[Incidence and risk factors for non-traumatic lower extremity amputation in hemodialysis patients]. / Incidencia y factores de riesgo de amputación no traumática de miembros inferiores en los pacientes en hemodiálisis.

BACKGROUND AND AIMS: The purpose of this study was to assess the incidence and risk factors for non-traumatic lower extremity amputation (LEA) in patients on haemodialysis (HD). METHODS: We investigated our HD population attending our clinic between Jan 1988 and Dec 2002, who had had LEA. Uni- and multivariate analyses were used to determine association of LEA with demographic characteristics such as diabetes, hypertension, smoking, myocardial infarction, stroke, dyslipidaemia, haematocrit, urea, creatinine, calcium, phosphorous, parathyroid hormone (PTH) and albumin levels. RESULTS: Of 516 patients, 20 (3.9%) underwent 32 amputations; 21 major and 11 minor. The incidence was 1. I amputees/100 p-years. There were 11 (10.8%) diabetics and 9 (2.2%) non-diabetics; incidence of 4.2 and 0.6 amputees/100 p-years, respectively. Non-diabetic amputees were older than non-amputees: 68.9 vs 58.2 years (p = 0.013) and had been on HD longer: 71.4 +/- 44 vs 42 +/- 37 months (p = 0.019). There were 60% deaths within the first year of amputation and the causes were 60% cardiovascular. Univariate analysis indicated significant association of LEA with ageing, diabetes, smoking, myocardial infarction, stroke, high cholesterol, and low PTH levels. Multivariate Cox regression identified independent associations of amputation with diabetes, previous myocardial infarction and stroke and/or transient ischaemic attack. CONCLUSIONS: The incidence of LEA in HD patients is very high and is associated with diabetes and previous cardiovascular events. Advanced age and longer time on HD are factors related to LEA in non-diabetics. With increasing numbers of diabetics and older people on HD, new strategies are needed for peripheral arterial disease management so as to avoid its progression to critical ischaemia.

Doxazosina asociada a la combinación bloqueante del eje-renina-angiotensina y calcioantagonista en pacientes con insuficiencia renal crónica / Doxazosine associated to renin-angiotensin blockers and calcioantagonists in chronic renal failure patients

Objetivo. El estudio ZAFRA se diseñó para evaluar la seguridad de un nuevo bloqueantede los canales del calcio, lercanidipino, en la insuficiencia renal crónica, ysu posible sobre la función renal en los pacientes tratados con fármacos que bloqueanel eje renina-angiotensina. Los pacientes que no controlaron su PA con estos fármacosfueron tratados con doxazosina.Diseño y métodos. El estudio reclutó 203 pacientes con insuficiencia renal (creatinina> 1,4 mg/dl en varones o > 1,2 mg/dl en mujeres, o aclaramiento de creatinina< 80 ml/min). Todos los pacientes estaban siendo tratados con IECA o antagonistasde receptores y la medicación se mantuvo a lo largo del estudio, sin quepudieran recibir diuréticos a lo largo del seguimiento. Los pacientes eran evaluadosclínica y analíticamente 1, 3 y 6 meses después de iniciar tratamiento con lercanidipino.Aquellos pacientes que en la segunda visita no estaban controlados añadierondoxazosina GITS (4 mg en dosis única) al tratamiento.Resultados: 57 pacientes que iniciaron el estudio fueron tratados con doxazosina(edad media 64,8 ± 12,7 años, 47,4 varones y 52,6 mujeres). La PA se redujo significativamentedesde 164 ± 17/92 ± 9 hasta 135 ± 13/78 ± 8 mmHg (p < 0,001). Seprodujeron reducciones significativas de la PA en el 67,6% de los enfermos y el32,4% de los pacientes redujeron su PA hasta los límites recomendados (<130/85mmHg). Únicamente 2 (3,6) pacientes han presentado reacciones adversas. No sedetectó aumento de la incidencia de edema. La creatinina plasmática (1,9 ± 0,6mg/dl) no se había modificado al final del estudio (2,0 ± 0,8 mg/dl) ni el aclaramientode creatinina (38,7 ± 15,7 vs 38,5 ± 14,5). También se detectó un descensosignificativo del urato plasmático (7,0 ± 1,9 vs 6,7 ± 1,6 mg/dl, p < 0,05).Conclusiones: La doxazosina ha presentado un excelente perfil de seguridad enlos pacientes renales, destacando la ausencia de edemas a pesar de la insuficienciarenal de los pacientes

Objective. To evaluate the safety and effectiveness of the alfa-blocker doxazosinGITS in CRF patients.Design and methods. The study recruited 203 CRF patients (creatinine > 1,4mg/dl for males, creatinine > 1,2 mg/dl for females, or creatinine clearance < 80ml/min). All patients were receiving ACE inhibitores (63.4%) or angiotensin II antagonist(36.6%) therapy but they had higher blood pressure than recommended forCRF (130/85 mmHg). Patients were clinically evaluated 1, 3 and 6 moths after startingtreatment with lercanidipine (10 mg once daily). Patients with high blood pressurein spite of combined therapy with two drugs added doxazosin GITS 4-8 mgonce daily to treatment.Result: 57 patients rendered evaluable for the study (age 64.8 ± 12.7 years,47.4% males and 52.6 females). BP significantly decrease from 164 ± 17/92 ± 9mmHg to 135 ± 13/78 ± 8 mmHg. 67.6% patients showed a significant BP reductionand 32.4% gets optimal BP control (< 130/85 mmHg). Two patients (3.6%)showed untoward effects. No biochemical changes were detected.Conclusions: Doxazosin showed a good antihypertensive effect in CRF patientswhen used as third drug in resistant severe hypertension. It has a good tolerabilityprofile and showed a neutral profile on biochemical parameters

[Fistulae or catheter for elderly who start hemodialysis without permanent vascular access?]. / Acceso vascular permanente en pacientes de edad avanzada que inician hemodiálisis: fístula o catéter?

