PMID- 20129016
OWN - NLM
STAT- MEDLINE
DCOM- 20100330
LR  - 20190608
IS  - 0301-0430 (Print)
IS  - 0301-0430 (Linking)
VI  - 73
IP  - 2
DP  - 2010 Feb
TI  - C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney 
      disease.
PG  - 94-103
AB  - BACKGROUND: C.E.R.A., a continuous erythropoietin receptor activator, is a 
      long-acting erythropoiesis-stimulating agent (ESA) that is approved for the 
      treatment of renal anemia. This analysis evaluated the safety profile of C.E.R.A. 
      in comparison to that of other ESAs in patients with chronic kidney disease 
      (CKD). METHODS: Safety parameters were analyzed in a pooled population comprising 
      all patients with CKD on dialysis and not on dialysis from the completed Phase II 
      and Phase III studies in the C.E.R.A. clinical program (Phase II/III population); 
      patients were treated with either C.E.R.A. (n = 1,789) or comparator ESA (n = 
      948). Differences between treatment groups in safety parameters were identified 
      by either a 2% difference in incidence between groups, or a statistically 
      significant difference between groups (p < or = 0.05 with the Fisher's exact 
      test, which was used as a conservative screening tool). To assess changes in 
      safety findings over time, long-term safety data were analyzed from patients who 
      were given the option to enter long-term safety studies upon completing their 
      initial Phase II/III study (safety extension population). RESULTS: Compared with 
      the C.E.R.A. group, the incidence of adverse events (AEs) was higher in the 
      comparator ESA group in the Phase II/III population (C.E.R.A. vs. comparator ESA, 
      89.5% vs. 91.8%, p = 0.067), and significantly so in the safety extension 
      population (93.0% vs. 95.8%, p = 0.003). The incidence of serious AEs was 
      significantly higher in the comparator ESA group than in the C.E.R.A. group in 
      both analysis populations (Phase II/III population, 37.8% vs. 42.4%, p = 0.021; 
      safety extension population, 53.3% vs. 59.7%, p = 0.001). However, there was no 
      consistent pattern of clinical events that could explain these differences 
      between the treatment groups. CONCLUSION: Analysis of safety events in patients 
      with renal anemia receiving long-term treatment with C.E.R.A. shows a safety 
      profile comparable to that of other ESAs.
FAU - Locatelli, F
AU  - Locatelli F
AD  - Department of Nephrology and Dialysis and renal Transplant, A. Manzoni Hospital, 
      Lecco Italy. f.locatelli@ospedale.lecco.it
FAU - Mann, J F E
AU  - Mann JF
FAU - Aldigier, J C
AU  - Aldigier JC
FAU - Sanz Guajardo, D
AU  - Sanz Guajardo D
FAU - Schmidt, R
AU  - Schmidt R
FAU - Van Vlem, B
AU  - Van Vlem B
FAU - Sulowicz, W
AU  - Sulowicz W
FAU - Dougherty, F C
AU  - Dougherty FC
FAU - Beyer, U
AU  - Beyer U
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Clin Nephrol
JT  - Clinical nephrology
JID - 0364441
RN  - 0 (Recombinant Proteins)
RN  - 0 (continuous erythropoietin receptor activator)
RN  - 11096-26-7 (Erythropoietin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Anemia/*drug therapy/epidemiology/etiology
MH  - Dose-Response Relationship, Drug
MH  - Erythropoietin/administration & dosage/*therapeutic use
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Kidney Failure, Chronic/*complications/therapy
MH  - Polyethylene Glycols/administration & dosage/*therapeutic use
MH  - Prospective Studies
MH  - Recombinant Proteins
MH  - Renal Dialysis
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2010/02/05 06:00
MHDA- 2010/03/31 06:00
CRDT- 2010/02/05 06:00
PHST- 2010/02/05 06:00 [entrez]
PHST- 2010/02/05 06:00 [pubmed]
PHST- 2010/03/31 06:00 [medline]
AID - 7308 [pii]
AID - 10.5414/cnp73094 [doi]
PST - ppublish
SO  - Clin Nephrol. 2010 Feb;73(2):94-103. doi: 10.5414/cnp73094.