Nighttime Heartburn Research Articles

Expert opinion on the prescription practice of a combination of rabeprazole and domperidone for managing nighttime heartburn in GERD among Indian patients

The synergistic effect of Rabeprazole and Domperidone suggested a more comprehensive treatment strategy, targeting both acid suppression and motility enhancement in GERD management in several clinical studies. However, studies regarding their prescription practices of this combination is scarce. This study aimed to gather comprehensive insights into various aspects of gastroesophageal reflux disease (GERD) management in Indian settings.This cross-sectional study was conducted from June 2023 to December 2023 using a 24-item structured questionnaire distributed via email and online platforms. Clinicians completed the survey independently, with the option to skip questions and provided written informed consent. The questionnaire covered GERD management aspects, including patient demographics, clinical challenges, treatment preferences, efficacy of treatment combinations, patient adherence, use of guidelines, comorbidities, risk factors and patient education methods.According to 39% of clinicians, 31-40 GERD patients per month report nighttime heart burn, while another 39% reported it as 21-30 cases monthly. Majority of the clinicians (95.65%) preferred rabeprazole for its longer action in managing nighttime heartburn in GERD. According to 96% and 89% of the clinicians, respectively, the combination of rabeprazole and domperidone was favored for managing nighttime heartburn and was more effective than other PPI combinations. Nearly 93% stated that this combination provides the fastest relief. The recommendation for taking the combination once a day was made by 67% of clinicians and 59% reported that their patients felt relieved within 1-2 weeks. Helirab D was preferred due to its advanced release profile 2 (ARP2) technology by 50% of clinicians.There was a strong clinical preference for using a combination of rabeprazole and domperidone to manage nighttime heartburn in patients with GERD. This combination seems to have advantages in terms of effectiveness, quick onset of action and relief for patients. The once-daily dosing schedule and formulation technology (ARP2) may be contributing factors to its popularity among clinicians.

Clinician’s Perspectives on the Management of Gastroesophageal Reflux Disease and Prescription Practice of Proton Pump Inhibitors in Indian Settings

Objective: To assess the clinicians’ perspectives on GERD management and the prescription practices of proton pump inhibitors (PPIs) in Indian settings. Methods: This cross-sectional study was conducted among clinicians specialized in GERD management. Participants completed a 24-question questionnaire distributed via email or online platforms. The survey explored prescription practices, clinical observations, and preferences regarding PPIs and GERD management. Data analysis involved descriptive statistics, with responses presented as frequencies and percentages. Results: Out of 123 survey participants, 57% identified diet as the most common predisposing factor for GERD. Nighttime heartburn and disturbed sleep were recognized as key alarm symptoms by 57% of participants. Epigastric tenderness was the most prevalent physical finding, reported by 68% of clinicians. PPIs were favored as the first-line treatment for GERD by 78.86% of respondents. Domperidone was preferred as an adjunctive treatment for functional dyspepsia and gastroparesis. An empirical PPI trial was widely supported for its simplicity and cost-effectiveness. Rabeprazole emerged as the preferred PPI for nighttime heartburn relief due to its rapid onset and sustained efficacy. Conclusion: This study highlighted a consensus among Indian clinicians on the use of PPIs as a primary treatment for GERD, with a preference for rabeprazole. Domperidone is favored as an adjunctive treatment for functional dyspepsia and gastroparesis. Rabeprazole emerged as the preferred option for nighttime heartburn relief, owing to its rapid onset and long-lasting effectiveness.

Treatment Response With Potassium-competitive Acid Blockers Based on Clinical Phenotypes of Gastroesophageal Reflux Disease: A Systematic Literature Review and Meta-analysis.

Gastroesophageal reflux disease (GERD) is typically managed based on the clinical phenotype. We evaluated the efficacy and safety of potassium-competitive acid blockers (PCABs) in patients with various clinical GERD phenotypes. Core databases were searched for studies comparing PCABs and proton pump inhibitors (PPIs) in clinical GERD phenotypes of erosive reflux disease (ERD), non-erosive reflux disease (NERD), PPI-resistant GERD and night-time heartburn. Additional analysis was performed based on disease severity and drug dosage, and pooled efficacy was calculated. In 9 randomized controlled trials (RCTs) evaluating the initial treatment of ERD, the risk ratio for healing with PCABs versus PPIs was 1.09 (95% CI, 1.04-1.13) at 2 weeks and 1.03 (95% CI, 1.00-1.07) at 8 weeks, respectively. PCABs exhibited a significant increase in both initial and sustained healing of ERD compared to PPIs in RCTs, driven particularly in severe ERD (Los Angeles grade C/D). In 3 NERD RCTs, PCAB was superior to placebo in proportion of days without heartburn. Observational studies on PPI-resistant symptomatic GERD reported symptom frequency improvement in 86.3% of patients, while 90.7% showed improvement in PPIresistant ERD across 5 observational studies. Two RCTs for night-time heartburn had different endpoints, limiting meta-analysis. Pronounced hypergastrinemia was observed in patients treated with PCABs. Compared to PPIs, PCABs have superior efficacy and faster therapeutic effect in the initial and maintenance therapy of ERD, particularly severe ERD. While PCABs may be an alternative treatment option in NERD and PPI-resistant GERD, findings were inconclusive in patients with night-time heartburn.

Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial

Potassium-competitive acid blockers have documented efficacy for erosive esophagitis. We performed a randomized trial in United States subjects diagnosed with non-erosive reflux disease of vonoprazan vs placebo for 4 weeks, followed by a 20-week active-treatment extension. Adult subjects with heartburn ≥4 days/week during screening without erosive esophagitis on endoscopy were randomized to placebo, vonoprazan 10 mg, or vonoprazan 20 mg. After 4 weeks, subjects on placebo were re-randomized to vonoprazan 10 mg or 20 mg, and those already on vonoprazan continued at the same dose for 20 weeks. Electronic diaries were completed twice daily. The primary endpoint was percentage of days without daytime or nighttime heartburn (24-hour heartburn-free days). Among 772 randomized subjects, the percentage of 24-hour heartburn-free days was 27.7% for placebo vs 44.8% for vonoprazan 10 mg (least squares mean difference, 17.1%; P < .0001) and 44.4% for vonoprazan 20 mg (least squares mean difference, 16.7%; P < .0001). Differences in percentage of subjects with a 24-hour heartburn-free day for vonoprazan 10 mg vs placebo and vonoprazan 20 mg vs placebo were 8.3% and 11.6% on day 1 and 18.1% and 23.2% on day 2. The mean/median percentages of 24-hour heartburn-free days over the extension period were similar across the 4 study arms: 61%-63%/76%-79%. Vonoprazan reduced heartburn symptoms in subjects diagnosed with non-erosive reflux disease, with the benefit appearing to begin as early as the first day of therapy. Treatment effect persisted after the initial 4-week placebo-controlled period throughout the 20-week extension period. The 2 vonoprazan doses (10 mg and 20 mg) were similar in efficacy. (ClinicalTrials.gov: NCT05195528).

Expert Opinion on the Prescription Practice of Rabeprazole and Other Common Proton Pump Inhibitors for Patients with Gastroesophageal Reflux Disease

Objective: The current survey-based study aims to provide further insights on expert opinion regarding the commonly prescribed PPIs in clinical practice, with a specific focus on the use of oral rabeprazole 20 mg as a treatment for gastroesophageal reflux disease (GERD) maintenance therapy in Indian settings.&#x0D; Methodology: The questionnaire-based survey involving 25 questions collected perspectives of experts across various regions of India regarding the prescription practice of rabeprazole 20 mg and other proton-pump inhibitors (PPIs) for treating GERD symptoms.&#x0D; Results: Out of 512 study participants, 44% reported obesity as the common comorbid condition observed in GERD patients, while 28% noted co-morbid diabetes mellitus. According to 68% of the respondents, rabeprazole demonstrated superiority over other PPIs in terms of quicker onset of action, maintaining intragastric pH &gt;4 over 24 hours’ post-dose, and reduced nighttime heartburn. For GERD patients with functional dyspepsia and gastroparesis, 52% of responders favored the addition of domperidone as a prokinetic drug to the PPI treatment. Moreover, the majority of participants (61.91%) observed that rabeprazole 20 mg did not cause a delay in stomach emptying, nor did it raise somatostatin levels or alter baseline motilin levels in GERD patients. These findings underscore the effectiveness of rabeprazole 20 mg in comparison to omeprazole and lansoprazole.&#x0D; Conclusion: Experts recommended rabeprazole 20 mg as the preferred treatment option over omeprazole and lansoprazole for GERD patients with coexisting obesity and diabetes mellitus conditions. Additionally, over half of the respondents reported using a combination of domperidone and other PPIs for GERD patients with functional dyspepsia and gastroparesis.

