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Background and Aims: Inflammatory pouch disorders exhibit a heterogeneous clinical spectrum and therapeutic requirements have not been properly studied., Methods: This retrospective, multicentre study included ulcerative colitis patients with ileal pouch construction and were later diagnosed with an inflammatory pouch disorder between 1995 and 2020. Classifications, behaviour and therapies applied were recorded and compared in the long-term., Results: Overall, 338 patients were recruited. The most common disorders were pouchitis (n = 258, 76%), Crohn's disease of the pouch (n = 55, 16%) and cuffitis (n = 25, 7%). Pouchitis presented mainly as chronic (65.2%) and recurrent (87%) forms. Crohn's disease manifested as stricturing/penetrating in 53% of cases and perianal disease in 42%. Patients received multiple therapies: 86% antibiotics, 42% steroids, 27% immunosuppressants, 43% biologics and 27% surgery. Compared with pouchitis, Crohn's disease of the pouch was characterised by a later diagnosis (99 vs. 55 months, p < 0.001) and greater needs for immunosuppressants (OR 3.53, 1.79-6.94, p < 0.0001), biologics (OR 5.45, 2.78-10.6, p < 0.0001) and surgeries (OR 2.65, 1.43-4.89, p < 0.001)., Conclusions: Chronic pouchitis is the most common pouch disorder presentation. These entities have diverse therapeutics requirements, particularly for Crohn's disease of the pouch., Competing Interests: Conflict of interest F. Mesonero has served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring Pharmaceuticals, Kern Pharma, Dr. Falk Pharma, Galapagos, Chiesi Farmaceutici and Faes Farma. - Y. Zabana has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Almirall, Amgen, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, MSD, Otsuka, Pfizer, Shire, Takeda, Galapagos, Boehringer Ingelheim and Tillotts Pharma AG. - A. Fernández-Clotet has served as a speaker for and received educational funding from Dr. Falk Pharma, Janssen, Takeda, Chiesi Farmaceutici and Pfizer. - B. Caballol has served as a speaker for and received consulting fees from MSD, AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Shire Pharmaceuticals and Faes Pharma. - E. Leo-Carnerero has served as a speaker and consultant for and received educational funding from AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Gilead, Pfizer and Dr. Falk Pharma. - M. J. García has received financial support for travel and educational activities from Janssen, Pfizer, AbbVie, Takeda, Kern Pharma, Faes Farma and Ferring Pharmaceuticals. - R. Ferreiro-Iglesias has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, MSD, Kern, Chiesi Farmaceutici, Gebro Pharma, Pfizer, Shire, Takeda and Tillotts Pharma AG. - M. Calafat has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Ferring Pharmaceuticals, Janssen, Pfizer, Takeda, Gilead, Chiesi Farmaceutici and Tillotts Pharma AG. - J. Miranda has received support for conference attendance, speaker fees and consulting and advisory fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, Pfizer, Takeda and Tillotts Pharma AG. - L. Torrealba has served as a speaker for and received educational funding from AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Gilead, Pfizer, Dr. Falk Pharma and Tillotts Pharma AG. - R. Sáiz-Chumillas has served as a speaker for and received consulting fees from Janssen, Ferring Pharmaceuticals and Faes Farma. - A. López has received support for conference attendance, educational funding and speaker fees from Chiesi Farmaceutici, AbbVie, Janssen, Ferring Pharmaceuticals, Takeda, Pfizer and Tillotts Pharma AG. - C. Rubín de Célix has received educational funding from Ferring Pharmaceuticals, Tillotts Pharma AG, AbbVie, Norgine, MSD, Pfizer, Takeda and Janssen and is supported by a grant from the Ministerio de Economía y Competitividad (Instituto de Salud Carlos III, Río Hortega CM21/00025) and co-financed by the European Social Fund Plus (ESF+) ‘Co-financed by the European Union’. - E. Brunet has served as a speaker and consultant for and received educational funding from Janssen, Takeda, Ferring Pharmaceuticals, Kern Pharma, AbbVie and Chiesi Farmaceutici. - A. Hernández has served as a speaker for and received educational funding from AbbVie, Takeda, Kern Pharma, Pfizer, Janssen, Adacyte Therapeutics, Chiesi Farmaceutici, Galapagos and Ferring Pharmaceuticals. - I. González-Partida has received support for conference attendance and speaker fees from AbbVie, Dr. Falk Pharma, Ferring Pharmaceuticals, Janssen, MSD, Kern, Pfizer, Shire, Takeda and Tillotts Pharma AG. - I. Rodríguez-Lago has received financial support for travel and educational activities from or has served as an advisory board member for AbbVie, Adacyte Therapeutics, Celltrion, Chiesi Farmaceutici, Danone, Ferring Pharmaceuticals, Faes Farma, Janssen, Galapagos, MSD, Otsuka Pharmaceutical, Pfizer, Roche, Takeda and Tillotts Pharma. I. R.