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1.
Gastroenterol Hepatol ; 45(5): 392-417, 2022 May.
Article in English, Spanish | MEDLINE | ID: mdl-34629204

ABSTRACT

Helicobacter pylori infection is very common in the Spanish population and represents the main cause of chronic gastritis, peptic ulcer, and gastric cancer. The last iteration of Spanish consensus guidelines on H. pylori infection was conducted in 2016. Recent changes in therapeutic schemes along with increasing supporting evidence were key for developing the V Spanish Consensus Conference (May 2021). Fourteen experts performed a systematic review of the scientific evidence and developed a series of recommendations that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. An eradication therapy, when prescribed empirically, is considered acceptable when it reliably achieves, or preferably surpass, 90% cure rates. Currently, only quadruple therapies (with or without bismuth) and generally lasting 14 days, accomplish this goal in first- and second-line therapies. A non-bismuth quadruple concomitant regimen (proton pump inhibitor, clarithromycin, amoxicillin, and metronidazole) or a quadruple bismuth-based combination (proton pump inhibitor, bismuth, tetracycline, and metronidazole), are recommended as first-line regimens. Rescue therapies after eradication failure and management of H. pylori infection in peptic ulcer disease were also reviewed.


Subject(s)
Helicobacter Infections , Helicobacter pylori , Peptic Ulcer , Amoxicillin/therapeutic use , Anti-Bacterial Agents/therapeutic use , Bismuth/therapeutic use , Clarithromycin/therapeutic use , Drug Therapy, Combination , Helicobacter Infections/complications , Helicobacter Infections/drug therapy , Humans , Metronidazole/therapeutic use , Peptic Ulcer/complications , Proton Pump Inhibitors/therapeutic use
2.
Rev Esp Enferm Dig ; 113(10)2021 Oct.
Article in English | MEDLINE | ID: mdl-34607441

ABSTRACT

Helicobacter pylori infection is very common in the Spanish population and represents the main cause of chronic gastritis, peptic ulcer, and gastric cancer. The last iteration of Spanish consensus guidelines on H. pylori infection was conducted in 2016. Recent changes in therapeutic schemes along with increasing supporting evidence were key for developing the V Spanish Consensus Conference (May 2021). Fourteen experts performed a systematic review of the scientific evidence and developed a series of recommendations that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. An eradication therapy, when prescribed empirically, is considered acceptable when it reliably achieves, or preferably surpass, 90% cure rates. Currently, only quadruple therapies (with or without bismuth) and generally lasting 14 days, accomplish this goal in first- and second-line therapies. A non-bismuth quadruple concomitant regimen (proton pump inhibitor, clarithromycin, amoxicillin, and metronidazole) or a quadruple bismuth-based combination (proton pump inhibitor, bismuth, tetracycline, and metronidazole), are recommended as first-line regimens. Rescue therapies after eradication failure and management of H. pylori infection in peptic ulcer disease were also reviewed.


Subject(s)
Helicobacter Infections , Helicobacter pylori , Amoxicillin/therapeutic use , Anti-Bacterial Agents/therapeutic use , Clarithromycin/therapeutic use , Drug Therapy, Combination , Helicobacter Infections/drug therapy , Humans , Metronidazole/therapeutic use , Proton Pump Inhibitors/therapeutic use
3.
Gastroenterol. hepatol ; 39(10): 697-721, dec. 2016.
Article in Spanish | BIGG - GRADE guidelines | ID: biblio-966088

ABSTRACT

Helicobacter pylori approximately infect 50% of Spanish population and causes chronic gastritis, peptic ulcer and gastric cancer. Until now, three consensus meetings on H.pylori infection had been performed in Spain (the last in 2012). The changes in the treatment schemes, and the increasing available evidence, have justified organizing the IVSpanish Consensus Conference (March 2016), focused on the treatment of this infection. Nineteen experts participated, who performed a systematic review of the scientific evidence and developed a series of recommendation that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. As starting point, this consensus increased the minimum acceptable efficacy of recommended treatments that should reach, or preferably surpass, the 90% cure rate when prescribed empirically. Therefore, only quadruple therapies (with or without bismuth), and generally lasting 14 days, are recommended both for first and second line treatments. Non-bismuth quadruple concomitant regimen, including a proton pump inhibitor, clarithromycin, amoxicillin and metronidazole, is recommended as first line. In the present consensus, other first line alternatives and rescue treatments are also reviewed and recommended