Effects of Tegoprazan Versus Esomeprazole on Nighttime Heartburn and Sleep Quality in Gastroesophageal Reflux Disease: A Multicenter Double-blind Randomized Controlled Trial.

Patients with gastroesophageal reflux disease (GERD) frequently experience nighttime heartburn and sleep disturbance. Tegoprazan is a new potassium-competitive acid blocker that can rapidly block acid secretion. This study aims to evaluate the efficacy of tegoprazan compared with esomeprazole in relieving nighttime heartburn and sleep disturbances. Patients with erosive esophagitis, nighttime heartburn, and sleep disturbances were randomized to receive tegoprazan 50 mg or esomeprazole 40 mg for 2 weeks. The primary endpoint was time to first nighttime heartburn-free interval. The percentage of nighttime heartburn-free days was also compared between the 2 groups. A total of 46 patients were enrolled in this study. Time to the first nighttime heartburn-free interval was shorter with tegoprazan than with esomeprazole but the difference was not statistically significant (1.5 days vs 3 days, P = 0.151). The percentage of nighttime heartburn-free days was higher in the tegoprazan group but the difference was insignificant (57.8% vs 43.1%, P = 0.107). Adverse events occurred in 2 patients. They were mild in severity. Tegoprazan may induce faster relief of nighttime heartburn symptoms and may improve sleep disorders associated with nighttime heartburn. Further large-scale studies are required to validate our findings.

Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole.

Background/AimsSince the use of dexlansoprazole in Asian subjects with gastroesophageal reflux disease (GERD) has not been adequately characterized, this study was conducted to evaluate the efficacy and safety of dexlansoprazole modified-release in Asian subjects with non-erosive reflux disease (NERD) and erosive esophagitis (EE).MethodsIn this phase 4, open-label, non-randomized, uncontrolled, multicenter, multi-country study sponsored by Takeda, subjects aged ≥ 20 years with persistent typical GERD symptoms for at least 6 months underwent endoscopy. Based on endoscopic findings, they were assigned to either dexlansoprazole modified-release 30 mg once-daily for 4 weeks (NERD group) or dexlansoprazole modified-release 60 mg once-daily for 8 weeks (EE group). The primary endpoint was the percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation.ResultsOf the 445 subjects screened from Hong Kong, South Korea, and Taiwan, 208 were enrolled in the NERD group (mean age: 53.6 years, male: 34.6%) and 88 in the EE group (mean age: 51.7 years, male: 55.7%). Over the treatment period, the median percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation was 26.9% and 65.5% in the NERD and EE groups, respectively; for nighttime heartburn or acid regurgitation the proportions were 59.3% and 83.3%, respectively. The treatment was well tolerated with low incidence of treatment-related adverse events in NERD and EE groups (6.7% and 5.7%, respectively).ConclusionIn Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.

Survey of nocturnal reflux in patients with gastroesophageal reflux disease in China.

This multicenter observational study was conducted in 44 hospitals in China from May 2017 to February 2018. Outpatients with nGER were recruited and their relevant data were collected using a questionnaire, including age, gender, body mass index, history of smoking and alcohol consumption, comorbid diseases, lifestyle, self-reported health status, medical history, nGER symptoms and severity, Hospital Anxiety Depression Scale, Pittsburgh Sleep Quality Index, diagnosis and treatment choices. The study was registered on the Chinese Clinical Trial Registry (no. ChiCTR1800017525). The study included 4978 individuals, with valid questionnaires collected from 4448 patients (89.4%). The symptoms of heartburn and regurgitation were more severe at night than during the day (P < 0.05). Age and body mass index were positively correlated with reflux severity at night and during the day (P < 0.05). The severity of nGER was positively associated with lifestyle factors such as smoking, a high-fat diet, carbonated beverage consumption, late supper (later than 9 pm), and snoring (all P < 0.05). Night-time heartburn and regurgitation were related with sleep disorder. Lifestyle factors are associated with nGER severity, and nGER affects sleep quality. It will be beneficial to popularize and strengthen the diagnosis and treatment of nGER.

