Sg. Mann et al., PREVENTION OF HEARTBURN RELAPSE BY LOW-DOSE FAMOTIDINE - A TEST MEAL MODEL FOR DURATION OF SYMPTOM CONTROL, Alimentary pharmacology & therapeutics, 11(1), 1997, pp. 121-127
Aim: To establish whether patients taking famotidine 10 mg to treat an
episode of heartburn were protected from a recurrence of symptoms aft
er 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 spon
taneous episode of heartburn. After 4 h, patients with no or slight re
sidual symptoms consumed a meal likely to induce heartburn. Over the n
ext 4 h patients recorded the severity of heartburn and any consumptio
n of 'rescue' antacids, At the end of this time they rated the global
efficacy of their treatment in controlling meal-induced symptoms. Resu
lts: Study groups were well matched for all baseline characteristics.
Of the 366 randomized patients, 276 took study medication and data fro
m 269 patients (132 famotidine, 137 alginate) were analysed for effica
cy. Compared to the alginate control group famotidine treated patients
reported better global efficacy following the test meal (P < 0.001; r
elative 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: 1.0
4-4.79]) and peak heartburn was significantly less severe with famotid
ine treatment (P < 0.001; relative odds for a more favourable response
: 2.90 [9.5% CI: 1.85-4.53]), Eleven famotidine-treated patients (8%)
and 13 alginate patients (9%) reported adverse events. Conclusion: Com
pared to patients receiving an alginate preparation, patients self med
icating with famotidine 10 mg for heartburn are better protected again
st a recurrence of their symptoms when they next eat. This suggests th
at the duration of acid control (9 h) previously demonstrated with thi
s dose translates into a similar duration of measurable symptom contro
l during the day.