Peura David, Le Moigne Anne, Wassel Heather, Pollack Charles
Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia, USA.
Clinical Excellence and Biometrics, Pfizer Consumer Healthcare, Madison, New Jersey, USA.
BMJ Open Gastroenterol. 2019 Jun 21;6(1):e000278. doi: 10.1136/bmjgast-2019-000278. eCollection 2019.
Drug exposure and corresponding antisecretory effects increase over the first 4-5 days of esomeprazole treatment. To date, this effect has not been correlated with symptomatic improvement. Therefore, the efficacy of esomeprazole was evaluated on days 1-4 and 5-14 using pooled data from two identical randomised, double-blind, placebo-controlled studies conducted in subjects with frequent heartburn who are likely to self-treat with over-the-counter medications.
Adults without confirmed diagnoses of gastro-oesophageal reflux disease experiencing heartburn 2 or more days per week in the past 4 weeks were randomly assigned to treatment with esomeprazole 20 mg or placebo once daily for 14 days following a 1-week placebo run-in period (esomeprazole: n=330; placebo: n=321). Heartburn episodes were documented in daily diaries. The current analyses evaluated the change in baseline percentage of heartburn-free days across days 1-4 and 5-14.
Change in the percentage of heartburn-free days from the run-in was significantly greater with esomeprazole compared with placebo (p<0.001) starting on days 1-4. The greatest treatment benefit was observed during days 5-14. During this period, esomeprazole-treated subjects increased their heartburn-free time over the run-in period by 32.5% compared with 14.3% with placebo (p<0.001).
Frequent heartburn sufferers treated with esomeprazole 20 mg had significantly more heartburn-free days relative to placebo throughout the studies. Maximal clinical benefits coincided with the estimated timing of maximal pharmacokinetic and pharmacodynamic effects and duration of acid control on days 5-14.
NCT01370525; NCT01370538.
在埃索美拉唑治疗的最初4 - 5天内，药物暴露量及相应的抗分泌作用会增加。迄今为止，这种效应与症状改善之间尚未建立关联。因此，利用两项相同的随机、双盲、安慰剂对照研究的汇总数据，对有频繁烧心症状且可能自行使用非处方药物治疗的受试者，在第1 - 4天和第5 - 14天评估了埃索美拉唑的疗效。
在过去4周内每周有2天或更多天出现烧心症状且未确诊为胃食管反流病的成年人，在经过1周的安慰剂导入期后，被随机分配接受每日1次20 mg埃索美拉唑或安慰剂治疗，为期14天（埃索美拉唑组：n = 330；安慰剂组：n = 321）。烧心发作情况记录在每日日记中。当前分析评估了第1 - 4天和第5 - 14天无烧心天数的基线百分比变化。
从导入期开始，与安慰剂相比，埃索美拉唑治疗组在第1 - 4天无烧心天数的百分比变化显著更大（p < 0.001）。在第5 - 14天观察到最大的治疗益处。在此期间，埃索美拉唑治疗的受试者无烧心时间较导入期增加了32.5%，而安慰剂组为14.3%（p < 0.001）。
在整个研究过程中，接受20 mg埃索美拉唑治疗的频繁烧心患者相对于安慰剂组有显著更多的无烧心天数。最大的临床益处与估计的最大药代动力学和药效学效应时间以及第5 - 14天的胃酸控制持续时间一致。
NCT01370525；NCT01370538。
