Subcutaneous injection pain with CERA, a continuous erythropoietin receptor activator, compared with darbepoetin alfa
Subcutaneous injection pain with CERA, a continuous erythropoietin receptor activator, compared with darbepoetin alfa
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DOI：
10.1185/030079907x242700
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发表时间：
2007-12-01
影响因子：
2.3
通讯作者：
Reigner, Bruno
中科院分区：
文献类型：
--
作者：
Pannier, Anne;Jordan, Paul;Reigner, Bruno
目的：本研究评估了连续皮下（SC）给予促红细胞生成素受体激活剂（C.E.R.A.）后的注射部位疼痛，方法：在一项随机、安慰剂对照、单中心、单盲、三向交叉研究中，受试者接受六种治疗序列（ABC/ACB/BAC/BCA/ CBA/CAB）之一，包括SC注射（A）C.E.R.A. 50 μ g，（B）达贝泊汀α 50 μ g，或（C）安慰剂，第1、29和57天。初始试验阶段（n = 12）用于确定验证阶段（n = 72）的样本量，并且数据被合并用于最终分析（n = 84）。主要结果测量：主要终点是给药后立即在100 mm视觉模拟量表（VAS）上的疼痛。次要终点包括给药后1小时的VAS和给药后立即和1小时的六点口头评分量表（VRS）疼痛。与达贝泊汀α相比，SC注射后即刻疼痛显著减轻：最小二乘平均VAS 21.5（95%置信区间[CI]：17.5，25.5）vs 33.4（95% CI：28.4，38.4）（p < 0.0001）。C.E.R.A.的VRS疼痛发生率较低。与给药后即刻的达贝泊汀α相比（p < 0.0001）。给药后1小时，大多数受试者无VRS疼痛。研究的局限性是样本量小，研究结果需要在慢性肾脏病患者的大型试验中得到证实。在健康成人中，疼痛程度显著低于SC达贝泊苷α。C.E.R.A.皮下注射治疗慢性肾脏病贫血与达贝泊苷α相比，可提供更低的疼痛负担。
Objective: This study assessed injection site pain following subcutaneous (SC) administration with a continuous erythropoietin receptor activator (C.E.R.A.), compared with darbepoetin alfa in healthy adults.Methods: In a randomized, placebo-controlled, single-centre, single-blind, three-way crossover study, subjects received one of six treatment sequences (ABC/ACB/BAC/BCA/ CBA/CAB) involving SC injection of (A) C.E.R.A. 50 mu g, (B) darbepoetin alfa 50 mu g, or (C) placebo on days 1, 29, and 57. An initial pilot phase (n = 12) was used to determine the sample size for the confirmatory phase (n = 72), and data were combined for the final analysis (n = 84).Main outcome measures: The primary endpoint was pain on the 100 mm visual analog scale (VAS) immediately after dosing. Secondary endpoints included VAS at 1 hour after dosing and pain on the six-point verbal rating scale (VRS) immediately and at 1 hour after dosing.Results: C.E.R.A. was associated with significantly less pain immediately after SC injection compared with darbepoetin alfa: least squares mean VAS 21.5 (95% confidence interval [CI]: 17.5, 25.5) versus 33.4 (95% CI: 28.4, 38.4) (p < 0.0001). Incidence of pain on the VRS was lower with C.E.R.A. compared with darbepoetin alfa immediately after dosing (p < 0.0001). One hour after administration, most subjects had no VRS pain. A study limitation is the small sample size and the findings need to be confirmed in a large trial of chronic kidney disease patients.Conclusions: SC injection with C.E.R.A. is significantly less painful than SC darbepoetin alfa in healthy adults. Treatment of anemia in chronic kidney disease with SC injection of C.E.R.A. may provide a lower pain burden compared with darbepoetin alfa.