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Tu1053 Effects of Omeprazole on Sleep Disturbance: Randomized Multicenter Double-Blind Placebo-Controlled Trial
NSAID (long-term use and as needed). Non-inferiority of T10 and T20 to L15 was verified for the recurrence rate of peptic ulcers at week 24. The recurrence rates of peptic ulcers in the T10 and T20 through week 24 were slightly lower than in the L15, although no statistically significant differences were observed (Table). No significant difference was observed in the incidence rates of peptic hemorrhagic lesions between the TAK-438 and lansoprazole groups. In the safety population (n=640), frequencies of adverse events (AEs) were 71.6%, 71.7%, and 76.7% in the T10, T20, and L15, respectively. Rates of serious AEs and AEs leading to drug discontinuation were similar across treatment groups. Conclusion: TAK438 10 mg and 20 mg once daily were as effective and safe as lansoprazole 15 mg for the prevention of peptic ulcer recurrence in Japanese patients with a definite history of peptic ulcers who required NSAID. Primary and secondary endpoints
Effects of Omeprazole on Sleep Disturbance: Randomized Multicenter DoubleBlind Placebo-Controlled Trial Masahito Aimi, Yoshinori Komazawa, Naoharu Hamamoto, Yuko Yamane, Koichiro Furuta, Yasushi Uchida, Shozo Yano, Miwa Ota, Hiroaki Oguro, Tatsuya Miyake, Toshitsugu Sugimoto, Kohji Naora, Seiichi Nagi, Shunji Ishihara, Yoshiyuki Goubaru, Yoshikazu Kinoshita Background and Aims: Gastroesophageal reflux is considered to cause sleep disturbance, while proton pump inhibitor (PPI) administration is reported to improve insomnia associated with gastroesophageal reflux disease (GERD). The majority of patients with gastroesophageal reflux are asymptomatic and a significant number with erosive esophagitis are also reported to be asymptomatic. Therefore, PPIs may improve sleep disturbance not only for symptomatic GERD patients, but also individuals without reflux symptoms if asymptomatic reflux is an important factor to cause insomnia. We examined whether PPI administration has a therapeutic effect for improving insomnia in patients without reflux symptoms in the same manner as patients with reflux symptoms. Methods: We performed a randomized multicenter doubleblind placebo-controlled trial using 176 patients with insomnia regardless of the presence of reflux symptoms. The patients were divided into those administered omeprazole (20 mg) or a placebo for 14 days. Four self-reporting questionnaires, QOLRAD-J(Japanese translation of Quality of Life in Reflux and Dyspepsia questionnaire), PSQI(Pittsburg Sleep Quality Index) , ESS (Epworth Sleepiness Scale), and a sleep diary, were used for evaluating GERDrelated quality of life and sleep disturbance. Results: We evaluated 171 patients with insomnia, of whom 69 had typical reflux symptoms. Omeprazole improved GERD-related quality of life and insomnia significantly better than the placebo in patients with reflux symptoms. On the other hand, the therapeutic effects of omeprazole and the placebo were not different in patients without reflux symptoms.(Table) Conclusion: Our results showed that PPI administration is effective only for insomnia in patients with reflux symptoms. Effects of omeprazole and placebo on reflux and sleep indices in patients with heartburn and/or acid regurgitation
