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M1914 The Effect of Obesity, Smoking, and Age On Healing of Los Angeles Grade C and D Erosive Esophagitis (EE)
ratio [OR]: 1.72 [95% CI, 1.15-2.58], P=0.0089). Among patients receiving LAN, baseline EE grade had a significant impact on healing rates (C vs D, OR: 2.95 [95% CI, 1.72-5.07], P<0.0001); healing rates were lower in smokers (59.4%) vs nonsmokers (76.1%, OR: 0.46; P=0.0033), those aged <45 years (64.1%) vs ≥65 years (77.6%, OR: 0.55) or 45-<65 years (77.6%, OR: 0.54; P=0.0444 for age groups), or those with BMI <25 (60.0%) vs ≥30 (74.2%, OR: 0.43) or 25-<30 (73.8%, OR: 0.52; P=0.0383 for BMI groups). CONCLUSIONS 1) TAK-390MR was more effective than LAN in patients with grade C and D esophagitis. 2) Healing rates with LAN but not TAK-390MR were influenced by obesity, age, or smoking. 3) Prolonging the duration of acid control with a PPI that employs modified-release technology may improve healing in Grade C and D esophagitis. M1915
M1913 Efficacy of Addition of Prokinetics for Proton Pump Inhibitor (PPI)-Resistant Non-Erosive Reflux Disease (NERD) Patients: Significance of Frequency Scale for the Symptoms of GERD(FSSG) On Decision of Treatment Strategy Masaki Miyamoto, Keisuke Takeuchi, Ken Haruma
A Randomized, Comparative Trial of the Speed of Onset of Symptom Relief of Gastroesophageal Reflux Disease By the Proton Pump Inhibitors: Rabeprazole vs Lansoprazole vs Omeprazole Masaki Miyamoto, Keisuke Takeuchi, Ken Haruma
Aims: We investigated whether the pretreatment score of FSSG, a screening tool of GERD, in NERD patients is effective to predict PPI-resistance and to determine treatment strategy with comparison to reflux esophagitis (RE). Methods: 118 RE patients (male/female: 66/ 52, 51.6±16.4 years) and 349 NERD patients (male/female: 122/227, 46.0±16.5 years) with reflux symptoms were enrolled. PPI was administered for 2 weeks, and questions(Q) on total score (TS), 7 Q of reflux symptoms(reflux score: RS), and 5 Q on dyspeptic symptoms(dyspeptic score: DS) were assessed using FSSG. Improvement <50% in TS was defined as PPI-resistant. Furthermore, effect of additional prokinetics (2-6 weeks) for 117 PPIresistant NERD patients was also examined using FSSG. Results: 1.Higher tendency of PPI-resistant NERD (52.7%, 184/349) than PPI-resistant RE (42.4%, 50/118) (P=0.0516). 2.Factors to be PPI-resistant a)RE group: younger age and higher score in Q-No.8 (satiety during meals) of FSSG b)NERD group: younger age, complication of constipation, higher TS, DS, Q-No.2 (bloated stomach), Q-No.3 (heavy stomach), Q-No.5 (sick feeling after meal), Q-No.8 (satiety during meal) of FSSG. 3.Addition of prokinetics for PPI-resistant NERD or RE patients a)Significant improvement in TS-FSSG after the addition (pretreatment: 17.4±7.7 vs. 2 weeks 14.6±6.0% vs. 6 weeks 7.7±5.2%, P<0.0001) b)Significant improvement in DS at 6 weeks despite worsen at 2 weeks (2 weeks: -11.5±9.0% vs 6 weeks: 36.7±7.8%, P<0.0001) Conclusions: Younger and high score of Q-No.8 in FSSG were factors influencing PPI-resistant NERD and RE. Constipation, high TS, DS, Q-No.2, Q-No.3 and Q-No.5 were specific factors in PPI-resistant NERD. As high DS co-relates with PPI-resistant in NERD, it is indicated that patients with strong dysmotility and Functional Dyspepsia (FD) complication might be PPI-resistant. Efficacy of additional prokinetics for PPI-resistant NERD patients was observed.
