New Study: Esophagitis Healing Linked to Gastric Acid Control
Monday May 22, 2006
New clinical data demonstrated a direct relationship between controlling gastric (or stomach) acid and healing erosive esophagitis caused by acid reflux disease.
Results from the multi-site, four-week, double blind trial demonstrated that patients were more likely to achieve healing of erosive esophagitis (EE) if their gastric acid was well controlled after five days of therapy. Gastric acid control was defined as intragastric pH > 4. In patients who were healed of EE acid was well controlled through day five an average of 61.3 percent of the time, compared to 42.1 percent of the time in unhealed patients; p=0.0002. A post hoc analysis showed that healed patients also experienced a longer duration of acid control in the esophagus (95.2 percent of a 24-hour period) compared to unhealed patients (88.9 percent of a 24-hour period), a statistically significant difference (p=0.0059). Better acid control also correlated to significantly lower heartburn and acid regurgitation symptom scores (Spearman rank correlation [r] = -29 percent and -21 percent; p=0.003 and 0.032, respectively).
"This is the first prospective study that showed an association between control of intragastric pH and clinical outcomes in GERD patients," said Philip Katz, MD, lead author of the study. "The results further support intragastric pH as a surrogate marker for assessing the efficacy of antisecretory therapy in GERD."
Acid reflux disease is frequent persistent heartburn (burning pain and pressure in the center of the chest) on two or more days a week. It occurs when the valve between the esophagus and stomach stops closing properly, allowing acid to leak back into the esophagus. About one in three people with frequent, persistent heartburn also experience erosive esophagitis, in which over time stomach acid begins to wear away, or erode, the inner lining of the esophagus. Since the frequency or severity of heartburn a person experiences does not reflect the presence of erosions, only a doctor can determine if damage has occurred.
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Study Details
The trial was a double-blind, prospective study to assess the relationship between the amount of time intragastric pH > 4 and healing in adult patients with endoscopically verified grade C or D of erosive esophagitis (EE), according to the Los Angeles Classification System for grading esophageal inflammation. This system categorizes patients by grades of severity (A-D), with grades A and B indicating mild erosive esophagitis and grades C and D representing severe disease. Patients were randomly given either NEXIUM® 10 mg or 40 mg once daily for four weeks. NEXIUM belongs to a class of acid- suppressing drugs known as proton pump inhibitors (PPIs). The study was not designed to compare the doses but rather to investigate a broad range of acid control. NEXIUM 10mg is not an approved dose. These drugs reduce acid by blocking the action of tiny "pumps" within the acid-secreting cells of the stomach.
Patients underwent an intraesophageal/intragastric 24-hour pH study on day five. When assessing acid control, clinicians measure pH on a 14-point scale, with 7 being neutral and lower numbers being more acidic. At week four, an endoscopist blinded to the pH study evaluated whether or not each patient's erosive esophagitis had healed. In addition, investigators scored patients' acid reflux disease symptoms before treatment and at four weeks, before the final endoscopy. Analyses included patients who completed the pH study and final endoscopy, and met predetermined protocol criteria (n=103). Of this group, 72 patients had healed erosive esophagitis at four weeks.
The study was sponsored by AstraZeneca.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
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Source: AstraZeneca
Results from the multi-site, four-week, double blind trial demonstrated that patients were more likely to achieve healing of erosive esophagitis (EE) if their gastric acid was well controlled after five days of therapy. Gastric acid control was defined as intragastric pH > 4. In patients who were healed of EE acid was well controlled through day five an average of 61.3 percent of the time, compared to 42.1 percent of the time in unhealed patients; p=0.0002. A post hoc analysis showed that healed patients also experienced a longer duration of acid control in the esophagus (95.2 percent of a 24-hour period) compared to unhealed patients (88.9 percent of a 24-hour period), a statistically significant difference (p=0.0059). Better acid control also correlated to significantly lower heartburn and acid regurgitation symptom scores (Spearman rank correlation [r] = -29 percent and -21 percent; p=0.003 and 0.032, respectively).
"This is the first prospective study that showed an association between control of intragastric pH and clinical outcomes in GERD patients," said Philip Katz, MD, lead author of the study. "The results further support intragastric pH as a surrogate marker for assessing the efficacy of antisecretory therapy in GERD."
Acid reflux disease is frequent persistent heartburn (burning pain and pressure in the center of the chest) on two or more days a week. It occurs when the valve between the esophagus and stomach stops closing properly, allowing acid to leak back into the esophagus. About one in three people with frequent, persistent heartburn also experience erosive esophagitis, in which over time stomach acid begins to wear away, or erode, the inner lining of the esophagus. Since the frequency or severity of heartburn a person experiences does not reflect the presence of erosions, only a doctor can determine if damage has occurred.
******
Study Details
The trial was a double-blind, prospective study to assess the relationship between the amount of time intragastric pH > 4 and healing in adult patients with endoscopically verified grade C or D of erosive esophagitis (EE), according to the Los Angeles Classification System for grading esophageal inflammation. This system categorizes patients by grades of severity (A-D), with grades A and B indicating mild erosive esophagitis and grades C and D representing severe disease. Patients were randomly given either NEXIUM® 10 mg or 40 mg once daily for four weeks. NEXIUM belongs to a class of acid- suppressing drugs known as proton pump inhibitors (PPIs). The study was not designed to compare the doses but rather to investigate a broad range of acid control. NEXIUM 10mg is not an approved dose. These drugs reduce acid by blocking the action of tiny "pumps" within the acid-secreting cells of the stomach.
Patients underwent an intraesophageal/intragastric 24-hour pH study on day five. When assessing acid control, clinicians measure pH on a 14-point scale, with 7 being neutral and lower numbers being more acidic. At week four, an endoscopist blinded to the pH study evaluated whether or not each patient's erosive esophagitis had healed. In addition, investigators scored patients' acid reflux disease symptoms before treatment and at four weeks, before the final endoscopy. Analyses included patients who completed the pH study and final endoscopy, and met predetermined protocol criteria (n=103). Of this group, 72 patients had healed erosive esophagitis at four weeks.
The study was sponsored by AstraZeneca.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
******
Source: AstraZeneca
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