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COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vs MITT in Spain in terms of treatment persistence, exacerbations, and other outcomes. Do COPD patients in Spain initiating SITT vs MITT have improved persistence, exacerbations, and health care resource utilization? This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged ≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60 days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed. Eligible patients (N = 4,625) initiating SITT (n = 1,011) or MITT (n = 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR] = 1.37; 95% CI = 1.22-1.53; P Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings.

Background Autosomal dominant polycystic kidney disease (ADPKD) is considered the most common inherited renal disease. Patient-Reported Outcomes (PROs) and patient experience in ADPKD are difficult to quantify and have not been well studied, particularly in the early stages of the disease. There is evidence to suggest that early-stage ADPKD patients have a lower Health-Related Quality of Life (HRQoL) than the general population due to the signs and symptoms of early-stage ADPKD. However, no research has been carried out on the HRQoL of early-stage ADPKD patients using validated ADPKD-specific PRO measures. Additionally, a new disease progression delaying treatment option has recently emerged for ADPKD. Patient preference for this treatment and unmet treatment needs have not yet been investigated. Methods The ACQUIRE study is a prospective, observational study investigating the influence of early-stage ADPKD-related symptoms and treatments on PROs. It aims to collect real-world data on patient demographics, treatment patterns, clinical outcomes, and PROs such as HRQoL, treatment satisfaction and treatment preference in early-stage ADPKD. Adult ADPKD patients in stages 1–3 of chronic kidney disease (CKD) with evidence of rapidly progressing disease are being recruited from seven European countries. At baseline and every 3 months, for a follow-up period of 18 months, general and disease-specific questionnaires are completed remotely to capture patients’ own assessment of their overall and ADPKD-related HRQoL. A Discrete Choice Experiment (DCE) is also used to investigate the value patients place on different attributes of hypothetical treatment options (e.g. treatment outcomes, side effects) and the role each attribute plays in determining overall patient treatment preference. Discussion The results of this study will highlight the real-world effects of ADPKD-related challenges on PROs including HRQoL, treatment experience and satisfaction; and help physicians gain greater insight into likely disease outcomes based on early-stage patient symptoms and patients’ experience with treatment. Data captured by the DCE may inform ADPKD treatment decision-making from a patient perspective. The DCE will also provide insights into which patients are more likely to perceive benefit from treatments based on the value and trade-offs they place on specific treatment attributes. Trial registration NCT02848521. Protocol Number/Version: 156–303-00096/Final

Aim Liraglutide and lixisenatide improved glycemic control, weight and cardiovascular risk factors (CVRF) in type 2 diabetes mellitus (T2DM) patients. Our objective was to analyze clinical efficacy and safety differences in routine clinical practice. Methods A 24-week prospective observational study to compare the effect of liraglutide versus lixisenatide in obese T2DM patients in routine clinical practice. The main objective was to analyze between-group glycosylated hemoglobin (HbA1c) differences at the end of the study. Secondary objectives included differences in body weight, other CVRF, changes in medication, side effects, satisfaction and safety. Results A total of 100 patients (50 liraglutide, 50 lixisenatide) were included. Both groups experienced a decrease in HbA1c values (liraglutide, −1.4%, CI 95% −2, −0.8, P Conclusions These results confirm the efficacy and safety of liraglutide and lixisenatide in routine clinical practice. Moreover, a different therapeutic effect between liraglutide and lixisenatide was detected.

Aim The EPICOR observational study was designed to describe antithrombotic strategies in a broad acute coronary syndrome (ACS) population; it also included information on inter-hospital transfers and institutional resources. Methods and results EPICOR enrolled 10,568 consecutively discharged patients with ST-elevation (STE) or non-STE (NSTE) ACS in 555 centres in 20 countries across Europe and Latin America. Patients were categorized as non-transferred, transferred in from another hospital and then discharged, or transferred out to a second hospital but discharged from their initial hospital after transfer back. Two-thirds of ACS patients were non-transferred, of which only 14% were hospitalized at a centre without a catheterization laboratory, and one-third were transferred in or transferred out. Almost all transferred out patients were transferred out to a hospital with catheterization facilities, most often for primary/urgent/rescue (78%) or planned catheterization (18%) in STE myocardial infarction (STEMI), and primary/urgent/rescue (44%) or planned (43%) catheterization in NSTE-ACS. Transferred in patients were more likely to have a STEMI (60%) than non-transferred (44%) and transferred out patients (36%). In STEMI patients, time from symptom onset to catheterization was shorter in non-transferred patients (median 3.5 h vs. 5.9 h for transferred in and 6.3 h for transferred out). In NSTE-ACS, cardiac markers were positive in 66% of non-transferred patients versus 78% and 82% in transferred in and transferred out, respectively. Conclusions The lack of on-site 24/7 facilities or the availability of more advanced care are frequent reasons for inter-hospital transfer in ACS. Further follow-up of these patients will help to determine whether these practice patterns affect outcome.

