Optimised empiric triple and concomitant therapy forHelicobacter pylorieradication in clinical practice: the OPTRICON study

Abstract

Summary Background Empiric triple therapy for Helicobacter pylori should be abandoned when clarithromycin resistance rate is >15–20%. Optimisation of triple therapy (high‐dose acid suppression and 14‐day duration) can increase eradication rates by 10%. Aim To compare the efficacy and safety of optimised triple (OPT‐TRI) and nonbismuth quadruple concomitant (OPT‐CON) therapies. Methods Prospective multicentre study in 16 Spanish centres using triple therapy in clinical practice. In a 3‐month two‐phase fashion, the first 402 patients received an OPT‐TRI therapy [esomeprazole (40 mg b.d.), amoxicillin (1 g b.d) and clarithromycin (500 mg b.d) for 14 days] and the last 375 patients an OPT‐CON treatment [OPT‐TRI therapy plus metronidazole (500 mg b.d)]. Results Seven‐hundred seventy‐seven consecutive patients were included (402 OPT‐TRI, 375 OPT‐CON). The OPT‐CON therapy achieved significantly higher eradication rates in the per‐protocol [82.3% (95% CI = 78–86%) vs. 93.8% (91–96%), P < 0.001] and intention‐to‐treat analysis [81.3% (78–86%) vs. 90.4% (87–93%), P < 0.001]. Adverse events (97% mild/moderate) were significantly more common with OPT‐CON therapy (39% vs. 47%, P = 0.016), but full compliance with therapy was similar between groups (94% vs. 92%, P = 0.4). OPT‐CON therapy was the only significant predictor of successful eradication (odds ratio, 2.24; 95% CI: 1.48–3.51, P < 0.001). The rate of participating centres achieving cure rates ≥90% favoured OPT‐CON therapy (OPT‐TRI 25% vs. OPT‐CON 62%). Conclusions Empiric OPT‐CON therapy achieved significantly higher cure rates (>90%) compared to OPT‐TRI therapy. Addition of metronidazole to OPT‐TRI therapy increased eradication rates by 10%, resulting in more mild adverse effects, but without impairing compliance with therapy.

Two-week Triple Therapy with either Standard or High-dose Esomeprazole for First-line H. pylori Eradication

“…However, even following this therapy the cure rate was 81.9-85.5%. To our knowledge, the efficacy of this therapy regimen has been tested only in another study recently performed in Spain, where the eradication rates were 81.3-82.3% [20]. Although modest, such a therapeutic gain in the presence of high clarithromycin resistance is probably clinically advantageous when considering that the cost of therapy, in Italy, is increased by only 10 Euros.…”

Management ofHelicobacter pyloriinfection—the Maastricht V/Florence Consensus Report

“…In another multicentre study, the OPTRICON trial,172 the authors compared the effectiveness and safety of two ‘optimised’ triple and concomitant therapies (with esomeprazole 40 mg twice daily) for 14 days. The optimised concomitant therapy achieved significantly higher eradication rates.…”

Efficacy of metronidazole versus placebo in pain control after hemorrhoidectomy. Results of a controlled clinical trial

“…It is an antimicrobial drug from the nitroimidazole family that acts primarily as a broad-spectrum antibiotic against anaerobic pathogens and protozoans (21,22). Metronidazole is used in clinical practice and surgery, and is also used with good results to treat Crohn's disease (23) and for Helicobacter pylori infection eradication (24) and colonic preparation before colorectal surgery (25). Metronidazole is used widely because of its efficacy, safety, low cost, and low rate of adverse events (21,26).…”