New possibilities for treatment of gastroesophageal reflux disease

Objective — to evaluate the clinical efficacy of the addition of Gyalera emulsion (Alpiflor SRL, Italy) to the standard therapy of patients with gastroesophageal reflux disease (GERD) and to study the effects of such treatment on the state of the esophagus epithelium.Materials and methods. A multicenter, randomized, open, comparative study with the parallel control has been carried out. It involved 60 patients with GERD aged 18 to 65 years, from them 25 women (42 %), and 35 men (58 %). The inclusion criteria included the presence of GERD symptoms (primarily heartburn), confirmed endoscopically and morphologically. The participants were divided into two groups of 30 subjects in each. Omeprazole in a dose of 20 mg 2 times a day and domperidone at a dose of 10 mg 3 times a day were used as basic therapy in both groups. In the first group, an additional «Gyalera» emulsion of 15 ml sticks was administered in a dose of 1 stick after a meal 3 times a day.Results. After the treatment, heartburn frequency in the first group was almost three times lower than in the comparison group (p = 0.035). This group did not suffer from nighttime heartburn and dysphagia, whereas in the second group it was observed in almost 7 % of patients. The incidence of belching after the treatment was 17 % and 20 % respectively. Esophagitis was detected endoscopically in 4.5 times more often in the second group than in the first, in one patient it was erosive. In the patients of the first group, morphologically significant positive dynamics was defined.Conclusions. In patients with GERD, the addition of Gyalera emulsion to the standard therapy with proton pump inhibitor and prokinetics promoted significant (in comparison with the control group) reduction of the heartburn frequency and severity, the degree of esophagus damage as per the esophagoscopy data, and elimination of dysphagia and nocturnal heartburn. Morphological analysis of esophageal mucosa demonstrated a decrease in the degree of epithelial inflammation and degeneration, and increase in the synthesis of protective mucus and epithelial integration on account of claudine 1 in tight junctions.

Practice styles, knowledge and attitudes of general practitioners and gastroenterology specialists who treat gastroesophageal reflux disease.

As little is known on the subject, our aim was to compare practice styles, knowledge and attitudes of general practitioners (GPs), and gastroenterology specialists (GIs) regarding the treatment of gastroesophageal reflux disease (GERD).An internet survey designed by the authors was sent nationwide and randomly to 290 GIs and 1312 GPs. We assessed for the burden of GERD, indications for referral for a GI consultation, criteria for proton pump inhibitors (PPIs) selection, and main unmet treatment needs.Forty (14%) GIs and 132 (10%) GPs returned the questionnaire. Both groups treat 13 to 14 GERD patients weekly (mean age 41–50 years). The most common first and second line drug of choice in both groups was omeprazole and esomeprazole, respectively. GIs stated that the most important consideration for the selection of treatment was high safety profile, whereas GPs considered it to be a rapid symptomatic relief. In the case of first and second line PPI failures, GIs tended to prescribe a non PPI treatment, whereas GPs restarted esomeprazole. GIs stated that the most prevalent conceived limitations of PPI treatment were nighttime heartburn and undesirable side effects, whereas GPs considered treatment inflexibility and drug interactions.GIs and GPs hold different practice styles, knowledge, and attitudes on the treatment of GERD. Our findings ascertain the need for the development of updated National Clinical Guidelines focusing on GERD.

Octurnal heartburn: there is a solution

This article describes a problem of sleep disorders, nighttime heartburn, the peculiarities of etiopathogenesis of night gastroesophageal reflux, the possibility of diagnosis and rational therapy of nighttime heartburn.

Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease

BackgroundProton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents.AimsTo assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD.MethodsA phase 2, open-label, multicenter study was conducted in adolescents aged 12–17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study.ResultsDiarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73–80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1–5) each decreased by an average of 0.7 units at week 4.ConclusionsUse of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life.Trial RegistrationThis study has the ClinicalTrials.gov identifier NCT01642602.

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

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.

The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study.

There is a bidirectional relationship between gastroesophageal reflux disease (GERD) and sleep. It has been demonstrated that antireflux treatment can improve sleep quality in GERD patients with nighttime reflux. Patients with heartburn and/or regurgitation ≥3 times/week and insomnia for ≥3 months were included. Patients were assessed at baseline with the demographic, GERD symptom assessment scale, Epworth sleepiness scale, Berlin sleep apnea, Pittsburgh sleep quality index, and the Insomnia severity index questionnaires. Subjects underwent an upper endoscopy followed by pH testing. Subsequently, subjects were randomized, in a double-blind, placebo-controlled trial, to receive either ramelteon 8 mg or placebo before bedtime for 4 weeks. During the last week of treatment, subjects completed a daily GERD symptom and sleep diary and underwent actigraphy. Sixteen patients completed the study, 8 in each arm (mean age and M/F were 48.5 vs. 57.8 y, and 8/0 vs. 6/2, respectively). Patients who received ramelteon demonstrated a statistically significant decrease in symptom score as compared with those who received placebo for daytime heartburn (-42% vs. -29%), nighttime heartburn (-42% vs. 78%), 24-hour heartburn (-42% vs. -3%), and 24-hour acid regurgitation (-26% vs. 19%) (all P<0.05). Insomnia severity index score was significantly reduced in patients receiving ramelteon as compared with placebo (-46% vs. -5%, P<0.05). Ramelteon group also demonstrated a significant improvement in sleep efficiency and sleep latency, as compared with placebo, P<0.05). No significant adverse events were observed with ramelteon. Ramelteon significantly improved symptoms in patients with GERD. In addition, ramelteon significantly improved patients' sleep experience. Further studies are needed in the future (NCT01128582).

