ST LOUIS (MD Consult) - On June 17, 2009, the US Food and Drug Administration (FDA) announced that it has finished its analysis of the mortality risk of antibiotic treatment with cefepime (marketed as Maxipime). The FDA's decision to conduct an analysis was prompted by the publication of a study in the May 2007 issue of The Lancet Infectious Diseases (authored by Yahov D et al) that suggested a higher rate of death in patients treated with this drug, compared with patients treated with similar drugs.
The FDA has reviewed this study data and conducted additional analyses using other data, including data submitted by Bristol Meyers Squibb. The FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients and that cefepime remains an appropriate therapy for its approved indications.
The following table shows a comparison of the Yahav et al meta-analysis and the FDA trial-level meta-analysisa:
|
|
Yahav et al meta-analysis
|
FDA meta-analysis
|
|
Trials not included in Yahav et al meta-analysis
|
Combined (Yahav et al. + additional trials)
|
|
Number of Trials Included
|
38 trials
(41 publications)
|
50 trials
|
88 trials
|
|
Risk of all-cause mortality cefepime against comparator at 30-days post-therapy
|
Risk Ratiob = 1.26
(95% CI: 1.08,1.49)
Adjusted risk difference= 17.02 per 1000 population (95% CI: 5.54, 28.5)
|
Adjusted risk difference = -2.83 per 1000 population (95% CI: -11.47, 5.80)
|
Adjusted risk difference = 5.38 per 1000 population (95% C.I.: -1.53, 12.28)
|
a Trial-level data refers to summary information from all patients in the trial without specifying details on any one patient.
b Note that different analyses methods were used in the Yahav et al meta-analysis and in the FDA analysis. The Adjusted risk difference for the Yahav et al meta-analysis was estimated by the FDA.
The FDA plans to continue reviewing the safety of cefepime. As part of this ongoing review, both the FDA and Bristol Meyers Squibb are examining hospital drug-use data in separate analyses of death potentially associated with cefepime. The results of these analyses likely will be reported in approximately 1 year.
圣路易斯(MD Consult)——2009年6月17日，美国食品药品管理局(FDA)宣布已完成对抗菌治疗中使用头孢吡肟(商品名：马斯平，Maxipime)死亡风险的分析。Yahov D等2007年5月发表在《柳叶刀·传染病》的一项研究表明，服用头孢吡肟的患者死亡率较服用其他同类药品者更高，这促使FDA决定对此进行分析。
FDA对试验数据做了回顾性研究，并采用其他数据进行了其他分析，这其中包括由百时美施贵宝公司提供的数据资料。FDA认为现有数据并不能表明头孢吡肟治疗患者的死亡率较高，按药品得到批准的适应证使用仍然安全。
下表为Yahav 等的Meta分析与FDA临床研究水平Meta分析的比较a：
|
|
Yahav等的Meta分析
|
FDA的Meta分析
|
|
Yahav等的Meta分析中未包括的试验
|
Yahav等的Meta分析及其他试验
|
|
分析纳入的试验数
|
38个试验(41篇文献)
|
50 个试验
|
88 个试验
|
|
头孢吡肟与其他抗生素在治疗后30天的各种原因致死风险比较
|
风险比b = 1.26 (95%置信区间为1.08～1.49)
调整的风险差=17.02每千人(95%置信区间为5.54～28.5)
|
调整的风险差= -2.83每千人(95%置信区间为-11.47～5.80)
|
调整的风险差= 5.38每千人(95%置信区间为-1.53～12.28)
|
a临床研究水平的数据是指来自所有患者的总体信息，而没有具体患者的特定细节信息。
b请注意Yahav等的Meta分析与FDA的Meta分析在分析方法上的差异。Yahav等的Meta分析中调整的风险差由FDA估算。
FDA计划将继续审查头孢吡肟的安全性。作为审查的一部分，FDA和美施贵宝公司正在收集头孢吡肟院内使用数据，对该药品的致死可能性进行独立分析。分析结果可能将在1年内公布。