La infección por Helicobacter pylori afecta aproximadamente al 50% de la población española y es causante de la gastritis crónica, la úlcera péptica y el cáncer gástrico. Se han llevado a cabo hasta el momento, en nuestro país, 3 reuniones de Consenso sobre el manejo de la infección por H. pylori (la última de ellas en 2012). Los cambios en los esquemas de tratamiento y la creciente evidencia disponible al respecto han justificado la organización de esta IV Conferencia Española de Consenso en marzo de 2016, centrada en el tratamiento de esta infección. Participaron 19 expertos sobre el tema, que realizaron una búsqueda sistemática de la evidencia científica y elaboraron una serie de recomendaciones que fueron sometidas a un proceso de interacción de votaciones anónimas seriadas mediante metodología Delphi. Para clasificar la evidencia científica y la fuerza de las recomendaciones se utilizó el sistema GRADE. Este consenso establece, como punto de partida, un aumento de la exigencia en la eficacia de los tratamientos recomendados, que deben alcanzar, o preferiblemente superar, el 90% de curación al ser administrados de forma empírica. De este modo, tanto en primera como en segunda línea se recomiendan tratamientos cuádruples con o sin bismuto, generalmente prescritos durante 14 días. El tratamiento cuádruple sin bismuto concomitante, que incluye un inhibidor de la bomba de protones, claritromicina, amoxicilina y metronidazol, se recomienda como primera línea. En el presente consenso se revisan también con detalle otras alternativas de tratamiento tanto de primera línea como de rescate.


Subject(s)
Humans , Helicobacter pylori , Gastritis/drug therapy , Recurrence , Stomach Neoplasms , Stomach Ulcer , Bismuth/therapeutic use , Algorithms , Helicobacter pylori/drug effects , Helicobacter Infections , Helicobacter Infections/drug therapy , Delphi Technique , Salvage Therapy , Treatment Failure , Probiotics , Drug Therapy, Combination , Proton Pump Inhibitors , Proton Pump Inhibitors/therapeutic use , Gastritis/complications , Anti-Bacterial Agents/therapeutic use
4.
Aliment Pharmacol Ther ; 41(6): 581-9, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25776067

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori/drug effects , Medication Adherence , Adolescent , Adult , Aged , Aged, 80 and over , Amoxicillin/administration & dosage , Amoxicillin/adverse effects , Amoxicillin/therapeutic use , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Clarithromycin/administration & dosage , Clarithromycin/adverse effects , Clarithromycin/therapeutic use , Drug Therapy, Combination , Esomeprazole/administration & dosage , Esomeprazole/adverse effects , Esomeprazole/therapeutic use , Female , Helicobacter pylori/isolation & purification , Humans , Male , Metronidazole/administration & dosage , Metronidazole/adverse effects , Metronidazole/therapeutic use , Middle Aged , Prospective Studies , Young Adult
5.
Dig Dis Sci ; 59(2): 383-9, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24126798

ABSTRACT

BACKGROUND: Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20 % of patients. AIM: To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures. METHODS: Prospective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire. RESULTS: Two hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60-74 %) and 65 % (58-72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe. CONCLUSION: A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Clarithromycin/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori/drug effects , Levofloxacin/therapeutic use , Organometallic Compounds/therapeutic use , Salvage Therapy , Adult , Amoxicillin/therapeutic use , Anti-Bacterial Agents/adverse effects , Drug Therapy, Combination , Female , Helicobacter Infections/diagnosis , Helicobacter Infections/microbiology , Helicobacter pylori/isolation & purification , Humans , Male , Metronidazole/therapeutic use , Middle Aged , Organometallic Compounds/adverse effects , Prospective Studies , Proton Pump Inhibitors/therapeutic use , Spain , Surveys and Questionnaires , Tetracycline/therapeutic use , Time Factors , Treatment Failure
6.
Emergencias (St. Vicenç dels Horts) ; 25(6): 472-481, dic. 2013. ilus, tab
Article in Spanish | IBECS | ID: ibc-118112

