Randomized equivalence study evaluating the possibility of switching hemodialysis patients receiving subcutaneous human erythropoietin directly to intravenous darbepoetin alfa.

BACKGROUND: Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used either intravenously or subcutaneously with no dose penalty; however, the direct switch from subcutaneous recombinant human erythropoietin (rHuEPO) to intravenous darbepoetin has barely been studied. OBJECTIVE: To establish the equivalence of a direct switch from subcutaneous rHuEPO to intravenous darbepoetin versus an indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin in patients undergoing hemodialysis. METHODS: In this open, randomized, 6-month, prospective study, patients with end-stage kidney disease who were on hemodialysis were randomized into 2 groups: direct switch from subcutaneous rHuEPO to intravenous darbepoetin (group 1) and indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin (group 2). A third, nonrandomized group (control), consisting of patients treated with intravenous rHuEPO who were switched to intravenous darbepoetin, was also studied to reflect possible variations of hemoglobin (Hb) levels due to change from one type of ESA to the other. The primary outcome was the proportion of patients with stable Hb levels at month 6. Secondary endpoints included Hb stability at month 3, dosage requirements for darbepoetin, and safety of the administration route. RESULTS: Among 154 randomized patients, the percentages with stable Hb levels were equivalent in groups 1 and 2, respectively, at month 3 (86.0% vs 91.3%) and month 6 (82.1% vs 81.6%; difference -0.5 [90% CI -12.8 to 11.8]). Mean Hb levels between baseline and month 6 remained stable in both groups, with no variation in mean darbepoetin dose. Mean ferritin levels remained above 100 microg/L in the 3 groups during the whole study, and darbepoetin was well tolerated. CONCLUSIONS: This study has shown equivalent efficacy on Hb stability without the need for dosage increase in patients switched directly from subcutaneous rHuEPO to intravenous darbepoetin.

Is there any survival advantage of obesity in Southern European haemodialysis patients?

BACKGROUND: In the general population, a high body mass index (BMI) is associated with increased cardiovascular disease and all-cause mortality. However, according to US epidemiological evaluation in maintenance haemodialysis (HD) patients, a reverse epidemiology is described and baseline obesity appears paradoxically associated with better survival. The aim of this study is to examine in a Southern European HD population the relationship between survival and BMI at the start of HD treatment, and how survival is influenced by the body weight (BW) variations during the first year of treatment. METHODS: A total of 85 dialysis centres located in Portugal, France and Italy and belonging to the FME European dialysis chain were included. The current prospective analysis focuses on incident patients admitted to these centres between 1 January 2000 and 30 September 2005 with <1 month of previous follow-up on RRT. Data were gained from the FME EuCliD database. Patients were classified at baseline in four categories according to the BMI: underweight, normal range, overweight and obese. Also, the patient survival was analysed according to five quintiles of BW changes during the first year of HD treatment <-5.8%, -5.8 to -1.1%, -1.1 to 1.7% (reference category), +1.7 to +5.5% and >+5.5%. Survival analysis was adjusted for a set of demographic and comorbids using Kaplan-Meier curves and Cox model. Hazard ratios and their 95% confidence intervals were calculated with the use of the estimated regression coefficients and their standard errors. RESULTS: A total of 5592 patients were analysed (40.9% females), and the mean age at admission was 64.4 + 16.5 years. Of them, 27.7% were diabetic. The mean follow-up was 2.0 +/- 1.6 years. Almost half of the patients (46.4%) were in the normal range of BMI (20-24.9 kg/m(2)). When analysed with the Cox model, the categories of baseline BMI (underweight, normal range, overweight and obese) significantly influenced the survival with the respective hazard ratio (HR) and confidence interval at 1.14 (0.96-1.35), 1, 0.74 (0.67-0.9) and 0.78 (0.56-0.87). The strength of the association as well as the shape of the curve remains unchanged after considering age, diabetes and comorbidities. Moreover, when compared to patients for whom BW remained stable during the first year of HD treatment, survival was significantly lower in patients presenting in the lower quintile of BW variation (<-5.8% in 1 year) with an HR of 1.6. CONCLUSIONS: Despite increased comorbidities, overweight and obese patients on maintenance HD carry a significant lower mortality risk than patients in the normal and lower BMI ranges. This confirms the reverse epidemiology previously reported in US HD patients for these categories of BMI. Also BW variation during the first year of HD treatment is associated with patient survival, highlighting the importance of nutrition in this setting.

Assessment of quality guidelines implementation using a continuous quality improvement programme.

BACKGROUND: Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) study suggest that the level of implementation of the European Best Practice Guidelines (EBPG) is at best partial. The main aim of this study is to describe the level of implementation of the EBPG in the European Fresenius Medical Care (FME) clinic network. METHODS: Data presented in this investigation were gained through the FME database EuCliD (European Clinical Database). Patient data from 4 countries (Great Britain, France, Italy, Spain) were selected from the EuCliD database. The parameters chosen were haemodialysis adequacy, biocompatibility, anaemia control and serum phosphate control, which are surrogate indicators for quality of care. They were compared, by country, between the first quarter (Q1) 2002 and the fourth quarter (Q4) 2005. RESULTS: During Q1 2002 and Q4 2005, respectively, a total of 7,067 and 9,232 patients were treated in FME clinics located in France, Italy, Spain and the UK. This study confirms variations in haemodialysis practices between countries as already described by the DOPPS study. A large proportion of patients in each country achieved the targets recommended by the EBPG in Q4 2005 and this represented a significant improvement over the results achieved in Q1 2002. CONCLUSIONS: Differences in practices between countries still exist. The FME CQI programme allows some of these differences to be overcome leading to an improvement in the quality of the treatment delivered.