Demographic and Baseline Characteristics of GERD Patients Based on Data From the Dexlansoprazole MR Clinical Trial Program Relative to Earlier Lansoprazole Trials: 16
Abstract
Purpose: To assess whether baseline characteristics of subjects participating in clinical studies of GERD treatments have changed over time. Methods: This is a retrospective analysis of demographic and baseline characteristics of patients enrolled in Phase 3 prospective clinical trials for dexlansoprazole MR (DEX) that began in 2005. Subjects underwent endoscopy before randomization into symptomatic nonerosive GERD (NERD) or erosive esophagitis (EE) healing trials, which were targeted to recruit about 30% of patients with Grades C and D EE. For comparison, data are presented from the lansoprazole (LAN) clinical trial program, which began in 1987, to assess any shift in the epidemiology of GERD over the intervening 18 years. Results: DEX pivotal studies enrolled 5947 US and ex-US patients (EE, n=4092; NERD, n=1855). LAN trials before approval included 2752 evaluable US patients from 1988-1994 (EE, n=1737) and 1995-1997 (NERD, n=1015); an additional 3510 EE patients participated in a 1999 trial. NERD patients tend to be female, a trend that appears to be accelerating (LAN studies, 58%; DEX studies, 71%, Table). Over time, alcohol use seems to be rising. More patients had milder EE in the 1999 LAN trial and DEX trials than in earlier LAN trials. Even with the enrichment of LA grade C & D EE patients in DEX trials, the distribution of severity appears similar between the DEX and the 1999 LAN trial.TableConclusion: The demography of GERD study subjects has remained fairly stable…
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