Sustained Response to PPIs in Patients Suffering From GERD
Background Gastro-oesophageal reflux disease (GERD), functional dyspepsia (FD) and irritable bowel syndrome (IBS) are highly prevalent gastrointestinal conditions with accumulating evidence of overlap in patients. Despite availability of a vast body of research related to individual disorders, major pharmacological breakthrough in treatment of the overlap condition is still lacking.
Aim To assess sustainability of GERD healing and whether known beneficial effects of proton pump inhibitor treatment on GERD also extend to symptoms suggestive of FD and IBS.
Methods A total of 626 patients with reflux oesophagitis were treated with pantoprazole for up to 16 weeks depending on healing of GERD, followed by an observational phase of up to 6 months without treatment. Rates of patients suffering from GERD, FD or IBS were assessed at baseline, and at last visits of treatment and observational phase.
Results Rates of patients with reflux oesophagitis and concomitantly with reflux symptoms, FD or IBS were each significantly lower after pantoprazole treatment (P < 0.0001). While rates of patients with reflux signs or symptoms increased again during observational phase, rates of FD and IBS were maintained at the low level after cessation of medication (P < 0.0001).
Conclusions Pantoprazole is efficacious in the treatment of patients suffering from signs and symptoms suggesting an overlap of GERD, FD and/or IBS, providing a sustained response post-treatment in FD and IBS symptom categories. Mechanisms underlying the beneficial effects of improvement in reflux oesophagitis on symptoms suggestive of FD or IBS still need to be determined.
Functional dyspepsia (FD), irritable bowel syndrome (IBS), and gastro-oesophageal reflux disease (GERD) are highly prevalent and almost endemic gastrointestinal (GI) disorders in the general population. Depending on the diagnostic criteria implemented, prevalence, predominantly in Western populations, is approximately 25% for overall reflux symptoms, 15% for FD and 3–20% for IBS. Recently published studies in Asian populations report prevalence of 8–12% for GERD, 8–10% for FD and 10–14% for IBS. However, symptomatic assessment of the individual clinical entities has proven difficult as the result of differences in inter-individual language preferences for symptoms and sensations, characteristics of populations studied and classification systems. Furthermore, research has provided insights into whether individual disorders present clinical and pathophysiological entities or spectra of different sub-conditions. Thus, further investigations will be helpful in unravelling additional aetiological evidence to determine whether these disorders could be expected to be mutually exclusive, whether they might overlap as a result of high prevalence or whether they are at least partially caused by a common pathophysiological mechanism in a separate cluster of individuals.
The international consensus provided in the Montreal definition and classification defines GERD as a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The classification system proposed establishes GERD as being comprised of a set of syndromes; however, it does not provide the aetiology underlying the generation of pathological reflux. In most cases, GERD is anticipated to represent a chronic condition, with its natural history being less well defined and demonstrating disease progression or remission to a variable extent at the individual patient level.
The Rome consensus criteria have provided a foundation for a unified definition of functional GI disorders. Nevertheless, recent reports challenge the concept within the Rome criteria that functional GI disorders are separate entities. Instead, patients are increasingly reported to suffer concomitantly from symptoms attributable to different GI disorders. A recent meta-analysis indicated that subjects with dyspepsia had an eightfold increase in the prevalence of IBS, potentially implying a shared aetiology leading to the development of both disease phenotypes. Although overlap of symptoms may initially complicate the clinical management of the condition, the concept of a common aetiology may provide guidance for therapeutic innovation and lead to opportunities for targeted medical intervention, especially in the difficult-to-treat patient.
Proton pump inhibitors (PPIs), such as lansoprazole/dexlansoprazole, pantoprazole, rabeprazole and omeprazole/esomeprazole, are the treatment of choice in patients with signs and symptoms of pathological gastro-oesophageal reflux. The PPIs have proven to be highly effective drugs for healing and symptom relief in GERD patients with mild-to-severe symptom intensity in both acute and maintenance therapy. However, only limited research is available investigating the efficacy of PPIs in patients suffering from overlap syndromes with functional GI disorders. Therefore, the aim of the current study was to assess the sustainability of healing of reflux oesophagitis, and determine whether the known beneficial effects of PPI treatment with pantoprazole on GERD also extend to symptoms suggestive of FD and IBS in patients with overlapping symptomatology.