(a) CI = confidence interval for difference from L15 (b) One-sided P value for Farrington and Manning test for non-inferiority (c) Two-sided P value for Wald test with a significance level of 5% Tu1055 TAK-438 Versus Lansoprazole 15 mg for Secondary Prevention of Peptic Ulcers Associated With Low-Dose Aspirin Therapy: Results of a Phase 3 Trial Takashi Kawai, Kiyoshi Ashida, Yuji Mizokami, Yasushi Matsumoto, Kazunori Oda, Kojiro Saito, Nobuo Funao, Akira Nishimura, Kentaro Sugano Background: TAK-438 is an oral potassium-competitive acid blocker (P-CAB), a novel class of acid suppressants. It was highly effective for healing reflux esophagitis in a phase 2 trial. Its efficacy and safety have now been compared with that of lansoprazole 15 mg for the secondary prevention of low-dose aspirin (LDA)-related peptic ulcers. Methods: This was a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority phase 3 trial. Japanese patients with a history of endoscopically confirmed peptic ulcer who required LDA therapy were randomized to once-daily treatment for 24 weeks with TAK438 10 mg (T10) or 20 mg (T20) or lansoprazole 15 mg (L15). The primary endpoint was the recurrence rate of peptic ulcers at week 24. The non-inferiority of T10 and T20 to L15 were estimated with one-sided p-value for a Farrington and Manning test with a noninferiority margin of 8.7% and a significance level of 2.5%. Secondary endpoints were the recurrence rate of peptic ulcers at week 12 and the incidence rate of peptic hemorrhagic lesions with Forrest classification. Endoscopy was performed at weeks 0, 12 and 24. Results: 621 patients (full analysis set [FAS]) were randomized to receive T10 (n=202), T20 (n= 202), or L15 (n=217). Patient demographics were similar between treatment groups. Around 40% of the FAS population had concomitant use of oral antithrombotic drugs. Non-inferiority of T10 and T20 to L15 was verified for the recurrence rate of peptic ulcers at week 24. The recurrence rates of peptic ulcers in the T10 and T20 through week 24 were slightly lower than in the L15, although no statistically significant differences were observed (Table). The incidence rates of peptic hemorrhagic lesions were significantly lower in the T10 and T20 than in the L15. In the safety population (n =621), frequencies of adverse events (AEs) were 71.3%, 75.7%, and 67.7% in the T10, T20, and L15, respectively. Rates of serious AEs and AEs leading to drug discontinuation were similar across treatment groups. Conclusion: TAK438 10 mg and 20 mg once daily were as effective and safe as lansoprazole 15 mg for the prevention of peptic ulcer recurrence in Japanese patients with a definite history of peptic ulcers who required LDA. Furthermore, TAK-438 10 mg and 20 mg showed significant effects on incidence rates of peptic hemorrhagic lesions compared to lansoprazole 15 mg. Primary and secondary endpoints
Values are shown as the mean ± SE Effects of omeprazole and placebo on reflux and sleep indices in patients without heartburn or acid regurgitation
Values are shown as the mean ± SE Tu1054 TAK-438 Versus Lansoprazole 15 mg for Secondary Prevention of Peptic Ulcers Associated With Non-Steroidal Anti-Inflammatory Drug (NSAID) Therapy: Results of a Phase 3 Trial Yuji Mizokami, Kiyoshi Ashida, Satoshi Soen, Takashi Kawai, Kazunori Oda, Kojiro Saito, Nobuo Funao, Akira Nishimura, Kentaro Sugano Background: TAK-438 is an oral potassium-competitive acid blocker (P-CAB), a novel class of acid suppressants. It was highly effective for healing reflux esophagitis in a phase 2 trial. Its efficacy and safety have now been compared with that of lansoprazole 15 mg for the secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-related peptic ulcers. Methods: This was a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority phase 3 trial. Japanese patients with a history of endoscopically confirmed peptic ulcer who required NSAID therapy were randomized to once-daily treatment for 24 weeks with TAK-438 10 mg (T10) or 20 mg (T20) or lansoprazole 15 mg (L15). The primary endpoint was the recurrence rate of peptic ulcers at week 24. The noninferiority of T10 and T20 to L15 were estimated with one-sided p-value for a Farrington and Manning test with a non-inferiority margin of 8.3% and a significance level of 2.5%. Secondary endpoints were the recurrence rate of peptic ulcers at week 12 and the incidence rate of peptic hemorrhagic lesions with Forrest classification. Endoscopy was performed at weeks 0, 12 and 24. Results: 642 patients (full analysis set [FAS]) were randomized to receive T10 (n=218), T20 (n=212), or L15 (n=212). Patient demographics were similar between treatment groups. Around 25% of the FAS population were using many kinds of
