Title: Efficacy and Safety of HIP1601 (Dual Delayed-release Esomeprazole) 40mg in Erosive
Esophagitis Compared to HGP1705 (Delayed-release Esomeprazole) 40mg: A Multicenter,
Randomized, Double-blind, Non-inferiority Study
Version: 3 Date: 24 Oct 2023
Reviewer's report:
Lim et al conducted RCT of conventional EPZ vs novel EPZ in sustained GERD resolution and
erosive esophagitis. This is well written. There is some concerns about the clinical significance
of this RCT.
1. The clinical significance of this RCT remains uncertain. Are there inherent issues with
conventional EPZ, and can the novel EPZ effectively address these concerns? If so, what
prompted the utilization of a non-inferiority analysis in the study design?
2. If one of the issues is nocturnal acid breakthrough (NAB), the comparison should have been
between a PPI and a potassium-competitive acid blocker (PCAB). It is well-established that
even double-dose PPIs often fail to control NAB, and PCAB is considered the most promising
option for NAB management. Why was the choice for comparison made as novel EPZ rather
than PCAB? Please provide clarification.
3. There is a compelling unmet need in the treatment of GERD. Consider conducting an
RCT comparing PPIs to PCABs, given that the acid-blocking efficacy of PCABs significantly
surpasses that of double-dose PPIs.
4. In the evaluation of NAB, the utilization of an insomnia scale is warranted.
5. To assess dyspepsia symptoms rigorously, the use of a validated gastrointestinal symptom
scale is indispensable.
6. Individuals who have Helicobacter pylori infection should be excluded. Current Helicobacter
pylori infection significantly influences dyspepsia symptoms as well as GERD symptoms.
Title: Efficacy and Safety of HIP1601 (Dual Delayed-release Esomeprazole) 40mg in Erosive
Esophagitis Compared to HGP1705 (Delayed-release Esomeprazole) 40mg: A Multicenter,
Randomized, Double-blind, Non-inferiority Study
Version: 3 Date: 24 Oct 2023
Reviewer's report:
Lim et al conducted RCT of conventional EPZ vs novel EPZ in sustained GERD resolution and
erosive esophagitis. This is well written. There is some concerns about the clinical significance
of this RCT.
1. The clinical significance of this RCT remains uncertain. Are there inherent issues with
conventional EPZ, and can the novel EPZ effectively address these concerns? If so, what
prompted the utilization of a non-inferiority analysis in the study design?
2. If one of the issues is nocturnal acid breakthrough (NAB), the comparison should have been
between a PPI and a potassium-competitive acid blocker (PCAB). It is well-established that
even double-dose PPIs often fail to control NAB, and PCAB is considered the most promising
option for NAB management. Why was the choice for comparison made as novel EPZ rather
than PCAB? Please provide clarification.
3. There is a compelling unmet need in the treatment of GERD. Consider conducting an
RCT comparing PPIs to PCABs, given that the acid-blocking efficacy of PCABs significantly
surpasses that of double-dose PPIs.
4. In the evaluation of NAB, the utilization of an insomnia scale is warranted.
5. To assess dyspepsia symptoms rigorously, the use of a validated gastrointestinal symptom
scale is indispensable.
6. Individuals who have Helicobacter pylori infection should be excluded. Current Helicobacter
pylori infection significantly influences dyspepsia symptoms as well as GERD symptoms.
Please review this paper.
user
Title: Efficacy and Safety of HIP1601 (Dual Delayed-release Esomeprazole) 40mg in Erosive
Esophagitis Compared to HGP1705 (Delayed-release Esomeprazole) 40mg: A Multicenter,
Randomized, Double-blind, Non-inferiority Study
Version: 3 Date: 24 Oct 2023
Reviewer's report:
Lim et al conducted RCT of conventional EPZ vs novel EPZ in sustained GERD resolution and
erosive esophagitis. This is well written. There is some concerns about the clinical significance
of this RCT.
1. The clinical significance of this RCT remains uncertain. Are there inherent issues with
conventional EPZ, and can the novel EPZ effectively address these concerns? If so, what
prompted the utilization of a non-inferiority analysis in the study design?
2. If one of the issues is nocturnal acid breakthrough (NAB), the comparison should have been
between a PPI and a potassium-competitive acid blocker (PCAB). It is well-established that
even double-dose PPIs often fail to control NAB, and PCAB is considered the most promising
option for NAB management. Why was the choice for comparison made as novel EPZ rather
than PCAB? Please provide clarification.
3. There is a compelling unmet need in the treatment of GERD. Consider conducting an
RCT comparing PPIs to PCABs, given that the acid-blocking efficacy of PCABs significantly
surpasses that of double-dose PPIs.
4. In the evaluation of NAB, the utilization of an insomnia scale is warranted.
5. To assess dyspepsia symptoms rigorously, the use of a validated gastrointestinal symptom
scale is indispensable.
6. Individuals who have Helicobacter pylori infection should be excluded. Current Helicobacter
pylori infection significantly influences dyspepsia symptoms as well as GERD symptoms.
assistant