A Study on the Efficacy of Rebamipide for Patients with Proton Pump Inhibitor-Refractory Non-Erosive Reflux Disease

Adachi, Kyoichi; Furuta, K.; Miwa, Hiroto; Oshima, Tadayuki; Miki, Masaharu; Komazawa, Yoshinori; Iwakiri, Katsuhiko; Furuta, Takahisa; Koike, Tomoyuki; Shimatani, Tomohiko; Kinoshita, Yoshikazu

doi:10.1007/s10620-012-2087-6

Cited by 23 publications

(11 citation statements)

References 44 publications

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“…Our results are consistent with previous studies of patients with NERD, which indicate that the pathology of NERD may be distinct from erosive acid-related diseases and patients with NERD may not respond as well to some treatments that are effective in GERD with erosive mucosal injury. For example, patients with NERD often respond poorly to some PPIs 12, 14, 15. However, the severity of acid reflux may correlate with response to therapy.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Kinoshita

Sakurai

Shiino

et al. 2016

Current Therapeutic Research

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BackgroundFor many patients, current treatments do not adequately resolve heartburn in nonerosive reflux disease (NERD).ObjectiveTo compare vonoprazan and placebo with respect to the frequency and severity of heartburn in patients with NERD.MethodsThis Phase III, double-blind, placebo-controlled, parallel-group, multicenter study included patients in Japan aged ≥20 years with Grade N or M NERD and recurrent acid reflux symptoms. Patients were blinded and randomized 1:1:1 to receive placebo or vonoprazan 10 mg or 20 mg. The primary efficacy outcome was the proportion of days without heartburn measured by patient scores during the 4-week treatment period.ResultsEight hundred twenty-seven patients were randomized (placebo: n = 278, vonoprazan 10 mg: n = 278, and vonoprazan 20 mg: n = 271). Median proportion of days without heartburn was 7.4% (placebo), 10.3% (vonoprazan 10 mg), and 12.0% (vonoprazan 20 mg). Proportion of days without heartburn was not statistically significant between the vonoprazan and placebo groups (P = 0.2310 [10 mg] and P = 0.0504 [20 mg]). Mean severity of heartburn was significantly higher with placebo (median score = 1.070) than with vonoprazan 10 mg (median score = 0.990; P = 0.0440) and 20 mg (median score = 0.960; P = 0.0139). Patients whose symptoms improved at Week 2 experienced significantly increased proportion of days without heartburn and reduced mean severity of heartburn at Week 4 with vonoprazan compared with placebo (proportion of days without heartburn: P = 0.0004 [10 mg] and P = 0.0001 [20 mg] and mean severity: P < 0.0001 [10 mg] and P < 0.0001 [20 mg]). A significant difference in median proportion of days without heartburn was observed for vonoprazan 20 mg compared with placebo in patients with Grade M NERD. Incidence of treatment-emergent adverse events was 32.7% (placebo), 27.7% (vonoprazan 10 mg), and 28.0% (vonoprazan 20 mg).ConclusionsVonoprazan at doses of 10 mg and 20 mg are not superior to placebo with respect to proportion of days without heartburn, whereas the mean severity of heartburn is lower with vonoprazan compared with placebo in patients with NERD. ClinicalTrials.gov identifier: NCT01474369.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Kinoshita

Sakurai

Shiino

et al. 2016

Current Therapeutic Research

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“…One clinical study showed that rebamipide and lansoprazole combination therapy was highly effective for preventing the recurrence of symptoms during long-term maintenance treatment for reflux esophagitis 8. Another study failed to show an advantage of rebamipide in terms of symptomatic improvement in patients with PPI-refractory nonerosive reflux disease (NERD) 32. Such a discrepancy in the results originates from differences in subject populations between studies.…”

Section: Discussionmentioning

confidence: 99%

The Benefits of Combination Therapy with Esomeprazole and Rebamipide in Symptom Improvement in Reflux Esophagitis: An International Multicenter Study

et al. 2016

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Background/AimsTo investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis.MethodsA total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score.ResultsThe mean decreases in the total symptom score at 4 weeks were estimated to be −18.1±13.8 in the combination therapy group and −15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were −8.4±6.6 in the combination therapy group and −6.8±5.9 in the monotherapy group (p=0.009).ConclusionsOver a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.

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“…A placebo-controlled study in 149 NERD subjects who failed PPI treatment assessed the efficacy of this compound. Unfortunately, the authors were unable to demonstrate a significant effect of rebamipide on subjects' symptoms 94. In another study, investigators evaluated the effect of combining a PPI with rebamipide to heal esophageal mucosal ulcers that occurred due to endoscopic submucosal dissection.…”

Section: Mucosal Protectantsmentioning

confidence: 99%

New and Future Drug Development for Gastroesophageal Reflux Disease

Maradey–Romero

Fass

2014

J Neurogastroenterol Motil

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Medical therapy remains the most popular treatment for gastroesophageal reflux disease (GERD). Whilst interest in drug development for GERD has declined over the last few years primarily due to the conversion of most proton pump inhibitor (PPI)'s to generic and over the counter compounds, there are still numerous areas of unmet needs in GERD. Drug development has been focused on potent histamine type 2 receptor antagonist's, extended release PPI's, PPI combination, potassium-competitive acid blockers, transient lower esophageal sphincter relaxation reducers, prokinetics, mucosal protectants and esophageal pain modulators. It is likely that the aforementioned compounds will be niched for specific areas of unmet need in GERD, rather than compete with the presently available anti-reflux therapies.

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A Study on the Efficacy of Rebamipide for Patients with Proton Pump Inhibitor-Refractory Non-Erosive Reflux Disease

Cited by 23 publications

References 44 publications

Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

The Benefits of Combination Therapy with Esomeprazole and Rebamipide in Symptom Improvement in Reflux Esophagitis: An International Multicenter Study

New and Future Drug Development for Gastroesophageal Reflux Disease

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