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Aim: End-stage renal failure (ESRF) and renal transplant recipients are thought to be associated with an increased risk of colorectal complications., Method: A review of the literature was performed to assess the prevalence and outcome in both benign and malignant colorectal disease., Results: No prospective randomized studies assessing colorectal complications in ESRF or renal transplant were identified. Case series and case reports have described the incidence and management of benign colorectal complications. Complications included diverticulitis,infective colitis, colonic bleeding and colonic perforation. There was insufficient evidence to associated iverticular disease with adult polycystic kidney disease.Three population-based studies have shown up to a twofold increased incidence of colonic cancer but not rectal cancer for renal transplant recipients. Bowel cancer screening (as per the general population) by faecal occult blood testing appears justified for renal transplant patients; however, evidence suggests that consideration of starting screening at a younger age may be worthwhile because of an increased risk of developing colonic cancer.Two population-based studies have shown a threefold and 10-fold increased incidence of anal cancer for renal transplant recipients. A single case–control study demonstrated significant increased prevalence of anal human papilloma virus (HPV) and intraepithelial neoplasia (AIN)in patients with established renal transplants., Conclusions: Despite the lack of high-level evidence,ESRF and renal transplantation were associated with colorectal complications that could result in major morbidity and mortality. Bowel cancer screening in this patient group appears justified. The effectiveness of screening for HPV, AIN and anal cancer in renal transplant recipients remains unclear.

Background: Renal disease is a recognized complication of orthotopic liver transplantation (OLT). We aimed to determine the incidence of all stages of chronic kidney disease (CKD), as defined in the Kidney Disease Outcomes Quality Initiative Guidelines. We also wanted to determine the risk factors for development of CKD and its impact on patient survival., Methods: All patients who underwent cadaveric OLT, from January 1993 until July 2004, were analysed. The glomerular filtration rate (GFR) was determined using the equation developed by the Modification of Diet in Renal Disease Study. Thirty potential risk factors were examined by univariate and multivariate ordinal logistic regression analysis. Kaplan-Meier survival analysis, the log-rank test and Cox regression analysis were performed to evaluate the survival data., Results: A total of 230 patients were included (107 males and 123 females) with a mean age of 47.7 years (4.5-70.35). Mean follow-up was 5.57 years (0.53-16.5). The following was the 10 year cumulative incidence for each stage of CKD: 0/1, 9.61%; 2, 53.71%; 3, 56.77%; 4, 6.11%; 5, 2.62%. Female gender, age, pre-OLT proteinuria, lower GFR from 1 year and higher creatinine from 6 months were associated with progression of CKD. The use of tacrolimus had a favourable impact. A GFR <30 ml/min, the need for re-transplantation and fulminant hepatic failure were all associated with reduced patient survival., Conclusions: Moderate CKD was very prevalent. We identified the risk factors for progression of CKD and also that severe CKD was associated with reduced patient survival.

Recombinant human erythropoietin (rHuEPO) is a new drug for treating anemia associated with end stage renal disease (ESRD). In a study of rHuEPO diffusion, costs, and effectiveness, we analyze ESRD program data and all claims submitted to Medicare for reimbursement of rHuEPO administered to ESRD dialysis patients. Access to rHuEPO was rapid and extensive during the first year of Medicare coverage. Dosing of rHuEPO and achieved hematocrit were lower than expected based on the results of clinical trials. rHuEPO cost Medicare $144 million in its first year. The analysis of insurance claims data allowed effective monitoring of access, costs, and effectiveness of this new biotechnology.

Controversy exists as to whether provider organizational characteristics such as profit status and setting are associated with the content of medical care or efficiency with which care is rendered. Following FDA approval of human recombinant erythropoietin (EPO) for use in clinical practice, Medicare approved coverage for beneficiaries in its end stage renal disease program and established a fixed payment per dose. Because cost of EPO administration varied positively with dose, providers could realize larger profit with prescription of smaller doses. We used Medicare claims data to assess EPO use by renal dialysis providers one year after FDA approval (June 1990) as a function of provider ownership (for-profit, not-for-profit, government agency) and setting (hospital-based, free-standing). Mean dose of EPO was 236 units greater (P = 0.0001) for not-for-profit freestanding facilities, 593 units greater (P = 0.0001) for government facilities, and 555 units greater for not-for-profit hospitals (P = 0.0001) than among for-profit freestanding providers. With fixed payment per dose of EPO, for-profit, freestanding providers prescribed EPO more often and administered smaller doses than not-for-profit or government providers, behavior that is consistent with profit maximization.

