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What is known and objectives The safety of continued ustekinumab ( UST) therapy during pregnancy remains unclear in patients with Crohn's disease ( CD). There are no meta-analysis reports of exposure to UST during pregnancy. The objective was to describe a case of a pregnant patient with CD who was successfully treated with UST maintenance therapy throughout the pregnancy and delivered a baby boy without any congenital malformations, neurological abnormalities or birth defects. Case summary A 37-year-old patient with CD treated with UST became pregnant. She had been receiving UST for 8 months at the time. After discussion with the patient and the obstetric team, the UST therapy was continued. The result of treatment was an uneventful pregnancy with delivery, at term, of a healthy boy and the maintenance of clinical, biological and endoscopic remission of CD during and after pregnancy. What is new and conclusion To our knowledge, this is the first reported use of continued UST therapy for CD throughout a pregnancy. The result of treatment was an uncomplicated pregnancy with the mother giving birth to a healthy boy at term and the maintenance of clinical biological and endoscopic remission of CD during and after pregnancy. [ABSTRACT FROM AUTHOR]

Aims: To determine the degree and factors related to non-insulin antidiabetic drug (NIAD) adherence in people with type 2 diabetes mellitus (DM2) treated in primary carecentres in Spain., Methods: We did a cross-sectional study. During the study visit, variables related todifferent clinical characteristics, Adherence to Refills and Medications Scale Spanishversion (ARMS-e) and usage of NIAD were collected. We estimated the adherence toNIADs using the proportion of days covered (PDC) equation., Results: In total, 515 participants were included in the study. The mean PDC ratio was70.6 ( ± 28.9), and 50.5% (260) were classified as good adherent (PDC ≥80). Good adherence was highest among users of metformin (67.3%) and lowest among the participants using thiazolidinedione (0.8%). The score for ARMS-e was higher in the poor adherence group. In the multivariable analysis, HbA1c and the use of GLP1-RA or SGLT-2i were negatively associated with good adherence (odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.54, 0.82, OR: 0.20, 95%CI: 0.08, 0.46; OR: 0.56, 95%CI: 0.35, 0.89, respectively)., Conclusions: Adherence to NIADs observed in our study is far from optimal. HbA1c and ARMS-e items could be used as adherence indicators to encourage treatment changes to improve T2DM control., Competing Interests: Declaration of interests The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M.M-C has received advisory and or speaking fees from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra- Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. J.F-N has received advisory and or speaking fees from Astra-Zeneca, Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. D.A. and X.C. are full-time employees of Almirall, S.A. F.L-S has received advisory and or speaking fees from Astra-Zeneca, Boehringer Ingelheim, Lilly, MSD, Novo Nordisk, and Sanofi. B.V., S.M. and J.E. declare no conflict of interest., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: To compare the persistence, retention rate and prescription pattern  of original infliximab and infliximab CT-P13 in biologic- naïve patients with ulcerative colitis., Method: This was an ambispective study of biologic-naive patients with  ulcerative colitis who received non-simultaneous first-line treatment with  Remicade ® (infliximab) and Remsima® (infliximab CT-P13) over a 10-year  study period (2012-2021). Data on their age, weight, persistence, retention  rate and on whether they required intensification or deintensification  throughout the study period was collected. The real patient/year cost of  Remicade® and Remsima® was determined individually based on the amounts  administered during the study period., Results: 27 biologic-naive patients were treated with Remicade® and 53 with  Remsima®. Neither patient group presented with differences in terms of  weight and age. Persistence (median ± interquartile range) with Remicade ®  was 42.49 ± 57.48 months, as compared to 27.50 ± 58.50 months for  Remsima®, without significant differences (p = 0.455). The retention rate at  6, 12, and 24 months was 81%, 63%, and 33%, respectively, for the Remicade® group and 71%, 47%, and 37%, respectively, for the Remsima® group. Nine subjects in the Remicade® group vs 11 patients in the Remsima ® group were intensified. Regarding deintensification, five patients treated with  Remicade® were deintensified, as compared with 7 patients on Remsima®.  Savings obtained with the use of Remsima® amounted to 203,649 €, which  would allow treating an additional 118 patients with biosimilar infliximab for  one year., Conclusions: There are no significant differences in persistence, retention, and number of intensifications or deintensifications between  iologicnaïve patients treated with Remicade® and those treated with  Remsima®, the latter being an effective, safe and economical alternative for  the treatment of ulcerative colitis., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Older age and cardiovascular comorbidities are well-known risk factors for all-cause mortality in patients with coronavirus disease 2019 (COVID-19). Hypertension and age are the 2 principal determinants of arterial stiffness (AS). This study aimed to estimate AS in patients with COVID-19 requiring hospitalization and analyze its association with all-cause in-hospital mortality. This observational, retrospective, multicenter cohort study analyzed 12 170 patients admitted to 150 Spanish centers included in the SEMI-COVID-19 Network. We compared AS, defined as pulse pressure ≥60 mm Hg, and clinical characteristics between survivors and nonsurvivors. Mean age was 67.5 (±16.1) years and 42.5% were women. Overall, 2606 (21.4%) subjects died. Admission systolic blood pressure (BP) <120 and ≥140 mm Hg was a predictor of higher all-cause mortality (23.5% and 22.8%, respectively, P <0.001), compared with systolic BP between 120 and 140 mm Hg (18.6%). The 4379 patients with AS (36.0%) were older and had higher systolic and lower diastolic BP. Multivariate analysis showed that AS and systolic BP <120 mm Hg significantly and independently predicted all-cause in-hospital mortality (adjusted odds ratio [ORadj]: 1.27, P =0.0001; ORadj: 1.48, P =0.0001, respectively) after adjusting for sex (males, ORadj: 1.6, P =0.0001), age tertiles (second and third tertiles, ORadj: 2.0 and 4.7, P =0.0001), Charlson Comorbidity Index (second and third tertiles, ORadj: 4.8 and 8.6, P =0.0001), heart failure, and previous and in-hospital antihypertensive treatment. Our data show that AS and admission systolic BP <120 mm Hg had independent prognostic value for all-cause mortality in patients with COVID-19 requiring hospitalization.