-L. has also received financial support for research from Tillotts Pharma AG and is supported by research grants from Gobierno Vasco – Eusko Jaurlaritza (grant no. 2020111061) and Biobizkaia HRI (grant no. BCB/I/LIB/22/008). - M. C. Rodríguez-Grau has served as a speaker for Takeda, Shire Pharmaceutics and Dr. Falk Pharma and has received education funding from Pfizer, Takeda, Janssen, MSD, Dr. Falk Pharma, Shire Pharmaceutics, Mylan, Norgine, Chiesi Farmaceutici, Faes Farma, Ferring Pharmaceuticals and AbbVie. - A. Elosua has served as a speaker for or has received educational funding from AbbVie, Adacyte Therapeutics, Takeda, Faes Farma, Ferring Pharmaceuticals, Janssen and Tillotts Pharma AG. - J. Huguet has received fees for educational activities, research projects, scientific meetings and advisory boards sponsored by MSD, Ferring Pharmaceuticals, AbbVie, Janssen, Biogen, Sandoz, Kern Pharma, Faes Farma and Takeda. - M. Barreiro de Acosta has served as a speaker, consultant and advisory member for and has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gilead, Galapagos, BMS, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring Pharmaceuticals, Faes Farma, Dr. Falk Pharma, Chiesi Farmaceutici, Gebro Pharma, Adacyte Therapeutics and Vifor Pharma. Remaining authors declare that they have no known competing financial interest or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders., Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders., Design: This was a retrospective and multicentre study., Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI)., Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis ( n  = 37) or Crohn's disease of the pouch ( n  = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy., Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option., Competing Interests: Francisco Mesonero has served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring, Kern-Pharma, Dr. Falk Pharma, Galapagos, Chiesi and Faes Farma. Yamile Zabana has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte, Almirall, Amgen, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, MSD, Otsuka, Pfizer, Shire, Takeda, Galapagos, Boehringer Ingelheim and Tillots. Agnés Fernández-Clotet has served as a speaker for and received educational funding from Dr. Falk Pharma, Janssen, Takeda, Chiesi and Pfizer. Eduardo Leo-Carnerero has served as a speaker and consultant for and received educational funding from AbbVie, Janssen, Takeda, Ferring, Gilead, Pfizer and Dr. Falk Pharma. Andrea Núñez-Ortiz has received educational funding from Janssen, Takeda, Ferring and Pfizer. Berta Caballol has served as a speaker for and received consulting fees from MSD, AbbVie, Janssen, Takeda, Ferring, Shire Pharmaceuticals and Faes Pharma. Rocío Ferreiro-Iglesias has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, MSD, Kern, Chiesi, Gebro Pharma, Pfizer, Shire, Takeda and Tillots. José Miranda-Bautista has received support for conference attendance, speaker fees, and consulting and advisory fees from AbbVie, Adacyte, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, Pfizer, Takeda and Tillots. Leyanira Torrealba has served as a speaker for and received educational funding from AbbVie, Janssen, Takeda, Ferring, Gilead, Pfizer, Dr. Falk Pharma and Tillotts Pharma. Rosa María Sáiz-Chumillas has served as a speaker for and received consulting fees from Janssen, Ferring and Faes Farma. Alicia López-García has received support for conference attendance, educational funding and speaker fees from Chiesi, AbbVie, Janssen, Ferring, Takeda, Pfizer and Tillots. Cristina Rubín de Célix has received educational funding from Ferring, Tillotts Pharma, AbbVie, Norgine, MSD, Pfizer, Takeda and Janssen and is supported by a grant from the Ministerio de Economía y Competitividad (Instituto de Salud Carlos III, Rio Hortega CM21/00025) and co-financed by the European Social Fund Plus (ESF+) ‘Co-financed by the European Union’. Eduard Brunet has served as a speaker and consultant for and received educational funding from Janssen, Takeda, Ferring, Kern-Pharma, AbbVie and Chiesi. Alejandro Hernández-Camba has served as a speaker for and received educational funding from AbbVie, Takeda, Kern Pharma, Pfizer, Janssen, Adacyte Therapeutics, Chiesi, Galapagus and Ferring. Iago Rodríguez-Lago has received financial support for travelling and educational activities from or has served as an advisory board member for AbbVie, Adacyte, Celltrion, Chiesi, Danone, Dr. Falk Pharma, Ferring, Faes Farma, Janssen, Galapagos, MSD, Otsuka Pharmaceutical, Pfizer, Roche, Takeda and Tillotts Pharma. Iago Rodríguez-Lago has also received financial support for research from Tillotts Pharma and is supported by a research grant from Gobierno Vasco – Eusko Jaurlaritza [Grant No. 2020222004]. Alfonso Elosua has served as a speaker for and has received educational funding from AbbVie, Adacyte, Takeda, FAES Farma, Ferring, Janssen and Tillots Pharma. José María Huguet has received fees for educational activities, research projects, scientific meetings and advisory boards sponsored by MSD, Ferring, AbbVie, Janssen, Biogen, Sandoz, Kern Pharma, Faes Farma and Takeda. Manuel Barreiro-de Acosta has served as a speaker, consultant and advisory member for and has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gilead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma., (© The Author(s), 2024.)

Background and Aims: Inflammatory bowel disease (IBD) is a prevalent chronic noncurable disease associated with profound metabolic changes. The discovery of novel molecular indicators for unraveling IBD etiopathogenesis and the diagnosis and prognosis of IBD is therefore pivotal. We sought to determine the distinctive metabolic signatures from the different IBD subgroups before treatment initiation., Methods: Serum and urine samples from newly diagnosed treatment-naïve IBD patients and age and sex-matched healthy control (HC) individuals were investigated using proton nuclear magnetic resonance spectroscopy. Metabolic differences were identified based on univariate and multivariate statistical analyses., Results: A total of 137 Crohn's disease patients, 202 ulcerative colitis patients, and 338 HC individuals were included. In the IBD cohort, several distinguishable metabolites were detected within each subgroup comparison. Most of the differences revealed alterations in energy and amino acid metabolism in IBD patients, with an increased demand of the body for energy mainly through the ketone bodies. As compared with HC individuals, differences in metabolites were more marked and numerous in Crohn's disease than in ulcerative colitis patients, and in serum than in urine. In addition, clustering analysis revealed 3 distinct patient profiles with notable differences among them based on the analysis of their clinical, anthropometric, and metabolomic variables. However, relevant phenotypical differences were not found among these 3 clusters., Conclusions: This study highlights the molecular alterations present within the different subgroups of newly diagnosed treatment-naïve IBD patients. The metabolomic profile of these patients may provide further understanding of pathogenic mechanisms of IBD subgroups. Serum metabotype seemed to be especially sensitive to the onset of IBD., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited., Aims: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD., Methods: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors., Results: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them., Conclusion: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Management of ulcerative colitis after surgery suggested by guidelines (total proctocolectomy with ileal-pouch anal anastomosis) is a big challenge for physicians because patients who believed that their disease had been cured started experiencing very uncomfortable symptoms repeatedly. A high number of patients develop episodes of pouchitis, which is a non-specific inflammation of the pouch whose etiology is unknown. Antibiotics are the elective treatment for acute pouchitis, but regarding chronic pouchitis, this condition is very complicated to treat due to the absence of well-designed specific studies for this group of patients. Antibiotics, budesonide, and biological therapies are some of the recommended drugs for these patients, but despite their use, some need a permanent ileostomy., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Calvino-Suarez, Ferreiro-Iglesias, Baston Rey and Barreiro-de Acosta.)

Background: Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice., Methods: A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety., Results: A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever)., Conclusions: Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice., (© 2022 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)

Ustekinumab has shown efficacy in Crohn's Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients' data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index ≤ 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission.

