Panes J.,Hospital Clinic IDIBAPS |
Panes J.,Research Center Biomedica En Red En El Area Tematica Of Enfermedades Hepaticas gestivas |
Lopez-Sanroman A.,Hospital Ramon y Cajal |
Bermejo F.,Hospital de Fuenlabrada |
And 12 more authors.
Gastroenterology | Year: 2013
Background & Aims A small placebo-controlled trial reported the efficacy of mercaptopurine therapy for children newly diagnosed with Crohn's disease, yet little is known about the efficacy of early thiopurine therapy in adults. Methods We performed a prospective double-blind trial of adult patients with a recent (<8 weeks) diagnosis of Crohn's disease. Patients were randomly assigned to groups given azathioprine (2.5 mg · kg-1 · day-1, n = 68) or placebo (n = 63) at 31 hospitals from February 2006 to September 2009. Corticosteroids but no other concomitant medications were allowed for control of disease activity. The primary measure of efficacy was sustained corticosteroid-free remission. Results After 76 weeks of treatment, 30 patients treated with azathioprine (44.1%) and 23 given placebo (36.5%) were in sustained corticosteroid-free remission (difference of 7.6%; 95% confidence interval, -9.2 to 24.4%; P =.48). The rates of relapse (defined as Crohn's Disease Activity Index score >175) and corticosteroid requirements were similar between groups. A post hoc analysis of relapse, defined as a Crohn's Disease Activity Index score >220, showed lower relapse rates in the azathioprine group than in the placebo group (11.8% vs 30.2%; P =.01). Serious adverse events occurred in 14 patients in the azathioprine group (20.6%) and 7 in the placebo group (11.1%) (P =.16). A larger percentage of patients in the azathioprine group had adverse events that led to study drug discontinuation (20.6%) than in the placebo group (6.35%) (P =.02). Conclusions In a study of adults with Crohn's disease, early azathioprine therapy was no more effective than placebo to achieve sustained corticosteroid-free remission but was more effective in preventing moderate to severe relapse in a post hoc analysis. EudraCT 2005-001186-34. © 2013 by the AGA Institute.
Gonzalez Saenz De Tejada M.,Hospital de Basurto |
Escobar A.,Hospital de Basurto |
Herrera C.,Hospital Virgen de Las Nieves |
Garcia L.,Canary Health |
And 2 more authors.
Value in Health | Year: 2010
Objectives: Patient psychological factors have been linked to health-related quality of life (HRQoL) outcomes after total joint replacement (TJR). We evaluated the relationship between patient expectations before TJR, their fulfillment and HRQoL outcomes at 3 and 12 months after surgery. Methods: Consecutive patients preparing for TJR of the knee or hip due to primary osteoarthritis in 15 hospitals in Spain were recruited for the study. Patients completed questionnaires before surgery, and 3 and 12 months afterward: five questions about expectations before surgery and their fulfillment at 3 and 12 months; three HRQoL instruments - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 (SF-12), and European Quality of Life Instrument (EQ-5D); as well as questions about sociodemographic information. Student's t test was used to assess the relationship between fulfillment of expectations and gains in HRQoL. Results: A total of 881 patients took part in the study. Preintervention expectations for TJR ranged from 85% to 86% of patients, with high expectations for pain relief and ability to walk to 70% with high expectations about interacting with others. Patients who reported having fulfilled their expectations at 3 and 12 months had significantly greater gains in HRQoL than those who did not. Besides, we observed a statistically significant improvement in the percentage of patients who fulfill their expectations from 3 to 12 months. Conclusions: Patients have high expectations for the benefits of TJR, and those who fulfill their expectations have greater gains in HRQoL assessing by SF-12, WOMAC and EQ-5D. Health-care providers should help their patients develop realistic expectations about the impact of TJR. © 2009, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Pascual-Pedreno A.,Hospital General la Mancha Centro |
Perez-Medina T.,Hospital Universitario Puerta Of Hierro |
Brouard Urkiaga I.,Hospital de Cruces |
Fernandez-Parra J.,Hospital Virgen de Las Nieves |
Sobreviela-Laserrada M.,Hospital Universitario Lozano Blesa
European Journal of Obstetrics Gynecology and Reproductive Biology | Year: 2013
Objective: To evaluate the implementation of endoscopic gynecologic surgery in Spanish hospitals. Study design: In January 2011, a questionnaire was sent to 198 gynecology departments to determine the diffusion and acceptance of specific endoscopic procedures (hysteroscopy and laparoscopy) in each hospital. Results: The response rate was 52% (103/198). The practice of basic laparoscopy in Spain is high (90% of the hospitals surveyed reported that >50% of their specialists use this technique). Although advanced laparoscopic procedures are used in 83.4% of hospitals, 59.2% of these hospitals reported that <25% of gynecologists knew how to perform these techniques. In the case of adnexal masses, the approach used depends on the characteristics of the mass. Most hospitals (96.1%) reported routine use of a laparoscopic approach for benign adnexal masses measuring <10 cm, while 42% of hospitals reported routine use of a laparoscopic approach for masses that appear to be suspicious on ultrasound. Regarding hysterectomy, 38 hospitals (36.9%) reported that an abdominal approach was used in <25% of hysterectomies, 53 hospitals (51.5%) reported that a vaginal approach was used in 25-50% of hysterectomies, and 53 hospitals (52%) reported that a laparoscopic approach was used in <25% of hysterectomies. For the treatment of gynecological cancers, 53 hospitals (52%) reported that a laparoscopic approach was used in <25% of cases; this approach was reported more commonly by teaching hospitals (81.9% vs. 46.75; p < 0.001) and hospitals with >200 beds (84.3% vs. 45.5%; p < 0.001). In teaching hospitals, the concordance between what the respondents felt residents should be able to do, in terms of laparoscopic techniques, and what residents were actually able to do upon finishing their residency training was quite high, with the degree of concordance varying between 84.3% (adnexal mass approach) and 100% (diagnostic laparoscopy and tubal sterilization). Conclusions: More than 90% of the Spanish hospitals surveyed perform basic endoscopic techniques, and 83.4% are able to perform advanced endoscopic procedures. © 2013 Elsevier Ireland Ltd. All rights reserved.