Abstract and Introduction
Abstract
Background Gastro-oesophageal reflux disease (GERD), functional dyspepsia (FD) and irritable bowel syndrome (IBS) are highly prevalent gastrointestinal conditions with accumulating evidence of overlap in patients. Despite availability of a vast body of research related to individual disorders, major pharmacological breakthrough in treatment of the overlap condition is still lacking.
Aim To assess sustainability of GERD healing and whether known beneficial effects of proton pump inhibitor treatment on GERD also extend to symptoms suggestive of FD and IBS.
Methods A total of 626 patients with reflux oesophagitis were treated with pantoprazole for up to 16 weeks depending on healing of GERD, followed by an observational phase of up to 6 months without treatment. Rates of patients suffering from GERD, FD or IBS were assessed at baseline, and at last visits of treatment and observational phase.
Results Rates of patients with reflux oesophagitis and concomitantly with reflux symptoms, FD or IBS were each significantly lower after pantoprazole treatment (P < 0.0001). While rates of patients with reflux signs or symptoms increased again during observational phase, rates of FD and IBS were maintained at the low level after cessation of medication (P < 0.0001).
Conclusions Pantoprazole is efficacious in the treatment of patients suffering from signs and symptoms suggesting an overlap of GERD, FD and/or IBS, providing a sustained response post-treatment in FD and IBS symptom categories. Mechanisms underlying the beneficial effects of improvement in reflux oesophagitis on symptoms suggestive of FD or IBS still need to be determined.
Introduction
Functional dyspepsia (FD), irritable bowel syndrome (IBS), and gastro-oesophageal reflux disease (GERD) are highly prevalent and almost endemic gastrointestinal (GI) disorders in the general population. Depending on the diagnostic criteria implemented, prevalence, predominantly in Western populations, is approximately 25% for overall reflux symptoms, 15% for FD and 3–20% for IBS. Recently published studies in Asian populations report prevalence of 8–12% for GERD, 8–10% for FD and 10–14% for IBS. However, symptomatic assessment of the individual clinical entities has proven difficult as the result of differences in inter-individual language preferences for symptoms and sensations, characteristics of populations studied and classification systems. Furthermore, research has provided insights into whether individual disorders present clinical and pathophysiological entities or spectra of different sub-conditions. Thus, further investigations will be helpful in unravelling additional aetiological evidence to determine whether these disorders could be expected to be mutually exclusive, whether they might overlap as a result of high prevalence or whether they are at least partially caused by a common pathophysiological mechanism in a separate cluster of individuals.
The international consensus provided in the Montreal definition and classification defines GERD as a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The classification system proposed establishes GERD as being comprised of a set of syndromes; however, it does not provide the aetiology underlying the generation of pathological reflux. In most cases, GERD is anticipated to represent a chronic condition, with its natural history being less well defined and demonstrating disease progression or remission to a variable extent at the individual patient level.
The Rome consensus criteria have provided a foundation for a unified definition of functional GI disorders. Nevertheless, recent reports challenge the concept within the Rome criteria that functional GI disorders are separate entities. Instead, patients are increasingly reported to suffer concomitantly from symptoms attributable to different GI disorders. A recent meta-analysis indicated that subjects with dyspepsia had an eightfold increase in the prevalence of IBS, potentially implying a shared aetiology leading to the development of both disease phenotypes. Although overlap of symptoms may initially complicate the clinical management of the condition, the concept of a common aetiology may provide guidance for therapeutic innovation and lead to opportunities for targeted medical intervention, especially in the difficult-to-treat patient.
Proton pump inhibitors (PPIs), such as lansoprazole/dexlansoprazole, pantoprazole, rabeprazole and omeprazole/esomeprazole, are the treatment of choice in patients with signs and symptoms of pathological gastro-oesophageal reflux. The PPIs have proven to be highly effective drugs for healing and symptom relief in GERD patients with mild-to-severe symptom intensity in both acute and maintenance therapy. However, only limited research is available investigating the efficacy of PPIs in patients suffering from overlap syndromes with functional GI disorders. Therefore, the aim of the current study was to assess the sustainability of healing of reflux oesophagitis, and determine whether the known beneficial effects of PPI treatment with pantoprazole on GERD also extend to symptoms suggestive of FD and IBS in patients with overlapping symptomatology.
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