Background: Bisphenol A analogs and derivatives (BPs) have emerged as new contaminants with little or no information about their toxicity. These have been found in numerous everyday products, from thermal paper receipts to plastic containers, and measured in human samples., Objectives: The objectives of this research were to identify in silico new protein targets of BPs associated with seven noncommunicable diseases (NCDs), and to study their protein-ligand interactions using computer-aided tools., Methods: Fifty BPs were identified by a literature search and submitted to a virtual high-throughput screening (vHTS) with 328 proteins associated with NCDs. Protein-protein interactions between predicted targets were examined using STRING, and the protocol was validated in terms of binding site recognition and correlation between in silico affinities and in vitro data., Results: According to the vHTS, several BPs may target proteins associated with NCDs, some of them with stronger affinities than bisphenol A (BPA). The best affinity score (the highest in silico affinity absolute value) was obtained after docking 4,4'-bis( N -carbamoyl-4-methylbenzensulfonamide)diphenylmethane (BTUM) on estradiol 17-beta-dehydrogenase 1 ( - 13.7  kcal / mol ). However, other molecules, such as bisphenol A bis(diphenyl phosphate) (BDP), bisphenol PH (BPPH), and Pergafast 201 also exhibited great affinities (top 10 affinity scores for each disease) with proteins related to NCDs., Discussion: Molecules such as BTUM, BDP, BPPH, and Pergafast 201 could be targeting key signaling pathways related to NCDs. These BPs should be prioritized for in vitro and in vivo toxicity testing and to further assess their possible role in the development of these diseases. https://doi.org/10.1289/EHP7466.

Introduction: The fastest growing segment of our population is that of people above 70 years of age. Elderly patients with IBD exhibit several specific problems. Our objective was to evaluate the clinical course, the side effects of the treatments and the need for surgery of elderly patients, regardless of the age of onset., Materials and Methods: This was a cross-sectional study wherein retrospective data were collected from multiple centers from seven hospitals within the Valencia metropolitan area. Data were collected on patients older than 70 y with inflammatory bowel disease., Results: We identified a total of 331 patients older than 70 years of age (5.3% of patients monitored at our centers). The mean age at the time of the study was 77.34 y (±5.39). Mesalamine were the most frequently used medications. Corticosteroids were used in 66% of the patients. However, the use of corticosteroids and biologics was less probable in older patients (OR 0.96, p = .06). The longer the disease progressed, the more immunosuppressive medications were used (OR 1.3, p = .052). Neoplasms appeared in 41 patients (13%). Of the 36 patients with tumors that appeared after the onset of the disease, 20 patients had not been treated with immunomodulators or biologics., Conclusions: Mesalamine was the most frequently used medication. There is no increased risk of tumors regarding the medications used. The use of immunosuppressive medications is more prevalent with longer disease progression times, although with a high rate of adverse events.

