Johnson David A, Le Moigne Anne, Li Jing, Pollack Charles, Nagy Peter
Eastern Virginia Medical School, 885 Kempsville Road, Suite 114, Norfolk, VA, 23502, USA.
Pfizer Consumer Healthcare, Madison, NJ, USA.
Clin Drug Investig. 2016 Jul;36(7):531-8. doi: 10.1007/s40261-016-0398-7.
Sleep disturbances related to reflux symptoms have a significant impact on the daily lives of affected individuals. These analyses identified clinical factors related to resolution of reflux-related sleep disturbance in subjects treated with esomeprazole 20 mg for 14 days.
Data from the first 14 days of 2 similar randomized, double-blind studies were pooled for subjects experiencing frequent heartburn and related sleep disturbances receiving esomeprazole 20 mg (n = 357) or placebo (n = 346). A stepwise logistic regression analysis was performed with pooled and individual study data to evaluate relationships between clinical factors [treatment (esomeprazole vs. placebo), run-in sleep disturbance frequency, occurrence (yes/no) of 24-h, daytime, and nighttime heartburn (yes: ≥1 episode in 14-day treatment period)] and complete sleep disturbance resolution (no disturbances for 7 consecutive days).
Absence of daytime (p = 0.0018) or nighttime (p < 0.0001) heartburn during treatment was a significant predictor of complete sleep disturbance resolution at 14 days for the total population, while higher run-in sleep disturbance frequency (p < 0.0001) was associated with a lower likelihood of resolution. Esomeprazole treatment was an independent significant predictor of improvement across all endpoints (p < 0.0001). A significant treatment by run-in sleep disturbance interaction was observed for complete resolution (p = 0.0231), indicating greater therapeutic benefit with esomeprazole in subgroups with higher run-in symptom frequency.
Lower run-in sleep disturbance frequency, no occurrence of daytime or nighttime heartburn during therapy, and esomeprazole treatment predicted complete reflux-related sleep disturbance resolution. The magnitude of therapeutic benefit for esomeprazole 20 mg over placebo increased with increasing baseline sleep disturbance.
与反流症状相关的睡眠障碍对受影响个体的日常生活有重大影响。这些分析确定了接受20毫克埃索美拉唑治疗14天的受试者中与反流相关睡眠障碍缓解相关的临床因素。
将两项类似的随机双盲研究前14天的数据合并，纳入有频繁烧心及相关睡眠障碍的受试者，他们接受20毫克埃索美拉唑（n = 357）或安慰剂（n = 346）治疗。使用合并数据和单个研究数据进行逐步逻辑回归分析，以评估临床因素[治疗（埃索美拉唑与安慰剂）、导入期睡眠障碍频率、24小时、白天和夜间烧心的发生情况（是/否）（是：在14天治疗期内≥1次发作）]与睡眠障碍完全缓解（连续7天无干扰）之间的关系。
治疗期间无白天（p = 0.0018）或夜间（p < 0.0001）烧心是总体人群在14天时睡眠障碍完全缓解的显著预测因素，而导入期睡眠障碍频率较高（p < 0.0001）与缓解可能性较低相关。埃索美拉唑治疗是所有终点改善的独立显著预测因素（p < 0.0001）。观察到导入期睡眠障碍与治疗之间存在显著的交互作用对完全缓解有影响（p = 0.0231），表明在导入期症状频率较高的亚组中，埃索美拉唑具有更大的治疗益处。
较低的导入期睡眠障碍频率、治疗期间无白天或夜间烧心以及埃索美拉唑治疗可预测反流相关睡眠障碍的完全缓解。20毫克埃索美拉唑相对于安慰剂的治疗益处程度随着基线睡眠障碍的增加而增加。