Background: Proton pump inhibitors (PPIs) are the first choice for the treatment of gastroesophageal reflux disease (GERD), and a direct link between rapid onset of symptom relief and improvement of QOL has been reported. However, few studies have examined symptoms on a daily basis and reported the speed of onset of symptom relief in the early stage of therapy. A comparative, 14-day study of the speed of onset of symptom relief in Japanese GERD patients was conducted using rabeprazole (RPZ), lansoprazole (LPZ), and omeprazole (OPZ). Methods: 342 GERD patients (age: 46.2±15.8 years, male/female: 137/205, RE/ NERD: 82/260) were randomized into 5 groups and given 14-day therapy with RPZ 10 mg/ day (R10: n=83), LPZ 15 mg/day (L15: n=62), LPZ 30 mg/day (L30: n=69), OPZ 10 mg/ day (O10: n=56), or OPZ 20 mg/day (O20: n=72). All daily doses are approved in Japan. Patients filled in a self-completed questionnaire every day for 14 days, with pretreatment symptom level as 10 points. Results: 1. Scores were significantly lower from day 1 with all regimens (P<0.001), and they remained to Day 14. 2. Day 1 scores: R10, 6.7±0.3; O20, 7.9±0.2; O10, 8.0±0.2; L30, 8.6±0.3; L15: 9.4±0.2 A significantly lower score was seen with R10 over other regimens (P<0.05). No inter-group differences were seen on Day 11. 3. Days to achieve 50% improvement: R10, 3.6±0.4; O10, 4.2±0.4; O20, 4.6±0.4; L30, 5.3±0.4; L15, 6.3±0.4 Significantly faster improvement was seen with R10 over L15 and L30, and with O10 and O20 over L15 (P<0.05) 4. Speed of onset in RE and NERD: Significantly faster improvement was seen in R10 over other regimens in both RE and NERD. Disappearance of Inter-group differences occurred earlier in NERD (day 8) than in RE (day 11). Conclusions: All PPI regimens showed significant efficacy for symptom relief from day 1 during 14-day administration; however, inter-group differences were observed, and R10 showed the fastest onset. Inter-group differences were also observed at the early stage; however, the duration of differences appeared to disappear earlier in NERD than in RE.
M1916
The Effect of Obesity, Smoking, and Age On Healing of Los Angeles Grade C and D Erosive Esophagitis (EE) Nimish B. Vakil, M. Claudia Perez, Cong Han, Betsy L. Pilmer
On-Demand Proton Pump Inhibitor Therapy for Erosive Gastroesophageal Reflex Disease in Japanese Patients Hiroyuki Unakami, Tomoyuki Koike, Shuichi Ohara, Wataru Iwai, Toru Horii, Ryosuke Kikuchi, Shigeyuki Kobayashi, Yasuhiko Abe, Katsunori Iijima, Akira Imatani, Tooru Shimosegawa
BACKGROUND Obesity (increased intragastric and transgastric pressure), smoking (relaxed lower esophageal sphincter), and increasing age (deteriorating esophageal function) are associated with more severe EE. It is unknown whether these factors influence healing rates in patients treated with proton pump inhibitors (PPIs). We assessed the impact of obesity, smoking, age, and other baseline characteristics on healing of moderate-to-severe EE (LA Grade C and D) using logistic regression analyses. METHODS: In this retrospective analysis, we evaluated 1133 adult patients enrolled in two randomized controlled trials treated with TAK-390MR 60 (n=376) or 90 mg (n=367), a modified-release PPI designed to extend the duration of acid suppression, or conventional lansoprazole (LAN) 30 mg (n=390), once daily for up to 8 weeks. Week 8 healing in each TAK-390MR group was compared with LAN using Cochran-Mantel-Haenszel tests stratified by baseline grade, age, sex, BMI, smoking, alcohol use, and caffeine use; statistical significance was determined at 0.05 using Hochberg's adjustment for multiplicity. 2 stepwise logistic regression models were separately fitted for Week 8 healing among patients treated with TAK-390MR or LAN. Initial models included as predictors baseline grade, dose (TAK-390MR only), and the aforementioned subgroup factors. RESULTS TAK-390MR produced significantly higher healing rates than LAN 30 mg after adjusting for baseline grade and subgroup factor. Crude healing rates were 81.5%, 81.3%, and 76.0% in patients with EE grade C at baseline after treatment with TAK390MR 60 and 90 mg and LAN 30 mg, respectively, and 67.6%, 75.9%, and 56.1% for patients with EE grade D. Logistic regression models showed that subgroup factors did not affect healing rates in patients receiving TAK-390MR except baseline EE grade C vs D (odds
