159

EFFECT OF ORAL ESOMEPRAZOLE (20, 40, 80mg) AND PANTOPRAZOLE (20, 40, 80mg) ON INTRAGASTRIC pH IN PATIENTS WITH SYMPTOMS OF GERD

C Wilder-Smith¹, A Backlund², G Eckerwall², T Lind², C Lundin², A Sandelin², M Fjellman², K Röhss²¹
¹Brain-Gut Research Group, Gastroenterology Group Practice, Berne, Switzerland; ²AstraZeneca R&D, Mölndal, Sweden

AIMS: To assess whether doubling the standard doses of esomeprazole (E) and pantoprazole (P) increases acid control in patients with symptoms of gastroesophageal reflux disease (GERD).
METHODS: In this open-label, single-center, randomized, six-way crossover study patients received E20, 40 and 80mg, and P20, 40 and 80mg once daily for 5d, with a washout period of <=13d between treatments. Continuous 24-h intragastric pH was recorded using a glass microelectrode on day 5 of each treatment period. Estimated differences in mean % time with intragastric pH>4 and median pH were analyzed using a mixed-model ANOVA.
RESULTS: 39 patients (22 men; mean age: 30y) were randomized. Dose escalation for both drugs increased acid control (Table). E20 provided significantly greater 24-h acid control than both P20 and P40 (% time pH>4: 47.3%, 28.6% and 37.5%, respectively), and E40 provided significantly greater 24-h acid control than both P40 and P80 (58.6%, 37.5% and 44.3%, respectively). E80 achieved acid control (pH>4) for 65.6% of the 24-h interval.

Comparison N Estimated mean difference (95% CI) Intragastric pH >4 (% time) Estimated mean difference (95% CI) Median pH
E40 v E20 36 10.9 (5.4,16.4)*** 0.53 (0.24,0.83)***
E80 v E40 35 6.9 (2.2,11.5)** 0.28 (0.05,0.51)*
P40 v P20 35 8.5 (3.0,14.1)** 0.53 (0.20,0.86)**
P80 v P40 36 7.1 (2.7,11.4)** 0.40 (0.14,0.65)**
E20 v P 20 35 18.2 (13.8,22.7)*** 1.08 (0.83,1.34)***
E20 v P40 35 9.8 (5.0,14.7)*** 0.52 (0.26,0.78)***
E20 v P80 36 2.4 (-2.5,7.3) 0.09 (-0.13,0.32)
E40 v P40 35 21.3 (16.5,26.1)*** 1.09 (0.83,1.34)***
E40 v P80 36 14.1 (9.7,18.5)*** 0.70 (0.45,0.94)***
E80 v P80 36 22.1 (17.9,26.4)*** 1.03 (0.81,1.25)***
*p<0.05, **p<0.01, ***p<0.001

CONCLUSION: These results demonstrate that doubling the doses of E and P up to 80mg significantly increases acid control. However, an 80mg dose of P was not shown to result in better acid control than a 20mg or 40mg dose of E in patients with symptoms of GERD.
Supported by AstraZeneca. CWS has received research funding from AstraZeneca; all other authors are employees of AstraZeneca

PREVIOUS NEXT

Comparison	N	Estimated mean difference (95% CI) Intragastric pH >4 (% time)	Estimated mean difference (95% CI) Median pH
E40 v E20	36	10.9 (5.4,16.4)***	0.53 (0.24,0.83)***
E80 v E40	35	6.9 (2.2,11.5)**	0.28 (0.05,0.51)*
P40 v P20	35	8.5 (3.0,14.1)**	0.53 (0.20,0.86)**
P80 v P40	36	7.1 (2.7,11.4)**	0.40 (0.14,0.65)**
E20 v P 20	35	18.2 (13.8,22.7)***	1.08 (0.83,1.34)***
E20 v P40	35	9.8 (5.0,14.7)***	0.52 (0.26,0.78)***
E20 v P80	36	2.4 (-2.5,7.3)	0.09 (-0.13,0.32)
E40 v P40	35	21.3 (16.5,26.1)***	1.09 (0.83,1.34)***
E40 v P80	36	14.1 (9.7,18.5)***	0.70 (0.45,0.94)***
E80 v P80	36	22.1 (17.9,26.4)***	1.03 (0.81,1.25)***
p<0.05, p<0.01, **p<0.001