ライフサイエンスコーパス: darbepoetin alfa

1 p Therapy (TREAT) among patients assigned to darbepoetin alfa.

2 The risk of stroke was doubled with darbepoetin alfa.

3 nt rates were 76% for daprodustat vs 72% for darbepoetin alfa.

4 randomly assigned to receive daprodustat or darbepoetin alfa.

5 Randomized 1:1 to daprodustat or darbepoetin alfa.

6 ] age, 52.0 [45-63] years; 96 [61%] male) or darbepoetin alfa (155 patients; median [IQR] age, 56.0 [

7 gned in a 1:1 ratio to receive vadadustat or darbepoetin alfa: 369 in the incident DD-CKD trial and 3

8 Of the patients treated with darbepoetin alfa, 85% achieved 2 consecutive hemoglobin

9 hip among the initial hemoglobin response to darbepoetin alfa after two weight-based doses, the hemog

10 nt group (20 [45%] were allocated to receive darbepoetin alfa and 24 [55%] were allocated to receive

11 ere administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P

12 stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (ha

13 r event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (h

14 disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (h

15 oximately 20 pg/mL for EPOzeta, 30 pg/mL for darbepoetin alfa, and 80 pg/mL for C.E.R.A.

16 enous EPO and the recombinant forms EPOzeta, darbepoetin alfa, and C.E.R.A., from human urine is desc

17 Pegfilgrastim and darbepoetin alfa are effective and safe in facilitating

18 onventional erythropoiesis-stimulating agent darbepoetin alfa, are unknown.

19 atients had a stroke, 101/2012 (5.0%) in the darbepoetin alfa arm and 53/2026 (2.6%) in the placebo a

20 Although darbepoetin alfa can effectively increase hemoglobin lev

21 poietin or the longer-acting erythropoietin, darbepoetin alfa, can improve anemia in 15% to 40% of pa

22 is widely treated in the United States with darbepoetin alfa (DA) or epoetin alfa (EA).

23 Treatment with darbepoetin alfa did not improve clinical outcomes in pa

24 rge pivotal outcome trial found that the ESA darbepoetin alfa did not improve long-term outcomes in p

25 ssure, hemoglobin level, platelet count, and darbepoetin alfa dose did not differ between those with

26 level achieved after 4 weeks, the subsequent darbepoetin alfa dose, and outcomes in 1872 patients wit

27 Recombinant human erythropoietin (rhEPO) and darbepoetin alfa (DPO) are protein-based drugs for the t

28 ninferiority trials comparing vadadustat and darbepoetin alfa for CKD-related anemia: two in dialysis

29 cular outcomes, we compared daprodustat with darbepoetin alfa for the treatment of anemia in patients

30 t group and 0.66 0.02 g per deciliter in the darbepoetin alfa group (difference, 0.08 g per deciliter

31 tat group and in 377 patients (19.3%) in the darbepoetin alfa group (hazard ratio, 0.96; 95% confiden

32 p and in 371 of 1935 patients (19.2%) in the darbepoetin alfa group (hazard ratio, 1.03; 95% CI, 0.89

33 were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the p

34 stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the pla

35 urred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%)

36 provement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo grou

37 lent DD-CKD trial, and the incidences in the darbepoetin alfa group were 56.5% and 58.3%, respectivel

38 %) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0

39 the daprodustat and 10.6 (0.9) g/dL for the darbepoetin alfa group, with an adjusted mean treatment

40 Patients who had a poor initial response to darbepoetin alfa had a lower average hemoglobin level at

41 alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialy

42 disease and RED-HF (Reduction of Events with Darbepoetin alfa in Heart Failure) in heart failure pati

43 The use of darbepoetin alfa in patients with diabetes, chronic kidn

44 h the erythropoiesis-stimulating agent (ESA) darbepoetin alfa in patients with non-dialysis-dependent

45 , daprodustat was not superior compared with darbepoetin alfa in reducing monthly IV iron use (adjust

46 t CKD, safety and efficacy of vadadustat and darbepoetin alfa in the United States and outside the Un

47 Our findings do not support the use of darbepoetin alfa in these patients.

48 The 2-fold increase in stroke with darbepoetin alfa in TREAT could not be attributed to any

49 al found that daprodustat was noninferior to darbepoetin alfa in treating anemia of CKD and may repre

50 and efficacy of vadadustat, as compared with darbepoetin alfa, in patients with anemia and incident o

51 parisons), despite receiving higher doses of darbepoetin alfa (median dose, 232 mug vs. 167 mug; P<0.

52 Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority cr

53 domized (double-blind) to placebo (N=157) or darbepoetin alfa (N=162) subcutaneously every 2 weeks fo

54 ) to assess noninferiority of daprodustat vs darbepoetin alfa (noninferiority margin, -0.75 g/dL).

55 predictors of stroke included assignment to darbepoetin alfa (odds ratio 2.1; 95% confidence interva

56 We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with s

57 either as monotherapy or in combination with Darbepoetin alfa on iron metabolism and anemia resolutio

58 d controlled trial to evaluate the effect of darbepoetin alfa on the number of erythrocyte transfusio

59 We aimed to investigate the effect of darbepoetin alfa on the prevention of postnatal anaemia

60 All patients received darbepoetin alfa once every 3 weeks and were randomly as

61 Treatment with darbepoetin alfa or other types of erythropoietin should

62 ey disease, and anemia randomized to receive darbepoetin alfa or placebo.

63 In patients assigned to darbepoetin alfa, postrandomization systolic and diastol

64 Darbepoetin alfa reduced the transfusion episodes after

65 rs could not be used to mitigate the risk of darbepoetin alfa-related stroke.

66 Consequently, the combination of KY1070 and Darbepoetin alfa resulted in an EPO-sparing effect.

67 omputer at birth to treatment with 10 mug/kg darbepoetin alfa subcutaneously once a week for 8 weeks

68 tients received vadadustat and 1732 received darbepoetin alfa, the hazard ratio for MACE was 1.17 (95

69 Darbepoetin alfa therapy was initiated in 92% of patient

70 nemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approx

71 0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g

72 isk was similar among vadadustat-treated and darbepoetin alfa-treated patients (hazard ratio [HR], 1.

73 isk was similar among vadadustat-treated and darbepoetin alfa-treated patients (HR, 0.88; 95% CI, 0.6

74 use mortality or first HF hospitalization in darbepoetin alfa-treated patients compared with placebo

75 yte transfusion episodes was identified with darbepoetin alfa treatment compared with standard care (

76 By intent-to-treat analysis, darbepoetin alfa treatment did not significantly improve

77 At week 27, darbepoetin alfa treatment increased median (interquarti

78 Darbepoetin alfa treatment was well tolerated and effect

79 tients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence inter

80 A poor initial hematopoietic response to darbepoetin alfa was associated with an increased subseq

81 The neutral effect of darbepoetin alfa was consistent across all prespecified

82 Darbepoetin alfa was initiated at 200 microg SQ every 2

83 th symptomatic HF and anemia, treatment with darbepoetin alfa was not associated with significant cli

84 esponsible for the increased risk related to darbepoetin alfa, we performed a nested case-control ana

85 -vis change in hemoglobin) of vadadustat and darbepoetin alfa were similar when stratified by region

86 D-CKD, safety and efficacy of vadadustat and darbepoetin alfa were similar.

87 er and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than

88 We defined a poor initial response to darbepoetin alfa (which occurred in 471 patients) as the

89 oing dialysis, vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety a

90 ing dialysis, daprodustat was noninferior to darbepoetin alfa with respect to the change in the hemog