Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study.

We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival.

Renal cell carcinoma in peritoneal dialysis patients.

Renal cell carcinoma is a rare but serious complication in ESRD patients. In these patients the incidence of renal cell carcinoma (RCC) is 20-40 times higher than in the general population. We performed a retrospective study to measure the incidence rate, prevalence, characteristics and survival among our peritoneal dialysis (PD) patients diagnosed with renal cell carcinoma. The study was carried out among 607 patients who were on the PD program from January 1997 to June 2002. RCC was detected in eight patients (four males and four females) with mean age of 52.1 +/- 10.6 years. Among these eight patients four were new cases that were diagnosed before the patients were started on dialysis (three in native kidneys and one in a transplanted kidney). In the other four patients the RCC was diagnosed after they had been on dialysis for 33-204 months (mean 60.75 +/- 50.48). We found an incidence rate of 1.3 per 1000 patients per year and a prevalence of 1.3%. Six of the eight patients had renal cysts. Tumor size was less than 7 cm in seven patients and in the other patient it was 8.5 cm. Seven of eight patients were alive at the time of study with a survival time ranging from 3-138 months (mean 122.25 +/- 88.2) months. In one patient, the RCC metastasised to the scalp, and, in two other patients, the tumors subsequently involved the second kidney. A cardiovascular complication was the cause of one death. Two patients received a renal transplant 36 and 66 months after diagnosis. We conclude that despite the low rate of metastases and mortality in our study, regular ultrasonography should be added to the follow-up of PD patients. Renal transplantation can be considered in these ESRD patients with RCC; however, close follow-up for metastases is recommended.

Left ventricular systolic and diastolic functional abnormalities in asymptomatic patients with non-insulin-dependent diabetes mellitus.

The aim of this study was to evaluate the relations between left ventricular (LV) functional abnormalities, microangiopathy, and autonomic dysfunction in patients with non-insulin-dependent diabetes mellitus (NIDDM). We studied 66 normotensive patients with NIDDM of > or =4 years' duration (age, 51 +/- 4.5 years; 35 men) and no clinical evidence of cardiac disease. Twenty-one healthy subjects matched for age and sex served as a control group. Echocardiography and Doppler studies were performed to assess LV systolic and diastolic function. Microangiopathy was assessed by fundus examination. Autonomic function was assessed by standing blood pressure and heart rate response to Valsalva maneuver. Patients with NIDDM had a lower ejection fraction (58% +/- 11% versus 66% +/- 4%, P <.0001), E-F deceleration slope (382 +/- 75 versus 427 +/- 31 cm/s(2), P <.05), and E velocity (55 +/- 11 vs. 58 +/- 6 cm/s, P =.02) of the mitral diastolic flow, compared with control subjects, respectively. Patients with ejection fraction <50% had a higher prevalence of retinopathy (65% versus 29%, P <.005), abnormal blood pressure response to standing (53% versus 8%, P <.0005), and proteinuria (65% versus 27%, P =.006). An inverse correlation was found between the duration of diabetes and both the ejection fraction (r = -0.53, P <.05) and E/A ratio (r = -0.4, P <.005). E/A ratio <1 was associated with a higher prevalence of retinopathy (49% versus 20%, P =.01) and abnormal blood pressure response to standing (29% versus 4%, P <.005). Patients with NIDDM and no symptoms of cardiovascular disease have a reduced LV systolic and diastolic function as compared with healthy subjects. LV systolic and diastolic abnormalities are correlated with the duration of diabetes and with other diabetic microangiopathies such as diabetic retinopathy and neuropathy.