Objective To assess, from the perspective of the National Healthcare System, the efficiency of a fixed-dose combination of naproxen and esomeprazole (naproxen/esomeprazole) in the treatment of osteoarthritis (OA) compared to other NSAID, alone or in combination with a proton pump inhibitor (PPI). Methods A Markov model was used; it included different health states defined by gastrointestinal (GI) events: dyspepsia, symptomatic or complicated ulcer; or cardiovascular (CV) events: myocardial infarction, stroke or heart failure. The model is similar to the one used by NICE in its NSAID evaluation of OA published in 2008. The total costs (€, 2012), including drug and event-related costs, and the health outcomes expressed in quality-adjusted life years (QALY) were estimated in patients with increased GI risk, aged 65 or over, for a 1-year time horizon and a 6-month treatment with celecoxib (200 mg/day), celecoxib+PPI, diclofenac (150 mg/day)+PPI, etoricoxib (60 mg/day), etoricoxib+PPI, ibuprofen (1800 mg/day)+PPI, naproxen (1000 mg/day)+PPI or naproxen/esomeprazole (naproxen 1000 mg/esomeprazole 40 mg/day). The selected PPI was omeprazole (20 mg/day). Results Naproxen/esomeprazole was a dominant strategy (more effective and less costly) compared to celecoxib, etoricoxib and diclofenac+PPI. Celecoxib+PPI and etoricoxib+PPI were more effective. Considering a cost-effectiveness threshold of € 30 000 per additional QALY, naproxen/esomeprazole was cost-effective compared to ibuprofen+PPI and naproxen+PPI with incremental cost-effectiveness ratios (ICER) of € 15 154 and € 5202 per additional QALY, respectively. Conclusions A fixed-dose combination of naproxen and esomeprazole is a cost-effective, and even dominant, alternative compared to other options in OA patients with increased GI risk.

Background Nowadays, 65-80% of pheochromocytoma and paraganglioma (PPGL) cases are explained by germline or somatic mutations in one of 22 genes. Several genetic testing algorithms have been proposed, but they usually exclude sporadic-PPGLs (S-PPGLs) and none include somatic testing. We aimed to genetically characterise S-PPGL cases and propose an evidence-based algorithm for genetic testing, prioritising DNA source. Methods The study included 329 probands fitting three criteria: single PPGL, no syndromic and no PPGL family history. Germline DNA was tested for point mutations in RET and for both point mutation and gross deletions in VHL, the SDH genes, TMEM127, MAX and FH. 99 tumours from patients negative for germline screening were available and tested for RET, VHL, HRAS, EPAS1, MAX and SDHB. Results Germline mutations were found in 46 (14.0%) patients, being more prevalent in paragangliomas (PGLs) (28.7%) than in pheochromocytomas (PCCs) (4.5%) (p= 6.62x10(-10)). Somatic mutations were found in 43% of those tested, being more prevalent in PCCs (48.5%) than in PGLs (32.3%) (p= 0.13). A quarter of S-PPGLs had a somatic mutation, regardless of age at presentation. Head and neck PGLs (HN-PGLs) and thoracic-PGLs (T-PGLs) more commonly had germline mutations (p= 2.0x10(-4) and p= 0.027, respectively). Five of the 29 metastatic cases harboured a somatic mutation, one in HRAS. Conclusions We recommend prioritising testing for germline mutations in patients with HN-PGLs and TPGLs, and for somatic mutations in those with PCC. Biochemical secretion and SDHB-immunohistochemistry should guide genetic screening in abdominal-PGLs. Paediatric and metastatic cases should not be excluded from somatic screening.

Amyotrophic lateral sclerosis is a chronic neurodegenerative disease of the central nervous system which affects the motor neurons and produces a progressive muscle weakness, leading to atrophy and muscle paralysis, and ultimately death. Performing a percutaneous endoscopic gastrostomy with sedation in patients with amyotrophic lateral sclerosis can be a challenge for the anesthesiologist. The case is presented of a 76-year-old patient who suffered from advanced stage amyotrophic lateral sclerosis, ASA III, in which a percutaneous endoscopic gastrostomy was performed with deep sedation, for which non-invasive ventilation was used as a respiratory support to prevent hypoventilation and postoperative respiratory complications.

