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: 01 Nov 2023
Reviewer's report:
The authors report the results of a multicenter, randomized, double-blind, non-inferiority study
comparing the efficacy of the newly developed Dual Delayed-release Esomeprazole versus
Delayed-release Esomeprazole in patients with reflux esophagitis.
Although the study was multicenter, randomized, double-blind, and had a high level of evidence,
the following concerns were raised
1. Although the primary endpoint was the endoscopic cure rate at 8 weeks, the patients with
endoscopic cure at 4 weeks had not undergone endoscopy at 8 weeks. The design of the study,
which included an endoscopy at 4 weeks, even though it was designed to evaluate at 8 weeks,
makes the study confusing. This should be clearly stated since it is the cure rate up to 8 weeks,
not the cure rate at 8 weeks.
2. It is stated in the limitation that the number of LA Grade C-D cases was extremely small
(9 cases), which may have influenced the results. It is known that acid reflux at night is more
common in Grade C-D patients.
3. Figure 2: LA Grade C-D patients are 100% cured at 4 weeks, but was endoscopy performed
at 8 weeks? Please clarify. If you are going to use Figure 2, I suggest you include the number
of cases.
4. In a similar study, Kim HC et al. showed that 24-hour gastric acid suppression was similar
between the two formulations, while the inhibition during night-time (22:00-06:00) showed a
better tendency in the DR formulation. (Drug Des Devel Ther. 2023 Apr 12;17:1115-1124.) It
is recommended to add it to the references.
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: 01 Nov 2023
Reviewer's report:
The authors report the results of a multicenter, randomized, double-blind, non-inferiority study
comparing the efficacy of the newly developed Dual Delayed-release Esomeprazole versus
Delayed-release Esomeprazole in patients with reflux esophagitis.
Although the study was multicenter, randomized, double-blind, and had a high level of evidence,
the following concerns were raised
1. Although the primary endpoint was the endoscopic cure rate at 8 weeks, the patients with
endoscopic cure at 4 weeks had not undergone endoscopy at 8 weeks. The design of the study,
which included an endoscopy at 4 weeks, even though it was designed to evaluate at 8 weeks,
makes the study confusing. This should be clearly stated since it is the cure rate up to 8 weeks,
not the cure rate at 8 weeks.
2. It is stated in the limitation that the number of LA Grade C-D cases was extremely small
(9 cases), which may have influenced the results. It is known that acid reflux at night is more
common in Grade C-D patients.
3. Figure 2: LA Grade C-D patients are 100% cured at 4 weeks, but was endoscopy performed
at 8 weeks? Please clarify. If you are going to use Figure 2, I suggest you include the number
of cases.
4. In a similar study, Kim HC et al. showed that 24-hour gastric acid suppression was similar
between the two formulations, while the inhibition during night-time (22:00-06:00) showed a
better tendency in the DR formulation. (Drug Des Devel Ther. 2023 Apr 12;17:1115-1124.) It
is recommended to add it to the references.
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: 01 Nov 2023
Reviewer's report:
The authors report the results of a multicenter, randomized, double-blind, non-inferiority study
comparing the efficacy of the newly developed Dual Delayed-release Esomeprazole versus
Delayed-release Esomeprazole in patients with reflux esophagitis.
Although the study was multicenter, randomized, double-blind, and had a high level of evidence,
the following concerns were raised
1. Although the primary endpoint was the endoscopic cure rate at 8 weeks, the patients with
endoscopic cure at 4 weeks had not undergone endoscopy at 8 weeks. The design of the study,
which included an endoscopy at 4 weeks, even though it was designed to evaluate at 8 weeks,
makes the study confusing. This should be clearly stated since it is the cure rate up to 8 weeks,
not the cure rate at 8 weeks.
2. It is stated in the limitation that the number of LA Grade C-D cases was extremely small
(9 cases), which may have influenced the results. It is known that acid reflux at night is more
common in Grade C-D patients.
3. Figure 2: LA Grade C-D patients are 100% cured at 4 weeks, but was endoscopy performed
at 8 weeks? Please clarify. If you are going to use Figure 2, I suggest you include the number
of cases.
4. In a similar study, Kim HC et al. showed that 24-hour gastric acid suppression was similar
between the two formulations, while the inhibition during night-time (22:00-06:00) showed a
better tendency in the DR formulation. (Drug Des Devel Ther. 2023 Apr 12;17:1115-1124.) It
is recommended to add it to the references.
assistant