Omega-3 free fatty acids for the maintenance of remission in Crohn disease -: The EPIC randomized controlled trials
Omega-3 free fatty acids for the maintenance of remission in Crohn disease -: The EPIC randomized controlled trials
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DOI：
10.1001/jama.299.14.1690
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发表时间：
2008-04-09
影响因子：
120.7
通讯作者：
Rutgeerts, Paul
中科院分区：
文献类型：
--
作者：
Feagan, Brian G.;Sandborn, William J.;Rutgeerts, Paul
克罗恩病的背景维持疗法的特点是使用免疫抑制药物，这与感染风险增加有关。确定安全有效的维持策略是当务之急。目的确定口服omega-3游离脂肪酸是否比安慰剂更有效预防克罗恩病的复发。设计、设置和患者两项随机、双盲、安慰剂对照研究(2003年1月至2007年2月在加拿大、欧洲、以色列和美国的98个中心进行的Epanova计划in Crohn‘s Study 1[EPIC-1]和EPIC-2)。来自363名和375名静止期克罗恩病患者的数据分别在EPIC-1和EPIC-2中进行评估。克罗恩病活动指数(CDAI)低于150的间歇期患者被随机分配接受4g/d的omega-3游离脂肪酸或安慰剂治疗长达58周。不允许对克罗恩病进行其他治疗。主要结果衡量临床复发，根据CDAI评分150分或更高，且比基准值增加70分以上，或开始治疗活动期克罗恩病。结果对于EPIC-1,188名患者被分配接受omega-3游离脂肪酸治疗，186名患者接受安慰剂治疗。EPIC-2的相应数字分别为189和190名患者。在EPIC-1中，接受omega-3游离脂肪酸治疗的患者1年复发率为31.6%，而接受安慰剂治疗的患者为35.7%(风险比0.82；95%可信区间0.51-1.19；P=。30)。EPIC-2的对应值分别为47.8%和48.8%(危险比0.90；95%可信区间0.67-1.21；P=。48)。结论在这些试验中，用omega-3游离脂肪酸治疗克罗恩病并不能有效预防复发。政府标识：EPIC-1：NCT00613197，EPIC-2：NCT00074542。
Context Maintenance therapy for Crohn disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection. Identification of safe and effective maintenance strategies is a priority.Objective To determine whether the oral administration of omega- 3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.Design, Setting, and Patients Two randomized, double- blind, placebo-controlled studies ( Epanova Program in Crohn's Study 1 [ EPIC- 1] and EPIC- 2) conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel, and the United States. Data from 363 and 375 patients with quiescent Crohn disease were evaluated in EPIC- 1 and EPIC- 2, respectively.Interventions Patients with a Crohn's Disease Activity Index ( CDAI) score of less than 150 were randomly assigned to receive either 4 g/ d of omega- 3 free fatty acids or placebo for up to 58 weeks. No other treatments for Crohn disease were permitted.Main Outcome Measure Clinical relapse, as defined by a CDAI score of 150 points or greater and an increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease.Results For EPIC- 1, 188 patients were assigned to receive omega- 3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC- 2 were 189 and 190 patients, respectively. The rate of relapse at 1 year in EPIC- 1 was 31.6% in patients who received omega- 3 free fatty acids and 35.7% in those who received placebo ( hazard ratio, 0.82; 95% confidence interval, 0.51- 1.19; P=. 30). Corresponding values for EPIC- 2 were 47.8% and 48.8% ( hazard ratio, 0.90; 95% confidence interval, 0.67- 1.21; P=. 48). Serious adverse events were uncommon and mostly related to Crohn disease.Conclusion In these trials, treatment with omega- 3 free fatty acids was not effective for the prevention of relapse in Crohn disease.Trial Registration clinicaltrials. gov Identifiers: EPIC- 1: NCT00613197, EPIC- 2: NCT00074542.