Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials

Johnson, David A.; Moigne, Anne Le; Hugo, Vincent; Nagy, Péter

doi:10.1185/03007995.2014.991818

Cited by 13 publications

(8 citation statements)

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“…Sleep quality according to the PSQI, work productivity, and regular daily activities were improved significantly in the esomeprazole group compared with the placebo group . In addition, the authors performed a similar study in which esomeprazole 20 mg for 2 weeks effectively reduced nighttime heartburn and GERD‐related sleep disturbances during the first 2 weeks of treatment . They showed that a relatively short duration of PPI treatment also improved nighttime heartburn and GERD‐related sleep disturbances.…”

Section: Role Of Nocturnal Reflux Symptoms In Sleep Disordersmentioning

confidence: 95%

“…57 In addition, the authors performed a similar study in which esomeprazole 20 mg for 2 weeks effectively reduced nighttime heartburn and GERD-related sleep disturbances during the first 2 weeks of treatment. 58 They showed that a relatively short duration of PPI treatment also improved nighttime heartburn and GERD-related sleep disturbances. Dexlansoprazole 30 mg once daily (n = 152) was also effective in those patients and was significantly better than placebo (n = 153) for improving GERD-related sleep disturbances (70% vs. 48%; P < 0.001).…”

Section: Effect Of Reflux Treatment On Sleepmentioning

confidence: 99%

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Gastroesophageal reflux disease: recent advances and its association with sleep

2016

Annals of the New York Academy of Sciences

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Gastroesophageal reflux disease (GERD) is prevalent in Asia as well as in Western countries. Sleep disturbance and breathing disorders during sleep are becoming increasingly prevalent, and they are commonly associated with GERD. The relationship between GERD and obstructive sleep apnea (OSA) is still questionable, and it has expanded to include Barrett's esophagus. Nocturnal gastroesophageal reflux (nGER) symptoms might be clinically important in the explanation of this association. The therapy for reflux symptoms has resulted in improved subjective sleep parameters and enhanced sleep quality, thus supporting a direct relationship between GERD and sleep disturbance. This review discusses the epidemiology of sleep disturbances in GERD patients; the causative relationship between GERD and OSA, even though it remains an area of controversy; and the possible role of nGER in sleep problems. It also provides an update on the current state of knowledge linking GERD and sleep.

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Section: Role Of Nocturnal Reflux Symptoms In Sleep Disordersmentioning

confidence: 95%

Section: Effect Of Reflux Treatment On Sleepmentioning

confidence: 99%

Gastroesophageal reflux disease: recent advances and its association with sleep

2016

Annals of the New York Academy of Sciences

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“…Other studies have also demonstrated improvements in sleep quality following effective treatment for reflux symptoms [ 18 , 19 ]. Previous analysis of the current dataset has demonstrated that esomeprazole was associated with rapid resolution and relief of sleep disturbance and improvement in sleep quality that was significantly superior to that seen with placebo; improvements were seen as early as the first night of treatment [ 20 ]. The predictive nature of esomeprazole treatment with regard to resolution and relief of sleep disturbance after 14 days was, therefore, to be expected.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Clinical Predictors of Resolution of Sleep Disturbance Related to Frequent Nighttime Heartburn and Acid Regurgitation Symptoms in Individuals Taking Esomeprazole 20 mg or Placebo

Johnson

Moigne

et al. 2016

Clin Drug Investig

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Background and ObjectiveSleep 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.MethodsData 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).ResultsAbsence 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.ConclusionsLower 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.

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“…In two studies conducted with individuals not specifically experiencing nocturnal heartburn, 43–46% of those treated with esomeprazole 20 mg were heartburn free on the first night of treatment [171]. A more detailed description of these study results is provided in Data Summaries (Online Resource 4) [176, 177]. …”

Section: Delphi Statementsmentioning

confidence: 99%

The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus

Johnson

Katz

Armstrong

et al. 2017

Drugs

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The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare professionals and consumers must actively participate in decision making when managing reflux-related symptoms in the self-care setting.Electronic supplementary materialThe online version of this article (doi:10.1007/s40265-017-0712-6) contains supplementary material, which is available to authorized users.

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Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials

Abstract: 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.

Cited by 13 publications

References 25 publications

Gastroesophageal reflux disease: recent advances and its association with sleep

Gastroesophageal reflux disease: recent advances and its association with sleep

Analysis of Clinical Predictors of Resolution of Sleep Disturbance Related to Frequent Nighttime Heartburn and Acid Regurgitation Symptoms in Individuals Taking Esomeprazole 20 mg or Placebo

The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus

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