First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial

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...

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Autores: Cuadrado Lavín, Antonio|||0000-0002-1363-864X, Salvines Caviedes, JR, Díaz Pérez, A, Carrascosa, MF, Ochagavia Sufrategui, María, Fernández Forcelledo, Jl, Cobo, M, Fernández Gil, P, Ayestarán, B, Sánchez, B, Campo, C, Llorca Díaz, Francisco Javier|||0000-0001-8569-861X, Lorenzo, S, Illaro, A
Tipo de recurso: artículo
Fecha de publicación:2015
País:España
Institución:Universidad de Cantabria (UC)
Repositorio:UCrea Repositorio Abierto de la Universidad de Cantabria
Idioma:inglés
OAI Identifier:oai:repositorio.unican.es:10902/9432
Acceso en línea:http://hdl.handle.net/10902/9432
Access Level:acceso abierto
Palabra clave:concomitant
H. pylori
non-bismuth-based quadruple regimens
randomized clinical trials
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spelling First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trialCuadrado Lavín, Antonio|||0000-0002-1363-864XSalvines Caviedes, JRDíaz Pérez, ACarrascosa, MFOchagavia Sufrategui, MaríaFernández Forcelledo, JlCobo, MFernández Gil, PAyestarán, BSánchez, BCampo, CLlorca Díaz, Francisco Javier|||0000-0001-8569-861XLorenzo, SIllaro, AconcomitantH. pylorinon-bismuth-based quadruple regimensrandomized clinical trialsOBJECTIVES: 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.Universidad de Cantabria20152015-01-01journal articlehttp://purl.org/coar/resource_type/c_6501NAhttp://purl.org/coar/version/c_be7fb7dd8ff6fe43info:eu-repo/semantics/articlehttp://hdl.handle.net/10902/9432J Antimicrob Chemother. 2015 Aug;70(8):2376-81reponame:UCrea Repositorio Abierto de la Universidad de Cantabriainstname:Universidad de Cantabria (UC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Atribución-NoComercial-SinDerivadas 3.0 Españahttp://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:repositorio.unican.es:10902/94322026-06-02T12:39:31Z
dc.title.none.fl_str_mv First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
title First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
spellingShingle First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
Cuadrado Lavín, Antonio|||0000-0002-1363-864X
concomitant
H. pylori
non-bismuth-based quadruple regimens
randomized clinical trials
title_short First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
title_full First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
title_fullStr First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
title_full_unstemmed First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
title_sort First-line eradication rates comparing two shortened non-bismuth quadruple regimens against Helicobacter pylori: an open-label, randomized, multicentre clinical trial
dc.creator.none.fl_str_mv Cuadrado Lavín, Antonio|||0000-0002-1363-864X
Salvines Caviedes, JR
Díaz Pérez, A
Carrascosa, MF
Ochagavia Sufrategui, María
Fernández Forcelledo, Jl
Cobo, M
Fernández Gil, P
Ayestarán, B
Sánchez, B
Campo, C
Llorca Díaz, Francisco Javier|||0000-0001-8569-861X
Lorenzo, S
Illaro, A
author Cuadrado Lavín, Antonio|||0000-0002-1363-864X
author_facet Cuadrado Lavín, Antonio|||0000-0002-1363-864X
Salvines Caviedes, JR
Díaz Pérez, A
Carrascosa, MF
Ochagavia Sufrategui, María
Fernández Forcelledo, Jl
Cobo, M
Fernández Gil, P
Ayestarán, B
Sánchez, B
Campo, C
Llorca Díaz, Francisco Javier|||0000-0001-8569-861X
Lorenzo, S
Illaro, A
author_role author
author2 Salvines Caviedes, JR
Díaz Pérez, A
Carrascosa, MF
Ochagavia Sufrategui, María
Fernández Forcelledo, Jl
Cobo, M
Fernández Gil, P
Ayestarán, B
Sánchez, B
Campo, C
Llorca Díaz, Francisco Javier|||0000-0001-8569-861X
Lorenzo, S
Illaro, A
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidad de Cantabria
dc.subject.none.fl_str_mv concomitant
H. pylori
non-bismuth-based quadruple regimens
randomized clinical trials
topic concomitant
H. pylori
non-bismuth-based quadruple regimens
randomized clinical trials
description 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.
publishDate 2015
dc.date.none.fl_str_mv 2015
2015-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
NA
http://purl.org/coar/version/c_be7fb7dd8ff6fe43
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10902/9432
url http://hdl.handle.net/10902/9432
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Atribución-NoComercial-SinDerivadas 3.0 España
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Atribución-NoComercial-SinDerivadas 3.0 España
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv J Antimicrob Chemother. 2015 Aug;70(8):2376-81
reponame:UCrea Repositorio Abierto de la Universidad de Cantabria
instname:Universidad de Cantabria (UC)
instname_str Universidad de Cantabria (UC)
reponame_str UCrea Repositorio Abierto de la Universidad de Cantabria
collection UCrea Repositorio Abierto de la Universidad de Cantabria
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300724

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