ABSTRACT

La hemorragia digestiva alta no varicosa (HDANV) es una emergencia médica frecuente que se asocia a una considerable morbilidad y mortalidad. En los últimos años se han producido importantes avances en el manejo de la HDANV, que han permitido disminuirla recidiva hemorrágica y la mortalidad en estos pacientes. El objetivo del presente documento es ofrecer una guía de manejo de la HDANV eminentemente práctica basada en la evidencia científica y en las recomendaciones de los recientes consensos. Lostres puntos clave del manejo de la HDANV son: a) la reanimación hemodinámica precozy la prevención de las complicaciones de la patología cardiovascular de base, quees frecuente en pacientes con HDANV; b) el tratamiento endoscópico de las lesiones con alto riesgo de recidiva; y c) el uso de inhibidores de la bomba de protones a dosis altas pre y postendoscopia. La combinación de estas medidas permite reducir la recidiva y la mortalidad de la HDANV (AU)


Nonvariceal upper gastrointestinal (GI) bleeding is a common medical emergency associated with appreciable morbidity and mortality. The significant advances made in managing this condition in recent years have reduced the rates of rebleeding and mortality. These clinical guidelines for managing this emergency are intended to be highly practical, evidence-based, and take recent consensus statements into account. The 3 keys to managing nonvariceal upper GIbleeding are a) early restoration of fluids and blood pressure and the prevention of underlying cardiovascular disease, which is common in these patients; b) endoscopy to treat lesions at high risk of rebleeding; and c) medical therapy with high doses of proton pump inhibitors before and after endoscopy. These 3 measures, used in combination, reduce upperGI rebleeding and mortality rates (AU)


Subject(s)
Humans , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/therapy , Gastroscopy , Practice Patterns, Physicians' , Proton Pump Inhibitors/therapeutic use , Helicobacter pylori/pathogenicity , Helicobacter Infections/complications , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Stomach Ulcer/complications
7.
Am J Gastroenterol ; 107(8): 1197-204, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22613904

ABSTRACT

OBJECTIVES: To evaluate the effect of Helicobacter pylori (H. pylori) eradication on ulcer bleeding recurrence in a prospective, long-term study including 1,000 patients. METHODS: Patients with peptic ulcer bleeding were prospectively included. Prior non-steroidal anti-inflammatory drug (NSAID) use was not considered exclusion criteria. H. pylori infection was confirmed by rapid urease test, histology, or (13)C-urea breath test. Several eradication therapies were used. Subsequently, ranitidine 150 mg o.d. was administered until eradication was confirmed by (13)C-urea breath test 8 weeks after completing therapy. Patients with therapy failure received a second, third, or fourth course of eradication therapy. Patients with eradication success did not receive maintenance anti-ulcer therapy and were controlled yearly with a repeat breath test. NSAID use was not permitted during follow-up. RESULTS: Thousand patients were followed up for at least 12 months, with a total of 3,253 patient-years of follow-up. Mean age 56 years, 75% males, 41% previous NSAID users. In all, 69% had duodenal ulcer, 27% gastric ulcer, and 4% pyloric ulcer. Recurrence of bleeding was demonstrated in three patients at 1 year (which occurred after NSAID use in two cases, and after H. pylori reinfection in another one), and in two more patients at 2 years (one after NSAID use and another after H. pylori reinfection). The cumulative incidence of rebleeding was 0.5% (95% confidence interval, 0.16-1.16%), and the incidence rate of rebleeding was 0.15% (0.05-0.36%) per patient-year of follow up. CONCLUSION: Peptic ulcer rebleeding virtually does not occur in patients with complicated ulcers after H. pylori eradication. Maintenance anti-ulcer (antisecretory) therapy is not necessary if eradication is achieved. However, NSAID intake or H. pylori reinfection may exceptionally cause rebleeding in H. pylori-eradicated patients.


Subject(s)
Helicobacter Infections/drug therapy , Helicobacter pylori , Peptic Ulcer Hemorrhage/microbiology , Breath Tests , Female , Helicobacter Infections/complications , Helicobacter Infections/diagnosis , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Peptic Ulcer/drug therapy , Peptic Ulcer/microbiology , Recurrence , Urea/analysis
8.
Aliment Pharmacol Ther ; 35(8): 941-7, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22372560