(a) CI = confidence interval for difference from L15 (b) One-sided P value for Farrington and Manning test for non-inferiority (c) Two-sided P value for Wald test with a significance level of 5%
S-739
AGA Abstracts
AGA Abstracts
Tu1053
Effects of Omeprazole on Sleep Disturbance: Randomized Multicenter DoubleBlind Placebo-Controlled Trial Masahito Aimi, Yoshinori Komazawa, Naoharu Hamamoto, Yuko Yamane, Koichiro Furuta, Yasushi Uchida, Shozo Yano, Miwa Ota, Hiroaki Oguro, Tatsuya Miyake, Toshitsugu Sugimoto, Kohji Naora, Seiichi Nagi, Shunji Ishihara, Yoshiyuki Goubaru, Yoshikazu Kinoshita Background and Aims: Gastroesophageal reflux is considered to cause sleep disturbance, while proton pump inhibitor (PPI) administration is reported to improve insomnia associated with gastroesophageal reflux disease (GERD). The majority of patients with gastroesophageal reflux are asymptomatic and a significant number with erosive esophagitis are also reported to be asymptomatic. Therefore, PPIs may improve sleep disturbance not only for symptomatic GERD patients, but also individuals without reflux symptoms if asymptomatic reflux is an important factor to cause insomnia. We examined whether PPI administration has a therapeutic effect for improving insomnia in patients without reflux symptoms in the same manner as patients with reflux symptoms. Methods: We performed a randomized multicenter doubleblind placebo-controlled trial using 176 patients with insomnia regardless of the presence of reflux symptoms. The patients were divided into those administered omeprazole (20 mg) or a placebo for 14 days. Four self-reporting questionnaires, QOLRAD-J(Japanese translation of Quality of Life in Reflux and Dyspepsia questionnaire), PSQI(Pittsburg Sleep Quality Index) , ESS (Epworth Sleepiness Scale), and a sleep diary, were used for evaluating GERDrelated quality of life and sleep disturbance. Results: We evaluated 171 patients with insomnia, of whom 69 had typical reflux symptoms. Omeprazole improved GERD-related quality of life and insomnia significantly better than the placebo in patients with reflux symptoms. On the other hand, the therapeutic effects of omeprazole and the placebo were not different in patients without reflux symptoms.(Table) Conclusion: Our results showed that PPI administration is effective only for insomnia in patients with reflux symptoms. Effects of omeprazole and placebo on reflux and sleep indices in patients with heartburn and/or acid regurgitation
(a) CI = confidence interval for difference from L15 (b) One-sided P value for Farrington and Manning test for non-inferiority (c) Two-sided P value for Wald test with a significance level of 5% Tu1055 TAK-438 Versus Lansoprazole 15 mg for Secondary Prevention of Peptic Ulcers Associated With Low-Dose Aspirin Therapy: Results of a Phase 3 Trial Takashi Kawai, Kiyoshi Ashida, Yuji Mizokami, Yasushi Matsumoto, Kazunori Oda, Kojiro Saito, Nobuo Funao, Akira Nishimura, Kentaro Sugano Background: TAK-438 is an oral potassium-competitive acid blocker (P-CAB), a novel class of acid suppressants. It was highly effective for healing reflux esophagitis in a phase 2 trial. Its efficacy and safety have now been compared with that of lansoprazole 15 mg for the secondary prevention of low-dose aspirin (LDA)-related peptic ulcers. Methods: This was a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority phase 3 trial. Japanese patients with a history of endoscopically confirmed peptic ulcer who required LDA therapy were randomized to once-daily treatment for 24 weeks with TAK438 10 