Introduction
Recents meta-analyses have shown that Tegoprazan (Tego) could be equal or superior to proton pump inhibitors in the eradication of Helicobacter pylori (HP). However, virtually all primary studies have been conducted in Asian populations, so validation in other regions is required.
Aims & Methods
Aim: To assess the efficacy and safety of Tego compared to Esomeprazole (Eso) in Latin population. Methods: We studied 117 consecutive treatment-naive HP infected patients [51.04±12.11 (48.85-53.24) years, 75% females] evidenced by endoscopic biopsy. Patients were randomized to receive either Tego (50 mg) or Eso (40 mg), both in combination with Amoxicillin (1 g) and Clarithromycin (500 mg), all administered twice daily for 14 days. Treatment efficacy was assessed using a urea breath test performed 35±2 days post-therapy. Treatment safety was monitored by recording adverse events. Additionally, dyspeptic symptoms, general laboratories and quality of life (SF-36 questionnaire) were assessed. Data expressed mean±SD and 95% CI or percentages, while statistical differences were evaluated with the unpaired and paired Student t test or the chi-square test, as appropriate. Alpha = 0.05.
Results
There were no differences between Tego and Eso groups in age [51±12.14 (47.79-54.21) vs. 51.08±12.28 (48.02-54.14) years respectively, p= 0.97] or sex (75.4% vs. 74.6% women respectively, p=0.76). Tego and Eso groups showed similar efficacy (94.55% vs 93.55% respectively, p=0.82) and adverse events (14.55% vs 22.58% respectively, p=0.26). Main symptoms in Tego group were diarrhea (n=4) and headache (n=2) meanwhile Eso group referred diarrhea (n=4) and abdominal pain (n=4). All adverse events were mild and suspend treatment was not required. Dyspeptic symptoms decreased after treatment in both Tego (78.88% vs 45.45%, p=0.0004) and Eso (79.03% vs 46.77%, p=0.0002) groups but there were no differences before (p=0.9108) and after (p=0.8864) treatment between them. There were no differences in the 18 components of the general laboratories (all in normal range) between groups before and after treatment. Physical component summary (CS) improved post treatment in both Tego [48.56±13.96 (44.87-52.25) vs 51.83±13.17 (48.35-55.31), p=0.03] and Eso [46.95±11.35 (44.13-49.78) vs 52.29±13.22 (49-55.58), p=0.01] groups. Mental CS showed no differences after treatment en Tego [47.35±5.99 (45.77-48.94) vs 47.8±6.48 (46.09-49.51), p=0.62] nor Eso [47.51±6.67 (45.86-49.17) vs 47.82±5.39 (46.47-49.16), p=0.78] groups. There was no difference in physical or mental CS between Tego and Eso groups before (p=0.49 and p=0.85, respectively) or post treatment (p=0.89 and p=0.98, respectively) Table 1.
Table 1. The 8 domains of SF-36 in both groups (*p<0.05 vs basal)
| Tego Group
Basal | Eso Group
Basal | p | Tego Group
Post-treatment | Eso Group
Post-treatment | p |
| Physical Function | 76.27±25.7
(69.48-83.06) | 72.18±23.08
(66.43-77.92) | 0.3656 | 79.64±25.47
(72.9-86.37) | 77.42±24.14
(71.41-83.43) | 0.6299 |
| Role-Physical | 61.82±62.15
(45.39-78.24) | 50.81±44.35
(39.77-61.84) | 0.2684 | 59.09±51.9
(45.37-72.81) | 67.34±39.62
(57.48-77.2)* | 0.3330 |
| Body Pain | 53.55±26.12
(46.64-60.45) | 58.06±26.77
(51.4-64.73) | 0.3586 | 58.36±27.74
(51.03-65.69) | 63.67±27.36
(56.86-70.48) | 0.3005 |
| General Health | 51.09±20.27
(45.73-56.45) | 49.84±16.14
(45.82-53.86) | 0.7110 | 57±19.4
(51.87-62.13)* | 56.77±19.16
(52-61.54)* | 0.9497 |
| Vitality | 52.18±21.7
(46.45-57.92) | 49.44±20.25
(44.4-54.48) | 0.4804 | 55.82±21.73
(50.08-61.56) | 56.21±18.26
(51.67-60.75) | 0.9159 |
| Social Functioning | 65.45±26.02
(58.58-72.33) | 64.92±24.15
(58.91-70.93) | 0.9084 | 70.45±28.09
(63.03-77.88) | 71.77±24.27
(65.73-77.81) | 0.7856 |
| Role Emotional | 70.3±57.62
(55.08-85.53) | 60.22±45.5
(48.89-71.54) | 0.2929 | 64.24±45.29
(52.27-76.21) | 66.67±44.76
(55.52-77.81) | 0.7718 |
| Mental Health | 64.95±20.78
(59.45-70.44) | 64.9±16.35
(60.83-68.97) | 0.9902 | 67.13±23.33
(60.96-73.29) | 68.45±16.02
(64.46-72.44) | 0.7186 |
Conclusion
Our work shows that Tegoprazan is equally effective and safe as Esomeprazole for triple therapy to eradicate Helicobacter pylori in Latin population. We also found that eradication treatment improves general health, physical functioning, and physical component summary, which warrants further investigation. Clinical Trials registration: NCT06318104.
References
(/10.1080/14787210.2025.2459722) (10.1002/jgh3.70134)
Disclosure
We would like to thank Carnot Laboratories for providing tegoprazan for this study.