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Objective: To compare the costs to the Spanish healthcare system of 35 days' treatment with triflusal (600 mg/day) and aspirin (300 mg/day) in patients with confirmed acute myocardial infarction within 24 hours of onset of symptoms.Design: A cost minimisation analysis based on the results of the Triflusal in Acute Myocardial Infarction study (TIM) was conducted. The hypothesis was that despite a higher acquisition cost of triflusal, savings would result because of differences in efficacy and safety outcome (non-fatal cerebrovascular event and haemorrhagic events). Diagnostic Related Groups were used as a proxy for determining hospital costs in Spain and the values were obtained from different sources and refer to year 2000 costs. Only direct medical costs were considered for the economic analysis.Results: Although the acquisition cost of triflusal was more expensive than that of aspirin, the cost of prevented events - non-fatal ischaemic cerebrovascular events and cerebral haemorrhages - entirely compensated for the cost of triflusal. The overall cost of treating patients with triflusal, compared with aspirin, represented a net saving of 28.4% per patient treated.Conclusion: Our study showed that triflusal is cost saving compared with aspirin in the treatment of the acute phase of myocardial infarction. [ABSTRACT FROM AUTHOR]

Invasive fungal infections (IFI) pose a significant complication after hematopoietic stem cell transplantation (HSCT). Isavuconazole (ISV) is a new generation azole with a favourable adverse effect and interaction profile approved for the treatment of invasive aspergillosis and mucormycosis. We analyzed the indications, effectiveness, adverse event profile and drug interaction management of ISV in the real-world setting in adults who received allogeneic-HSCT (allo-HSCT) within the Spanish Group of HSCT and Cell Therapy (GETH-TC). We conducted a multicenter retrospective study of all consecutive adult allo-HSCT recipients (≥18 years) who received ISV either for IFI treatment or prophylaxis, from December 2017 to August 2021, in 20 centers within the Spanish Group of Hematopoietic Stem Cell Transplantation and Cell Therapy (GETH-TC). A total of 166 adult allografted patients who received ISV from 2017 to 2021 were included. Median age was 48 years with 43% females. In 81 (49%) patients, ISV was used for treatment of IFI, and in 85 (51%) for prophylaxis. Median duration of ISV administration for IFI treatment was 57 days (range 31-126) and 86 days (range 33-196) for prophylaxis. Most frequent indication for treatment was invasive aspergillosis (78%), followed by mucormycosis (6%). Therapeutic success (45%) was the most frequent reason for ISV withdrawal. In the prophylaxis group, the resolution of IFI risk factors was the most frequent reason for withdrawal (62%). Six (7%) breakthrough IFI were reported. The majority of patients (80%) presented pharmacologic interactions. Twenty-one patients (13%) reported adverse events related to ISV, mainly liver biochemistry abnormalities, which led to ISV withdrawal in 7 patients (4%). ISV was effective and well tolerated for IFI treatment and prophylaxis, with a manageable interaction profile., (Copyright © 2024 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Introduction: Age differences between athletes born in the same year, as well as an over-representation of older players, are known as the Relative Age Effect (RAE). Players born at the beginning of the selection year have a physical and anthropometric advantage over their younger peers. Experts keep looking for new prediction variables for talent identification., Objectives: The aim of the study is to correlate anthropometric, strength and power variables with the relative age (RA) and the level of the teams in which players played in each age category., Methods: All players ( N  = 366) from an elite soccer academy of a Spanish club volunteered to participate in the study (U23-U10)., Results: There was a significant correlation between the RA of the players and the level of the team in which they played in each age category but no correlation between trimester of birth and level of the team. We found significant correlations between the players' physical capacities, anthropometry, RA and the level of the team in which they played for the same age category, mainly from U16 to U10. U23 did not show any correlation between RA and physical or anthropometric variables., Conclusion: Coaches should be cautious of choosing players based only on anthropometric or physical attributes.