ABSTRACT

BACKGROUND: In some cases, Helicobacter pylori infection persists even after three eradication treatments. AIM: To evaluate the efficacy of an empirical fourth-line rescue regimen with rifabutin in patients with three eradication failures. DESIGN: Multicentre, prospective study. PATIENTS: In whom the following three treatments had consecutively failed: first (PPI + clarithromycin + amoxicillin); second (PPI + bismuth + tetracycline + metronidazole); third (PPI + amoxicillin + levofloxacin). INTERVENTION: A fourth regimen with rifabutin (150 mg b.d.), amoxicillin (1 g b.d.) and a PPI (standard dose b.d.) was prescribed for 10 days. OUTCOME: Eradication was confirmed by (13) C-urea breath test 4-8 weeks after therapy. Compliance and tolerance: Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated using a questionnaire. RESULTS: One-hundred patients (mean age 50 years, 39% men, 31% peptic ulcer/69% functional dyspepsia) were included. Eight patients did not take the medication correctly (in six cases due to adverse effects). Per-protocol and intention-to-treat eradication rates were 52% (95% CI = 41-63%) and 50% (40-60%). Adverse effects were reported in 30 (30%) patients: nausea/vomiting (13 patients), asthenia/anorexia (8), abdominal pain (7), diarrhoea (5), fever (4), metallic taste (4), myalgia (4), hypertransaminasemia (2), leucopenia (<1,500 neutrophils) (2), thrombopenia (<150,000 platelets) (2), headache (1) and aphthous stomatitis (1). Myelotoxicity resolved spontaneously in all cases. CONCLUSIONS: Even after three previous H. pylori eradication failures, an empirical fourth-line rescue treatment with rifabutin may be effective in approximately 50% of the cases. Therefore, rifabutin-based rescue therapy constitutes a valid strategy after multiple previous eradication failures with key antibiotics, such as clarithromycin, metronidazole, tetracycline and levofloxacin.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Dyspepsia/drug therapy , Helicobacter Infections/drug therapy , Helicobacter pylori/isolation & purification , Peptic Ulcer/drug therapy , Rifabutin/therapeutic use , Adult , Anti-Bacterial Agents/adverse effects , Drug Therapy, Combination , Dyspepsia/microbiology , Female , Follow-Up Studies , Helicobacter Infections/microbiology , Humans , Male , Middle Aged , Patient Compliance , Peptic Ulcer/microbiology , Prospective Studies , Rifabutin/adverse effects , Surveys and Questionnaires , Treatment Failure , Treatment Outcome
10.
Dig Liver Dis ; 42(4): 287-90, 2010 Apr.
Article in English | MEDLINE | ID: mdl-19632166

ABSTRACT

AIM: To assess the efficacy and tolerability of Helicobacter pylori first-line treatment (omeprazole-clarithromycin-metronidazole) and second-line rescue option (omeprazole-clarithromycin-levofloxacin) in patients allergic to penicillin. PATIENTS: Prospective multicenter study including consecutive patients allergic to penicillin. Therapy regimens: First-line treatment (50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and metronidazole (500 mg b.i.d.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and levofloxacin (500 mg b.i.d.) for 10 days. OUTCOME VARIABLE: Negative (13)C-urea breath test 8 weeks after completion of treatment. RESULTS: (1) First-line treatment (omeprazole-clarithromycin-metronidazole): Per-protocol and intention-to-treat eradication rates were 55% (27/49; 95%CI=40-70%) and 54% (27/50; 95%CI=39-69%). Compliance with treatment and follow-up was complete in 98% of cases (one patient was not compliant due to nausea). Adverse events were reported in 5 patients (10%): 4 nausea, 1 diarrhoea. (2) Second-line treatment (omeprazole-clarithromycin-levofloxacin): Per-protocol and intention-to-treat eradication rates were both 73% (11/15; 95%CI=45-92%). Compliance with treatment and follow-up was complete in all the cases. Adverse events were reported in 4 patients (20%), which did not prevent the completion of treatment: Mild nausea (2 patients), and vomiting and myalgias/arthralgias (1 patient). CONCLUSION: In H. pylori infected patients allergic to penicillin, the generally recommended first-line treatment with omeprazole, clarithromycin and metronidazole has low efficacy for curing the infection. On the other hand, a levofloxacin-containing regimen (together with omeprazole and clarithromycin) represents an encouraging second-line alternative in the presence of penicillin allergy.


Subject(s)
Anti-Infective Agents/administration & dosage , Drug Hypersensitivity/complications , Helicobacter Infections/drug therapy , Helicobacter pylori , Levofloxacin , Ofloxacin/administration & dosage , Penicillins/adverse effects , Anti-Bacterial Agents/administration & dosage , Anti-Ulcer Agents/administration & dosage , Clarithromycin/administration & dosage , Drug Administration Schedule , Drug Therapy, Combination/adverse effects , Female , Humans , Male , Metronidazole/administration & dosage , Middle Aged , Omeprazole/administration & dosage , Prospective Studies , Treatment Outcome
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