Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.
Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.
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DOI：
10.1093/cid/cis499
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发表时间：
2012-08
期刊：
影响因子：
--
通讯作者：
Study 003/004 Teams
中科院分区：
文献类型：
--
作者：
Crook DW;Walker AS;Kean Y;Weiss K;Cornely OA;Miller MA;Esposito R;Louie TJ;Stoesser NE;Young BC;Angus BJ;Gorbach SL;Peto TE;Study 003/004 Teams
最近完成的两项III期试验（003和004）显示，非达霉素在治疗艰难梭菌感染（CDI）方面不劣于万古霉素，在减少CDI复发方面具有上级优势。在这两项研究中，患有活动性CDI的成人被随机分配接受盲法非达霉素200 mg每日2次或万古霉素125 mg每日4次，持续10天。使用固定效应荟萃分析和考克斯回归模型，对合并的研究003和004数据进行事后探索性意向治疗（ITT）至事件时间分析。对1164例患者003/004数据的ITT分析显示，与万古霉素相比，非达霉素在40天内使持续性腹泻、复发或死亡减少了40%（95%置信区间[CI]，26%-51%; P < .0001）。持续性腹泻或死亡减少37%（95%CI，2%-60%; P = 0.037），直到第12天（异质性P = 0.50 vs 13-40天），由7例（1.2%）非达霉素vs 17例（2.9%）万古霉素在<12天死亡驱动。低白蛋白水平、低嗜酸性粒细胞计数和CDI治疗是持续腹泻或12天死亡的危险因素，CDI治疗前3个月是复发的危险因素（均P <0.01）。Fidaxomicin有可能显著改善CDI的结局。
Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%–51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%–60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13–40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI.
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