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

Objective: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.Research design and methods: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.Clinical trial registration:ClinicalTrials.gov identifier: NCT00628342.ClinicalTrials.gov identifier: NCT00660660.Main outcome measures: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.Results: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).Conclusions: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.

Dexlansoprazole - a new-generation proton pump inhibitor.

Dexlansoprazole modified release (MR) is an R-enantiomer of lansoprazole and a new-generation proton pump inhibitor exhibiting high efficacy in the treatment of symptoms and lesions associated with erosive oesophagitis caused by gastroesophageal reflux disease (GERD). The dual release of the active ingredient – in the duodenum and the small intestine – makes it possible to achieve two peak concentrations at various times, within two and five hours of administration. Dexlansoprazole MR ensures the longest maintenance of drug concentration in the plasma of all known proton pump inhibitors, and the longest proton pump inhibitory effect. The basic indications for the drug include all forms of gastroesophageal reflux disease, especially with night-time heartburn and sleep disorders resulting from GERD. Dexlansoprazole can be taken regardless of meal times. It has a good safety profile and carries a low risk of adverse interactions with other drugs.

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

Introduction: Determine predictors of gastroesophageal reflux disease (GERD)-related sleep disturbance resolution with 14-day esomeprazole (ESO) 20 mg (administered as 22.3 mg ESO magnesium trihydrate) or placebo treatment. Methods: Data were pooled from the first 14 days in subjects with frequent nighttime heartburn (HB) and GERD-related sleep disturbances assigned to ESO 20 mg or placebo in 2 similarly designed randomized, double-blind studies.(1,2) Multivariate analyses were performed to identify predictors of complete resolution of GERD-related sleep disturbance (no sleep disturbance for 7 consecutive days as documented on subject diary cards). Clinical variables (treatment; study; site; age; gender; BMI [available in 1 study]; run−in sleep disturbance frequency; 24−hour, daytime, and nighttime HB) were assessed by stepwise logistic regression. Results: In the pooled data set, treatment (P<.0001), absence of daytime (P=.0018) or nighttime HB (P<.0001), and lower run−in sleep disturbance frequency (P<.0001) were significant predictors of complete resolution of GERD-related sleep disturbance at 14 days (Table 1, 2).Table 1: Complete Resolution of Sleep Disturbance by 14 DaysTable 2: Predictors of Complete Resolution of Sleep Disturbance at 14 DaysConclusion: Individuals with less frequent baseline sleep disturbance and those without daytime or nighttime HB during the first 14 days’ treatment were more likely to have complete resolution of GERDrelated sleep disturbance. Studies were funded by AstraZeneca, which entered into an agreement with Pfizer for the over-thecounter rights for NEXIUM® (esomeprazole magnesium). Medical writing support provided by Diane Sloan, PharmD, of Peloton Advantage, LLC; funded by Pfizer.

Tu1115 Efficacy of 14-Day Treatment With Esomeprazole 20 mg for Nighttime Heartburn: A Pooled Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

Tu1115 Efficacy of 14-Day Treatment With Esomeprazole 20 mg for Nighttime Heartburn: A Pooled Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

Tu1125 Relief and Resolution of GERD-Related Sleep Disturbances With Esomeprazole 20 mg: Results From Two Randomized, Double-Blind Trials in Subjects With Frequent Nighttime Heartburn and Associated Sleep Disturbance

Tu1125 Relief and Resolution of GERD-Related Sleep Disturbances With Esomeprazole 20 mg: Results From Two Randomized, Double-Blind Trials in Subjects With Frequent Nighttime Heartburn and Associated Sleep Disturbance

Atypical Manifestation of Gastroesophageal Reflux Disease: A Disease With a Thousand Faces

Atypical Manifestation of Gastroesophageal Reflux Disease: A Disease With a Thousand Faces