Objectives: To describe and analyze the training programs carried out during the COVID-19 forced confinement in men´s professional football in Spain., Methods: Observational Study based on a telematic ad-hoc questionnaire developed to meet the objective of the study. The sample consisted of thirty-six coaches representing thirty-six professional men's soccer teams in the Spanish first and second division., Results: Training programs developed during confinement prioritized conditioning and functional emphasis, in addition to general and nonspecific resistance training, due to contextual limitations., Conclusion: The structure of training during the COVID-19 confinement was limited by contextual circumstances. This study has made possible to record the training and strategies used in professional football during a confinement due to a worldwide state of alarm, with the aim of resuming competitive activity in the best possible conditions.

Objective: ESPRINT-15 is a specific and validated instrument to measure health-related quality of life in adults with allergic rhinitis. The aim of this study was to obtain new reference values based on disease severity using both the original and the modified versions of the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines., Methods: ESPRINT-15 was administered to a representative sample of adults with allergic rhinitis in Spain. As in a previous study by our group, means and percentiles were analyzed for 16 quotas based on gender, allergic rhinitis type (intermittent vs persistent), and 4 symptom intensity groups according to the total symptom score (TSS4). The novel aspect of the present study was our application the severity criteria proposed by both the original and the modified ARIA classifications., Results: Of the 2756 patients in our previous dataset, 2580 were included in the present analysis. In terms of symptom severity, women ha relatively more intense symptoms than men with both ARIA classifications. In fact, using only the modified ARIA classification, we were abl to determine that severe rhinitis is moderately more frequent in women (27% vs 23%), although the difference is not statistically significant., Conclusions: The new set of reference values enables the ESPRINT-15 questionnaire to be adapted to the current severity classification Consequently, this quality of life tool (http://www.seaic.org/inicio/esprint) can be easily used and better interpreted in daily clinical practice.

Purpose: Triflusal is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. It was initially marketed as capsules containing 300 mg of active substance. In 2006 a new 600 mg (10 ml) oral solution form of triflusal was authorized in Spain. The primary aim of this study was to compare the gastrointestinal safety of the new triflusal oral solution with triflusal capsules in healthy volunteers., Methods: Sixty healthy subjects were randomly assigned, in a 2.5:2.5: 1 ratio, into one of three groups, with 25 subjects receiving one bottle of triflusal oral solution (600 mg) daily, 25 subjects receiving two triflusal capsules (600 mg) once daily, and ten subjects receiving two placebo capsules once daily, respectively, during 7 consecutive days. Gastroscopy was performed at baseline before the administration of study drugs and after 4-8 h of the last dose of study drugs. Effects on the esophagus, stomach, and duodenum were measured in accordance with a modified Lanza scale., Results: No differences between groups were detected at baseline. After treatment, median global scores in the placebo, triflusal solution, and triflusal capsules groups were, respectively, 0, 1, and 3 (p = 0.003 for comparison between placebo and triflusal capsules and p = 0.042 for comparison between triflusal solution and triflusal capsules). There were no significant differences between the scores on the triflusal solution and placebo groups. All treatments were well tolerated., Conclusion: In healthy subjects, triflusal solution induced less endoscopically apparent gastrointestinal mucosal damage than triflusal capsules and did not induce more damage than the placebo in healthy volunteers.

Background: Exacerbations are a frequent cause of morbidity and mortality in COPD. It is crucial to identify risk factors for failure after treatment of exacerbations of COPD. This study evaluates the COPD severity score (COPDSS) as a predictor of clinical failure, together with other severity, activity and quality of life measurements, in patients with exacerbated COPD., Method: Multicenter, prospective, observational study in ambulatory patients with exacerbation of COPD. The patients completed the COPDSS, the London Chest Activities of Daily Living (LCADL) and the EuroQol 5D (EQ-5D). A follow-up visit was scheduled one month after presentation with the exacerbation to assess the clinical evolution., Results: A total of 346 patients were included (mean age 68.5 years (SD=9.5 years and 90.7% male) and mean FEV(1)(% predicted) 46.9% (SD=17)). After one month, 28.2% of episodes were classified as failures, with half of them requiring hospital admission. Patients who failed were more frequently active smokers, with more severe dyspnoea at presentation and worse lung function. They had significantly worse scores of COPDSS, LCADL, EQ-5D index and EQ-5D visual analogue score (VAS) and shorter mean time walking per day. ROC analysis of relationship between COPDSS and failure gave AUC 0.72, which improved only to 0.77 when the other significant variables in univariate analysis were considered., Conclusions: Clinical failure after ambulatory treatment of exacerbation of COPD is frequent. Usual markers of severity (impaired lung function, active smoking and severe dyspnoea) are associated with failure; however, a short severity questionnaire (COPDSS) provides better predictive value than the usual variables., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background: Rupatadine (Rupafin), a novel antihistamine approved recently in Europe for the treatment of allergic rhinitis (AR) and chronic idiopathic urticaria in patients aged>or=12 years, has been shown to be highly efficacious, and as safe and well tolerated as other commonly employed antihistamines in the treatment of allergic disease. There are, however, few data on the long-term safety of these antihistamines derived in accordance with the clinical safety recommendations of the European Agency for the Evaluation of Medicinal Products (EMEA) and the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline., Objective: To assess the safety and tolerability of treatment with rupatadine 10 mg/day for 12 months in subjects with persistent AR (PER)., Methods: A multicentre, open-label, phase IV study in patients recruited from 33 centres in Spain, from September 2002 to November 2005. The study enrolled 324 male and female patients (aged 12-70 years) with a medical history of PER for at least 12 months and a documented positive skin-prick test to an appropriate allergen. On 4 of the 7 days prior to start of treatment, the patients were required to have a minimum total nasal symptom score (TNSS [for sneezing, rhinorrhoea, nasal obstruction/congestion and nasal itching]) of >or=5. Of the 324 eligible patients starting treatment, 120 needed to be treated for more than 6 months and were followed up until the end of 12 months. All patients received rupatadine 10 mg/day and were allowed to continue their normal concomitant medication for all conditions, other than rhinitis, for up to 6 or 12 months. Safety was assessed by means of adverse events (AEs) reported by patients or detected by investigators, scheduled centralized ECG with special attention to Bazzet corrected QT interval (QTcB) and standard laboratory investigations., Results: Assessment of treatment compliance rates indicated 90% and 83% of patients to be compliant during the 1-6 months and 1-12 months treatment periods, respectively, with compliance rates>80% being associated with the majority of the study population reporting at least one AE. Overall, 74.1% and 65.8% of the patients reported at least one AE during the 1-6 months and 1-12 months treatment periods, respectively, compared with 20.4% and 10.8% of patients reporting at least one treatment-related AE during these periods. Disorders of the nervous system and respiratory thoracic and mediastinal system, in particular headache, somnolence and catarrh, were the three most common AEs reported by >5% of the patients during both treatment periods. Detailed ECG assessments demonstrated no clinically relevant abnormal ECG findings, nor any QTcB increases >60 msec or QTcB values>470 msec for any patient at any time during treatment. Serious AEs were reported in seven patients, of whom six were considered as unlikely to be related to rupatadine treatment, whereas one involving increased blood enzyme levels was considered as possibly related to rupatadine treatment., Conclusion: This study confirmed the good long-term safety and tolerability of rupatadine at the therapeutic dose of 10 mg/day in patients with PER.

Objective: ESPRINT-15 is a specific, short-form instrument to measure health-related quality of life in adults suffering from allergic rhinitis. The aim of this study was to obtain reference values in order to improve its interpretability., Methods: ESPRINT-15 was administered to a representative sample of Spanish adults with allergic rhinitis. Means and percentiles were obtained, taking into account the kind of rhinitis (persistent/intermittent) and symptom severity (very mild/mild/moderate/severe)., Results: A total of 2756 patients participated in the study. Mean (SD) scores were significantly lower (better) for men than for women (2.2 [1.4] vs 2.4 [1.4], P<.001, effect size [ES] is congruent to 0.15). Patients with intermittent rhinitis showed better scores than patients with persistent rhinitis (2.1 [1.4] vs. 2.5 [1.4], P<.001, ES is congruent to 0.21). Mean (SD) scores were higher (worse) when severity of symptoms increased, ranging from 0.9 (0.9) (very mild) to 3.7 (1.0) (severe) (ES is congruent to 1.0 between each consecutive group of symptom severity)., Conclusions: The magnitude of the differences found among groups of patients reinforces the usefulness of providing reference values stratified by gender, type of allergic rhinitis, and symptom severity. The percentiles obtained can be used in clinical practice to evaluate individual scores, and assign the patient to the corresponding reference group.