UNLABELLED: Autologous access is the best vascular access for dialysis also in older patients and it should be mature when patient needs hemodialysis. It is not always possible. Surgeon availability and demographic characteristics of patients (age, diabetes, vascular disease...) are factors that determine primary vascular access. AIM: To analyse outcome and vascular access complications in elderly who start hemodialysis without vascular access. PATIENTS AND METHODS: All patients older than 75 years who initiated hemodialysis without vascular access between January 2000 and June 2002 were included, They were divided en two groups depending on primary vascular access. GI: arterio-venous fistulae. GIIl: Tunnelled cuffed catheter. Epidemiological and analytical data, vascular access complications related, as well as patient and first permanent vascular access survival from their inclusion in dialysis up to December 2002 were analysed and compared in both groups. RESULTS: 32 patients were studied. GI: n = 17 (4 men) and GIIl: n =1 5 (8 men), age: 79.9 +/- 3.8 and 81.7 +/- 4 years respectively (ns). There were no differences in sex and comorbidity (diabetes, ischemic heart disease, peripheral vascular disease and hypertension). It took GI 3 months to get a permanent vascular access suitable for using, while it took GIIl 1.3 months (p < 0.005) The number of temporary untunnelled catheters was higher in GI (3.35 vs 1.87 p < 0.05). Vascular access complications: 70.6% of infections occur in GI (incidence (I) = 48 infections/100 patients-year) while only 29.4% were detected in GII (I = 25 infections/100 patients-year). 70% of central venous thrombosis happen in GI (I: 25 CVT/100 patients-year) vs 30% in GIIl (I = 14.4/100 patients-year) (ns). No significant differences neither in bleeding (66.7% vs 33.3%) nor ischemia (75% vs 25%) were found. Dialysis dose (Kt/V) as well as anaemia degree were similar in both groups. Permanent vascular access survival after 2 years was 45.8% in GI and 24% in GII (ns). Patient survival was similar in GI and GII (72% vs 51% ns). CONCLUSIONS: Elderly who start hemodialysis without vascular access took longer to get a suitable permanent vascular access when arterio-venous fistulae is placed than with a tunnelled cuffed hemodialysis catheter. As a consequence, vascular access complications are larger, infection ones are the most common. In these patients a tunnelled catheter should be inserted at the time a peripheral arterio-venous access is created, in order to avoid temporary untunnelled catheters.

Incidencia y factores de riesgo de amputación no traumática de miembros inferiores en los pacientes en hemodiálisis / Incidence and risk factors for non-traumatic lower extremity amputation in hemodyalisis patients

A pesar de la alta prevalencia de enfermedad cardiovascular en los pacientesen hemodiálisis (HD), la incidencia de amputación de miembros inferiores (MMII)es poco conocida.Objetivo: Analizar incidencia y factores condicionantes de amputación no traumáticade MMII en los pacientes en HD.Métodos: Analizamos los pacientes incluidos en HD de 1/1/88 a 31/12/02 eidentificamos amputados y amputaciones efectuadas. Realizamos análisis uni ymultivariante de la asociación de amputación con edad, sexo, tiempo en HD, historiade diabetes, hipertensión arterial, infarto de miocardio (IM), accidente cerebrovascular(ACV), tabaquismo y niveles de colesterol, triglicéridos, hematocrito,urea, creatinina, calcio, fósforo, PTH y albúmina.Resultados: Se incluyeron 516 pacientes (59,5 ± 17 años, 102 diabéticos), tiempoen HD 40,15 ± 37 meses, seguimiento de 1.726 pacientes-año. Veinte (3,9%)sufrieron una o varias amputaciones, con incidencia de 1,1 paciente amputados/100 p-año. Once (10,8%) eran diabéticos, incidencia 4,2 amputados/100p-año. Nueve (2,2%) no diabéticos, con 0,6 amputados/100 p-año. Las amputacionesfueron 32: 21 mayores (supra e infracondíleas) y 11 menores (pies y dedos).El 60% falleció al año de su primera amputación y las causas de muerte fueroncardiovasculares en el 60% de los casos. En el análisis univariante los amputadostenian mayor edad, presencia de diabetes, tabaquismo, antecedentes de IM y ACV,colesterol y menor PTH. En el multivariante, diabetes: OR: 5,9 (IC 95%: 2,4-16,p = 0,000), IM: OR: 7,2 (IC 95%: 2,1-24,7, p = 0,002) y ACV: OR: 4,8 (IC 95%:1,3-17, p = 0,015), se asociaron de forma independiente con el riesgo de amputación.Conclusiones: La incidencia de amputación de MMII en los pacientes en HDes elevada. Factores de riesgo conocidos como diabetes y patología cardiovascularaterosclerótica establecida son condicionantes de amputación. La creciente inclusiónen HD de pacientes diabéticos y de edades avanzadas hace previsible elaumento de arteriopatia periférica lo que hace necesario planificar estrategias queprevengan su aparición y progresión a isquemia crítica

Background and aims: The purpose of this study was to assess the incidenceand risk factors for non-traumatic lower extremity amputation (LEA) in patients onhaemodialysis (HD).Methods: We investigated our HD population attending our clinic between Jan1988 and Dec 2002, who had had LEA. Uni- and multivariate analyses were usedto determine association of LEA with demographic characteristics such as diabetes,hypertension, smoking, myocardial infarction, stroke, dyslipidaemia, haematocrit,urea, creatinine, calcium, phosphorous, parathyroid hormone (PTH) and albuminlevels.Results: Of 516 patients, 20 (3.9%) underwent 32 amputations; 21 major and11 minor. The incidence was 1.1 amputees/100 p-years. There were 11 (10.8%)diabetics and 9 (2.2%) non-diabetics; incidence of 4.2 and 0.6 amputees/100p-years, respectively. Non-diabetic amputees were older than non-amputees: 68.9vs 58.2 years (p = 0.013) and had been on HD longer: 71.4 ± 44 vs 42 ± 37months (p = 0.019). There were 60% deaths within the first year of amputationand the causes were 60% cardiovascular. Univariate analysis indicated significantassociation of LEA with ageing, diabetes, smoking, myocardial infarction, stroke,high cholesterol, and low PTH levels. Multivariate Cox regression identified independentassociations of amputation with diabetes, previous myocardial infarctionand stroke and/or transient ischaemic attack.Conclusions: The incidence of LEA in HD patients is very high and is associatedwith diabetes and previous cardiovascular events. Advanced age and longertime on HD are factors related to LEA in non-diabetics. With increasing numbersof diabetics and older people on HD, new strategies are needed for peripheral arterialdisease management so as to avoid its progression to critical ischaemia

Acceso vascular permanente en pacientes de edad avanzada que inician hemodiálisis: ¿Fístula o catéter? / Permanent vascular access in the elderly patient who starts on hemodialysis: fistulae or catheter?

Introducción: La fístula arteriovenosa (FAV) autóloga es el acceso vascular permanente (AVP) de elección en los pacientes en hemodiálisis y debería realizarse en prediálisis. Esta situación ideal no siempre es posible. La disponibilidad del cirujano vascular y las características del paciente (edad, comorbilidad...) son factores que, entre otros, determinan el acceso vascular de inicio. Objetivo: Estudiar la evolución y complicaciones derivadas del acceso vascular en pacientes de edad avanzada, que comienzan hemodiálisis sin acceso vascular funcionante. Pacientes y métodos: Incluimos los pacientes mayores de 75 años que iniciaron hemodiálisis desde enero del 2000 hasta junio del 2002 sin acceso vascular permanente funcionante. Los clasificamos en dos grupos según el primer AVP realizado (Grupo I: FAV, Grupo II: Catéter Permanente). Analizamos y comparamos en ambos grupos datos epidemiológicos, analíticos, complicaciones derivadas del acceso vascular y supervivencia de pacientes y del primer AVP funcionante desde su inclusión en diálisis hasta diciembre de 2002. Resultados: Estudiamos 32 pacientes. GI: n = 17 (4 hombres) y GII: n = 15 (8 hombres), edad 79,9 ± 3,8 y 81,7 ± 4 años respectivamente (ns). No existían diferencias en sexo, nefropatía de base y comorbilidad (diabetes, cardiopatía isquémica, arteriopatía periférica e HTA). El GI tardó 3 meses en conseguir un AVP funcionante y el GII 1,3 meses (p < 0,05). El número de catéteres transitorios fue mayor en GI (3,35 vs 1,87 p < 0,05). Complicaciones derivadas del acceso vascular: El 70,6% de las infecciones ocurren en GI (incidencia (I): 48 infecciones/100 pacientes-año) frente al 29,4% en GII (I = 24 infecciones/100 pacientes-año) p < 0,05. El 70% de las trombosis venosas profundas se dan en GI (I: 25 TVP/100 pacientes-año) frente 30% en GII (I = 14,4/100 pacientes-año) (ns). No se encontraron diferencias en hemorragias (66,7% vs 33,3%) ni isquemia (75% vs 25%). La eficacia de diálisis (Kt/V) y el grado de anemia fue similar en ambos grupos. La supervivencia del AVP a los 2 años en GI fue 45,8% y en GII 24 % (ns). La supervivencia de los pacientes fue similar en GI y GII (72% vs 51% ns) Conclusiones: Los pacientes de edad avanzada que inician hemodiálisis sin acceso vascular tardan más tiempo en conseguir un AVP funcionante cuando se opta por una FAV frente a un catéter permanente. Como consecuencia, las complicaciones derivadas del acceso vascular son mayores, siendo más frecuentes las infecciosas. Una opción para estos pacientes sería la colocación de un catéter permanente como primer acceso vascular y la realización simultánea de una FAV, manteniendo el catéter hasta el desarrollo de la misma

Autologous access is the best vascular access for dialysis also in older patients and it should be mature when patient needs hemodialysis. It is not always possible. Surgeon availability and demographic characteristics of patients (age, diabetes, vascular disease...) are factors that determine primary vascular access. Aim: To analyse outcome and vascular access complications in elderly who start hemodialysis without vascular access. Patients and methods: All patients older than 75 years who initiated hemodialysis without vascular access between january 2000 and june 2002 were included, They were divided en two groups depending on primary vascular access. GI: arterio-venous fistulae. GII: Tunnelled cuffed catheter. Epidemiological and analytical data, vascular access complications related, as well as patient and first permanent vascular access survival from their inclusion in dialysis up to december 2002 were analysed and compared in both groups. Results: 32 patients were studied. GI: n = 17 (4 men) and GII: n =1 5 (8 men), age: 79.9 ± 3.8 and 81.7 ± 4 years respectively (ns). There were no differences in sex and comorbidity (diabetes, ischemic heart disease, peripheral vascular disease and hypertension). It took GI 3 months to get a permanent vascular access suitable for using, while it took GII 1.3 months (p < 0.005) The number of temporary untunnelled catheters was higher in GI (3.35 vs 1.87 p < 0.05). Vascular access complications: 70.6% of infections occur in GI (incidence (I) = 48 infections/100 patients-year) while only 29.4% were detected in GII (I = 25 infections/100 patients-year). 70% of central venous thrombosis happen in GI (I: 25 CVT/100 patients-year) vs 30% in GII (I = 14.4/100 patients-year) (ns). No significant differences neither in bleeding (66.7% vs 33.3%) nor ischemia (75% vs 25%) were found. Dialysis dose (Kt/V) as well as anaemia degree were similar in both groups. Permanent vascular access survival after 2 years was 45.8% in GI and 24% in GII (ns). Patient survival was similar in GI and GII (72% vs 51% ns). Conclusions: Elderly who start hemodialysis without vascular access took longer to get a suitable permanent vascular access when arterio-venous fistulae is placed than with a tunnelled cuffed hemodialysis catheter. As a consequence, vascular access complications are larger, infection ones are the most common. In these patients a tunnelled catheter should be inserted at the time a peripheral arterio- venous access is created, in order to avoid temporary untunnelled catheters

Lercanidipine in patients with chronic renal failure: the ZAFRA study.

OBJECTIVE: The objective was primary to evaluate the safe use of a new calcium channel blocker, lercanidipine, in patients with chronic renal failure (CRF). The secondary objective was to study the protective effect of calcium channel blocker on renal function in CRF patients previously treated with ACE inhibitors or angiotensin receptor blockers. DESIGN AND METHODS: The study recruited 203 CRF patients (creatinine >1.4 mg/dL for males, creatinine > 1.2 mg/dL for females, or creatinine clearance <70 mL/min). All patients were receiving ACE inhibitors (63.4%) or angiotensin II antagonist (36.6%) therapy, but they had higher blood pressure than recommended for CRF (130/85 mmHg). No patients were under diuretic treatment. Patients were clinically evaluated 1, 3, and 6 months after starting treatment with lercanidipine. Samples for urine and blood examination were taken during the examination. When needed, a third drug was added to the treatment, excluding diuretics. Creatinine clearance was measured using 24 h urine collection. RESULTS: 175 patients rendered valuable for the study (age 63.9+/-11.9 years, 52.9% males and 47.1% females). Blood pressure (BP) significantly decreased from 162+/-17/93+/-8.3 mmHg to 132+/-12/78+/-6 mmHg. 89.2% of patients showed a significant BP reduction, and 58.1% achieved optimal BP control (<130/85 mmHg). Seven patients (3.4%) showed untoward effects. Not one case of edema was detected, and the prevalence of adverse effects related to vasodilatation was extremely low (three patients, 1.48%). Plasmatic creatinine did not change (1.9+/-0.5 baseline versus 1.9+/-0.6 mg/dL), but creatinine clearance increased at the end visit (41.8+/-16.0 baseline versus 45.8+/-18.0 mL/min, p=0.019). Plasmatic cholesterol also decreased from 221+/-46 to 211+/-35 mg/dL (p=0.001). CONCLUSIONS: Lercanidipine showed a high antihypertensive effect in CRF patients. It has a good tolerability profile and showed an interesting effect on plasmatic lipids. An improvement in renal function, measured through creatine clearance, was detected.

[Doxazosine associated to renin-angiotensin blockers and calcioantagonists in chronic renal failure patients]. / Doxazosina asociada a la combinación bloqueante del eje-renina-angiotensina y calcioantagonista en pacientes con insuficiencia renal crónica.

OBJECTIVE: To evaluate the safety and effectiveness of the alfa-blocker doxazosin GITS in CRF patients. DESIGN AND METHODS: The study recruited 203 CRF patients (creatinine > 1,4 mg/dl for males, creatinine > 1,2 mg/dl for females, or creatinine clearance < 80 ml/min). All patients were receiving ACE inhibitores (63.4%) or angiotensin II antagonist (36.6%) therapy but they had higher blood pressure than recommended for CRF (130/85 mmHg). Patients were clinically evaluated 1, 3 and 6 moths after starting treatment with lercanidipine (10 mg once daily). Patients with high blood pressure in spite of combined therapy with two drugs added doxazosin GITS 4-8 mg once daily to treatment. RESULT: 57 patients rendered evaluable for the study (age 64.8 +/- 12.7 years, 47.4% males and 52.6 females). BP significantly decrease from 164 +/- 17/92 +/- 9 mmHg to 135 +/- 13/78 +/- 8 mmHg. 67.6% patients showed a significant BP reduction and 32.4% gets optimal BP control (< 130/85 mmHg). Two patients (3.6%) showed untoward effects. No biochemical changes were detected. CONCLUSIONS: Doxazosin showed a good antihypertensive effect in CRF patients when used as third drug in resistant severe hypertension. It has a good tolerability profile and showed a neutral profile on biochemical parameters.

[Lercanidipine in diabetic patients with renal failure]. / Lercanidipino en pacientes diabéticos it con insuficiencia renal.

OBJECTIVE: To evaluate the safe use of a new calcium channel blocker, lercanidipine, in diabetic chronic renal failure (CRF) patients. DESIGN AND METHODS: The study recruited 42 diabetic CRF patients (creatinine > 1.4 mg/dl for males, creatinine > 1.2 mg/dl for females, or creatinine clearance < 70 ml/min). Mean age was 68.2 +/- 9.1 years. 53.8% were males and 46.2% females. Three patients were type 1 diabetics and 39 ones were type II. All patients were receiving ACE inhibitors (67.4%) or angiotensin II antagonist (32.6%) therapy but they had higher blood pressure than recommended for CRF patients (130/85 mmHg). No patients were under diuretic treatment. Patients were clinically evaluated 1, 3 and 6 months after starting treatment with lercanidipine. Samples for urine and blood examination were taken during the examination. When needed, a third drug was added to treatment, excluding diuretics. Creatinine clearance was measured using 24 h urine collection. RESULTS: BP significantly decrease from 163 +/- 18/90 +/- 8 mmHg to 134 +/- 12/77 +/- 9 mmHg. One half of patients showed significant reduction of blood pressure, 26.7% reached the target blood pressure (< 130/85 mmHg) and 20.0% gets optimal BP control (< 130/85 mmHg). No one patient showed untoward effects. No edema was detected nor adverse effects related to vasodilatation were found. Plasmatic creatinine did not change (1.9 +/- 0.5 baseline vs 1.8 +/- 0.5 mg/dl) and creatinine clearance increased at the end visit (40.1 +/- 14.5 baseline vs 45.4 +/- 18.2 ml/min) but the difference was not significant. Proteinuria was unchanged. CONCLUSIONS: Lercanidipine showed a good antihypertensive effect in diabetics CRF patients. It has a good tolerability profile and showed neutral effect on plasmatic lipids. Neither impairment of renal function nor increment in proteinuria were detected.

Lercanidipino en pacientes diabéticos con insuficiencia renal / Lercanidipine in diabetic patients with renal failure

Objetivo: El estudio ZAFRA se diseñó para evaluar la seguridad de un nuevo bloqueante de los canales del calcio, lercanidipino, en la insuficiencia renal crónica, y su posible efecto protector sobre la función renal en los pacientes tratados con fármacos que bloquean el eje renina-angiotensina. Se han valorado por separado los resultados de los pacientes diabéticos incluidos en el estudio. Diseño y métodos: El estudio reclutó 42 pacientes diabéticos con insuficiencia renal (creatinina > 1,4 mg/dl en varones o > 1,2 mg/dl en mujeres, o aclaramiento de creatinina < 70 ml/min). Todos los pacientes estaban siendo tratados con IECA o antagonistas de receptores y la medicación se mantuvo a lo largo del estudio, sin que pudieran recibir diuréticos a lo largo del seguimiento. Los pacientes eran evaluados clínica y analíticamente 1, 3 y 6 meses después de iniciar tratamiento con lercanidipino. Resultados: La PA se redujo significativamente desde 163 ñ 18/90 ñ 8 hasta 134 ñ 12/77 ñ 9 mmHg (p < 0,001). Se produjeron reducciones significativas de la PA en el 50,0 por ciento de los enfermos y el 26,7 por ciento alcanzaron la PA objetivo (< 130/85 mmHg). El 20,0 por ciento de los pacientes redujeron su PA hasta los límites recomendados (< 130/80 mmHg). No se detectaron reacciones adversas ni aumento de la incidencia de edema. La creatinina plasmática (1,9 + 0,5 mg/dl) no se había modificado al final del estudio (1,8 ñ 0,5 mg/dl) ni el aclaramiento de creatinina (40,1 ñ 14,5 vs 45,5 ñ 18,2). Conclusiones: El lercanidipino ha presentado un excelente perfil de seguridad en los pacientes renales, destacando la ausencia de edemas a pesar de la insuficiencia renal y la diabetes de los pacientes. Se obtuvo una buena respuesta hipotensora a pesar de que el porcentaje de pacientes que alcanzaron la PA objetivo fuera pequeña (AU)

[Health-related quality of life in elderly patients in haemodialysis]. / Calidad de vida relacionada con la salud en pacientes ancianos en hemodiálisis.

INTRODUCTION: In view of the increasing interest in measuring health-related quality of life (HRQOL) and that is widely accepted Quality of life (QL) is a valid marker of results of treatment in chronic dialysis, we marked the aim to determine QL of the patients > or = 75 years in chronic haemodialysis and to determine the influence of different factors (comorbidity, analytical, cognitive deterioration, depression and self-sufficiency) over the results. METHODS: We used the Kidney Disease Quality of Life (KDQOL-SF), questionnaire of health that has been become an useful instrument for measuring CV into this population. Demographic and analytical data, comorbidity (Charlson Index), depression (Yesavage), self-sufficiency (Karnofsky) and impaired cognitive function (Cognitive Mini-Exam) were collected. We evaluated the influence of these factors on the different dimensions of the KDQOI-SF and compared our scores with general Spanish population scores standardised according to age and sex. RESULTS: We included 51 patients (24 men) with a mean age 79.5 +/- 3.7 years and 39 +/- 56 months in dialysis. Women had lower scores than men in all scales of KDQOL-SF. We found that months in dialysis, depression scale, Karnofsky scale and cognitive deterioration test were also influencing about these scores. Multivariate analysis showed that CV is especially associated with sex, depression, cognitive deterioration and self-sufficiency. After we calculated standardised scores according to age and gender, out population showed a level of CV lower than general population, especially in female gender. CONCLUSIONS: In our population the women had worse CV than men. The CV of the elders in HD is lower than general population of equal sex and age and it was not modified with factors related to the end-stage renal disease and its treatment. Suffering from cognitive deterioration or depression had an important impact on the well-being of our patients, which would justify a wider diagnostic and therapeutic boarding in these patients.

[Platelet antiaggregation and hemorrhagic risk in hemodialysis]. / Antiagregación plaquetaria y riesgo hemorrágico en hemodiálisis.

UNLABELLED: Although the efficacy of antiplatelet therapy in the prevention of cardiovascular disease in chronic renal failure is not clearly defined, the improvement in cardiovascular disease outcomes in the general population has resulted in its use in dialysis patients. The hemorrhagic risk of hemodialysis patients treated with anti-platelet agents has not been clarified. Our aim was to evaluate the risk of bleeding in hemodialysis patients treated with antiplatelet agents. We assessed haemorrhagic complications (HC) in 190 haemodialysis patients from May 1998 to August 2000. HC was defined an event that required hospitalization and/or blood product transfusion. We evaluated the bleeding events in the haemodialysis patients treated with antiplatelet agents and compare them to those not receiving this therapy to establish the relative risk of bleeding. Uni- and multivariate analyses were conducted to establish the relationships between the haemorrhagic event and the following variables: age, gender, time on dialysis, dialysis membrane (synthetic or cellulosic), systemic anticoagulation during haemodialysis, anaemia (haematocrit), PTH, urea, dialysis efficacy (Kt/V), hypertension, diabetes, use of erythropoietin and antisecretory gastric agents. RESULTS: 81 (42.6%) were treated with antiplatelet agents. Of the 190 patients, 28 (14.7%) had 36 haemorrhagic events (10.3 episodes/100 patient-years); 31 digestive-tract haemorrhages, 4 intracranial and 1 pulmonary. Twenty (24.7%) of patients treated with antiplatelet agents had 16.2 episodes/100 patient-years and 8 (7.3%) without this therapy had 6 episodes/100 patient-years (p < 0.01). In the multivariate analysis the antiplatelet therapy remained associated with higher probability of having a haemorrhagic complication (OR 3.8; CI 95%: 1.52-9.76, p = 0.004). Older age (OR 1.03; CI 95%: 1-1.06, p = 0.043), anaemia (OR 0.91; CI 95%; 0.84-0.9, p = 0.027) and hypertension (OR 2.99; CI 95%: 1.05-8.48, p = 0.039) remained associated with the risk of bleeding. 88.2% of patients that had a digestive-tract haemorrhage with antiplatelet therapy were receiving an antisecretory agent (histamine H2-receptor antagonist or a proton-pump inhibitor). CONCLUSIONS: 1) dialysis patients with antiplatelet therapy had a higher haemorrhagic risk. The relative risk of bleeding was more than three times that of the dialysis population without antiplatelet therapy, and 2) older age and hypertension were associated with the haemorrhagic risk. Optimal correction of anaemia was associated with less probability of bleeding.

Antiagregación plaquetaria y riesgo hemorrágico en hemodiálisis / Antiplatelet therapy and risk of bleeding in hemodialysis patients

La alta morbi-mortalidad cardiovascular de los pacientes en hemodiálisis condiciona una gran utilización del tratamiento antiagregante plaquetario, en ocasiones de forma empírica y con fines para los que su eficacia no ha sido suficientemente documentada. No está definido el riesgo hemorrágico que esta práctica conlleva. Nuestro objetivo ha sido valorar el riesgo hemorrágico que presentan los pacientes en hemodiálisis que son sometidos a tratamiento con antiagregantes plaquetarios. Analizamos las complicaciones hemorrágicas sufridas por 190 pacientes en hemodiálisis desde mayo de 1998 a agosto 2000. Consideramos complicación hemorrágica la que motivó hospitalización y/o transfusión. Comparamos el riesgo hemorrágico de los pacientes en tratamiento con antiagregantes con el de los no tratados y realizamos análisis uni y multivariante de factores demográficos (sexo, edad, tiempo de diálisis), relacionados con la diátesis hemorrágica urémica (anemia, hiperparatiroidismo, toxinas urémicas), con la técnica (dializador, anticoagulación del circuito), presencia de diabetes e hipertensión arterial y uso de eritropoyetina e inhibidores de la secreción ácida gástrica. Resultados: Ochenta y uno (42,6 por ciento) seguían tratamiento antiagregante. De los 190 pacientes, 28 (14,7 por ciento) presentaron 36 complicaciones hemorrágicas (10,3 episodios/100 p-año). Treinta y uno fueron digestivas, 4 intracraneales y 1 pulmonar.24,7 por ciento de los pacientes antiagregados presentaron 16,2 episodios/100 p-año y 7,3 por ciento de los que no lo estaban presentaron 6 episodios/100 p-año (p < 0,01). En el análisis multivariante la antiagregación se comportó como el mayor predictor de probabilidad de sangrado (OR 3,8; IC 95 por ciento: 1,52-9,76, p = 0,004). Mayor edad (OR 1,03; IC 95 por ciento: 1-1,06, p = 0,043), anemia (OR 0,91; IC 95 por ciento: 0,84-0,99, p = 0,027) e hipertensión arterial (OR 2,99; IC 95 por ciento: 1,05-8,48, p = 0,039) se asociaron, así mismo, de forma independiente con el riesgo hemorrágico. El 88,2 por ciento de los pacientes antiagregados que sufrieron hemorragias digestivas seguían tratamiento con inhibidores de la secreción ácida gástrica. Conclusiones: 1) el uso de los antiagregantes plaquetarios en la población en hemodálisis ha incrementado más de tres veces la aparición de complicación hemorrágica; 2) la eficacia reconocida de la antiagregación plaquetaria como terapia antitrombótica debe confrontarse al riesgo hemorrágico que conlleva, y 3) cuando se estime adecuada su indicación, debe optimizarse la corrección de la anemia y considerar mayor edad e hipertensión arterial como factores de riesgo hemorrágico añadidos (AU)

[Rhabdomyolysis and acute renal failure secondary to statins]. / Rabdomiolisis y fracaso renal agudo secundario a estatinas.

Statins are competitive inhibitors of hydroxy-methyl-glutaryl coenzyme A (HMG-CoA) reductase and are the most commonly used drugs to treat hyperlipidaemia. Muscle toxicity is an adverse effect reported with a low incidence and rarely associated with acute renal failure due to rhabdomyolysis. We describe two patients with chronic renal failure treated with pravastatin and simvastatin who suffered rhabdomyolysis and acute renal failure. One patient started pravastatin several days after cessation of bezafibrate and developed acute renal failure without needing dialysis. The other was treated with simvastatin three years ago and suffered rhabdomyolysis when renal function was impaired after indomethacin was prescribed for backache. He needed hemodialysis because of acute cardiac failure and died from a respiratory infection while on mechanical ventilation. Myopathy was reversible in both patients. We recommend starting statins with the lower doses in chronic renal failure and monitoring muscle enzymes when renal function changes or when new drugs with potential interactions are prescribed.

Efecto beneficioso de las membranas de AN69 sobre la anemia de los pacientes en hemodiálisis / Effects of biocompatible membranes on uremic anemia in hemodialysis patients

La utilización de membranas de AN69 generalmente, aumenta el aclaramiento de toxinas urémicas de mayor peso molecular e induce una menor activación de mediadores inflamatorios que las membranas celulósicas, ambos procesos podrían tener un efecto beneficioso sobre la eritropoyesis.Objetivo: Valorar la influencia de las membranas de AN69 sobre la anemia en pacientes con Insuficiencia Renal Crónica en programa de hemodiálisis (HD).Material y métodos: Estudiamos 25 pacientes en HD, dializados con membrana de cuprofán durante un mínimo de 6 meses, en situación estable, en los que se descartó otras causas de anemia (ferritina > 200 ng/ml. IST > 20 por ciento). Se dividieron en 2 grupos homogéneos. Los pacientes del grupo I (GI, n = 14) pasaron a dializarse con membrana de AN69 y los del grupo II (GII, n = 11) permanecieron con membrana cuprofán. El seguimiento fue de 5 meses. Se analizaron hematocrito ( por ciento), ferritina (ng/ml), IST ( por ciento), KTV, PCR (g/kg/día) y dosis de EPO (UI/semana) mensual en GI y Basal 2, 4 y 5 meses en GII. El hematocrito diana fue de 33 por ciento-35 por ciento.Resultados: El hematocrito en el GI aumentó de forma significativa a partir del 2º mes de tratamiento, sin modificaciones en la dosis de EPO ni en la dosis de diálisis. La ferritina e IST disminuyeron de forma significativa como reflejo de una mayor utilización. En GII no se modificó el hematocrito durante los 5 meses que duró el estudio.Conclusión: La utilización de membranas de AN69 aumenta el hematocrito de forma significativa sin modificaciones en la dosis de Eritropoyetina. (AU)

Rabdomiolisis y fracaso renal agudo secundario a estatinas / Rhabdomyolysis and acute renal failure associated with pravastatin and simvastatin

Las estatinas son los fármacos más empleados en el tratamiento de las hipercolesterolemias en la actualidad. Normalmente son bien toleradas, aunque en ocasiones causan toxicidad muscular que normalmente no deteriora la función renal.Presentamos dos pacientes con insuficiencia renal crónica en tratamiento con estatinas que desarrollaron rabdomiolisis y fracaso renal agudo. Un paciente inició pravastatina tras suspender un tratamiento previo con bezafibrato, sin mediar período de lavado, sufriendo fracaso renal agudo con diuresis conservada. La función renal se recuperó sin requerir diálisis. El otro paciente estaba siendo tratado con simvastatina desde hacía años y desarrolló rabdomiolisis y fracaso renal agudo, con necesidad de diálisis por insuficiencia cardíaca aguda, falleciendo finalmente de sepsis respiratoria. La toxicidad muscular fue reversible en los dos casos. Recomendamos iniciar dosis bajas de estatinas en pacientes con insuficiencia renal crónica, monitorizar las enzimas musculares y revisar los fármacos que se prescriben a estos pacientes. (AU)

[Beneficial effect of AN69 membranes on anemia in hemodialyzed patients]. / Efecto beneficioso de las membranas de AN69 sobre la anemia de los pacientes en hemodiálisis.