Background: Ustekinumab is effective in Crohn's disease. However, a substantial proportion of patients will not respond or lose response to ustekinumab. The current evidence to support the effectiveness of dose-optimisation for ustekinumab nonresponse is limited., Aim: To assess the effectiveness of dose escalation of ustekinumab., Methods: This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard-dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation., Results: A total of 142 patients (22 centres/14 countries) were included. The patients were dose-escalated after a median treatment duration of 30 weeks. At week 16 from escalation, 73/142 (51.4%) responded to treatment, including 55/142 (38.7%) in clinical remission. Corticosteroid-free remission was achieved in 6/34 (17.6%) patients on corticosteroids at the time of escalation; 118/142 (83%) continued treatment beyond week 16. Follow-up data beyond week 16 were available for 74/118 (62.7%) patients. On the last follow-up, 51/98 (52%) patients with available data responded to treatment, including 41/98 (42%) in clinical remission., Conclusions: Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing., (© 2020 John Wiley & Sons Ltd.)

Background/objectives: The epidemiology of exocrine pancreatic insufficiency (EPI) after acute pancreatitis (AP) is uncertain. We sought to determine the prevalence, progression, etiology and pancreatic enzyme replacement therapy (PERT) requirements for EPI during follow-up of AP by systematic review and meta-analysis., Methods: Scopus, Medline and Embase were searched for prospective observational studies or randomized clinical trials (RCTs) of PERT reporting EPI during the first admission (between the start of oral refeeding and before discharge) or follow-up (≥ 1 month of discharge) for AP in adults. EPI was diagnosed by direct and/or indirect laboratory exocrine pancreatic function tests., Results: Quantitative data were analyzed from 370 patients studied during admission (10 studies) and 1795 patients during follow-up (39 studies). The pooled prevalence of EPI during admission was 62% (95% confidence interval: 39-82%), decreasing significantly during follow-up to 35% (27-43%; risk difference: - 0.34, - 0.53 to - 0.14). There was a two-fold increase in the prevalence of EPI with severe compared with mild AP, and it was higher in patients with pancreatic necrosis and those with an alcohol etiology. The prevalence decreased during recovery, but persisted in a third of patients. There was no statistically significant difference between EPI and new-onset pre-diabetes/diabetes (risk difference: 0.8, 0.7-1.1, P = 0.33) in studies reporting both. Sensitivity analysis showed fecal elastase-1 assay detected significantly fewer patients with EPI than other tests., Conclusions: The prevalence of EPI during admission and follow-up is substantial in patients with a first attack of AP. Unanswered questions remain about the way this is managed, and further RCTs are indicated.

Objective: The benefits of pancreatic enzyme replacement therapy (PERT) in chronic pancreatitis (CP) are inadequately defined. We have undertaken a systematic review and meta-analysis of randomised controlled trials of PERT to determine the efficacy of PERT in exocrine pancreatic insufficiency (EPI) from CP., Design: Major databases were searched from 1966 to 2015 inclusive. The primary outcome was coefficient of fat absorption (CFA). Effects of PERT versus baseline and versus placebo, and of different doses, formulations and schedules were determined., Results: A total of 17 studies (511 patients with CP) were included and assessed qualitatively (Jadad score). Quantitative data were synthesised from 14 studies. PERT improved CFA compared with baseline (83.7±6.0 vs 63.1±15.0, p<0.00001; I 2 =89%) and placebo (83.2±5.5 vs 67.4±7.0, p=0.0001; I 2 =86%). PERT improved coefficient of nitrogen absorption, reduced faecal fat excretion, faecal nitrogen excretion, faecal weight and abdominal pain, without significant adverse events. Follow-up studies demonstrated that PERT increased serum nutritional parameters, improved GI symptoms and quality of life without significant adverse events. High-dose or enteric-coated enzymes showed a trend to greater effectiveness than low-dose or non-coated comparisons, respectively. Subgroup, sensitive and meta-regression analyses revealed that sample size, CP diagnostic criteria, study design and enzyme dose contributed to heterogeneity; data on health inequalities were lacking., Conclusions: PERT is indicated to correct EPI and malnutrition in CP and may be improved by higher doses, enteric coating, administration during food and acid suppression. Further studies are required to determine optimal regimens, the impact of health inequalities and long-term effects on nutrition., Competing Interests: Competing interests: JED-M has provided consultancy to and received financial support from Abbott (Mylan) for lecture fees and travel expenses; RS has provided consultancy to Abbott (Mylan)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)