AIMS: To describe international patterns and opportunities for improvement of pre- and in-hospital care of patients hospitalized for acute coronary syndromes (ACS), with special focus on anti-thrombotic therapy. METHODS AND RESULTS: EPICOR (long-tErm follow-uP of anti-thrombotic management patterns In acute CORonary syndrome patients), an international, cohort study, which enrolled 10,568 consecutive ACS survivors from 555 hospitals in 20 countries across Europe and Latin America (September 2010 to March 2011), prospectively registered detailed information on pre- and in-hospital management. Globally, 4738 (44.8%) were attended before hospitalization, 4241 (40.1%) had an ECG, 2119 (20%) received anti-platelet therapy and 101 STEMI patients (2%) fibrinolysis. In-hospital, 7944 patients (75.2%) received dual anti-platelet therapy, most often with clopidogrel (69.7%), and less with prasugrel (5.4%); 1705 (16.1%) had triple anti-platelet therapy, and 849 (8%) single anti-platelet therapy. STEMI patients more often received pre-hospital anti-thrombotics, and prasugrel, GP IIb/IIIa inhibitors and UFH in-hospital (all p < 0.001). More NSTE-ACS patients received clopidogrel, single anti-platelet therapy, and fondaparinux (all p < 0.001). As many as 33% of ACS patients were medically managed. A significant decreasing gradient was found between Northern, Southern and Eastern Europe and Latin America in use of more potent patterns of anti-platelet therapy, reperfusion therapy and invasive strategy. CONCLUSION: This large international study shows room for improvement in use of anti-thrombotic drugs and other strategies for optimal management of ACS, including pre-hospital ECG and anti-thrombotic therapy. Regional practice differences not based on evidence or conditioned by economic constraints should be reduced.

Resumen Objetivo Evaluar la eficiencia de la terapia combinada de metformina y dapagliflozina, un nuevo antidiabético oral con un mecanismo de acción independiente de la insulina, en el tratamiento de la diabetes mellitus tipo 2 (DM2) en comparación con inhibidores de DPP4, sulfonilureas y tiazolidindionas, combinados también con metformina. Diseño Análisis de coste-efectividad utilizando un modelo de simulación de eventos discretos a partir de los resultados de los ensayos clínicos disponibles y considerando un horizonte temporal de toda la vida del paciente. Emplazamiento Perspectiva del Sistema Nacional de Salud. Participantes El modelo simuló la historia natural de 30.000 pacientes con DM2 para cada opción comparada. Mediciones principales Años de vida ajustados por calidad (AVAC) y consecuencias económicas del manejo de la enfermedad y sus complicaciones. Se consideraron los costes directos (actualizados a euros de 2013) y se aplicó un descuento del 3% tanto para costes como para resultados en salud. Resultados El análisis principal comparó dapagliflozina con los inhibidores de DPP4, resultando dapagliflozina como una opción de tratamiento que aportaría una ligera mayor efectividad (0,019 AVAC) con menores costes totales asociados (−42 €). En los análisis adicionales, dapagliflozina fue una opción coste-efectiva en comparación con sulfonilureas y tiazolidindionas con razones de coste por AVAC ganado de 3.560 € y 2.007 €, respectivamente. Los análisis de sensibilidad univariantes y probabilístico confirmaron la solidez de los resultados. Conclusiones Los resultados del análisis realizado sugieren que dapagliflozina, en combinación con metformina, sería una alternativa coste-efectiva en el contexto español para el tratamiento de la DM2.

The aim of this study is to evaluate the diagnostic performance of human epididymis protein 4 (HE4), cancer antigen 125 (Ca125) and the risk of ovarian malignancy algorithm (ROMA) in discriminating ovarian cancer from other benign gynaecological diseases. Serum levels of HE4 and Ca125 were measured in 119 women with benign gynaecological diseases, 29 patients with primary ovarian cancer, 32 patients with ovarian cancer on chemotherapy treatment (18 of them with progressive disease), 6 patients treated and free of disease and 32 healthy women. Sensitivity, specificity, positive and negative predictive values and positive and negative likelihood ratios (LR ±) were calculated. Receiver operator characteristic (ROC) curves were constructed, and the areas under the curve (AUC) were calculated. High serum levels for HE4, Ca125 and ROMA were observed in cancer patients. HE4 was elevated in 12.6 %, Ca125 in 21 % and ROMA in 9.2 % in the benign group, but HE4 was not elevated in endometriosis. The AUC values for HE4, Ca125 and ROMA were 0.92, 0.911 and 0.945 respectively. The sensitivity for discriminating ovarian cancer from benign gynaecological diseases was 86.2 % for HE4 and Ca125 and 93.1 % for ROMA. The specificity was 87.4, 78.9 and 90.7 % for HE4, Ca125 and ROMA. The overall positive likelihood ratio (LR+) was 6.84 for HE4, 4.1 for Ca125 and 10.01 for ROMA. In premenopausal women, LR + was 11.86 for HE4, 5.11 for ROMA and 2.02 for Ca125. HE4 might be significant in the differential diagnosis of ovarian cancer. HE4 seems to be superior to Ca125 in terms of diagnostic performance of all premenopausal women. ROMA could help to discriminate in cases with any doubt with a high diagnostic accuracy.

