COST SAVINGS IN DUODENAL-ULCER THERAPY THROUGH HELICOBACTER-PYLORI ERADICATION COMPARED WITH CONVENTIONAL THERAPIES - RESULTS OF A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TRIAL

Background: We hypothesized that treatment of duodenal ulcer disease w ith antibiotic therapy directed toward Helicobacter pylori infection i s more cost-effective than therapy with antisecretory agents. Methods: A randomized, double-blind, multicenter clinical trial of adult patie nts with active duodenal ulcer and H pylori infection was conducted. P atients were randomized to receive 500 mg of clarithromycin 3 times a day plus 40 mg of omeprazole daily for 14 days followed by 20 mg of om eprazole daily for an additional 14 days (group 1), 20 mg of omeprazol e daily for 28 days (group 2), or 150 mg of ranitidine hydrochloride t wice a day for 28 days (group 3). The use of ulcer-related health care resources was documented during monthly interviews for 1 year after t he initial therapy. Clinical success was evaluated 4 to 6 weeks and 1 year after the end of therapy. Results: Of the 819 patients enrolled, 727 completed the study Group 1 included 243 patients; group 2, 248 pa tients; and group 3, 236 patients. Patients in group 1 used fewer ulce r-related health care resources during the 1 year after therapy compar ed with groups 2 and 3 (comparisons are given as group 1 vs group 2 an d group 1 vs group 3, respectively) the number of endoscopies performe d, 28 vs 76 (P<.001) and vs 71 (P<.001); patients receiving drugs to t reat an ulcer, 118 vs 180 (P<.001) and vs 168 (P<.001); clinic visits, 83 vs 135 (P=.05) and vs 161 (P<.001); hospitalizations, 0 vs 5 (P=.0 45) and vs 6 (P=.02); and length of hospital stay, 0 vs 24 days (P=.04 ) and vs 37 (P=.04). When ulcer-related costs were defined as the outc ome variable in a multivariate linear regression analysis, therapy was determined to have a significant influence on costs (group 1 vs group 2, P<.001; group 1 vs group 3, P=.008). Clinical success rates at the end of the study and cure of H pylori infection were significantly gr eater in group 1 compared with groups 2 and 3 (P<.001). Therapy with c larithromycin plus omeprazole provided savings of $1.94 and $2.96 (com pared with therapy with omeprazole and with ranitidine hydrochloride, respectively) per dollar spent within the first year after therapy. Th is incremental cost benefit translates to savings of $547 or $835 per patient in group 1 (compared with patients in group 2 or group 3, resp ectively) during the first year after therapy. Conclusions: Combinatio n therapy with clarithromycin and omeprazole resulted in significantly fewer uses of ulcer-related health care resources than conventional a ntisecretory therapy during a 1-year follow-up and significant savings in associated costs during the same period. Patients who received cla rithromycin plus omeprazole also showed a significantly improved clini cal outcome compared with patients who received only omeprazole or ran itidine.