Relief of Night-time Symptoms Associated With Gastroesophageal Reflux Disease Following 4 Weeks of Treatment With Pantoprazole Magnesium: The Mexican Gastroesophageal Reflux Disease Working Group

Juan Carlos López-Alvarenga, William Orr, José Antonio Vargas-Romero, José María Remes-Troche, Miguel Morales-Arámbula, Julio César Soto-Pérez, Gualberto Mateos-Pérez, Sergio Sobrino-Cossío, Oscar Teramoto-Matsubara, Aurelio López-Colombo, Antonio Orozco-Gamiz, Adolfo Saez-Ríos, Araceli Arellano-Plancarte, Jazmin Chiu-Ugalde, Anne Tholen, Silke Horbach, Lars Lundberg, Ronnie Fass, Juan Carlos López-Alvarenga, William Orr, José Antonio Vargas-Romero, José María Remes-Troche, Miguel Morales-Arámbula, Julio César Soto-Pérez, Gualberto Mateos-Pérez, Sergio Sobrino-Cossío, Oscar Teramoto-Matsubara, Aurelio López-Colombo, Antonio Orozco-Gamiz, Adolfo Saez-Ríos, Araceli Arellano-Plancarte, Jazmin Chiu-Ugalde, Anne Tholen, Silke Horbach, Lars Lundberg, Ronnie Fass

Abstract

Background/aims: To evaluate the effectiveness of pantoprazole magnesium (pantoprazole-Mg) 40 mg in the relief of esophageal and extra-esophageal symptoms of gastroesophageal reflux disease (GERD), particularly night-time symptoms.

Methods: Patients (aged 18-50 years) with 3-month history of heartburn and/or acid regurgitation plus at least one other symptom in the last week were enrolled in a nationwide, prospective and observational study in Mexico. Patients received pantoprazole-Mg 40 mg once daily during 4 weeks. Symptoms were assessed through a physician-administered structured interview and the patient-completed ReQuest in Practice™ questionnaire. Night-time GERD was defined as arousal from sleep during the night due to GERD-associated symptoms.

Results: Out of 4,343 patients included at basal visit, 3,665 were considered for the effectiveness per protocol analysis. At baseline, patients had a median of 8 GERD related symptoms. Patients with night-time GERD symptoms (42.7%) were more likely to have extra-esophageal symptoms (P < 0.001) than other GERD patients. Pantoprazole-Mg 40 mg once daily for 4 weeks improved a broad range of GERD-associated symptoms from baseline (80% reduction on physicians assessments; 68-77% reduction on ReQuest in Practice™ dimensions), including both day- and night-time GERD symptoms; improvements were the greatest for extra-esophageal symptoms in patients with night-time symptoms. Pantoprazole-Mg was well tolerated.

Conclusions: Pantoprazole-Mg 40 mg significantly improved a broad range of esophageal and extra-esophageal GERD related symptoms including sleep disturbances, as well as well-being, in patients with daytime or night-time GERD, making it a good option for patients with GERD, especially when extra-esophageal and night-time symptoms are present.

Keywords: Gastroesophageal; Night-time symptoms; Pantoprazole; Proton pump inhibitors.

Conflict of interest statement

Conflicts of interest: Anne Tholen, Lars Lundberg and Silke Horbach are employees of Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. Antonio Vargas, Adolfo Saez, Araceli Arellano and Jazmin Chiu are employees of Takeda México S.A. de C.V., Mexico City, Mexico. Juan Carlos López is Biometrician at Takeda México S.A. de C.V.

Figures

Figure 1
Figure 1
Flow diagram of patients' attrition. V0, visit 0; SAE, serious adverse events; AE, adverse events; V1, visit 1.
Figure 2
Figure 2
Patient-assessed ReQuest in Practice™ scores during 4 weeks of treatment with pantoprazole magnesium 40 mg. Bonferroni post hoc test was used for comparison between week means (P < 0.001 for all cases).
Figure 3
Figure 3
Odds ratio of sleep disturbances, chronic cough and dyspnea, according to night-time gastroesophageal reflux disease prevalence. None = no symptoms (absent or non-detectable); Mild = hardly perceptible symptoms, with only slight general discomfort; Moderate = clearly perceptible symptoms, but tolerable without demanding immediate relief; Severe = overwhelming discomfort, urging immediate relief.
Figure 4
Figure 4
Symptom scores before and after 4 weeks of treatment with pantoprazole magnesium for patients with night-time gastroesophageal reflux disease (GERD) (arousal from sleep during the night due to GERD-associated symptoms). NTG, night-time GERD.
Figure 5
Figure 5
ReQuest in Practice™ scores. (A) ReQuest in Practice™ scores for the dimension acid complaints during 4 weeks of treatment with pantoprazole magnesium (pantoprazole-Mg) 40 mg in patients with night-time gastroesophageal reflux disease (GERD) (arousal from sleep during the night due to GERD-associated symptoms) or daytime GERD (no arousal from sleep during the night due to GERD-associated symptoms). (B) ReQuest in Practice™ scores for the dimension nausea during 4 weeks of treatment with pantoprazole-Mg for patients with night-time or daytime GERD.

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