Prevention of heartburn relapse by low-dose famotidine: a test meal model for duration of symptom control.
OBJECTIVE
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 x 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.


CONCLUSIONS
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.
Mann
S G
SG
Clinical Research and Development Group, J & J MSD Europe, High Wycombe, Buckinghamshire, UK.
Cottrell
J
J
Murakami
A
A
Stauffer
L
L
Rao
A N
AN
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D015738:Famotidine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D020723:Glucuronic Acid; D006261:Headache / Q000139:chemically induced; D006356:Heartburn / Q000517:prevention & control*; D006603:Hexuronic Acids; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence
D000464:Alginates; D006603:Hexuronic Acids; D006635:Histamine H2 Antagonists; D015738:Famotidine; D020723:Glucuronic Acid