Purpose: A case report of Legionella pneumophila pneumonia associated with off-label use of ustekinumab in a patient with Crohn's disease (CD) is presented., Summary: A 57-year-old man with longstanding CD was hospitalized with a four-day history of fever (38.5 °C), dyspnea, left pleuritic pain, and weight loss (more than 6 kg) about six weeks after beginning treatment with ustekinumab, a human monoclonal antibody approved in the United States for two indications (plaque psoriasis and psoriatic arthritis) and currently under investigation as a potential treatment for CD and other inflammatory disorders. During the preceding 25 years, the man had been treated for severe CD with a number of agents (e.g., infliximab, adalimumab, certolizumab); ultimately, off-label ustekinumab therapy (90 mg subcutaneously weekly) was initiated due to persistent severe CD symptoms. Chest x-ray studies at the time of admission demonstrated left upper lobar consolidation, and a urine antigen test was positive for L. pneumophila . The patient was treated with i.v. levofloxacin and methylprednisolone and discharged after two weeks. Ustekinumab was reintroduced (45 mg subcutaneously every two weeks), and the patient continued to receive the drug for 16 months, with clinical remission of CD symptoms and no further adverse events. A literature search identified two case reports of pneumonia associated with ustekinumab use, but neither case involved L. pneumophila ., Conclusion: Pneumonia caused by L. pneumophila developed in a patient with CD treated with ustekinumab. Pneumonia symptoms resolved after ustekinumab was discontinued., (Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Objective To evaluate the reliability of the motor function measure (MFM) scale in the assessment of disease severity and progression when administered at home and clinic and assess its correlation with the Paediatric Outcomes Data Collection Instrument (PODCI). Methods In this prospective study, two assessors rated children with hereditary neuromuscular diseases (HNMDs) using the MFM at the clinic and then 2 weeks later at the patients' home. Intraclass correlation coefficient (ICC) was calculated for the reliability of the MFM and its domains. The reliability of each item was assessed and the correlation between MFM and three domains of PODCI was evaluated. Results A total of 48 children (5-17 years of age) were assessed in both locations and the MFM scale demonstrated excellent inter-rater reliability (ICC, 0.98). Weighted kappa ranged from excellent to poor. Correlation of the home-based MFM with the PODCI domain 'basic mobility and transfers' was excellent, with the 'upper extremity' domain was moderate, but there was no correlation with the 'happiness' domain. Conclusion The MFM is a reliable tool for assessing patients with HNMD when used in a home-based setting.

Aim: To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response., Methods: We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician's global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database., Results: Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted., Conclusion: This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase., Competing Interests: Conflict-of-interest statement: None of the authors has any conflict of interest to declare.

Lipoic acid (LA) is an essential cofactor required for the activity of five multienzymatic complexes that play a central role in the mitochondrial energy metabolism: four 2-oxoacid dehydrogenase complexes [pyruvate dehydrogenase (PDH), branched-chain ketoacid dehydrogenase (BCKDH), 2-ketoglutarate dehydrogenase (2-KGDH), and 2-oxoadipate dehydrogenase (2-OADH)] and the glycine cleavage system (GCS). LA is synthesized in a complex multistep process that requires appropriate function of the mitochondrial fatty acid synthesis (mtFASII) and the biogenesis of iron-sulphur (Fe-S) clusters. Defects in the biosynthesis of LA have been reported to be associated with multiple and severe defects of the mitochondrial energy metabolism. In recent years, disease-causing mutations in genes encoding for proteins involved in LA metabolism have been reported: NFU1, BOLA3, IBA57, LIAS, GLRX5, LIPT1, ISCA2, and LIPT2. These studies represented important progress in understanding the pathophysiology and molecular bases underlying these disorders. Here we review current knowledge regarding involvement of LA synthesis defects in human diseases with special emphasis on the diagnostic strategies for these disorders. The clinical and biochemical characteristics of patients with LA synthesis defects are discussed and a workup for the differential diagnosis proposed.

