Pantoprazole On-Demand Effectively Treats Symptoms in Patients with GERD
Pantoprazole On-Demand Effectively Treats Symptoms in Patients with GERD
Objective: The efficacy of pantoprazole as on-demand therapy for the long-term management of patients with mild gastro-oesophageal reflux disease (GORD) has been demonstrated in clinical studies. In this study, the efficacy of pantoprazole 20mg and esomeprazole 20mg as on-demand therapy for relief of symptoms of mild GORD was compared.
Methods: Patients with reflux oesophagitis grade A or B (Los Angeles classification) or endoscopy-negative reflux disease (enGORD) were treated with pantoprazole 20mg once daily for 28 days during the acute phase (AP, n = 236). Patients without heartburn during the final 3 days of the AP entered the long-term phase (LTP, n = 199) and were randomised to either pantoprazole 20mg or esomeprazole 20mg as on-demand treatment for 6 months. Antacids were provided as rescue medication during this phase. The mean intensities of the symptoms of heartburn, acid eructation and pain on swallowing, both separately and as a combined symptom score, together with the mean duration of these symptoms during on-demand treatment, were compared between the two treatment groups. The number of tablets taken was also compared.
Results: After 4 weeks of treatment with pantoprazole, 87.3% of patients had relief from heartburn, 74.1% from epigastric pain and 80.8% from acid eructation, according to the investigator assessment. A total of 236 patients were eligible for the on-demand phase. Based on patient diary data, on-demand treatment with pantoprazole resulted in significantly lower mean intensity of heartburn compared with that in the esomeprazole group (1.12 for pantoprazole and 1.32 for esomeprazole, respectively [p = 0.012], in the intention-to-treat [ITT] population). The mean symptom intensities of acid eructation and pain on swallowing, together with the duration of these symptoms, were comparable in the two treatment groups. The combined symptom score of the three symptoms heartburn, acid eructation and pain on swallowing was numerically lower in the pantoprazole group compared with the esomeprazole group (1.72 vs 1.99, respectively, in the ITT population). Tablet intake was comparable in both groups. Relief of symptoms in Helicobacter pylori-positive and -negative patients was also similar in both treatment groups. Both treatments were well tolerated with a good safety profile.
Conclusion: On-demand therapy with either pantoprazole 20mg or esomeprazole 20mg is a comparably effective treatment strategy for the long-term treatment of non-erosive and mild GORD. However, the mean intensity of heartburn was significantly lower with pantoprazole treatment.
Gastro-oesophageal reflux disease (GORD) is a common condition with a broad spectrum of symptoms, including heartburn, acid eructation and pain on swallowing. Heartburn has been reported to occur in approximately 20-40% of adults. The symptoms of GORD vary in severity and frequency but correlate significantly with the pH of refluxate. However, the majority of patients with GORD-related symptoms have no endoscopic evidence of oesophagitis. Furthermore, endoscopy-negative patients have symptom severities comparable to those with erosive disease.
Because of its chronic relapsing character, GORD has a significant negative impact on quality of life. Symptom severity correlates closely with quality of life, regardless of the presence or absence of oesophagitis. Relapse of symptoms is very common after cessation of treatment in patients with erosive or endoscopy-negative (en)GORD. Indeed, it is well established that approximately 75% of GORD patients, regardless of endoscopic status, will experience a relapse within 6 months of cessation of short-term acid suppressant therapy. Hence, symptom relief and prevention of relapse are the primary goals of therapy for the majority of patients with GORD, while healing is also an important outcome for patients with erosive oesophagitis and/or complications.
It has been shown that therapy with proton pump inhibitors (PPIs) is superior to alternative medications in patients with GORD-related symptoms. PPIs readily cross the membrane of active acid-secreting parietal cells of the gastric mucosa and form in their highly acidic canaliculi covalent disulphide bonds with cysteine residues in the a-subunit of H/K-ATPase. PPIs currently constitute the most effective pharmacological means of achieving symptom resolution, healing of oesophagitis and prevention of relapse in patients with GORD.
For many patients with mild and infrequent GORD symptoms, it is now widely believed that on-demand therapy offers a reasonable approach for long-term treatment. It is common for patients with mild GORD to use a PPI only when symptoms demand. On-demand therapy with pantoprazole 20mg for example is effective in patients with symptomatic GORD or mild oesophagitis, and the most effective therapy is likely to be the most cost-effective one. Initial therapy with a PPI followed by on-demand PPI treatment seems to be the most cost-effective approach to long-term management of mild to severe GORD.
The aim of this multicentre pilot study was to investigate the symptom pattern in patients with mild GORD taking long-term (24 weeks) on-demand treatment. In addition, the mean symptom intensities and the mean symptom duration in patients with non-erosive and mild reflux disease during 6 months of on-demand treatment with pantoprazole 20mg or esomeprazole 20mg were compared.
