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Gisbert J.P.,Hospital Universitario Of La Princesa | Calvet X.,Autonomous University of Barcelona
Alimentary Pharmacology and Therapeutics | Year: 2012

Background: Even with the current most effective treatment regimens, a relevant proportion of patients will fail to eradicate Helicobacter pylori infection. Aim To evaluate the role of rifabutin in the treatment of H. pylori infection. Methods Bibliographical searches were performed in MEDLINE. Data on the efficacy of rifabutin-containing regimens on H. pylori eradication were combined and meta-analysed using the generic inverse variance method. Results Rifabutin shows good in vitro activity against H. pylori. Mean H. pylori rifabutin resistance rate (calculated from 11 studies including 2982 patients) was 1.3% (95% confidence interval = 0.9-1.7%). When only studies including patients naîve to H. pylori eradication treatment were considered, this figure was even lower (0.6%). On the other hand, higher values of rifabutin resistance were calculated (1.59%) when only post-treatment patients were considered. Overall, mean H. pylori eradication rate (intention-to-treat analysis) with rifabutin-containing regimens (1008 patients) was 73% (67-79%). Respective cure rates for second-line (223 patients), third-line (342 patients) and fourth/fifth-line (95 patients) rifabutin therapies were 79% (67-92%), 66% (55-77%) and 70% (60-79%) respectively. For treating H. pylori infection, almost all studies have administered rifabutin 300 mg/day; this dose seems to be more effective than 150 mg/day. The ideal length of treatment remains unclear, but 10- to 12-day regimens are generally recommended. The mean rate of adverse effects was 22% (19-25%). Myelotoxicity is the most significant, although this complication was rare. Until now, all patients have recovered of leucopenia uneventfully in a few days, and there have been no reports of infection or other adverse outcomes related to it. Conclusion Rifabutin-containing rescue therapy constitutes an encouraging strategy after multiple (usually three) previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, tetracycline and levofloxacin. © 2011 Blackwell Publishing Ltd.

Gisbert J.P.,Hospital Universitario Of La Princesa
Inflammatory Bowel Diseases | Year: 2010

The aim of this article is to critically review available data regarding the safety of immunomodulators and biological therapies during pregnancy and breast-feeding in women with inflammatory bowel disease. Methotrexate and thalidomide can cause congenital anomalies and are contraindicated during pregnancy (and breast-feeding). Although thiopurines have a Food and Drug Administration (FDA) rating D, available data suggest that these drugs are safe and well tolerated during pregnancy. Although traditionally women receiving azathioprine or mercaptopurine have been discouraged from breast-feeding because of theoretical potential risks, it seems that these drugs may be safe in this scenario. Treatment with cyclosporine for steroid-refractory ulcerative colitis (UC) during pregnancy can be considered safe and effective, and the use of this drug should be considered in cases of severe UC as a means of avoiding urgent surgery. Breast-feeding is contraindicated for patients receiving cyclosporine. Biological therapies appear to be safe in pregnancy, as no increased risk of malformations has been demonstrated. Therefore, the limited clinical results available suggest that the benefits of infliximab and adalimumab in attaining response and maintaining remission in pregnant patients might outweigh the theoretical risks of drug exposure to the fetus. Stopping therapy in the third trimester may be considered, as it seems that transplacental transfer of infliximab is low prior to this. Certolizumab differs from infliximab and adalimumab in that it is a Fab fragment of an antitumor necrosis factor alpha monoclonal antibody, and therefore it may not be necessary to stop certolizumab in the third trimester. The use of infliximab is probably compatible with breast-feeding. Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.

