RESUMO
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.
RESUMO
BACKGROUND: Gastro-oesophageal reflux disease (GORD) is widespread in the general population and presents in most cases with heartburn as the main symptom. The severity of symptoms is not necessarily related to erosive damage to the oesophagus due to acid reflux, but the frequency and severity of symptoms have an impact on the health-related QOL (HR-QOL) of the patient. OBJECTIVE: To characterise patients with GORD who consult a physician because of heartburn with respect to medical background and burden of disease in Germany and Sweden. METHODS: A total of 1011 patients who had been experiencing symptoms of GORD, including heartburn, for at least 1 year were recruited by physicians, who collected data on the patients' previous diagnosis and treatment. The patients themselves were interviewed by telephone about their heartburn. The EuroQOL 5-dimensional HR-QOL questionnaire (EQ-5D) and the Gastrointestinal Symptom Rating Scale (GSRS) were used to measure patient-reported outcomes. RESULTS: About half of the patients had been experiencing symptoms of GORD for >5 years. The majority (54%) perceived the severity of their heartburn as moderate. Thirty-eight percent of the patients had been examined by endoscopy during the last 12 months and 79% of these had macroscopic oesophagitis. Medical treatment for heartburn had been prescribed to 88% of the patients. The mean annual number of days with heartburn was assessed as 170 days per patient, with the majority of patients (64%) experiencing heartburn every week. HR-QOL was reduced in these patients as expressed by EQ-5D scores compared to scores for a general population. Patients with GORD had problems related to gastrointestinal symptoms as rated by GSRS scores. More severe heartburn was associated with a greater number of symptom days and reduced HR-QOL scores, whereas a relationship between the findings at endoscopy and the severity of symptoms or HR-QOL could not be found. CONCLUSION: This study demonstrates that heartburn confers a significant burden on patients with GORD, related to the frequency and severity of symptoms and reflected in the reduction in HR-QOL as perceived by the patients.