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Creating
new analytical methods to predict elevated esophageal acidity
Probing further into the Janssen data, SFO's analysis showed that integrated gastric acidity after a meal was a particularly robust measure of meal-stimulated secretion. Furthermore, GERD patients had significantly greater meal-stimulated gastric acid secretion than did control subjects. Finally, the analysis showed that it is possible to predict the probability of pathological esophageal acid exposure from the value of gastric acidity after eating. As a result of these findings, clients of SFO, such as Santarus Inc., could estimate the effect of their drugs that inhibited gastric acid secretion on esophageal acid exposure by measuring gastric pH alone. [View the details in References 336 and 337.] Showing how symptom severity can be used to predict elevated esophageal acidity Determining integrated acidity from recordings of esophageal pH made it possible to show that the severity of heartburn in GERD patients could be used to predict the probability of esophageal acid exposure with high reliability. [View the detailed results in Reference 338.] This finding was important because some investigators and regulatory authorities had maintained that no apparent relationship existed between esophageal acid and heartburn, and would not accept measures of esophageal pH as a surrogate for symptom relief in GERD patients. |