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.
OBJECTIVE
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.
Dirección de Investigación, Hospital General de México OD, Mexico City, Mexico. ; Medical Research Department, Takeda Mexico S.A. de C.V., Naucalpan, Edo. Mex, Mexico.
Juan Carlos
JC
López-Alvarenga
The Lynn Health Science Institute, Oklahoma City, Oklahoma, USA.
William
W
Orr
Medical Research Department, Takeda Mexico S.A. de C.V., Naucalpan, Edo. Mex, Mexico.
José Antonio
JA
Vargas-Romero
Instituto de Investigaciones Médico Biológicas, Universidad Veracruzana, Veracruz, Ver, Mexico.
José María
JM
Remes-Troche
Departamento de Gastroenterología, Hospital General de Occidente, SS, Zapopan, Jal., Mexico.
Miguel
M
Morales-Arámbula
Departamento de Endoscopia, Hospital de Alta Especialidad PEMEX Sur, Mexico City, Mexico.
Julio César
JC
Soto-Pérez
Departamento de Cirugía General y Gastroenterología, Hospital Ángeles del Pedregal, Mexico City, Mexico.
Gualberto
G
Mateos-Pérez
Departamento de Endoscopia, Instituto Nacional de Cancerología, Mexico City, Mexico.
Sergio
S
Sobrino-Cossío
Departamento de Endoscopía, Hospital ABC, Mexico City, Mexico.
Oscar
O
Teramoto-Matsubara
Coordinación de Investigación en Salud, IMSS, Puebla, Pue. Mexico.
Aurelio
A
López-Colombo
Gastrolab S.A. de C.V., Clinical Research, Laboratorio de Fisiología Digestiva, Guadalajara, Jalisco, Mexico.
Antonio
A
Orozco-Gamiz
Medical Research Department, Takeda Mexico S.A. de C.V., Naucalpan, Edo. Mex, Mexico. ; Dirección de Enseñanza, Fundación Altius Internacional, Mexico City, Mexico.
Adolfo
A
Saez-Ríos
Medical Research Department, Takeda Mexico S.A. de C.V., Naucalpan, Edo. Mex, Mexico.
Araceli
A
Arellano-Plancarte
Medical Research Department, Takeda Mexico S.A. de C.V., Naucalpan, Edo. Mex, Mexico.
Jazmin
J
Chiu-Ugalde
Global Medical Affairs, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
Anne
A
Tholen
Global Medical Affairs, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
Silke
S
Horbach
Global Medical Affairs, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
Lars
L
Lundberg
Division of Gastroenterology and Hepatology, Esophageal and Swallowing Center, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Ronnie
R
Fass
Gastroesophageal; Night-time symptoms; Pantoprazole; Proton pump inhibitors