Aims: On-demand proton pump inhibitor (PPI) therapy is effective in maintaining symptomatic control in mild gastroesophageal reflex disease (GERD). However, few studies have examined the effectiveness of on-demand therapy in Japanese patients with erosive GERD. The aims of this study were to evaluate the efficacy of PPIs as on-demand therapy, and to compare the effects of rabeprazole (RPZ) 10 mg and lansoprazole (LPZ) 15 mg in Japanese patients with erosive GERD. Methods: Forty-one patients with symptomatic erosive GERD were treated with a PPI for at least 8 weeks. Endoscopically healed patients were randomized to either RPZ 10mg (n=24) or LPZ 15 mg (n=17) on-demand therapy for 12 weeks. Their symptoms were evaluated using the frequency scale for the symptoms of GERD (FSSG), a GERD-specific questionnaire developed in Japan (J Gastroenterol 2004; 39: 888-91, Dig Dis Sci 2007; 52: 1673-7) before and after 4, 8 and 12 weeks of on-demand therapy. Results: There were no significant differences in patient characteristics, including FSSG scores, before on-demand therapy between the 2 treatment groups. No significant differences in mean PPI usage (tablets/day) were seen between groups (RPZ 0.48±0.06 vs LPZ 0.36±0.05 /1-4 weeks; RPZ 0.43±0.06 vs LPZ 0.37±0.06 /5-8 weeks; RPZ 0.45±0.06 vs LPZ 0.34±0.07 /9-12 weeks). The total FSSG score in the LPZ group was significantly higher after 4 (4.24±1.28, P=0.009) and 12 weeks (2.71±0.070, P=0.045) than before on-demand therapy (1.71±0.57). The reflux score in the LPZ group was also significantly higher after 4 (2.35±0.78, P=0.023) and 12 weeks (1.65±0.45, P=0.021) than before on-demand therapy (0.88±0.34), and the acid-related dyspepsia score was significantly higher after 4 weeks (1.88±0.56, P=0.025) than before on-demand therapy (0.82±0.30). No significant differences in the total FSSG,
M1914
A-445
AGA Abstracts
AGA Abstracts
revealed non-erosive reflux disease (NERD) in 54%, of whom 55% were classified as disadvantaged SES. Univariate analyses did not show associations of lifestyle factors (BMI, smoking, alcohol, marital status) and change in SSS. However, employment status was associated with improvement of SSS (p=.029). In Multiple Linear Regression the set of possible predictors did not explain a significant proportion of differences in symptom severity (p=.099) only SES & employment status were significant. Employed status was associated with less improvement in SSS (2.6 pts < unemployed; p=.008) as was average SES compared to advantaged (3.6 pts < advantaged SES; p=.021). CONCLUSIONS: a) The improvement in reflux symptoms after diagnostic work-up and initiation of therapy in a routine clinical setting can be partly explained by sociodemographic factors b) Paradoxically, advantaged SES and unemployment are each associated with greater improvement of reflux symptoms.
M1913 Efficacy of Addition of Prokinetics for Proton Pump Inhibitor (PPI)-Resistant Non-Erosive Reflux Disease (NERD) Patients: Significance of Frequency Scale for the Symptoms of GERD(FSSG) On Decision of Treatment Strategy Masaki Miyamoto, Keisuke Takeuchi, Ken Haruma
A Randomized, Comparative Trial of the Speed of Onset of Symptom Relief of Gastroesophageal Reflux Disease By the Proton Pump Inhibitors: Rabeprazole vs Lansoprazole vs Omeprazole Masaki Miyamoto, Keisuke Takeuchi, Ken Haruma
Aims: We investigated whether the pretreatment score of FSSG, a screening tool of GERD, in NERD patients is effective to predict PPI-resistance and to determine treatment strategy with comparison to reflux esophagitis (RE). Methods: 118 RE patients (male/female: 66/ 52, 51.6±16.4 years) and 349 NERD patients (male/female: 122/227, 46.0±16.5 years) with reflux symptoms were enrolled. PPI was administered for 2 weeks, and questions(Q) on total score (TS), 7 Q of reflux symptoms(reflux score: RS), and 5 Q on dyspeptic symptoms(dyspeptic score: DS) were assessed using FSSG. Improvement <50% in TS was defined as PPI-resistant. Furthermore, effect of additional prokinetics (2-6 weeks) for 117 PPIresistant NERD patients was also examined using FSSG. Results: 1.Higher tendency of PPI-resistant NERD (52.7%, 184/349) than PPI-resistant RE (42.4%, 50/118) (P=0.0516). 2.Factors to be PPI-resistant a)RE group: younger age and higher score in Q-No.8 (satiety during meals) of FSSG b)NERD group: younger age, complication of constipation, higher TS, DS, Q-No.2 (bloated stomach), Q-No.3 (heavy stomach), Q-No.5 (sick feeling after meal), Q-No.8 (satiety during meal) of FSSG. 3.Addition of prokinetics for PPI-resistant NERD or RE patients a)Significant improvement in TS-FSSG after the addition (pretreatment: 17.4±7.7 vs. 2 weeks 14.6±6.0% vs. 6 weeks 7.7±5.2%, P<0.0001) b)Significant improvement in DS at 6 weeks despite worsen at 2 weeks (2 weeks: -11.5±9.0% vs 6 weeks: 36.7±7.8%, P<0.0001) Conclusions: Younger and high score of Q-No.8 in FSSG were factors influencing PPI-resistant NERD and RE. Constipation, high TS, DS, Q-No.2, Q-No.3 and Q-No.5 were specific factors in PPI-resistant NERD. As high DS co-relates with PPI-resistant in NERD, it is indicated that patients with strong dysmotility and Functional Dyspepsia (FD) complication might be PPI-resistant. Efficacy of additional prokinetics for PPI-resistant NERD patients was observed.
