FAMOTIDINE/ANTACID COMBINATION TABLETS ARE MORE EFFECTIVE FOR THE TREATMENT OF HEARTBURN THAN EITHER COMPONENT ALONE

Abstract

Purpose: To compare heartburn relief provided by famotidine/antacid combination tablet (FACT) to its components and placebo. Objectives were to demonstrate that FACT has faster onset than famotidine (FAM) 10 mg and longer duration than antacid. Methods: Randomized, double-blind, placebo-controlled, parallel group study at 32 primary care centers in the US. A total of 1,640 adults (mean age 46 yr.) with food-induced heartburn at least 3 times per wk. (mean: 6 episodes/wk.) were randomly assigned to treat 4 episodes of heartburn with FACT (FAM 10 mg + antacid 21 mEq calcium-carbonate-magnesium hydroxide tablet) (n = 410), FAM 10 mg(n = 411), antacid 21 mEq calcium-carbonate-magnesium hydroxide (n = 414) or placebo (n = 405). Patients rated heartburn relief (adequate relief: Y or N) at 15-min. intervals for the first hour postdose and then hourly through 8 hr. postdose, use of rescue antacid, and global evaluation of treatment. Results: 1640 randomized patients treated a total of 6290 episodes, 20% of which were rated as mild, 56% moderate, 24% severe. The onset of symptom relief was significantly faster with FACT than with FAM 10 mg (p = 0.001), or placebo (p <0.001). The odds ratios indicate that heartburn episodes treated with FACT were 1.42 or 1.59 times more likely to achieve adequate relief at an earlier time point compared to episodes treated with FAM 10 mg or placebo, respectively. The proportion of episodes relieved at 15 min. was greater with FACT (33.7%) compared to FAM 10 mg (27.3%) or placebo (25.4%). Duration of effect was significantly longer with FACT than with antacid or placebo (p <0.001). The odds-ratios indicate that heartburn episodes for FACT patients were 1.60 or 2.15 times more likely to maintain adequate relief at a later time point than episodes for antacid or placebo patients, respectively. The proportion of episodes relieved for at least 7 hr. was greater with FACT (70.0%) than antacid (58.5%) or placebo (51.4%). FACT-treated patients reported better global efficacy than the other 3 treatment groups (p <0.001) and had a lower percentage of episodes that required the use of rescue medication. Comparisons of FACT with FAM 10 mg, antacid, and placebo were statistically significant for the analysis of time to rescue antacid (p <0.001). All 4 treatments were generally well-tolerated. Conclusions: FACT provides more rapid relief of heartburn than FAM 10 mg, and longer lasting relief than antacid alone.