Prospective comparative study between two first-line regimens for Helicobacter pylori eradication: Non-bismuth quadruple versus bismuth quadruple therapy / Estudio comparativo prospectivo entre 2 tratamientos de primera línea para la erradicación de Helicobacter pylori: tetraterapia sin bismuto frente a tetraterapia con bismuto

BACKGROUND: The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. AIMS: To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. METHOD: Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. RESULTS: 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p = 0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p = 0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p = 0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p = 0.109), being longer (12 vs 7 days, p < 0.0001) and more severe (p < 0.0001) with OCAM. CONCLUSIONS: In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile

ANTECEDENTES: El Consenso de Maastricht V recomienda tetraterapias como tratamiento de primera línea de Helicobacter pylori en áreas con elevada resistencia a claritromicina (CLA). OBJETIVOS: Comparar la eficacia, los efectos secundarios y el cumplimiento terapéutico entre la tetraterapia sin bismuto y la tetraterapia con bismuto. MÉTODO: Estudio prospectivo que incluyó a pacientes con H. pylori. Se prescribió omeprazol y una formulación 3 en uno de bismuto-metronidazol-tetraciclina (OBMT-3/1) durante 10 días, o una combinación de omeprazol-claritromicina-amoxicilina-metronidazol (OCAM) durante 14 días. El resultado de la erradicación se evaluó mediante una prueba de aliento con urea o histología. Los efectos secundarios y el cumplimiento terapéutico se registraron durante el período de tratamiento empleando cuestionarios específicos. RESULTADOS: Se incluyeron 404 pacientes (mediana de edad de 53 años; un 62,87% de mujeres). El resultado de la prueba posterior al tratamiento estuvo disponible en 382 pacientes (183 con OCAM, 199 con OBMT-3/1). Las tasas de erradicación fueron del 85,94% (IC 95%: 80,20-90,52) con OCAM y del 88,21% (IC 95%: 83,09-92,22) con OBMT-3/1 (p = 0,595) en el análisis por intención de tratar, mientras que en el análisis por protocolo fueron del 91,12% (IC 95%: 85,78-94,95) y del 96,17% (IC 95%: 92,28-98,45), respectivamente (p = 0,083). El cumplimiento terapéutico superior al 90% fue del 91,35% con OCAM y del 92,04% con OBMT-3/1 (p = 0,951). Se observaron efectos secundarios en el 94,02% de los pacientes tratados con OCAM y en el 88,89% de los tratados con OBMT-3/1 (p = 0,109), y fueron más prolongados (12 frente a 7 días, p < 0,0001) y más graves (p < 0,0001) con OCAM. CONCLUSIONES: En un área con elevada resistencia a la CLA no se observan diferencias entre OBMT-3/1 y OCAM en la erradicación de H. pylori ni en las tasas de cumplimiento, pero OBMT-3/1 presenta un perfil de seguridad superior

Prospective comparative study between two first-line regimens for Helicobacter pylori eradication: Non-bismuth quadruple versus bismuth quadruple therapy.

BACKGROUND: The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. AIMS: To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. METHOD: Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. RESULTS: 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p=0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p=0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p=0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p=0.109), being longer (12 vs 7 days, p<0.0001) and more severe (p<0.0001) with OCAM. CONCLUSIONS: In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile.

Effectiveness of anti-TNFα drugs in patients with Crohn's disease who do not achieve remission with their first anti-TNFα agent.

BACKGROUND: Anti-TNF treatment is effective for Crohn's disease (CD); however, some patients did not achieve remission with these drugs. AIMS: To evaluate the short-term effectiveness of a second anti-TNF in CD patients who did not achieve remission with the first one and to assess its durability. METHODS: Patients who did not achieve remission with their first anti-TNF were included. The short-term response of the second anti-TNF was assessed, the long-term response was evaluated in patients who achieved remission (Kaplan-Meier). Cox-regression was performed to identify predictors of loss of efficacy. RESULTS: In all, 118 CD patients received a second anti-TNF after primary failure of the first. The first anti-TNF was discontinued because of non-response in 54% of patients and partial response in 46%. Fifty-one percent of patients achieved remission in the short-term. The probability of remission was lower in patients for whom the drug indication was perianal disease (OR=0.3, 95% CI=0.1-0.7, P=0.005). The dose was increased in 33% of patients, and 37% achieved/regained remission. The probability of maintaining remission was 76%, 68% and 64% at 12, 18 and 24 months, respectively. CONCLUSIONS: Approximately half of the patients achieved remission with a second anti-TNF after primary failure of the first, this strategy was less effective in patients with perianal disease.