Data From Investigational Use of Procrit (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting. Hospital trials.
Thursday, November 13th, 2008All three dosing groups, including the FDA-approved three-times-per-week (TIW) regimen, together with once-a-week (QW) and once-every-two-weeks (Q2W) investigational regimens, achieved a uncharitable terminal hemoglobin (Hb) within the latitude of 11.0 - 11.9 g/dL. Based on the increases in Hb, the QW and Q2W investigational regimens were statistically non-inferior to the TIW regimen (lower limits of 95 percent conviction intervals [CIs] within the non-inferiority bound of -1 g/dL). The percent of subjects with Hb extraordinary 11.9 g/dL during the first off 22 weeks of therapy was higher in the TIW squad (86.2 percent) than in the QW (78.4 percent) and Q2W (71.2 percent) groups; the median per-subject frequency of Hb exceptional 11.9 g/dL was 6, 4 and 3 times for the TIW, QW and Q2W groups, respectively. In the basic 22 weeks of treatment, the relationship of subjects experiencing not joking adverse events (SAEs) was 15 percent in the TIW group, compared with 22 percent in both the QW and Q2W groups.
During the unconditional 44 weeks of treatment, the modify of subjects experiencing SAEs was 29, 33 and 33 percent in the TIW, QW and Q2W groups, respectively. The or slue of subjects with investigator-confirmed thromboembolic vascular events (TVEs) over the cardinal 22 weeks was 2 in the TIW, 2 in the QW and 3 in the Q2W groups; over 44 weeks, these numbers were 2, 5 and 8 in the TIW, QW and Q2W groups, respectively. The tot of subjects who died during the elementary 22 weeks was 0 in the TIW, 6 in the QW and 3 in the Q2W groups. Over 44 weeks, 4, 6 and 4 subjects died, respectively. None of the deaths were considered coordinate to the survey drug. "These details state impressive insights into the capability use of extended-dosing regimens of Epoetin alfa in this unaggressive population," said Pablo E. Pergola, M.D., Ph.D., Division of Nephrology, Health Science Center and Renal Associates, P.A., San Antonio, Texas. In the study, 375 subjects averaging 70 years of discretion were randomized equally to one of the three dosing groups (TIW, QW and Q2W) and treated for 44 weeks.