Abstract and Introduction
Abstract
Objective: The efficacy of pantoprazole as on-demand therapy for the long-term management of patients with mild gastro-oesophageal reflux disease (GORD) has been demonstrated in clinical studies. In this study, the efficacy of pantoprazole 20mg and esomeprazole 20mg as on-demand therapy for relief of symptoms of mild GORD was compared.
Methods: Patients with reflux oesophagitis grade A or B (Los Angeles classification) or endoscopy-negative reflux disease (enGORD) were treated with pantoprazole 20mg once daily for 28 days during the acute phase (AP, n = 236). Patients without heartburn during the final 3 days of the AP entered the long-term phase (LTP, n = 199) and were randomised to either pantoprazole 20mg or esomeprazole 20mg as on-demand treatment for 6 months. Antacids were provided as rescue medication during this phase. The mean intensities of the symptoms of heartburn, acid eructation and pain on swallowing, both separately and as a combined symptom score, together with the mean duration of these symptoms during on-demand treatment, were compared between the two treatment groups. The number of tablets taken was also compared.
Results: After 4 weeks of treatment with pantoprazole, 87.3% of patients had relief from heartburn, 74.1% from epigastric pain and 80.8% from acid eructation, according to the investigator assessment. A total of 236 patients were eligible for the on-demand phase. Based on patient diary data, on-demand treatment with pantoprazole resulted in significantly lower mean intensity of heartburn compared with that in the esomeprazole group (1.12 for pantoprazole and 1.32 for esomeprazole, respectively [p = 0.012], in the intention-to-treat [ITT] population). The mean symptom intensities of acid eructation and pain on swallowing, together with the duration of these symptoms, were comparable in the two treatment groups. The combined symptom score of the three symptoms heartburn, acid eructation and pain on swallowing was numerically lower in the pantoprazole group compared with the esomeprazole group (1.72 vs 1.99, respectively, in the ITT population). Tablet intake was comparable in both groups. Relief of symptoms in Helicobacter pylori-positive and -negative patients was also similar in both treatment groups. Both treatments were well tolerated with a good safety profile.
Conclusion: On-demand therapy with either pantoprazole 20mg or esomeprazole 20mg is a comparably effective treatment strategy for the long-term treatment of non-erosive and mild GORD. However, the mean intensity of heartburn was significantly lower with pantoprazole treatment.
Introduction
Gastro-oesophageal reflux disease (GORD) is a common condition with a broad spectrum of symptoms, including heartburn, acid eructation and pain on swallowing. Heartburn has been reported to occur in approximately 20-40% of adults. The symptoms of GORD vary in severity and frequency but correlate significantly with the pH of refluxate. However, the majority of patients with GORD-related symptoms have no endoscopic evidence of oesophagitis. Furthermore, endoscopy-negative patients have symptom severities comparable to those with erosive disease.
Because of its chronic relapsing character, GORD has a significant negative impact on quality of life. Symptom severity correlates closely with quality of life, regardless of the presence or absence of oesophagitis. Relapse of symptoms is very common after cessation of treatment in patients with erosive or endoscopy-negative (en)GORD. Indeed, it is well established that approximately 75% of GORD patients, regardless of endoscopic status, will experience a relapse within 6 months of cessation of short-term acid suppressant therapy. Hence, symptom relief and prevention of relapse are the primary goals of therapy for the majority of patients with GORD, while healing is also an important outcome for patients with erosive oesophagitis and/or complications.
It has been shown that therapy with proton pump inhibitors (PPIs) is superior to alternative medications in patients with GORD-related symptoms. PPIs readily cross the membrane of active acid-secreting parietal cells of the gastric mucosa and form in their highly acidic canaliculi covalent disulphide bonds with cysteine residues in the a-subunit of H/K-ATPase. PPIs currently constitute the most effective pharmacological means of achieving symptom resolution, healing of oesophagitis and prevention of relapse in patients with GORD.
For many patients with mild and infrequent GORD symptoms, it is now widely believed that on-demand therapy offers a reasonable approach for long-term treatment. It is common for patients with mild GORD to use a PPI only when symptoms demand. On-demand therapy with pantoprazole 20mg for example is effective in patients with symptomatic GORD or mild oesophagitis, and the most effective therapy is likely to be the most cost-effective one. Initial therapy with a PPI followed by on-demand PPI treatment seems to be the most cost-effective approach to long-term management of mild to severe GORD.
The aim of this multicentre pilot study was to investigate the symptom pattern in patients with mild GORD taking long-term (24 weeks) on-demand treatment. In addition, the mean symptom intensities and the mean symptom duration in patients with non-erosive and mild reflux disease during 6 months of on-demand treatment with pantoprazole 20mg or esomeprazole 20mg were compared.