Arnal-Garcia C.,Hospital Virgen de Las Nieves |
Garcia-Montero M.R.,Hospital Virgen de la Salud |
Malaga I.,University of Oviedo |
Millan-Pascual J.,Hospital Complex Mancha Centro |
And 3 more authors.
European Journal of Paediatric Neurology | Year: 2013
Background: Not all pediatric patients with relapsing-remitting multiple sclerosis (MS) may respond to traditional disease-modifying therapies. Natalizumab has been shown to be effective but is currently only approved in adults. Objective: To analyze the safety and efficacy of natalizumab in patients under 18 years of age diagnosed with MS. Method: Data for pediatric patients with MS treated with natalizumab in a compassionate use setting were retrospectively collected and analyzed. Results: Valid data were obtained for nine patients under 18 years from seven different centers (mean age, 15 years 4 months [range 9.8-17.7]; 5 were boys). Patients received a median of 17 infusions of natalizumab (range, 2-31) and eight received at least 12 infusions. For these 8 patients, the median score on the Expanded Disability Status Scale decreased from 3.0 to 1.0 and the median annualized relapse rate decreased from 3.0 to 0. After 12 months, no patients reported gadolinium-enhancing lesions compared to seven at baseline. Four post-baseline adverse events occurred and one patient discontinued due to hypersensitivity reaction. Conclusion: Natalizumab is a highly effective treatment as a second-line option in pediatric patients. In as far as the limited numbers allowed comparisons, the safety and efficacy of natalizumab in children was in line with the experience published in adult populations. © 2012 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.
Fernando M.M.A.,Kings College London |
Freudenberg J.,Feinstein Institute for Medical Research |
Lee A.,Feinstein Institute for Medical Research |
Morris D.L.,Kings College London |
And 8 more authors.
Annals of the Rheumatic Diseases | Year: 2012
Objectives: Systemic lupus erythematosus (SLE) is a chronic multisystem genetically complex autoimmune disease characterised by the production of autoantibodies to nuclear and cellular antigens, tissue inflammation and organ damage. Genome-wide association studies have shown that variants within the major histocompatibility complex (MHC) region on chromosome 6 confer the greatest genetic risk for SLE in European and Chinese populations. However, the causal variants remain elusive due to tight linkage disequilibrium across disease-associated MHC haplotypes, the highly polymorphic nature of many MHC genes and the heterogeneity of the SLE phenotype. Methods: A high-density case-control single nucleotide polymorphism (SNP) study of the MHC region was undertaken in SLE cohorts of Spanish and Filipino ancestry using a custom Illumina chip in order to fine-map association signals in these haplotypically diverse populations. In addition, comparative analyses were performed between these two datasets and a northern European UK SLE cohort. A total of 1433 cases and 1458 matched controls were examined. Results: Using this transancestral SNP mapping approach, novel independent loci were identified within the MHC region in UK, Spanish and Filipino patients with SLE with some evidence of interaction. These loci include HLA-DPB1, HLA-G and MSH5 which are independent of each other and HLA-DRB1 alleles. Furthermore, the established SLE-associated HLA-DRB1*15 signal was refined to an interval encompassing HLA-DRB1 and HLA-DQA1. Increased frequencies of MHC region risk alleles and haplotypes were found in the Filipino population compared with Europeans, suggesting that the greater disease burden in non-European SLE may be due in part to this phenomenon. Conclusion: These data highlight the usefulness of mapping disease susceptibility loci using a transancestral approach, particularly in a region as complex as the MHC, and offer a springboard for further fine-mapping, resequencing and transcriptomic analysis.