Effect of esomeprazole triple therapy on eradication rates of Helicobacter pylori, gastric ulcer healing and prevention of relapse in gastric ulcer patients.
OBJECTIVE
To compare esomeprazole-based triple therapy with esomeprazole alone for the eradication of Helicobacter pylori (H. pylori), healing of ulcer and prevention of relapse in H. pylori-related gastric ulcer (GU) diseases.


METHODS
In this double-blind study, 401 H. pylori-positive patients with more than or equal to two GUs were randomized to: esomeprazole (20 mg) twice daily (bid) and amoxicillin (1000 mg) bid and clarithromycin (500 mg) bid (EAC) for 1 week, followed by placebo for 3 weeks (EAC and placebo); EAC for 1 week, followed by esomeprazole (20 mg) once daily (E20) for 3 weeks (EAC and E20); or esomeprazole (20 mg) bid and placebo antimicrobials for 1 week, followed by E20 for 3 weeks (E20 bid and E20). Patients with unhealed GUs at 4 weeks received E20 for an additional 4 weeks. Healed patients were followed up for 12 months.


RESULTS
Eradication rates at 4 weeks or 8 weeks were 82% for EAC and E20, 77% for EAC and placebo and 9.5% for E20 bid and E20 (intention-to-treat analysis). Significantly more patients receiving EAC than those receiving esomeprazole alone remained free of GUs during follow-up [EAC and E20, 90%; EAC and placebo, 87%; P=0.0005 for combined group vs. esomeprazole alone [E20 bid and E20 (74%)]. All treatments were well tolerated.


CONCLUSIONS
Esomeprazole-based triple therapy is effective for the eradication of H. pylori, healing of GU and prevention of relapse. Esomeprazole monotherapy for 3 weeks after triple therapy may be beneficial in terms of healing.
Tulassay
Zsolt
Z
2nd Medical Clinic, Semmelweis University, Budapest, Hungary. tulassay@bel2.sote.hu
Stolte
Manfred
M
Sjölund
Maria
M
Engstrand
Lars
L
Butruk
Eugeniusz
E
Malfertheiner
Peter
P
Dite
Petr
P
Tchernev
Konstantin
K
Wong
Benjamin C Y
BC
Gottlow
Mattis
M
Eklund
Stefan
S
Wrangstadh
Michael
M
Nagy
Péter
P
D000328:Adult; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole