An optimized clarithromycin-free 14-day triple therapy for Helicobacter pylori eradication achieves high cure rates in Uruguay / El tratamiento triple, optimizado y sin claritromicina durante 14 días consigue altas tasas de curación de Helicobacter pylori en Uruguay

Background: Strong acid inhibition increases cure rates with triple therapy and 14-day are more effective than 7-day treatments. The combination of amoxicillin plus metronidazole at full doses has been shown to overcome metronidazole resistance and to achieve good eradication rates even in patients harboring resistant strains. No previous studies have been reported in Latin-America with this optimized triple-therapy scheme. Aims: The aim of the present study was to assess the eradication rate and tolerance of a new first-line treatment regimen associating strong acid inhibition, amoxicillin and metronidazole. Methods: Patients from the Clínica de Gastroenterología of the Hospital de Clínicas (Montevideo, Uruguay) were included. Hp status was mainly assessed by at least one of the following: histologyor urea breath test (UBT). A 14-day treatment was prescribed comprising esomeprazole 40mg twice a day plus amoxicillin 1g and metronidazole 500mg, both three times a day. H. pylori cure was assessed by UBT. Results: Forty-one patients were enrolled. Mean age was 53.3±13 years and 17.1% of patients were male. Main indications for treatment were: functional dyspepsia (27.5%), gastritis (45%), gastric or duodenal erosions (20%), gastric ulcer (5%) and intestinal metaplasia (2.5%). H. pylori eradication was achieved in 33 of the 37 patients who returned for follow-up. Eradication rates were 80.5% (95% CI: 68.4-92.6) by intention-to-treat (ITT) analysis and 89.2% (95% CI; 79.2-99.2) per protocol (PP). No major side effects were reported; 26 patients (65.8%) complained of mild side effects (nausea, diarrhea and headache). Conclusions: Cure rates of this triple therapy including esomeprazole, amoxicillin and metronidazole were 81% per ITT and the treatment was well tolerated. These optimal results with a simple clarithromycin-free triple therapy are better than described for standard triple therapy but there is still room for improvement to reach the desired target of 90% per ITT (AU)

Antecedentes: La inhibición ácida potente aumenta las tasas de curación de la triple terapia, y 14 días de tratamiento son más efectivos que 7 días. La combinación de amoxicilina y metronidazol a dosis completas ha demostrado que supera la resistencia al metronidazol y que consigue buenas tasas de erradicación, incluso en pacientes que poseen cepas resistentes. No se han reportado estudios con este tratamiento triple optimizado en Latinoamérica. Objetivos: El objetivo del presente estudio es valorar las tasas de erradicación y la tolerancia de un nuevo tratamiento de primera línea que asocia inhibición ácida potente, amoxicilina y metronidazol. Métodos: Pacientes provenientes de la Clínica de Gastroenterología del Hospital de Clínicas (Montevideo, Uruguay) se incluyeron en el estudio. La infección por Helicobacter pylori fue demostrada por, al menos, una de las siguientes: histología o test del aliento. Se prescribió un tratamiento de 14 días con esomeprazol 40mg 2 veces al día junto a amoxicilina 1g y metronidazol 500mg ambos 3 veces al día. La curación de Helicobacter pylori fue confirmada por el test del aliento. Resultados: Se incluyeron 41 pacientes. La edad media fue de 53,3±13 años y el 17,1% de los pacientes eran hombres. La principal indicación para el tratamiento fue: dispepsia funcional (27,5%); gastritis (45%), erosiones gástricas o duodenales (20%), úlcera gástrica (5%) y metaplasia intestinal (2,5%). La erradicación de Helicobacter pylori se consiguió en 33 de los 37 pacientes que regresaron para el test de control. Las tasas de erradicación fueron del 80,5% (IC 95%: 68,4-92,6) por intención de tratar y del 89,2% (IC 95%: 79,2-99,2) por protocolo. No se reportaron efectos secundarios graves. Veintiséis pacientes (65,8%) presentaron efectos secundarios leves (náuseas, diarrea y cefalea). Conclusiones: Las tasas de erradicación de esta triple terapia que incluye esomeprazol, amoxicilina y metronidazol fueron del 81% por intención de tratar y el tratamiento fue bien tolerado. Estos resultados óptimos con un tratamiento triple sencillo, sin claritromicina, son mejores que los descritos para el tratamiento triple estándar, pero todavía existe espacio de mejora para alcanzar el objetivo deseado del 90% por intención de tratar (AU)

An optimized clarithromycin-free 14-day triple therapy for Helicobacter pylori eradication achieves high cure rates in Uruguay.

BACKGROUND: Strong acid inhibition increases cure rates with triple therapy and 14-day are more effective than 7-day treatments. The combination of amoxicillin plus metronidazole at full doses has been shown to overcome metronidazole resistance and to achieve good eradication rates even in patients harboring resistant strains. No previous studies have been reported in Latin-America with this optimized triple-therapy scheme. AIMS: The aim of the present study was to assess the eradication rate and tolerance of a new first-line treatment regimen associating strong acid inhibition, amoxicillin and metronidazole. METHODS: Patients from the Clínica de Gastroenterología of the Hospital de Clínicas (Montevideo, Uruguay) were included. Hp status was mainly assessed by at least one of the following: histologyor urea breath test (UBT). A 14-day treatment was prescribed comprising esomeprazole 40mg twice a day plus amoxicillin 1g and metronidazole 500mg, both three times a day. H. pylori cure was assessed by UBT. RESULTS: Forty-one patients were enrolled. Mean age was 53.3±13 years and 17.1% of patients were male. Main indications for treatment were: functional dyspepsia (27.5%), gastritis (45%), gastric or duodenal erosions (20%), gastric ulcer (5%) and intestinal metaplasia (2.5%). H. pylori eradication was achieved in 33 of the 37 patients who returned for follow-up. Eradication rates were 80.5% (95% CI: 68.4-92.6) by intention-to-treat (ITT) analysis and 89.2% (95% CI; 79.2-99.2) per protocol (PP). No major side effects were reported; 26 patients (65.8%) complained of mild side effects (nausea, diarrhea and headache). CONCLUSIONS: Cure rates of this triple therapy including esomeprazole, amoxicillin and metronidazole were 81% per ITT and the treatment was well tolerated. These optimal results with a simple clarithromycin-free triple therapy are better than described for standard triple therapy but there is still room for improvement to reach the desired target of 90% per ITT.