Background: We compared the psychometric properties of the ESPRINT-15, the short form of a new Spanish instrument to measure health-related quality of life in allergic rhinitis (AR) patients, with those of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)., Methods: The questionnaires were compared in Spanish patients with intermittent allergic rhinitis (IAR) or persistent AR in a prospective, observational study. Floor and ceiling effects, internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient; ICC), convergent and known groups validity, and sensitivity to change (standardized response means; SRMs) were compared., Results: In terms of content, while the MiniRQLQ has a dimension covering practical problems and places more emphasis on symptoms, the ESPRINT-15 has two dimensions (Sleep and Psychological impact) which are not included in the MiniRQLQ. In the validation study, 400 patients were included and 59% of the sample had persistent AR. There were no significant floor or ceiling effects on any dimension on either questionnaire. Cronbach's alpha values for the ESPRINT-15 and MiniRQLQ overall scores were 0.92 and 0.90, respectively. In 48 clinically stable patients, ICCs were 0.80 and 0.77, respectively. Both instruments discriminated between patients with IAR and persistent AR. Correlations with symptom scores and generic measures were moderate to strong. SRMs for overall scores and individual dimensions on the two questionnaires in the 197 patients reporting a change in health status ranged from 0.7 to 1.3., Conclusions: Both questionnaires performed well in psychometric terms. The ESPRINT-15 is particularly recommended for use in Spanish-speaking populations.

Objective: The aim of this study was to evaluate the results of high frequency ventilation (HFV) used as a rescue strategy in newborn infants with severe lung disease who either failed conventional mechanical ventilation (CMV) or had an air block., Patients and Methods: From April 1995 to June 1998, 241 infants with severe lung disease and managed according to a common protocol of HFV used as a rescue strategy were prospectively evaluated in the nine participating level III Spanish Neonatal Intensive Care Units. The most frequent diagnoses were respiratory distress syndrome (119), meconium aspiration (24), pneumonia (19) and congenital diaphragm hernia (18)., Results: Mean +/- SD gestational age and birth weight were 32.0 +/- 5.5 weeks and 1,187 +/- 1,071 g, respectively. All babies were previously manages with CMV for a mean of 59 hours. HFV was started at a mean postnatal age of 82 hrs, with a mean oxygenation index (OI) of 28.3 +/- 15.3 and an a/A DO2 of 0.10 +/- 0.08. Initial mean HFV settings were: mean airway pressure 12.8 +/- 3.4 mbar, frequency 8.3 +/- 1.4 Hz, amplitude 53 +/- 20 percent, tidal volume 2.2 +/- 0.7 ml/kg and FiO2 0.88 +/- 0.2. At two hours of HFV there was a significant increase in the mean PaO2 (from 48 to 80 mmHg), with a concomitant decrease in FiO2 (from 0.88 to 0.79), PaCO2 (from 60 to 46 mmHg) and OI (from 28 to 18). Mean a/A DO2 increased from 0.10 to 0.19; these changes remained similar thereafter. HFV was suspended after a mean of 95 hrs because of improvement in 70%, death in 19% and failure to improve the clinical condition in the remaining 19%. Intrahospital death rate was 32%. The following complications were observed: pneumothorax (10%), interstitial emphysema (4%), intraventricular hemorrhage grades III and IV (14.5%) and bronchopulmonary dysplasia (35%)., Conclusions: HFV is an effective rescue strategy that improves pulmonary gas exchange within two hours of its initiation.

The methodological quality of 50 clinical trial protocols submitted to our hospital has been assessed by means of a check-list. The most frequent methodological deficiencies found were related to statistical analysis, selection criteria, sample size, incorrect use of placebo, homogeneity of the groups, concomitant medication, randomisation plan, monitoring of adverse events and study design. Lack of insurance for the patients and inadequacies in the investigators' brochure and case report forms were observed in a significant number of cases. The results suggest the importance of a multidisciplinary team in the elaboration of clinical trial protocols to prevent methodological errors.