First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial. (7th April 2015)

• Record Type: Journal Article
• Authors: Cuadrado-Lavín, Antonio; Salcines-Caviedes, J. Ramón; Diaz-Perez, Ainhoa; Carrascosa, Miguel F.; Ochagavía, María; Fernandez-Forcelledo, José Luis; Cobo, Marta; Fernández-Gil, Pedro; Ayestarán, Blanca; Sánchez, Blanca; Campo, Cristina; Llorca, Javier; Lorenzo, Silvia; Illaro, Aitziber
• Is Part Of: Journal of antimicrobial chemotherapy. Volume 70:Number 8(2015:Aug.)
• Page Start: 2376
• Page End: 2381
• Publication Date: 2015-04-07
• Subjects: concomitant -- H. pylori -- hybrid -- non-bismuth-based quadruple regimens -- randomized clinical trials; Anti-infective agents -- Periodicals; Chemotherapy -- Periodicals; 615.58
• DOI: 10.1093/jac/dkv089
• Languages: English
• ISSNs: 0305-7453

Abstract

Abstract: Objectives: Helicobacter pylori eradication remains a challenge. Non-bismuth-based quadruple regimens (NBQR) have shown high eradication rates (ER) elsewhere that need to be locally confirmed. The objective of this study was to compare the first-line ER of a hybrid therapy (20 mg of omeprazole twice daily and 1 g of amoxicillin twice daily for 10 days, adding 500 mg of clarithromycin twice daily and 500 mg of metronidazole every 8 h for the last 5 days; OA-OACM) with that of a 10 day concomitant regimen consisting of taking all four drugs twice daily every day (including 500 mg of metronidazole every 12 h; OACM). A 10 day arm with standard triple therapy (OAC; 20 mg of omeprazole/12 h, 1 g of amoxicillin/12 h and 500 mg of clarithromycin/12 h) was included. Patients and methods: Three hundred consecutive patients were randomized (1: 2: 2) into one of the three following regimens: (i) OAC (60); (ii) OA-OACM (120); and (iii) OACM (120). Eradication was generally confirmed by a [ 13 C]urea breath test at least 4 weeks after the end of treatment. Adverse events and compliance were assessed. EudraCT: 2011-006258-99. Results: ITT cure rates were: OAC, 70.0% (42/60) (95% CI: 58.3–81.7); OA-OACM, 90.8% (109/120) (95% CI: 85.6–96.0); and OACM, 90.0% (107/119) (95% CI: 84.6–95.4). PP rates were: OAC, 72.4% (42/58) (95% CI: 60.8–84.1); OA-OACM, 93.9% (108/115) (95% CI: 89.5–98.3); and OACM, 90.3% (102/113) (95% CI: 84.8–95.8). Both NBQR significantly improved ER compared with OAC ( P < 0.01), but no differences were seen between them. Mean compliance was elevated [98.0% (SD = 9.8)] with no differences between groups. There were more adverse events in the quadruple arms (OACM, 65.8%; OA-OACM, 68.6%; OAC, 46.6%; P < 0.05), but no significant differences between groups in terms of severity were seen. Conclusions: Hybrid and concomitant regimens show good ER against H. pylori infection with an acceptable safety profile. They clearly displace OAC as first-line regimen in our area.