Objective: The objective of this is manuscript is to evaluate the impact of a vaccination protocol in the prevention of infection in autoimmune inflammatory disease (AUTID) patients treated with Anti-TNF-alpha therapies., Research Design and Methods: The authors conducted an observational study to test the effect of a vaccination program in AUTID patients that received anti-TNF-alpha therapies in hospital admissions related to infections. This effect was evaluated by comparing patients admitted before the program started (prevaccination period, 2009-2011) and after the program (postvaccination period, 2011-2014)., Results: The study included 581 patients: 280 in the pre-vaccination group and 301 in the post-vaccination group. During the prevaccination period, 27.3% of patients treated with anti-TNF-alpha drugs were vaccinated before biological therapy. During the postvaccination period, this percentage increased to 97.0%. Statistically significant differences were detected in emergency room visits per 10.000 treatment days, in hospital admissions related to an infectious disease and in the rate of invasive pneumococcal disease due to Streptococcus pneumoniae infection per 10.000 days of treatment., Conclusions: This vaccination program decreases infectious complications and was associated with a lower amount of hospital admissions due to infections, emergency room visits and the rate of invasive pneumococcal disease.

Objective: To report of a case successful use of infliximab (IFX) and tacrolimus (TAC) in a patient with ulcerative colitis (UC)., Case Summary: A 22-year-old woman diagnosed with UC started treatment with azathioprine 2.5 mg/kg. After 3 years of therapy, she developed a severe relapse. A colonoscopy was performed showing diffuse continuous mucosal disease and multiple erosions (< 5 mm) with no signs of spontaneous bleeding. Treatment with IFX 5 mg/kg at weeks 0, 2, and 6 was started. After IFX induction, she remained with symptoms: six stools per day, as well as presenting bloody diarrhea, tenesmus, and no abdominal pain. An IFX dose intensification of 5 mg/kg every 6 weeks was prescribed. After 6 months of azathioprine plus IFX therapy, patient's clinical condition was improved: 3 - 4 stools per day, 20% of bloody diarrhea, tenesmus, and no abdominal pain. Her Mayo endoscopic subscore was 6.3 months later, and a severe relapse of ulcerative colitis was presented. The patient refused a surgical treatment. Azathioprine 2.5 mg/kg/day was suspended and TAC 0.2 mg/kg/day (12 mg/day) as a compassionate use was added to IFX dose intensification of 10 mg/kg every 8 weeks and mesalamine 800 mg 3 times daily. After the first month of combined therapy, the patient's clinical condition improved with no bloody stools and abdominal pain. After 6 months of combination therapy, the patient was in remission, with two stools per day, no tenesmus and no abdominal pain. Due to the patient's clinical remission, IFX was suspended. Tacrolimus was continued on 10 mg/day. After 6 months of TAC monotherapy, the patient continued without symptoms (1 - 2 normal stools per day)., Conclusions: Based on our case, the combination therapy of IFX and TAC could be selected as an effective approach for the patients with UC refractory to IFX dose intensification plus AZA. However, further studies need to be performed to evaluate the efficacy of this combination therapy.

Objective: In January 2011, a biological therapies commission was created in our hospital to fully address the management of biological drugs. A biological therapy prioritization protocol was developed for ankylosing spondylitis (AS) patients. Here, we describe it and report on its economic impact to illustrate how we are optimizing the use of these expensive new drugs., Methods: The biological therapies commission established several procedures for the rational use of biological drugs such as cost-efficiency therapeutic protocols, pharmacovigilance, and therapeutic drug monitoring programs. The AS protocol was based on clinical and economic aspects. We estimated the economic impact of the protocol by comparing the cost of treating AS patients with biological drugs in the pre-commission (2009 - 2010) vs. post-commission period (2011 - 2013). AS patients treated with adalimumab (ADA), etanercept (ETN) or infliximab (IFX) for at least 6 months in the 2009 - 2013 period were included., Results: 107 patients were included. In the pre-commission period, total expenses increased by +30,944 Euro (+4%). After protocol implementation, total expenses decreased by 11,441 Euro (-1%) during 2011, and by an additional 36,781 Euro (-4%) and 53,872 Euro (-8%) in 2012 and 2013, respectively. In the 2010 - 2013 period the cost of biological therapy per patient-year decreased by 869 €, suggesting the positive effects of the biological therapy prioritization protocol instauration., Conclusion: We describe the establishment of a multidisciplinary biological therapy commission to optimize the use of biological therapies. We illustrate its work in developing a protocol for the management of AS patients with such therapies. We show that after 3-years of implementation, the biological therapy prioritization protocol allowed us to steadily decrease the direct cost of biological drug therapies per patient, up to 869 Euro.

Objective: To report a case of successful use of infliximab (IFX) and tacrolimus (TAC) in a patient with Crohn's disease (CD)., Case Summary: A 42-year-old man with no significant previous medical history was referred to our emergency department because of a 3-month history of weight loss, severe abdominal pain, and bloody diarrhea. His Harvey Bradshaw Index was 39. Ileocolonoscopic revealed severe Crohn colitis. Treatment with IFX 5 mg/kg, azathioprine 2.5 mg/kg/day and corticosteroids was started. After a second IFX infusion, he remained with symptoms with a Harvey Bradshaw Index of 17. An IFX dose intensification of 10 mg/kg every 8 weeks was prescribed. After 16 weeks, a new colonoscopic examination revealed multiple deep ulcerations in sigma and rectum. IFX was intensified to 10 mg/kg every 6 weeks. After 4 doses of IFX intensified dose, the patient's clinical condition was not improved, with a Harvey Bradshaw Index of 10. Azathioprine (AZA) 2.5 mg/kg/day was suspended. Tacrolimus 0.2 mg/kg/day as a compassionate use was added to IFX 10 mg/kg every 6 weeks. After 6 months of combination therapy, the patient was in clinical remission. His Harvey Bradshaw Index was 3. After 1 year on combination IFX and TAC therapy, the patient continued in clinical remission., Conclusions: This case documents that the combination therapy of IFX and TAC could be selected as an effective approach for patients with CD refractory to IFX dose-intensification plus AZA. However, further studies need to be performed to evaluate the efficacy of this combination therapy.

Aim: To obtain preliminary safety and efficacy data on intravenous (IV) administration of infliximab (IFX) and ferric carboxymaltose (FCM) to inflammatory bowel disease (IBD) patients in a single treatment session., Methods: A two-phase non-interventional, observational, prospective pilot study was performed to evaluate safety and efficacy of FCM given immediately after IFX. IBD patients were recruited consecutively in the outpatient clinic in two groups. Control group patients (n = 12) received FCM on a separate day from IFX. Subsequently, single-session group patients (n = 33) received FCM after IFX on the same day. All patients received 5mg/kg IFX and 1000mg FCM for iron-restricted anemia (IRA) or 500mg FCM for iron deficiency without anemia. Safety assessment was performed by recording adverse events (AEs) during and immediately after infusion, 30 minutes afterwards, and via follow-up at 7 days and 8 weeks. For efficacy assessment, hematological parameters were assessed prior to FCM infusion (pre-FCM) and after 8 weeks. Economic impact of FCM given immediately after IFX was assessed., Results: All 45 patients (35 Crohn´s disease, 10 ulcerative colitis) received IFX 5mg/kg. 21 patients received 500mg FCM and 24 received 1000mg. FCM administration immediately after IFX corrected iron deficiency or IRA as shown by increases in hematological parameters. No AEs were reported during the safety evaluation at the end of FCM or IFX administration, 30 minutes, 7 days and 8 weeks afterwards, in either control or single-session groups. Total cost per patient for single-session administration was 354.63€; for patients receiving IFX and FCM on separate days, it was 531.94€, giving a 177.31€ per-patient cost saving., Conclusion: Single-session administration of FCM after IFX was safe and effective in IBD patients and can offer a good cost-benefit ratio and improve treatment adherence. To our knowledge, this study is the first to evaluate FCM and IFX administration in a single treatment session.

