Variability of the prevalence of depression in function of sociodemographic and environmental factors: ecological model

Major depression etiopathogenesis is related to a wide variety of genetics, demographic and psychosocial factors, as well as to environmental factors. The objective of this study is to analyze sociodemographic and environmental variables that are related to the prevalence of depression through correlation analysis and to develop a regression model that explains the behavior of this disease from an ecological perspective. This is an ecological, retrospective, cross-sectional study. The target population was 1,148,430 individuals over the age of 16 who were registered in Aragon (Spain) during 2010, with electronic medical records in the community’s primary health care centers. The spatial unit was the Basic Health Area (BHA). The dependent variable was the diagnosis of Depression and the ecological independent variables were: Demographic variables (gender and age), population distribution, typology of the entity, population structure by sex and age, by nationality, by education, by work, by salary, by marital status, structure of the household by number of members, and state of the buildings. The results show moderate and positive correlations with higher rates of depression in areas having a higher femininity index, higher population density, areas with a higher unemployment rate and higher average salary. The results of the linear regression show that aging +75 and rural entities act as protective factors for depression, while urban areas and deficient buildings act as risk factors. In conclusion, the ecological methodology may be a useful tool which, together with the statistical epidemiological analysis, can help in the political decision making process

Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up.

Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen's d=1.43 at 6 months) and pain measured with a sphygmomanometer (d=1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval=2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval=3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM

Clinical effectiveness and bacteriological eradication of three different Short-COurse antibiotic regimens and single-dose fosfomycin for uncomplicated lower Urinary Tract infections in adult women (SCOUT study): study protocol for a randomised clinical trial

Introduction: Uncomplicated lower urinary tract infections (uLUTI) are a common problem in primary care. Current local guidelines recommend the use of a single 3 g dose of fosfomycin. However, most general practitioners (GP) prefer short-course therapies to single-dose therapy. No study has compared head-to-head short-course antimicrobial agents for uLUTIs. Therefore, the aim of this randomised clinical trial is to compare three different short-course antibiotic therapies with a single-dose of fosfomycin for these infections. Methods and analysis: This will be a pragmatic, multicentre, parallel group, open trial. Women aged 18 or older and with symptoms of uLUTI and a positive urine dipstick analysis will be randomised to one of the following four groups: a single dose of 3 g of fosfomycin, 2 days of 3 g of fosfomycin o.d., 3 days of pivmecillinam 400 mg three times per day (t.i.d) or 5 days of nitrofurantoin 100 mg t.i.d. A total sample of 1120 patients was calculated. The primary endpoint is clinical effectiveness at day 7, defined as cure of symptoms reported by the patients in a diary including four symptoms: dysuria, urgency, frequency and suprapubic pain, which will be scored on a 4-point severity scale (not present/mild/moderate/severe). Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the three antibiotics studied will be performed. Bacterial eradication will be measured at days 14 and 28

Impact of age on the appearance of adverse eventsat the beginning of biological treatment: data from the BIOBADASER 3.0 registry

Background: Currents medical advances are allowing patients with chronic arthritis to live to advanced ages. Although the risks of biological therapies in elderly patients have been previously evaluated, data are scarce since they are mainly derived from clinical trials, in which elderly populations are often underrepresented or event excluded (patients up to 75 years old). In addition, comparisons between such studies are difficult in the absence of a consensus in defining the groups’ age. Objectives: To evaluate the impact of age on the appearance of adverse events (AE) in patients with rheumatic diseases (rheumatoid arthritis -RA-, ankylosing spondylitis -AS- and psoriatic arthritis -PsA) at the start of biological treatment. Methods: Multicenter prospective study in a real-world setting. Information was obtained from BIOBADASER, a national safety registry of patients with rheumatic diseases treated with biologics or targeted synthetic disease modifying anti-rheumatic drugs. For this analysis, all patients included in this registry since 2000 and diagnosed with RA, AS or PsA were included, and classified into four categories according to age at initiation of biologic treatment: young ( 75 years-old). Data collected included: 1) patient’s data 2) data on treatment and 3) data on AE. Proportions, means and standard deviations were used to describe the population. Poisson regression model was carried out to explore factors associated with the appearance of AEs. Crude and adjusted incidence rate ratios (IRRs) were calculated. Results: A total of 2531 patients were included: 1154 RA (45.59%), 680 PsA (26.87%), and 697 AS (27.54%). Age groups: there were 64 young patients (2.52%), 2166 adults (85.57%), 243 elderly adults (9.6%), and 58 very elderly adults (2.29%). Comorbidities increased with age, while smoking rates decreased. Methotrexate use was similar in all age groups (53.99% in the total sample), but corticosteroid treatment increased with age (young 27.7%, adults 47%, elderly adults 64.36% and the very elderly 70.21%). 77.87% received anti-TNF treatment, and 22.13% other biological drugs. Poisson regression model showed an increased probability of suffering a first adverse event with increasing age regardless of the disease (IRR for AS: 1.04 (0.87-1.26); IRR for PsA: 1.08 (0.92-1.28)). Other factors associated with higher IRR were sex (being woman), type of biological treatment (TNF inhibitors), concomitant therapy (methotrexate), smoking, comorbidities (Charlson Index) and time of evolution of rheumatic disease. No differences were found between pathologies. Conclusion: A mix of clinical and patient factors seem to explain the appearance of a first AE after biological therapy initiation, with age being one of those explanatory variables

