Prevention of heartburn relapse by low‐dose famotidine: a test meal model for duration of symptom control

Abstract

Aim: To establish whether patients taking famotidine 10 mg to treat an episode of heartburn were protected from a recurrence of symptoms after a subsequent test meal. Methods: Frequent heartburn sufferers (n=366) were randomized to receive double blind treatment with famotidine 10 mg or 2×250 mg chewable alginate tablets within 30 min of a spontaneous episode of heartburn. After 4 h, patients with no or slight residual symptoms consumed a meal likely to induce heartburn. Over the next 4 h patients recorded the severity of heartburn and any consumption of ‘rescue’ antacids. At the end of this time they rated the global efficacy of their treatment in controlling meal‐induced symptoms. Results: Study groups were well matched for all baseline characteristics. Of the 366 randomized patients, 276 took study medication and data from 269 patients (132 famotidine, 137 alginate) were analysed for efficacy. Compared to the alginate control group famotidine treated patients reported better global efficacy following the test meal (P<0.001; relative odds for a more favourable response: 2.26 [95% CI: 1.45–3.53]). Fewer patients receiving famotidine resorted to antacid rescue (P = 0.038; relative odds for a more favourable response: 2.24 [95% CI: 1.04–4.79]) and peak heartburn was significantly less severe with famotidine treatment (P<0.001; relative odds for a more favourable response: 2.90 [95% CI: 1.85–4.53]). Eleven famotidine‐treated patients (8%) and 13 alginate patients (9%) reported adverse events. Conclusion: Compared to patients receiving an alginate preparation, patients self medicating with famotidine 10 mg for heartburn are better protected against a recurrence of their symptoms when they next eat. This suggests that the duration of acid control (9 h) previously demonstrated with this dose translates into a similar duration of measurable symptom control during the day.

Drug utilization evaluation of nonprescription H2‐receptor antagonists and alginate‐containing preparations for dyspepsia

“…The finding that fewer customers using H 2 ‐receptor antagonists experienced return of symptoms than those who had previously used simple antacids is in agreement with the results of published work from controlled studies [1, 2]. The results also suggest that H 2 ‐receptor antagonists had a longer effect on symptom relief than alginate‐containing preparations [3].…”

Review article: over‐the‐counter drugs and the gastrointestinal tract

“…There is evidence that this lower dose raises gastric pH, and can be effective for some hours, although as previously mentioned the onset of action is delayed compared with simple antacids 44–48 . Effectiveness has also been demonstrated in patients with heartburn 49 . Thus, despite the intuitive feeling that the over‐the‐counter dosage is not enough, this view is not supported on present evidence, although perhaps it is effective only for mild disease.…”

Inhibition of intragastric acidity in healthy subjects dosed with ranitidine 75 mg: a comparative study with cimetidine and placebo

“…There is some evidence that OTC drugs are effective in preventing post-prandial dyspepsia and heartburn but there are few symptom-based studies in the literature. 14,15 In this study we have demonstrated that the gastric acid inhibitory effect of ranitidine is superior to cimetidine 200 mg in the 10 h after an oral dose. We have also shown that the effect of ranitidine 75 mg, taken around midday, can persist for 10±15 h. It is uncertain whether this late and modest effect can translate into a symptomatic bene®t for patients.…”