patients with chronic kidney disease (CKD), and is relevant at all stages of CKD. Renin-angiotensin-aldosterone system (RAAS) blockers have shown to be effective, not only in BP control but also in reducing proteinuria and slowing CKD progression. However, there is a lack of evidence for recommending RAAS blockers in elderly patients with CKD without proteinuria. The primary outcome of the present study is to evaluate the impact of RAAS blockers on CKD progression in elderly patients without proteinuria. MATERIALS AND METHODS: The PROERCAN trial (trial registration, NCT03195023) is a multicentre open-label, randomized controlled clinical trial with 110 participants over 65 years-old with hypertension and CKD stages 3-4 without proteinuria. Patients will be randomized in a 1:1 ratio to either receive RAAS blockers or other antihypertensive drugs, and will be followed up for three years. Primary outcome is the estimated glomerular filtration rate (eGFR) decline at 3 years. Secondary outcomes include BP control, renal and cardiovascular events, and mortality. RESULTS AND CONCLUSIONS: The design of this trial is presented here. The results will show if antihypertensive treatment with RAAS blockers has an impact on CKD progression in elderly patients without proteinuria. Any differences in BP control, cardiovascular events, and mortality with each antihypertensive treatment will be also clarified

INTRODUCCIÓN: El control de la presión arterial (PA) es fundamental para los pacientes con enfermedad renal crónica (ERC) y es relevante en todos los estadios de ERC. Los bloqueantes del sistema renina-angiotensina-aldosterona (BSRAA) han demostrado su efectividad no solo en el control de la PA sino también en la reducción de la proteinuria y de la progresión de la ERC. Sin embargo, no existe evidencia para recomendar el uso de BSRAA en pacientes añosos con ERC sin proteinuria. El objetivo principal del estudio es evaluar el impacto de los BSRAA en la progresión de ERC en pacientes añosos sin proteinuria. MATERIAL Y MÉTODOS: El estudio PROERCAN (NCT03195023) es un ensayo clínico multicéntrico, abierto, aleatorizado de 110 pacientes hipertensos, mayores de 65 años con ERC estadios3 y4 sin proteinuria. Los pacientes son aleatorizados 1:1 a recibir tratamiento con BSRAA u otros antihipertensivos y el seguimiento será de 3años. La variable principal es el descenso del filtrado glomerular estimado durante el tiempo de seguimiento. Las variables secundarias incluyen las cifras de PA, eventos renales y cardiovasculares y mortalidad. RESULTADOS Y CONCLUSIÓN: El diseño del ensayo clínico se desarrolla en el presente artículo. Los resultados determinarán si el tratamiento antihipertensivo con BSRAA tiene un impacto en la progresión de la ERC en pacientes añosos sin proteinuria. Así mismo, se aclararán las diferencias en el control de la PA, los eventos cardiovasculares y la mortalidad con los distintos tratamientos antihipertensivos

The effect of renin-angiotensin-aldosterone system blockers on the progression of chronic kidney disease in hypertensive elderly patients without proteinuria: PROERCAN study. Rationale and design.

INTRODUCTION: Blood pressure (BP) control is fundamental to the care of patients with chronic kidney disease (CKD), and is relevant at all stages of CKD. Renin-angiotensin-aldosterone system (RAAS) blockers have shown to be effective, not only in BP control but also in reducing proteinuria and slowing CKD progression. However, there is a lack of evidence for recommending RAAS blockers in elderly patients with CKD without proteinuria. The primary outcome of the present study is to evaluate the impact of RAAS blockers on CKD progression in elderly patients without proteinuria. MATERIALS AND METHODS: The PROERCAN trial (trial registration, NCT03195023) is a multicentre open-label, randomized controlled clinical trial with 110 participants over 65 years-old with hypertension and CKD stages 3-4 without proteinuria. Patients will be randomized in a 1:1 ratio to either receive RAAS blockers or other antihypertensive drugs, and will be followed up for three years. Primary outcome is the estimated glomerular filtration rate (eGFR) decline at 3 years. Secondary outcomes include BP control, renal and cardiovascular events, and mortality. RESULTS AND CONCLUSIONS: The design of this trial is presented here. The results will show if antihypertensive treatment with RAAS blockers has an impact on CKD progression in elderly patients without proteinuria. Any differences in BP control, cardiovascular events, and mortality with each antihypertensive treatment will be also clarified.

