BMC Gastroenterology (Dec 2023)

Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study

  • Hyun Lim,
  • Jong Kyu Park,
  • Hyunsoo Chung,
  • Si Hyung Lee,
  • Jae Myung Park,
  • Jung Ho Park,
  • Gwang Ha Kim,
  • Sung Kwan Shin,
  • Su Jin Hong,
  • Kwang Jae Lee,
  • Moo In Park,
  • Hye-Kyung Jung,
  • Hyun-Soo Kim,
  • Jae Kyu Sung,
  • Seong Woo Jeon,
  • Suck Chei Choi,
  • Jeong Seop Moon,
  • Nayoung Kim,
  • Jong-Jae Park,
  • Sung Hee Hong,
  • Na Young Kim,
  • Hwoon-Yong Jung

DOI
https://doi.org/10.1186/s12876-023-03087-6
Journal volume & issue
Vol. 23, no. 1
pp. 1 – 11

Abstract

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Abstract Background Proton-pump inhibitors (PPIs) are the most effective drugs for treating acid-related disorders. However, once-daily dosing with conventional PPIs fail to fully control acid secretion over 24 h. This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE). Methods We enrolled 213 patients with EE randomized in a 1:1 ratio to receive 40 mg HIP1601 (n = 107) or HGP1705 (n = 106) once daily for 4 or 8 weeks. The primary endpoint was the EE healing rate, confirmed by endoscopy up to week 8. GERD-related symptoms and treatment-emergent adverse events were compared between both groups. Results By week 8, the estimated healing rates of EE were 97.8% and 96.8% in the HIP1601 and HGP1705 groups, respectively, with a 95% confidence interval of -4.7 to 7.2. After 4 or 8 weeks of treatment, the EE healing rate at week 4, complete resolution rate of symptoms, time to sustained resolution of symptoms, and number of rescue medications used were similar in both groups. The proportion of heartburn- and acid regurgitation-free nights by week 4 were higher in the HIP1601 group compared to the HGP1705 group, but the difference did not reach clinical significance (87.7% vs. 85.8%, P = 0.514, 87.5% vs. 85.8%, P = 0.774). The number of adverse events did not differ significantly between the two groups. Conclusions The efficacy and safety of HIP1601 40 mg were comparable to those of HGP1705 40 mg for the treatment of EE and symptomatic improvement of GERD. Trial registration NCT04080726 ( https://classic.clinicaltrials.gov/ct2/show/NCT04080726 ), registration date: 25/10/2018.

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