Johnson David A, Le Moigne Anne, Hugo Vincent, Nagy Peter
Eastern Virginia Medical School , Norfolk, VA , USA.
Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.
To investigate the resolution of heartburn and gastroesophageal reflux disease (GERD)-related sleep disturbances during the first 14 days of treatment with esomeprazole 20 mg compared to placebo in subjects with frequent nighttime heartburn and GERD-related sleep disturbances.
This was a post hoc analysis of 2 week data from two previously published, similarly designed randomized, placebo-controlled trials of 4 weeks' duration comparing esomeprazole 20 mg, 40 mg (one study), and placebo. Inclusion and exclusion criteria for both trials were the same.
NCT00628342; NCT00660660.
The main outcome measures for this analysis were the resolution and/or relief of GERD-related sleep disturbances during 2 weeks of treatment with esomeprazole 20 mg or placebo. Resolution and/or relief of heartburn symptoms were also measured.
In trial 1, 455 subjects were randomized, with 225 and 229 receiving esomeprazole 20 mg and placebo, respectively. In trial 2, 276 subjects were randomized, with 142 and 132 receiving esomeprazole and placebo, respectively. After 2 weeks, significantly more subjects who received esomeprazole 20 mg (50.5% [95% confidence interval: 43.8%-57.1%] and 39.4% [31.2%-47.6%] in trials 1 and 2, respectively) had resolution of sleep disturbances compared to placebo (19.9% [14.6%-25.2%] and 16.0% [9.6%-22.4%], respectively; p < 0.0001 for both trials). The median time to resolution of sleep disturbances with esomeprazole 20 mg was 1 day in both trials. After 2 weeks, significantly more subjects receiving esomeprazole 20 mg (32.3% [26.1%-38.5%] and 26.3% [18.9%-33.6%] in trials 1 and 2, respectively) had resolution of nighttime heartburn symptoms compared to placebo (5.4% [2.4%-8.4%] and 4.8% [1.1%-8.5%], respectively; p < 0.0001 for both trials).
Esomeprazole 20 mg significantly and effectively reduced nighttime heartburn and GERD-related sleep disturbances in the first 2 weeks of treatment compared to placebo, with rapid resolution of sleep disturbances in the first days of treatment.
在有频繁夜间烧心及与胃食管反流病（GERD）相关睡眠障碍的受试者中，比较埃索美拉唑20毫克与安慰剂在治疗的前14天对烧心及GERD相关睡眠障碍的缓解情况。
这是一项对两项先前发表的、设计相似的为期4周的随机、安慰剂对照试验的2周数据进行的事后分析，比较了埃索美拉唑20毫克、40毫克（一项研究）及安慰剂。两项试验的纳入和排除标准相同。
NCT00628342；NCT00660660。
该分析的主要结局指标是在接受埃索美拉唑20毫克或安慰剂治疗2周期间GERD相关睡眠障碍的缓解和/或减轻情况。还测量了烧心症状的缓解和/或减轻情况。
在试验1中，455名受试者被随机分组，分别有225名和229名接受埃索美拉唑20毫克和安慰剂。在试验2中，276名受试者被随机分组，分别有142名和132名接受埃索美拉唑和安慰剂。2周后，与安慰剂相比，接受埃索美拉唑20毫克的受试者中睡眠障碍得到缓解的比例显著更高（试验1中分别为50.5%[95%置信区间：43.8%-57.1%]和39.4%[31.2%-47.6%]，试验2中分别为19.9%[14.6%-25.2%]和16.0%[9.6%-22.4%]；两项试验p均<0.0001）。在两项试验中，使用埃索美拉唑20毫克缓解睡眠障碍的中位时间均为1天。2周后，与安慰剂相比，接受埃索美拉唑20毫克的受试者中夜间烧心症状得到缓解的比例显著更高（试验1中分别为32.3%[26.1%-38.5%]和26.3%[18.9%-33.6%]，试验2中分别为5.4%[2.4%-8.4%]和4.8%[1.1%-8.5%]；两项试验p均<0.0001）。
与安慰剂相比，埃索美拉唑20毫克在治疗的前2周能显著且有效地减轻夜间烧心及GERD相关睡眠障碍，且在治疗的头几天就能快速缓解睡眠障碍。