Factors associated to persistence of treatment with golimumab in the biobadaser registry, with up to 6 years of follow-up

Background: Survival, or persistence in treatment with a biological drug can be considered an indirect measure of efficacy, safety and tolerability Objectives: We assessed the probability of persistence (survival) of treatment with golimumab in patients with rheumatic diseases and the factors associated to persistence with up to 6 years of follow-up. Methods: BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. A data-base analysis was done in December 2018 on all the patients aged 18 years or more who had initiated golimumab for one of the approved indications (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). The probability of persistence was calculated with a Kaplan-Meier test. Factors related to persistence were analyzed with a Cox-regression model. Results: 581 patients were included (165 [28.4%] RA, 249 [42.9%] axial SpA and 167 [28.7%] PsA), mean age 51 [12] years, 53% women). Median duration of disease at the onset of golimumab was 8.0 (3.0-14.7) years. Golimumab was prescribed as first biological drug in 37.9% of the patients, as second in 32.1% and as third or further in 30.0%. Concomitant medications at golimumab initiation included steroids (28.2%), methotrexate (MTX) (35.5%), sulphasalazine (7.2%) and leflunomide (13.9%). The probability of persistence of treatment with golimumab since treatment initiation was 74.3% at year 1 (95% CI 70.3 ? 77.8), 63.5% at year 2 (59.0 ? 67.6), 60.5% at year 3 (55.9 ? 65.8), 54.5% (49.1 ? 59.7) at year 4 and 5, and 52.1% (44.9 ? 57.7) at year 6. Persistence was higher when golimumab was used as first biological agent (p log-rank <0.001) and for the treatment of axial SpA or PsA compared to RA (p log-rank <0.001). As first biological drug the probability of persistence was 82.8% (year 1) and 66.5% at year 4. At year 5, survival rates (all lines of therapy) were 59.7%, 63.4% and 37.3% for axial SpA, PsA and RA respectively. Cox-regression analysis (table) showed that the probability of persistence in treatment with golimumab therapy was higher in first vs second or third biological line patients (Hazard Ratio [HR] for discontinuation: 1.78 for second and 2.41 for third or further line versus first line), in SpA and PsA patients (HR discontinuation of RA patients: 1.94 versus PsA), and lower in women (HR: 1.62), in those needing steroids (HR: 1.47) or DMARDs different to MTX (HR: 2.17). Patients treated with MTX had higher but non-significant persistence rate (HR discontinuation 0.79, table). Conclusion: The probability of persistence (survival) on therapy with golimumab was high up to 6 years of follow-up and was higher in patients treated with golimumab as first biological drug or for PsA and SpA, and lower in those needing steroids, DMARDs different to MTX and in women

Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry

The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug

ABATACEPT in rheumatoid arthritis with interstitial lung disease. A multicenter study of 181 patients

Background Interstitial Lung Disease (ILD) is a severe extraarticular manifestation of rheumatoid arthritis (RA). Objectives Our aim was to assess the efficacy of abatacept (ABA) in RA patients with ILD. Methods Retrospective multicenter study of RA patients with ILD treated with ABA. ILD was diagnosed by HRCT. We have analyzed the following variables: a) 1-point change the Modified Medical Research Council (MMRC); b) FVC improvement ≥10%; and improvement ≥10% in DLCO; c) radiological improvement in HRCT scan, d) changes in DAS28 score. Values were compared with baseline e) prednisone doses Results We studied 181 patients (94women/87 men) with ILD associated to RA. The follow-up was 12.1[6.2-24.1] months. The mean age was 64.54 ± 9.7 years. The median to progression of ILD was 12 [3-43.75] months. 81 patients were treated in monotherapy, 100 patients in combination therapy. The most frequent pattern was UIP 45,3%. The most of patients who did not have dyspnea remained asymptomatic. See results in Figure1. DAS28 also improved. We appreciate a decrease in the dose of prednisone compared to the initial dose. Conclusion ABA seems to be effective. However, should be verified in prospective and randomized studies

Standardization and chemical characterization of intravenous therapy in adult patients

Background: Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. Aim: The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature to better guide the selection of the most appropriate vascular access. Methods: The project was conducted in three phases: (i) standardization of intravenous therapy, which was conducted using a modified double-round Delphi method; (ii) characterization of the dilutions agreed on in the previous phase by means of determining the osmolarity and pH of each of the agreed concentrations, and recording the vesicant nature based on the information in literature; and (iii) algorithm proposal for selecting the most appropriate vascular access, taking into account the information gathered in the previous phases. Results: In total, 112 drugs were standardized and 307 different admixtures were assessed for pH, osmolarity and vesicant nature. Of these, 123 admixtures (40%), had osmolarity values >600 mOsm/L, pH 9, or were classified as vesicants. In these cases, selection of the most suitable route of infusion and vascular access device is crucial to minimize the risk of phlebitis-type complications. Conclusions: Increasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices