[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.

[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.

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.

[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.

[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.

[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.

[Colorectal cancer: its incidence in the province of Guadalajara]. / Cáncer colorrectal: su incidencia en la provincia de Guadalajara.

The present study was designed to establish the incidence of colorectal cancer in the province of Guadalajara. During an 8-year-period, 347 cases of colorectal cancer were detected. The adjusted global incidence rate of colorectal cancer was 15.4 per 100,000 population; 17.5 for men and 13.5 for women. The global crude rate was 29.6; 31.4 for men and 27.8 for women. The global adjusted truncated rate was 23.9; 26.2 and 21.6 for men and women, respectively. The global truncated rate was 29.6; 31.4 for men and 27.7 for women. In the case of colon cancer, the global adjusted rate was 10.9 per 100,000 population; 12.1 for men and 9.8 for women. In the case of rectum cancer, 4.5; 5.3 for men and 3.7 for women. The incidence of colorectal cancer in the province of Guadalajara compared with Spain is medium, and compared with the rest of the world, median-low. The incidence trend is towards a progressive increase for the colon location of cancer among men of non-advanced age.