Gisbert J.P.,Hospital Universitario Of La Princesa
Gastroenterology Research and Practice | Year: 2012

Helicobacter pylori infection is the main cause of gastritis, gastroduodenal ulcer disease, and gastric cancer. After 30 years of experience in H. pylori treatment, however, the ideal regimen to treat this infection has still to be found. Nowadays, apart from having to know well first-line eradication regimens, we must also be prepared to face treatment failures. In designing a treatment strategy, we should not only focus on the results of primary therapy alone but also on the finaloveralleradication rate. The choice of a rescue treatment depends on which treatment is used initially. If a first-line clarithromycin-based regimen was used, a second-line metronidazole-based treatment (quadruple therapy) may be used afterwards, and then a levofloxacin-based combination would be a third-line rescue option. Alternatively, it has recently been suggested that levofloxacin-based rescue therapy constitutes an encouraging 2nd-line strategy, representing an alternative to quadruple therapy in patients with previous PPI-clarithromycin- amoxicillin failure, with the advantage of efficacy, simplicity and safety. In this case, quadruple regimen may be reserved as a 3rd-line rescue option. Even after two consecutive failures, several studies have demonstrated that H. pylori eradication can finally be achieved in almost all patients if several rescue therapies are consecutively given. © 2012 Javier P. Gisbert.

Dauden E.,Hospital Universitario Of La Princesa
Journal of the European Academy of Dermatology and Venereology : JEADV | Year: 2014

Treatment non-adherence is a general challenge and a complex problem. It is a key factor that impacts the 'real-life' effectiveness of topical treatments for chronic disorders, such as psoriasis. Here, we provide our expert opinion on the real-life effectiveness of topical psoriasis treatment, using the fixed combination gel (Daivobet(®) gel; calcipotriol plus betamethasone dipropionate) as a case study. The fixed combination gel is a first-line topical treatment for mild-to-moderate psoriasis, developed to be the gold-standard therapy for psoriasis patients. This fixed combination gel is an effective and well-tolerated topical psoriasis treatment that the majority of our patients prefer to the ointment formulation. We assessed our real-life experience and considered any gaps between daily practice and clinical trials data. We recommend a multifaceted approach to improve real-life effectiveness and bridge the gap between investigational trials and treatment reality and propose the following recommendations: (1) educate primary healthcare providers on how to effectively manage topical psoriasis treatment and the patients who use the treatment; (2) educate the patient on why treatment needs to be maintained, even when symptoms improve; and (3) provide a supportive environment that will not allow the patient to feel abandoned. A patient-centric approach may improve adherence, which will lead to patients receiving more effective treatment for psoriasis. © 2014 European Academy of Dermatology and Venereology.

Gisbert J.P.,Hospital Universitario Of La Princesa | Calvet X.,University of Barcelona
Alimentary Pharmacology and Therapeutics | Year: 2011

Background: Traditional standard triple therapy for Helicobacter pylori infection (PPI-clarithromycin-amoxicillin) can easily be converted to non-bismuth quadruple (concomitant) therapy by the addition of a nitroimidazole twice daily. Aim: To critically review evidence on the role of non-bismuth quadruple therapy (PPI-clarithromycin-amoxicillin-nitroimidazole) in the treatment of H. pylori infection. Methods: Bibliographical searches were performed in MEDLINE and relevant congresses. Results: The first randomised comparison of the non-bismuth quadruple therapy and the sequential (PPI-amoxicillin 5 days plus PPI-clarithromycin-nitroimidazole 5 days) regimens recently concluded that both were similar in terms of efficacy and safety and that the sequential administration protocol may be unnecessarily complex. Several randomised controlled trials (and one meta-analysis) have demonstrated that non-bismuth quadruple therapy is more effective than and is equally well tolerated as standard triple therapy. A meta-analysis of 15 studies (1723 patients) revealed a mean H. pylori cure rate (intention-to-treat) of 90% for non-bismuth quadruple therapy. A tendency towards better results with longer treatments (7-10 days vs. 3-5 days) has been observed, so it seems reasonable to recommend the length of treatment by achieving maximal cure rates (10 days). Clarithromycin resistance may reduce the efficacy of non-bismuth quadruple therapy, although the decrease in eradication rates seems to be far lower than in standard triple therapy. Experience with the non-bismuth quadruple therapy in patients with metronidazole-resistant strains is still very limited. Conclusions: Non-bismuth quadruple (concomitant) therapy appears to be an effective, safe, and well-tolerated alternative to triple therapy and is less complex than sequential therapy. Therefore, this regimen appears well suited for use in settings where the efficacy of triple therapy is unacceptably low. © 2011 Blackwell Publishing Ltd.

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