Background: Proton pump inhibitors (PPIs) are the first choice for the treatment of gastroesophageal reflux disease (GERD), and a direct link between rapid onset of symptom relief and improvement of QOL has been reported. However, few studies have examined symptoms on a daily basis and reported the speed of onset of symptom relief in the early stage of therapy. A comparative, 14-day study of the speed of onset of symptom relief in Japanese GERD patients was conducted using rabeprazole (RPZ), lansoprazole (LPZ), and omeprazole (OPZ). Methods: 342 GERD patients (age: 46.2±15.8 years, male/female: 137/205, RE/ NERD: 82/260) were randomized into 5 groups and given 14-day therapy with RPZ 10 mg/ day (R10: n=83), LPZ 15 mg/day (L15: n=62), LPZ 30 mg/day (L30: n=69), OPZ 10 mg/ day (O10: n=56), or OPZ 20 mg/day (O20: n=72). All daily doses are approved in Japan. Patients filled in a self-completed questionnaire every day for 14 days, with pretreatment symptom level as 10 points. Results: 1. Scores were significantly lower from day 1 with all regimens (P<0.001), and they remained to Day 14. 2. Day 1 scores: R10, 6.7±0.3; O20, 7.9±0.2; O10, 8.0±0.2; L30, 8.6±0.3; L15: 9.4±0.2 A significantly lower score was seen with R10 over other regimens (P<0.05). No inter-group differences were seen on Day 11. 3. Days to achieve 50% improvement: R10, 3.6±0.4; O10, 4.2±0.4; O20, 4.6±0.4; L30, 5.3±0.4; L15, 6.3±0.4 Significantly faster improvement was seen with R10 over L15 and L30, and with O10 and O20 over L15 (P<0.05) 4. Speed of onset in RE and NERD: Significantly faster improvement was seen in R10 over other regimens in both RE and NERD. Disappearance of Inter-group differences occurred earlier in NERD (day 8) than in RE (day 11). Conclusions: All PPI regimens showed significant efficacy for symptom relief from day 1 during 14-day administration; however, inter-group differences were observed, and R10 showed the fastest onset. Inter-group differences were also observed at the early stage; however, the duration of differences appeared to disappear earlier in NERD than in RE.