mg (T10) or 20 mg (T20) or lansoprazole 15 mg (L15). The primary endpoint was the recurrence rate of peptic ulcers at week 24. The non-inferiority of T10 and T20 to L15 were estimated with one-sided p-value for a Farrington and Manning test with a noninferiority margin of 8.7% and a significance level of 2.5%. Secondary endpoints were the recurrence rate of peptic ulcers at week 12 and the incidence rate of peptic hemorrhagic lesions with Forrest classification. Endoscopy was performed at weeks 0, 12 and 24. Results: 621 patients (full analysis set [FAS]) were randomized to receive T10 (n=202), T20 (n= 202), or L15 (n=217). Patient demographics were similar between treatment groups. Around 40% of the FAS population had concomitant use of oral antithrombotic drugs. Non-inferiority of T10 and T20 to L15 was verified for the recurrence rate of peptic ulcers at week 24. The recurrence rates of peptic ulcers in the T10 and T20 through week 24 were slightly lower than in the L15, although no statistically significant differences were observed (Table). The incidence rates of peptic hemorrhagic lesions were significantly lower in the T10 and T20 than in the L15. In the safety population (n =621), frequencies of adverse events (AEs) were 71.3%, 75.7%, and 67.7% in the T10, T20, and L15, respectively. Rates of serious AEs and AEs leading to drug discontinuation were similar across treatment groups. Conclusion: TAK438 10 mg and 20 mg once daily were as effective and safe as lansoprazole 15 mg for the prevention of peptic ulcer recurrence in Japanese patients with a definite history of peptic ulcers who required LDA. Furthermore, TAK-438 10 mg and 20 mg showed significant effects on incidence rates of peptic hemorrhagic lesions compared to lansoprazole 15 mg. Primary and secondary endpoints
Values are shown as the mean ± SE Effects of omeprazole and placebo on reflux and sleep indices in patients without heartburn or acid regurgitation
Values are shown as the mean ± SE Tu1054 TAK-438 Versus Lansoprazole 15 mg for Secondary Prevention of Peptic Ulcers Associated With Non-Steroidal Anti-Inflammatory Drug (NSAID) Therapy: Results of a Phase 3 Trial Yuji Mizokami, Kiyoshi Ashida, Satoshi Soen, Takashi Kawai, Kazunori Oda, Kojiro Saito, Nobuo Funao, Akira Nishimura, Kentaro Sugano Background: TAK-438 is an oral potassium-competitive acid blocker (P-CAB), a novel class of acid suppressants. It was highly effective for healing reflux esophagitis in a phase 2 trial. Its efficacy and safety have now been compared with that of lansoprazole 15 mg for the secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-related peptic ulcers. Methods: This was a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority phase 3 trial. Japanese patients with a history of endoscopically confirmed peptic ulcer who required NSAID therapy were randomized to once-daily treatment for 24 weeks with TAK-438 10 mg (T10) or 20 mg (T20) or lansoprazole 15 mg (L15). The primary endpoint was the recurrence rate of peptic ulcers at week 24. The noninferiority of T10 and T20 to L15 were estimated with one-sided p-value for a Farrington and Manning test with a non-inferiority margin of 8.3% and a significance level of 2.5%. Secondary endpoints were the recurrence rate of peptic ulcers at week 12 and the incidence rate of peptic hemorrhagic lesions with Forrest classification. Endoscopy was performed at weeks 0, 12 and 24. Results: 642 patients (full analysis set [FAS]) were randomized to receive T10 (n=218), T20 (n=212), or L15 (n=212). Patient demographics were similar between treatment groups. Around 25% of the FAS population were using many kinds of
(a) CI = confidence interval for difference from L15 (b) One-sided P value for Farrington and Manning test for non-inferiority (c) Two-sided P value for Wald test with a significance level of 5%
S-739
AGA Abstracts
AGA Abstracts
Tu1053