UNLABELLED: Biocompatible hemodialysis membranes induce a smaller inflammatory response in hemodialysis patients, and remove a larger amount of higher molecular weight retention products, then cellulose membranes. These phenomena could improve uremic anemia in hemodialysis patients. The objective was to evaluate the effects of biocompatible AN69 membranes on anemia in hemodialysis patients. Twenty-five stable patients undergoing hemodialysis with cuprophane membrane for more than 6 months were studied prospectively. These patients were stratified in 2 groups. Group I (GI): 14 patients switched over to a more biocompatible dialyzer (from cuprophan to AN69) and Group II (GII): 11 patients continued treatment with the same cuprophan membrane. The study lasted 5 months. Baseline hematocrit (%), ferritin (ng/mL), transferrin saturation (%), KTV, PCR (g/kg/day) and dose of erythropoietin (EPO) (UI/week) were measured and were revised monthly. Target hematocrit was 33%-35%. A significant increase of hematocrit became obvious after 2 months in GI without changes in dose of EPO and intensity of dialysis, meanwhile GII remains stable. CONCLUSION: Hemodialysis using AN69 membranes increases hematocrit without modifying intensity of dialysis.

[A comparison of phosphorus-chelating effect of calcium carbonate versus calcium acetate before dialysis]. / Comparación del efecto quelante del fósforo de carbonato vs acetato cálcico en prediálisis.

INTRODUCTION: The hyperphosphatemia, hypocalcemia and low calcitriol levels are pathogenic factors for secondary hyperparathyroidism in chronic renal failure. The phosphorus control is essential to prevent secondary hyperparathyroidism. There are not comparatives studies to test the efficacy of control of phosphorus binders in predialysis patients. AIM: To compare the efficacy of calcium carbonate vs calcium acetate as phosphate binder in predialysis patients. MATERIAL AND METHODS: The present study includes 28 patients with chronic renal failure (mean clearance of creatinine 21 ml/min). Patients were separated into two groups: Group 1: (n = 14) received calcium carbonate 2,500 mg/day (1,000 mg of calcium); Group 2: (n = 14) receives calcium acetate 1,000 mg (254 mg of calcium). Calcium and phosphorus were determined every 4 months; i-PTH, alkaline phosphatase and clearance of creatinine were determined every six months. RESULTS: Both groups were comparable regarding age, renal function, calcium, phosphorus, alkaline phosphatase and i-PTH on basal situation and the end of study were not different. The serum calcium increased, not significantly, in the calcium carbonate group (group 1) [from 9.2 to 9.8 mg/dl (p = 0.05)], however it was not modified in the calcium acetate group (group 2). The serum phosphorus decreased significantly (p < 0.05) in both groups, independently of the calcium levels. Alkaline phosphatase and i-PTH not was modified during the study period. CONCLUSIONS: 1) Both calcium carbonate and calcium acetate are similarly effective as phosphate binder. 2) The carbonate group required four fold greater doses of calcium that acetate group. 3) The calcium acetate has less hypercalcemic effect than calcium carbonate.

[Hemodialysis with 2.5 mEq/L of calcium in relative hypoparathyroidism: long-term effects on bone mass]. / Hemodiálisis con 2,5 mEq/L de calcio en el hipoparatiroidismo relativo: efectos a largo plazo en la masa ósea.

Low PTH secretion is known to be associated with Adynamic Bone Disease (ABD). Positive balance calcium by CaCO3 or dialysate calcium (DCa) might play a role in the parathyroid gland suppression and a decrease in DCa to 2.5 mEq-l or lower has been proposed. The long-term effect of this procedure on bone mineral density (BMD) has not been established. The aim was to evaluate the effect of lowering dialysate calcium on bone mass in patients with relative hypoparathyroidism. We studied 20 patients with intact PTH below 120 pg/ml, using 3 mEq/l DCa and CaCO3 as sole phosphate binder. Sex: 10M/10F. Age: 57 +/- 13 yrs. Months on dialysis: 40 +/- 29. None of them had previous renal transplantation, parathyroidectomy nor aluminic toxicity. BMD of the lumbar spine was assessed by Quantitative Computed Tomography (QCT). They were randomized in two groups (GI and GII), with similar age, sex, and time on dialysis. There were no difference in BMD, levels of intact PTH, serum calcium, phosphate and AP (Alkaline Phosphatase) GI (n = 11; 5M/6F) was transferred to 2.5 mEq/l DCa and GII (n = 9; 5M/4F) continued using 3 mEq/l. BMD was measured one year later. Calcium, phosphate and AP were measured monthly and PTH every three months. After one year of hemodialysis with 2.5 mEq/l of calcium dialysate, BMD showed a significant reduction. BMD mg/cc Baseline (B): 146.09 +/- 54; Final (F): 125.42 +/- 54 (p < 0.01). Z-score B: 0.13 +/- 1.89; F: -0.68 +/- 1.89 (p < 0.05). GII did no show change. The mean change: GI: -15 +/- 13%, GII: 1.28 +/- 17% (p < 0.05); Z-Score GI: -0.81 +/- 0.92, GII: 0.27 +/- 0.67 (p < 0.01). A separate analysis of BMD in both sexes (GI) revealed a tendency for females to lose more bone mineral than males: F: = 17.12 +/- 7.1%. M: -12.23 +/- 18.6% (ns). GI: PTH and AP increased: PTH B: 38.75 +/- 41; F: 99 +/- 69 (p < 0.01); AP: B: 118.4 +/- 47; F: 152 +/- 38 (p < 0.01). GII: PTH B: 53.8 +/- 28; F: 79 +/- 5 (ns). AP: B: 125.1 +/- 36; F: 138 +/- 38 (ns). The rate of BMD loss inversely correlated with the increase of PTH (r = -0.61, p < 0.01). Serum calcium and phosphate did not change. In GI CaCO3 doses were: B: 332 +/- 261; F: 537 +/- 260 (as grams of element calcium, every three months, p < 0.01). By multiple lineal regression only delta PTH and DCa were predictors of greater BMD loss. In conclusion, the use of 2.5 mEq/l dialysate calcium resulted in: 1) Loss of trabecular vertebral bone mass. 2) Increase in PTH secretion and biochemical markers of bone formation. 3) A greater CaCO3 dose.

