Aims: Anaemia is a major risk factor in end-stage renal disease (ESRD) and leads to enhanced cardiac output and left-ventricular hypertrophy (LVH). Recombinant human erythropoietin (rhEPO) partially corrects anaemia and reduces LVH in ESRD. The current study retrospectively analysed mortality data from haemodialysis patients included in the clinical development database for epoetin-beta.
Methods: The unselected database, set up to monitor safety from clinical studies of epoetin-beta, comprised 3,111 adult haemodialysis patients included in 17 clinical trials in the clinical development programme (1987-1994). 1,726 and 466 patients were treated for >1 and >2 years, respectively. Untreated control patients (n = 246) were available in two studies. Mortality was measured from fatal adverse event documentation.
Results: The controlled studies showed an approximately 20% reduction in the mortality risk for epoetin-beta versus controls after 1 year. For the overall patient population, all-cause mortality fell from a peak (after about 150 days) of about 10 to about 6 deaths per 100 patient-years in the 3rd year of treatment (p < 0.01). The proportion of deaths due to cardiovascular causes fell from 50 to 20-30% over 3 years. The decline in cardiovascular mortality could not be explained by changes in covariate distribution or by drop-outs.
Conclusions: The cardiovascular mortality risk decreased over time in this population of ESRD patients. The beneficial effects of long-term anaemia correction by epoetin-beta therapy was a likely cause of this favourable development.