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Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

Orlando RC, Liu S, Illueca M - Clin Exp Gastroenterol (2010)

Bottom Line: In this study population, no relationship was apparent between esomeprazole dosage and efficacy variables for sustained heartburn resolution (seven days without symptoms) at week 4 (48.0%, 44.0%, and 41.4% for esomeprazole 20 mg once daily, 40 mg once daily, and 40 mg twice daily, respectively).Nocturnal heartburn resolution with esomeprazole 40 mg twice daily showed a numeric improvement trend versus esomeprazole 20 and 40 mg once daily, but this was not statistically significant.Heartburn resolution rates at four weeks were similar for all esomeprazole dosages and comparable with rates reported previously, suggesting a plateau effect in terms of clinical response to acid suppression with PPI therapy in this population of selected GERD patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.

ABSTRACT

Objective: To increase response rates to therapy by increasing the dosage of proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease (GERD) whose symptoms are predominantly associated with acid reflux.

Methods: In this double-blind, randomized, proof-of-concept study, 369 patients with GERD and moderate heartburn lasting ≥three days/week, a history of response to antacids/acid suppression therapy, and a positive esophageal acid perfusion test result were randomized to esomeprazole 20 or 40 mg once daily, or to 40 mg twice daily for four weeks. Heartburn symptom relief/resolution was subsequently evaluated.

Results: In this study population, no relationship was apparent between esomeprazole dosage and efficacy variables for sustained heartburn resolution (seven days without symptoms) at week 4 (48.0%, 44.0%, and 41.4% for esomeprazole 20 mg once daily, 40 mg once daily, and 40 mg twice daily, respectively). Nocturnal heartburn resolution with esomeprazole 40 mg twice daily showed a numeric improvement trend versus esomeprazole 20 and 40 mg once daily, but this was not statistically significant.

Conclusions: Heartburn resolution rates at four weeks were similar for all esomeprazole dosages and comparable with rates reported previously, suggesting a plateau effect in terms of clinical response to acid suppression with PPI therapy in this population of selected GERD patients.

No MeSH data available.


Related in: MedlinePlus

Patient disposition.
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f1-ceg-3-117: Patient disposition.

Mentions: Of 630 patients screened, 369 were randomly assigned to treatment. The major reasons for study exclusion and discontinuation are summarized in Figure 1. All 369 randomized patients who reported that their heartburn responded to antacids/acid suppression therapy also had a positive esophageal acid perfusion test result except for one. This patient died in a traffic accident and thus was not included in the intent-to-treat population (368 patients) because no data were recorded after the second visit (day 0). All randomized patients received ≥one dose of study drug; data from all randomized patients were analyzed for safety. Patients in this population had a mean age of 45 years, were predominantly white women, and had a mean body mass index of >29 kg/m2 (Table 1). All patients had a history of heartburn, tested negative for H. pylori, and had a positive esophageal acid perfusion test result. Thirteen percent of patients had a history of erosive esophagitis. Prior to study enrollment, 31 (8.4%) of the 368 patients were receiving histamine-2 receptor antagonists and 114 (31.0%) were receiving PPI therapy, including 35 (9.5%) patients who were receiving esomeprazole. Most patients were classified as compliant (ie, took ≥80% of their study medication), including 112 (93%) in the 20-mg once-daily and 40-mg once-daily groups, and 113 (90%) in the 40-mg twice-daily groups. No instances of treatment overdose were reported.


Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

Orlando RC, Liu S, Illueca M - Clin Exp Gastroenterol (2010)

Patient disposition.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3108657&req=5

f1-ceg-3-117: Patient disposition.
Mentions: Of 630 patients screened, 369 were randomly assigned to treatment. The major reasons for study exclusion and discontinuation are summarized in Figure 1. All 369 randomized patients who reported that their heartburn responded to antacids/acid suppression therapy also had a positive esophageal acid perfusion test result except for one. This patient died in a traffic accident and thus was not included in the intent-to-treat population (368 patients) because no data were recorded after the second visit (day 0). All randomized patients received ≥one dose of study drug; data from all randomized patients were analyzed for safety. Patients in this population had a mean age of 45 years, were predominantly white women, and had a mean body mass index of >29 kg/m2 (Table 1). All patients had a history of heartburn, tested negative for H. pylori, and had a positive esophageal acid perfusion test result. Thirteen percent of patients had a history of erosive esophagitis. Prior to study enrollment, 31 (8.4%) of the 368 patients were receiving histamine-2 receptor antagonists and 114 (31.0%) were receiving PPI therapy, including 35 (9.5%) patients who were receiving esomeprazole. Most patients were classified as compliant (ie, took ≥80% of their study medication), including 112 (93%) in the 20-mg once-daily and 40-mg once-daily groups, and 113 (90%) in the 40-mg twice-daily groups. No instances of treatment overdose were reported.

Bottom Line: In this study population, no relationship was apparent between esomeprazole dosage and efficacy variables for sustained heartburn resolution (seven days without symptoms) at week 4 (48.0%, 44.0%, and 41.4% for esomeprazole 20 mg once daily, 40 mg once daily, and 40 mg twice daily, respectively).Nocturnal heartburn resolution with esomeprazole 40 mg twice daily showed a numeric improvement trend versus esomeprazole 20 and 40 mg once daily, but this was not statistically significant.Heartburn resolution rates at four weeks were similar for all esomeprazole dosages and comparable with rates reported previously, suggesting a plateau effect in terms of clinical response to acid suppression with PPI therapy in this population of selected GERD patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.

ABSTRACT

Objective: To increase response rates to therapy by increasing the dosage of proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease (GERD) whose symptoms are predominantly associated with acid reflux.

Methods: In this double-blind, randomized, proof-of-concept study, 369 patients with GERD and moderate heartburn lasting ≥three days/week, a history of response to antacids/acid suppression therapy, and a positive esophageal acid perfusion test result were randomized to esomeprazole 20 or 40 mg once daily, or to 40 mg twice daily for four weeks. Heartburn symptom relief/resolution was subsequently evaluated.

Results: In this study population, no relationship was apparent between esomeprazole dosage and efficacy variables for sustained heartburn resolution (seven days without symptoms) at week 4 (48.0%, 44.0%, and 41.4% for esomeprazole 20 mg once daily, 40 mg once daily, and 40 mg twice daily, respectively). Nocturnal heartburn resolution with esomeprazole 40 mg twice daily showed a numeric improvement trend versus esomeprazole 20 and 40 mg once daily, but this was not statistically significant.

Conclusions: Heartburn resolution rates at four weeks were similar for all esomeprazole dosages and comparable with rates reported previously, suggesting a plateau effect in terms of clinical response to acid suppression with PPI therapy in this population of selected GERD patients.

No MeSH data available.


Related in: MedlinePlus