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Excerpt
Methods: This multicentre clinical trial recruited 236 patients with endoscopy-negative GERD (enGERD) or with GERD grade A or B (Los Angeles classification). Additionally, patients had to have a history of frequent episodes of heartburn, defined as heartburn of at least moderate intensity for at least three consecutive days during the last week before inclusion. After an initial treatment period of 28 days with PANTO 20 mg once daily, patients without heartburn during the last 3 days were randomized to 6 months’ therapy with either PANTO 20 mg or ESO 20 mg to be taken only when symptoms required treatment (i.e. on demand). The number of tablets, the mean intensity and mean duration of heartburn, acid eructation and pain on swallowing were determined separately and as a combined symptom score. The intensity of symptoms was rated on a 4-point scale with the values 0–3 (0: none, 1: mild, 2: moderate, 3: severe). The treatment groups were compared by Wilcoxon rank–sum test.
Results: In the acute treatment phase, relief of heartburn was achieved in 87.3% of patients and relief of all GERD-associated symptoms (heartburn, epigastric pain and acid eructation) was achieved in 74.2% of patients. During 6 months of on-demand therapy, the mean intensity of heartburn was significantly lower in the PANTO group than in the ESO group for both intention to treat (ITT) (n=199) and per protocol (PP) (n=153) populations (ITT: 1.12 PANTO vs. 1.32 ESO, P=0.0115; PP: 1.10 PANTO vs. 1.33 ESO, P=0.0096). The mean intensities of acid eructation, pain on swallowing, and the combination of all three symptoms together were numerically but not statistically lower in the PANTO group compared with the ESO group (combined symptom score ITT: 1.72 PANTO vs. 1.99 ESO; PP: 1.66 PANTO vs. 2.02 ESO). The mean duration (days) of symptoms during the on-demand phase was similar in both treatment groups (three symptoms combined, ITT: 82.57 PANTO vs. 74.66 ESO, PP: 79.48 PANTO vs. 74.26 ESO). There was no significant difference in the amount of study medication taken in the two treatment groups (average intake PANTO 0.29 tablets/day; ESO 0.33 tablets/day). Both treatments were well tolerated and safe.
Conclusion: During 6 months of on-demand therapy for mild GERD, PANTO 20 mg and ESO 20 mg were equally effective in reducing the mean intensity for the combined symptoms of heartburn, acid eructation and pain on swallowing. However, PANTO 20 mg was statistically superior to ESO 20 mg in reducing the symptom load of heartburn.
This work was supported by a grant from ALTANA Pharma AG.