The Medicare payment policy for recombinant human erythropoietin (rHuEPO) treatment for dialysis patients changed in January 1991 from a relatively fixed payment per treatment (allowed charge of $40 per < or = 10,000 units injected) to a more variable payment based on the amount of rHuEPO administered with each treatment (allowed charge of $11 per 1,000 units injected). This change provided an opportunity to examine how payment policy can effect the use, cost, and health outcome of a biotechnology product used in the dialysis population. In cross-sectional (n = 71,880 Medicare-entitled dialysis patients) and longitudinal (n = 29,088 Medicare-entitled dialysis patients) study designs, we used Medicare end-stage renal disease program and claims data in bivariate and multivariate analyses to examine the effect of the change in payment policy for rHuEPO on access to the biotechnology, dosing, costs, and hematocrit, including the prescribing patterns at for-profit versus not-for-profit providers. The observation period included several months before (July 1989 to December 1990) and 6 months after (January to June 1991) the change in Medicare payment policy. The mean dose per treatment during the initial and fourth month of therapy was low (2,742 [95% confidence interval, 2,703 to 2,781] units and 2,632 [95% confidence interval, 2,598 to 2,667] units, respectively, in June 1990) and increased 3.4% and 5.0%, respectively, in the next 6 months prior to the change in Medicare payment policy compared with 14.6% and 14.8%, respectively, in the 6 months following the change in payment policy. The average monthly allowed charge for rHuEPO per dialysis patient receiving rHuEPO decreased from $455 before the policy change to $349 immediately following the policy change, because the allowed charge per unit of rHuEPO was lower when payment became more dependent on the amount of rHuEPO administered with each treatment than when the payment was fixed at $40 per treatment. The average monthly allowed charge for rHuEPO increased to $375 in the sixth month following the change in payment policy as a result of the increase in dose and the new variable payment. The unadjusted and adjusted changes in mean hematocrit 6 months after the payment change were positive but clinically very small (0.3 and 0.2 percentage points, respectively).(ABSTRACT TRUNCATED AT 400 WORDS)

In a national longitudinal-cohort study of 59,462 end-stage renal disease (ESRD) patients, we examined dosing and effectiveness of erythropoietin (EPO) during the first year of its use in clinical practice (July 1989 through June 1990). In unadjusted and multivariate analyses of Medicare claims data, the mean dose of EPO prescribed was: relatively small and similar for initial and maintenance therapy, 2752 (95% confidence interval 2740 to 2764) and 2668 (95% confidence interval 2654 to 2682) units, respectively; lower when initial therapy was started later (591 units lower in September 1989 and 760 units lower in November 1989 vs. July 1989, P < 0.0001); lower by 135 units during initial therapy and by 116 units during maintenance therapy for females (who weigh less) compared to males (P < 0.001); and lower by 400 units for patients treated in for-profit versus not-for-profit centers. In multivariate analysis: hematocrit response was less and mean maintenance dose was 298 units and 621 units greater for patients whose ESRD was due to multiple myeloma and sickle cell disease, respectively, compared to those with hypertension-related ESRD (P < 0.01); and hematocrit response was logarithmically related to dose [hematocrit = 0.97 ln (dose), P < 0.0001]. Forty-four percent of patients had a hematocrit > or = 30 after four months of therapy. The percent of patients transfused during three month periods before and after therapy decreased from 20% to 5%, respectively (P < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Purpose: The purpose of this study was to determine the efficacy of recombinant human erythropoietin (rHuEPO) given subcutaneously three times/week in patients with chronic renal failure and anemia (predialysis)., Patients and Methods: Eleven patients with predialysis chronic renal failure participated in a double-blind, placebo-controlled study of subcutaneously administered erythropoietin. For 12 weeks, patients received either rHuEPO 100 mu/kg body weight three times/week subcutananeously or a placebo. After 12 weeks of placebo, patients now also received rHuEPO in a dose up to 150 mu/kg three times/week until target hematocrit was achieved. Throughout the study, blood pressure was monitored closely and blood work was obtained regularly for hemoglobin, hematocrit, reticulocyte count, and iron profile determinations., Results: At 12 weeks, the hematocrit of the treated group had risen from 29% +/- 2% to 35% +/- 2% (p less than 0.001). The placebo group baseline hematocrit was 28% +/- 2% and at 12 weeks 26% +/- 2% After 12 weeks of rHuEPO therapy, the hematocrit of the prior placebo group was 32% +/- 2% (p less than 0.001 versus baseline). No significant change in biochemical parameters was noted. Mean blood pressure values were comparable before and after treatment. All protein ultimately required iron supplementation. In two patients, the rate of progression of renal failure appeared to increase as their hematocrit rose and rHuEPO was discontinued., Conclusions: It is concluded that rHuEPO given subcutaneously is an effective and safe therapy for patients with chronic renal failure who are anemic and who are not receiving dialysis.