M1916
The Effect of Obesity, Smoking, and Age On Healing of Los Angeles Grade C and D Erosive Esophagitis (EE) Nimish B. Vakil, M. Claudia Perez, Cong Han, Betsy L. Pilmer
On-Demand Proton Pump Inhibitor Therapy for Erosive Gastroesophageal Reflex Disease in Japanese Patients Hiroyuki Unakami, Tomoyuki Koike, Shuichi Ohara, Wataru Iwai, Toru Horii, Ryosuke Kikuchi, Shigeyuki Kobayashi, Yasuhiko Abe, Katsunori Iijima, Akira Imatani, Tooru Shimosegawa
BACKGROUND Obesity (increased intragastric and transgastric pressure), smoking (relaxed lower esophageal sphincter), and increasing age (deteriorating esophageal function) are associated with more severe EE. It is unknown whether these factors influence healing rates in patients treated with proton pump inhibitors (PPIs). We assessed the impact of obesity, smoking, age, and other baseline characteristics on healing of moderate-to-severe EE (LA Grade C and D) using logistic regression analyses. METHODS: In this retrospective analysis, we evaluated 1133 adult patients enrolled in two randomized controlled trials treated with TAK-390MR 60 (n=376) or 90 mg (n=367), a modified-release PPI designed to extend the duration of acid suppression, or conventional lansoprazole (LAN) 30 mg (n=390), once daily for up to 8 weeks. Week 8 healing in each TAK-390MR group was compared with LAN using Cochran-Mantel-Haenszel tests stratified by baseline grade, age, sex, BMI, smoking, alcohol use, and caffeine use; statistical significance was determined at 0.05 using Hochberg's adjustment for multiplicity. 2 stepwise logistic regression models were separately fitted for Week 8 healing among patients treated with TAK-390MR or LAN. Initial models included as predictors baseline grade, dose (TAK-390MR only), and the aforementioned subgroup factors. RESULTS TAK-390MR produced significantly higher healing rates than LAN 30 mg after adjusting for baseline grade and subgroup factor. Crude healing rates were 81.5%, 81.3%, and 76.0% in patients with EE grade C at baseline after treatment with TAK390MR 60 and 90 mg and LAN 30 mg, respectively, and 67.6%, 75.9%, and 56.1% for patients with EE grade D. Logistic regression models showed that subgroup factors did not affect healing rates in patients receiving TAK-390MR except baseline EE grade C vs D (odds
Aims: On-demand proton pump inhibitor (PPI) therapy is effective in maintaining symptomatic control in mild gastroesophageal reflex disease (GERD). However, few studies have examined the effectiveness of on-demand therapy in Japanese patients with erosive GERD. The aims of this study were to evaluate the efficacy of PPIs as on-demand therapy, and to compare the effects of rabeprazole (RPZ) 10 mg and lansoprazole (LPZ) 15 mg in Japanese patients with erosive GERD. Methods: Forty-one patients with symptomatic erosive GERD were treated with a PPI for at least 8 weeks. Endoscopically healed patients were randomized to either RPZ 10mg (n=24) or LPZ 15 mg (n=17) on-demand therapy for 12 weeks. Their symptoms were evaluated using the frequency scale for the symptoms of GERD (FSSG), a GERD-specific questionnaire developed in Japan (J Gastroenterol 2004; 39: 888-91, Dig Dis Sci 2007; 52: 1673-7) before and after 4, 8 and 12 weeks of on-demand therapy. Results: There were no significant differences in patient characteristics, including FSSG scores, before on-demand therapy between the 2 treatment groups. No significant differences in mean PPI usage (tablets/day) were seen between groups (RPZ 0.48±0.06 vs LPZ 0.36±0.05 /1-4 weeks; RPZ 0.43±0.06 vs LPZ 0.37±0.06 /5-8 weeks; RPZ 0.45±0.06 vs LPZ 0.34±0.07 /9-12 weeks). The total FSSG score in the LPZ group was significantly higher after 4 (4.24±1.28, P=0.009) and 12 weeks (2.71±0.070, P=0.045) than before on-demand therapy (1.71±0.57). The reflux score in the LPZ group was also significantly higher after 4 (2.35±0.78, P=0.023) and 12 weeks (1.65±0.45, P=0.021) than before on-demand therapy (0.88±0.34), and the acid-related dyspepsia score was significantly higher after 4 weeks (1.88±0.56, P=0.025) than before on-demand therapy (0.82±0.30). No significant differences in the total FSSG,
M1914
A-445
AGA Abstracts
AGA Abstracts
revealed non-erosive reflux disease (NERD) in 54%, of whom 55% were classified as disadvantaged SES. Univariate analyses did not show associations of lifestyle factors (BMI, smoking, alcohol, marital status) and change in SSS. However, employment status was associated with improvement of SSS (p=.029). In Multiple Linear Regression the set of possible predictors did not explain a significant proportion of differences in symptom severity (p=.099) only SES & employment status were significant. Employed status was associated with less improvement in SSS (2.6 pts < unemployed; p=.008) as was average SES compared to advantaged (3.6 pts < advantaged SES; p=.021). CONCLUSIONS: a) The improvement in reflux symptoms after diagnostic work-up and initiation of therapy in a routine clinical setting can be partly explained by sociodemographic factors b) Paradoxically, advantaged SES and unemployment are each associated with greater improvement of reflux symptoms.