Table 3.
Criteria | Scores (mean ± SD) | Comments |
---|---|---|
Disease severity | 2.9 ± 0.6 |
Morbidity: There was no elevated risk of all-cause mortality associated with GERD. Progression: Most patients remained stable or showed improvement in their grade of esophagitis in 5 years. There was a positive association between reflux symptoms and the risk of esophageal adenocarcinoma. Quality of life: Respondents with GERD experienced heartburn, eating and drinking problems, sleep impairment, reduced work productivity, etc. |
Size of the affected population | 3.5 ± 1.1 |
Age-standardized prevalence of GERD in China is below 5%. Around 3,000 patients annually have been diagnosed with GERD in the study’s host hospital. |
Unmet needs | 4.2 ± 0.6 |
PPI response rate: 10–54% of patients with GERD symptoms failed to respond to a standard-dose PPI. PPI compliance: PPIs are used before meals and take 3–5 days to achieve a steady-state antisecretory effect. Nocturnal acid breakthrough: More than 70% of patients treated with PPIs had NAB. Genetic polymorphism: CYP2C19 genetic polymorphism causes significant inter-individual pharmacodynamic variability with PPI treatment. |
Comparative effectiveness |
VPZ 3.9 ± 1.1 TPZ 3.4 ± 1.0 |
VPZ and TPZ are non-inferior to PPIs for patients with GERD. VPZ may be more effective than PPIs for severe erosive esophagitis. Nocturnal pH ≥ 4 HTRs of VPZ and TPZ were greater than PPIs. 24-hour pH ≥ 4 HTRs of VPZ were greater than PPIs. The acid inhibitory effects of VPZ and TPZ are irrespective of the CYP2C19 genotype. |
Comparative safety |
VPZ 3.0 ± 0.6 TPZ 3.1 ± 0.5 |
Safety of VPZ and TPZ is comparable with PPIs. |
Comparative patient-perceived health |
VPZ 2.5 ± 1.0 TPZ 2.4 ± 1.2 |
There were no substantial differences in improvement of heartburn between VPZ and PPIs. Nocturnal heartburn improvement of VPZ and TPZ was greater than PPIs. |
Type of preventive benefit |
VPZ 3.6 ± 0.9 TPZ 3.4 ± 1.0 |
Long-term maintenance therapy and on-demand therapy with VPZ and TPZ can reduce the GERD recurrence rate. |
Type of therapeutic benefit |
VPZ 4.1 ± 0.9 TPZ 3.8 ± 1.1 |
The therapeutic target is to relieve symptoms, heal, prevent complications, and improve health-related quality of life. The therapeutic effect is mainly shown in improvement of reflux esophagitis healing rate, GerdQ/FSSG/GOS scores, heartburn symptoms, etc. |
Costs of intervention |
VPZ 0.9 ± 0.7 TPZ − 0.6 ± 0.5 |
In 2022, China’s per capita disposable income reached ¥36,883. The treatment phase takes 8 weeks, VPZ costs ¥558.88, and TPZ costs ¥626.08. The maintenance phase, VPZ costs ¥4.945 daily, TPZ costs ¥5.59 daily. |
Other medical costs |
VPZ 1.3 ± 0.9 TPZ 0 |
VPZ generates incremental QALYs at a lower cost compared with PPIs. TPZ retrieved no evidence. |
Non-medical costs |
VPZ 0 TPZ 0 |
Neither VPZ nor TPZ retrieved evidence. |
Quality of evidence | 2.4 ± 0.7 |
The quality of evidence on which the comparison data are based is highly relevant and valid. There is still a lack of direct comparisons between VPZ and TPZ. |
Expert consensus/clinical practice guidelines | 3.5 ± 1.0 | The results of the current expert opinions and clinical practice guidelines clearly indicate that PPIs and P-CABs are the first-line treatment for GERD. |
Notes: VPZ, vonoprazan; TPZ, tegoprazan; GERD, gastroesophageal reflux disease; NAB, nocturnal acid breakthrough; PPIs, proton-pump inhibitors; CYP2C19, cytochrome P450 2C19; pH ≥ 4 HTR, pH ≥ 4 holding time ratio; GerdQ, GERD questionnaire; FSSG, Frequency Scale for the Symptoms of GERD; GOS, Global Overall Symptom; QALYs, quality adjusted life years; P-CABs, potassium-competitive acid blockers