As the use of Epoetin alfa to treat the anemia of chronic renal failure (CRF) expands, nurses play an ever-increasing role in patient monitoring and control. One area that relies heavily on nurses is blood pressure monitoring. Clinical trials with Epoetin alfa in hemodialysis patients indicate that its use may be associated with the onset or aggravation of elevated blood pressure as the hematocrit level increases. Because high blood pressure is a risk factor for left ventricular hypertrophy and cardiovascular mortality in this patient population, use of an agent that may cause high blood pressure requires careful monitoring. As the following two cases reports illustrate, sufficient data to provide better insight into the clinical aspects of this potential problem have now been accumulated.

The prolonged bleeding times of 12 patients with chronic renal failure were significantly shortened at 1 and 2 h after an infusion of 0.4 microgram/kg 1-deamino-8-D-arginine vasopressin (DDAVP). In 5 of these patients, the bleeding times 24 h after infusion had returned to approximate baseline values, suggesting that the effect of DDAVP is a temporary one. The levels of factor VIII coagulant activity, factor VIII related antigen activity, and factor VIII ristocetin cofactor activity were all normal or elevated prior to infusion, and a tendency to further elevation, although significant only for the factor VIII ristocetin cofactor activity, was observed after infusion of DDAVP. The latter observation suggests that the effect of DDAVP infusion on the bleeding time is unrelated to alteration of factor VIII activities.

The traditional options available for the correction of hemodialysis-related anemia are blood transfusions and androgen therapy to stimulate erythropoiesis. A new therapeutic option, recombinant human erythropoietin (r-HuEPO; EPOGEN, AMGEN Inc, Thousand Oaks, CA), is currently undergoing clinical trials. Each treatment alternative has certain attendant adverse effects. The adverse effects of transfusion include transmission of infections such as hepatitis or acquired immunodeficiency syndrome, iron overload, and sensitization to histocompatibility antigens. Androgen therapy can cause masculinization of women and children and, in some forms, is associated with a high incidence of abnormal liver function. Treatment with r-HuEPO has some potential adverse effects, including hypertension, thrombosis of arteriovenous fistulae, prolonged duration of dialysis, hyperkalemia, and iron deficiency. Gradual and careful introduction of r-HuEPO should prevent hypertension from becoming problematic.

The treatment of the bleeding diathesis of renal failure remains unsatisfactory. 1-Deamino-8-D-arginine vasopressin (DDAVP) has recently been shown to shorten the prolonged bleeding time of renal failure and may as a result diminish the risk of clinical hemorrhage. We describe 2 cases where DDAVP was used successfully in the management of hemorrhage in the setting of renal insufficiency.

Echocardiographic evidence of left ventricular hypertrophy with well-preserved systolic function was established in 4 chronic hemodialysis patients with a history of refractory pulmonary congestion. In each patient a trial of treatment with verapamil (40 mg t.i.d.) resulted in symptomatic improvement, an increase in nadir intradialysis blood pressure, and a marked reduction in intradialytic symptomatic hypertensive episodes and the need for intravenous saline administration. These data suggest that (a) a subset of chronic hemodialysis patients with refractory congestive heart failure and dialysis-related hypotension have hypertrophic cardiomyopathy with well-preserved systolic function, and (b) such patients may derive greater benefit from verapamil treatment than from the more conventional approach to drug therapy with digoxin and nitrates.

Recurrence of diabetic nephropathy in the allograft of diabetics with end-stage renal disease who undergo renal transplantation has been reported. We report a case of a patient who underwent cadaveric renal transplantation for end-stage renal disease secondary to chronic glomerulonephritis 13 years ago. He developed steroid-induced, insulin-dependent diabetes mellitus 9 months after transplantation and florid nephrotic syndrome with progressive functional impairment due to biopsy-proven diabetic nephropathy 11 years later. This is, to our knowledge, the first report of de novo diabetic nephropathy in a renal allograft of a patient who was not a diabetic at the time of transplantation. It is suggested that histopathologic changes of diabetes mellitus cannot only recur in a renal allograft, but also can develop de novo and lead to functional impairment and ultimately affect graft survival. In view of increasing patient and graft survival in transplanted diabetic and non-diabetic patients, it is reasonable to anticipate an increased incidence of this complication.