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.

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.

• Authors: 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
• Journal: Journal of neurogastroenterology and motility (J Neurogastroenterol Motil) Vol. 20 Issue 1 Pg. 64-73 (Jan 2014) ISSN: 2093-0879 [Print] Korea (South)
• PMID: 24466446 (Publication Type: Journal Article)