Dose equivalence between continuous erythropoietin receptor activator (CERA), Darbepoetin and Epoetin in patients with advanced chronic kidney disease.

BACKGROUND: Anemia is a prevalent situation in patients with chronic kidney disease (CKD) and can be well managed with erythropoiesis-stimulating agents (ESAs). Continuous erythropoietin receptor activator (CERA) has a long half-life that allows to be administered once monthly. The lowest recommended dose for patients with non dialysis CKD is 120 µg per month. The objectives were to assess the efficacy of subcutaneous monthly dosing of CERA in CKD stages 4 and 5 not on dialysis, and to determine the equivalent dose to epoetin ß and darbepoetin α. METHODS: This is a cohort study. A 30-patient group that ESAs was changed to CERA (µg/month) was used as treatment group. We used the following clinically-based equivalent dosing: epoetin ß (IU/week) and darbepoetin α (µg/week): 3000/15= 50; 4000/20=75; 6000/30=100; 8000/40=150. Another group of 30 patients with similar characteristics was used as control group and received the same epoetin ß and darbepoetin α doses. RESULTS: The mean CERA initial dose and at 6 months was 81.9 ± 35.2 and 82.0 ± 37.82 µg/month (p=0.37). The mean erythropoietin resistance index (ERI) and hemoglobin at baseline and at 6 months in the CERA group and in the control group were not statistically significant. CONCLUSION: Monthly dosing treatment with CERA is safe and effective. A dose of 75-100 µg/month is enough to maintain stable levels of hemoglobin. Hippokratia 2014; 18 (4): 315-318.

Factors predicting mortality in elderly patients on dialysis.

UNLABELLED: Elderly patients are increasingly enrolled in dialysis programs and present a series of special characteristics due to their high morbidity and mortality. OBJECTIVE: To describe the characteristics of incident dialysis patients aged >75 years, their comorbidities and their admissions, with a view to determining the factors that influence their course and mortality. PATIENTS AND METHODS: The study included all patients aged >75 years who started dialysis in our center since January 2000. The mean duration of follow-up was 3.3 +/- 2.2 years. Data were collected on incident comorbidity, admissions and their causes. A total of 139 patients were included, with a mean age of 78.6 +/- 2.6 years (67.6% males, 33.8% diabetic and 7.9% on peritoneal dialysis). Three groups were established according to age: 75-79, 80-85 and >85 years. The most frequent comorbidities were chronic obstructive pulmonary disease (25.9%), ischemic heart disease (25.2%), heart failure (25.9%), neoplasms (23.7%), peripheral vascular disease (23.7%), cerebrovascular disease (18.7%) and arterial hypertension (81%). The Charlson index was calculated, not adjusted for age, and comorbidity tertiles were established. RESULTS: During follow-up, the patients presented 0.82 +/- 0.99 admissions/patient/year, with a duration of 12.1 +/- 20.6 days/patient/year. The main causes of admission were infection (33%), vascular access problems (27%) and peripheral vascular events (14%). A total of 61 patients died (44%), and 4 underwent kidney transplantation (2.9%). The mean duration of follow-up of the transplanted patients was 3.6 +/- 1.8 years. The main causes of death were infection (32%), cardiovascular problems (28.3%) and neoplastic disease (11.3%). The global survival rate was 90, 82 and 53% after 1, 2 and 5 years, respectively. No significant differences in survival or annual admission rate were found in relation to age group and dialysis technique. In contrast, the annual admission rate and days of admission were directly correlated to the Charlson index (p = 0.009 and p = 0.032, respectively). No significant differences in the Charlson index were found between the patients on hemodialysis and those subjected to peritoneal dialysis. In the univariate model, the factors associated to mortality were diabetes, chronic obstructive pulmonary disease, heart failure and the Charlson index. In the multivariate model, only the Charlson index remained as an independent predictive factor (p = 0.006). CONCLUSIONS: Unlike the general population, age does not influence mortality or admissions in elderly patients on dialysis. Incident comorbidity is the factor exerting the greatest influence upon mortality and admissions. Advanced age in itself should not be regarded as an excluding factor for starting dialysis.

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