Comparación del efecto quelante del fósforo de carbonato vs acetato cálcico en prediálisis / Comparation of the binder phosphorus effect of calcium carbonate vs calcium acetate during chronic renal failure before dialysis

Introducción: La hiperfosfatemia, la hipocalcemia y el déficit de calcitriol son factores patogénicos del hiperparatiroidismo secundario de la insuficiencia renal. El control del fósforo es esencial en la prevención del mismo. No existen estudios comparativos de la eficacia de los diferentes quelantes en prediálisis. Objetivo: Comparar la eficacia quelante del carbonato y acetato cálcico en pacientes con insuficiencia renal crónica avanzada prediálisis. Material y métodos: Estudiamos 28 pacientes con IRC avanzada (CICr 21 ml/min) divididos en dos grupos: Grupo 1: 14 pacientes que reciben carbonato cálcico a dosis de 2.500 mg/día (1.000 mg de calcio elemento); Grupo 2: 14 pacientes que reciben acetato cálcico a dosis de 1.000 mg (equivalente a 254 mg de calcio elemento). Ambos grupos realizaron dieta baja fósforo. El período de seguimiento fue de 24 meses. Se hicieron determinaciones analíticas de calcio y fósforo trimestral y PTH, F, alcalina y ClCr semestralmente. Resultados: Ambos grupos fueron comparables en edad, CICr, calcio, fósforo, F alcalina y PTH. El calcio sérico se incrementó, aunque no de forma significativa, en el grupo de carbonato cálcico (grupo 1) [de 9,2 a 9,8 mgldl (p = 0,05)J, no modificándose en el grupo de acetato cálcico (grupo 2); el fósforo disminuyó de forma significativa (p < 0,05) en ambos grupos, independientemente de los niveles de calcio. Fosfatasa alcalina y PTH no se modificaron durante el período de estudio. Conclusiones: 1) Tanto carbonato como acetato cálcico se muestran igualmente eficaces como quelantes del fósforo a las dosis administradas. 2) Para obtener el mismo efecto quelante del fósforo, el grupo de carbonato cálcico recibe una dosis de calcio cuatro veces superior a los del grupo de acetato cálcico. 3) El acetato cálcico se muestra discretamente menos hipercalcemiante, sin perder eficacia quelante del fósforo. (AU)

Hemodiálisis con 2,5 mEq/l de calcio en el hipoparatiroidismo relativo: efectos a largo plazo en la masa ósea / Long-term hemodialysis with 2,5 mEq/l dialysate calcium concentration in relative hypoparathyroidism: effects on bone mass

Los niveles de PTH < 120 pg/ml en pacientes en diálisis están relacionados con bajo remodelado y defecto de formación ósea y tienen gran valor predictivo de enfermedad ósea adinámica no relacionada con el aluminio. Este hipoparatiroidismo relativo se ve favorecido por los balances positivos de calcio producidos por los compuestos cálcicos y el concentrado para diálisis habiéndose propuesto la reducción del calcio en PI dializante a 2,5 mEg/l. Se desconoce la repercusión de esta medida sobre la masa ósea. Nuestro objetivo fue valorar el efecto de un concentrado de 2,5 mEg/l de calcio sobre la masa ósea en los pacientes con PTH suprimida. Estudiamos 20 pacientes con PTH intacta < 120 pg/ml, sin intoxicación alumínica, trasplante o paratiroidectomía, en hemodiálisis con 3 mEg/l de calcio y CO3Ca como captor del fósforo. Sexo: 10 hombres/10 mujeres, edad: 57 ñ 13 años, meses en diálisis: 40 ñ 29. Se valoró la masa ósea trabecular en columna vertebral mediante tomografía axial computerizada cuantitativa. Se dividieron en grupo 1 (11 pacientes) y grupo II (9 pacientes) similares en sexo, edad y tiempo en diálisis. Sin diferencias en densidad ósea, PTH, calcio, fósforo y fosatasa alcalina. El grupo I fue transferido a 2,5 mEg/I y el II continuó con 3 mEq/l. Se midieron calcio, fósforo (mg/dl) y fosfatasa alcalina (Ul/1) mensualmente. PTH (pg/ml) cada tres meses y la densidad ósea (mg/cc) al término del estudio. Tras un año de hemodiálisis con 2,5 mEg/I de calcio hubo una reducción de la masa ósea: basa] 149,09 ñ 54; final: 125 ñ 42 (p < 0,01), Z-Score basa]: 0,13 ñ 1,89; final: -0,68 ñ 1,89 (p < 0,05), sin cambios en grupo control. Pérdida ósea en unidades Z-Score: Grupo l: -0,81 ñ 0,92; grupo ll: 0,27 ñ 0,67 (p < 0,01). Cambio porcentual: grupo l: -15 ñ 1_3 por ciento; grupo II: 1,28 ñ 17 por ciento (p < 0,05). En grupo I hubo tendencia a mayor pérdida en mujeres: -17,12 ñ 7,1 por ciento que en hombres: - 12,33 ñ 18,6 por ciento (ns). En grupo I aumentaron PTH (basa]: 38,75 ñ 41, final: 99 ñ 69, p < 0,01) y fosfatasa alcalina (basa]: 118,4 ñ 47, final: 152 ñ 38, p < 0,01), sin cambios en grupo II. La pérdida ósea se relacionó inversamente con incremento de PTH (r = -0,61, p < 0,01). Calcio y fósforo no se modificaron. En grupo I la dosis acumulativa de CO3Ca se incrementó: 1.°' trimestre: 332 ñ 261; 4. ' trimestre: 537 ñ 260 (expresado como calcio elemento; p < 0,01). En análisis de regresión lineal múltiple, un mayor incremento de PTH y el tipo de concentrado utilizado se comportaron como únicos predictores de pérdida ósea (r = 0,74, p < 0,01). En conclusión, el uso de un concentrado de 2,5 mEg/l de calcio resultó en: 1.=' Pérdida de masa ósea. 2.=' Au mento de PTH y marcadores bioquímicos de formación ósea. 3.=' Mayor dosificación de CO,Ca. (AU)