Background: Until 2010 the cost of biological treatments in Rheumatoid Arthritis (RA) was increasing annually by 15% in our hospital. In 1st January 2011, a Hospital Commission of Biological Therapies involving rheumatology and pharmacy services was created to improve the management of biological drugs and a biological therapy prioritization protocol in RA patients was also established to improve the efficient usage of biological drugs in RA., Objective: To evaluate the economic impact associated with a biological therapy prioritization protocol for RA patients in the Hospital of Sagunto., Methods: Observational, ambispective study comparing the associated cost of RA patients treated with biological drugs in the pre-protocol (2009 - 2010) versus post-protocol periods (2011 - 2012). RA patients treated with Abatacept (ABA), Adalimumab (ADA), Etanercept (ETN) or Infliximab (IFX) for at least 6 months during the study period (2009 - 2012) were included. In 2012, Tocilizumab (TCZ) was also included in the prioritization protocol. Prioritization protocol was established based on both clinical and economical aspects and supervised case by case by our Commission. Cost savings and economic impact were calculated using Spanish official prices., Results: In the pre-protocol period (2009 - 2010), total expenses were increasing by €110,000, up to €1,761,000 in 2010 (€11,362 pat/year). After protocol implementation, total expenses decreased by 53,676€ on the 2010 - 2011 period, and 149,200€ on the 2011 - 2012 period. On the 2010 - 2011 period the cost of biological therapy per patient-year decreased 355€ (11,007€ pat/year) and additional 653€ (up to 10,354€ pat/year) by 2012, with a cumulative effect of the protocol implementation of 1,008€ per patient-year. In the pre-protocol period (2009), the annual cost/patient was 10.812€ with ETN, 10.942€ with IFX, 12.961€ with ADA and 12.739€ with ABA. By 1st January 2013, the annual cost per patient was 9,469€ with ETN, 10,579€ with IFX, 11,117€ with ADA, 13,540€ with ABA and 14,932€ with TCZ., Conclusions: The creation of our Commission of Biological Therapies is key to rational management of RA patients and optimization of resources, allowing us to save 200,000€ after 2-year efficiency protocol implementation.

Background: Endoscopic recurrence occurs in up to 80% of patients with Crohn's disease 1 year after intestinal resection. Imidazole antibiotics, thiopurines, and particularly their combination have proven efficacy in preventing endoscopic recurrence. The aim of the study was to compare the efficacy of the addition of metronidazole (for 3 months after the surgical treatment) to azathioprine for the prevention of postsurgical endoscopic recurrence., Methods: A pilot study was made of 50 patients with Crohn's disease undergoing intestinal resection with ileocolic anastomosis and treated with 2 to 2.5 mg/kg of azathioprine per day for 1 year. The patients were randomized to receive additional 15 to 20 mg/kg of metronidazole per day or placebo for the first 3 months (n = 25 per arm). Endoscopic assessment was performed 6 and 12 months after the surgical resection. The primary end point was the prevention of endoscopic recurrence as defined by a Rutgeerts score of <2 at 6 months. The initial sample size had an 80% statistical power in detecting an absolute risk reduction of ≥30%., Results: Endoscopic recurrence occurred in 28% and 44% of the patients at 6 months (P = 0.19) and in 36% and 56% (P = 0.15) at 12 months in the metronidazole and placebo groups, respectively. No statistically significant differences were found between the treatment groups regarding severe endoscopic recurrence (Rutgeerts score ≥ 3) at 6 and 12 months. Likewise, there were no differences in the rate of adverse events between the treatment groups., Conclusions: The addition of metronidazole to azathioprine did not significantly reduce the risk of endoscopic recurrence beyond azathioprine alone in this study but does not worsen its safety profile.

Unlabelled: An observational cross-sectional study was conducted to assess calcium intake and vitamin D status by measurement of 25-hydroxyvitamin D (25(OH)D), in postmenopausal osteoporotic women (PMOW) treated and untreated for osteoporosis. To assess the influence of sunlight exposure on vitamin D status, the study group was categorized on the basis of sunlight exposure (above or below 2500 sunlight h/year). A group of 336 PMOW older than 65 years was identified (190 [56.5%] treated and 146 [43.5%] untreated for osteoporosis). The demographic and clinical data of the PMO women included history of prior fractures, pharmacological treatments and dietary calcium intake. BMD was measured by DEXA and 25(OH)D was determined by an HPLC method., Results: vitamin D serum levels were lower in the untreated group as compared with the treated group (58±27 vs. 67±27nmol/l; p=0.006). Prevalence of vitamin D deficiency (cut-off point set at <50nmol/l) was higher in the non-treated group (43.8% vs. 29.5%; p=0.009). Nearly all PMOW, whether treated or not for osteoporosis had a total calcium intake of less than 1200mg. Sunlight exposure did not influence the vitamin D status., Conclusions: vitamin D deficiency and an insufficient calcium intake are highly prevalent in both treated and untreated Spanish PMOW older than 65 years. This can be related to low therapeutic adherence and/or insufficient prescription. Therefore physician's and patient's knowledge regarding the optimization of vitamin D status and calcium intake should be improved and implemented. This article is part of a Special Issue entitled 'Vitamin D workshop'., (Copyright © 2012 Elsevier Ltd. All rights reserved.)