To assess the quality of life (QOL) and satisfaction (SF) in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) compared with multiple daily insulin injections (MDI).A descriptive study was conducted to assess the QOL and SF of 68 patients on CSII or MDI treatment (1:2). The instruments used were, the Spanish version of the Diabetes Quality of Life (EsDQOL) specific for diabetes related QOL, SF-36 for general QOL, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) for SF evaluation.The EsDQOL scores for patients on CSII therapy were similar to those treated with MDI (87.20±21.11 vs 86.83±20.7, P=.86), with lower scores in the SF-36 questionnaire (66.91±15.76 vs 75.90±14.56, P=.03) except in Health Transition section, where patients treated with CSII showed higher scores (68.75±19.66 vs 57.93±17.18, p=.02). The values obtained in the DTSQ questionnaire were higher in CSII patients compared with the MDI group in last weeks (31.50±4.66 vs 27.83±6.06, p=.01) and last three months periods (13.2±6.73 vs 8.77±7.40, p=.01).Patients with T1DM on CSII therapy showed a poorer global QOL, although they felt more satisfied with their treatment than those treated with MDI. No differences in diabetes related QOL were detected between groups.

Make known the important urological work of Sanchez Covisa, third chief of the Urology Service of the Hospital Provincial de Madrid, who beginning in 1928 was able to transform and convert it into possibly the more outstanding one of its time in Spain, comparable to the best hospitals in foreign countries.We have analyzed the contents of the publication Urología Clínica, that collect the changes introduced and the work carried out in said service between 1928 and 1936, reflected in a careful yearly statistics on the care, operations and mortality in addition to the articles published by the members of the Service together with a short bibliographic review of each one.In 1914, he became chief of the Service, and after 14 years, was able to overcome all the obstacles and to extend and modernize the surgery rooms, hospitalization wards and examination resources. In 1931, once the changes were made, he began important clinical and scientific activity, and constituted one of the principal urological schools of the first half of the XXth century in our country.The prestige reached by the Urology Unit of the Hospital Provincial of Madrid attracted patients from all over Spain, many of them treated or operated on in their place of origin. This explains why the condition was complicated with some acceptable results. The quality and honesty of the Urology unit justify its qualification. The works in general are mere reviews and those regarding surgery of the uretero-intestinal shunt stand out.

Safety in the use of small volumes of hypertonic saline solution for hypovolaemic shock and in the treatment of intracranial hypertension has been demonstrated in studies in the field of resuscitation. There is little experience of this for septic shock in humans. Beneficial immunomodulatory effects have been detected in pre-clinical studies. Interactions with the pituitary-adrenal axis and with the secretion of anti-diuretic hormone are varied and suggestive, but are not sufficiently understood. On the other hand, vasopressin has cardiovascular, osmoregulatory, and coagulation effects, and also acts on the hypothalamic-pituitary-adrenal axis. There is a relative deficit of vasopressin in septic shock. Its use in these patients does not seem to have any advantages as regards mortality, but may be beneficial in patients at risk from acute renal failure, or those who receive corticosteroids. Terlipressin is a vasopressin analogue that has also been studied. The synergy between vasopressin and hypertonic saline is a hypothesis that is mainly supported in pre-clinical studies. The use of hypertonic saline solution in septic shock, although promising, is still experimental, and must be restricted to the field of controlled clinical trials.

Incidentalomas are clinically silent adrenal masses that are discovered incidentally during diagnostic testing for clinical conditions unrelated to suspicion of adrenal disease. Several decision algorithms are used in the management of adrenal masses. We evaluated the routine use of these algorithms through a clinical activity questionnaire.The questionnaire included data on the work center, initial hormonal and radiological study, imaging and hormonal tests performed to complete the study, surgical indications and clinical follow-up.Thirty-three endocrinologists (79%) attending the annual congress of the Castilla-La Mancha Society of Endocrinology, Nutrition and Diabetes completed the questionnaire. Forty-six percent considered tumoral size to be the most important factor suggesting malignancy in the initial evaluation of adrenal incidentalomas, the limit being 4 cm for 78% of the endocrinologists. Imaging study was completed by magnetic resonance imaging by 39%. All the physicians always performed screening for hypercortisolism and pheochromocytoma. Other assessments always conducted in all incidentalomas included hyperaldosteronism (76%), sex hormone-producing tumor (51%) and congenital adrenal hyperplasia (30%). Seventy-nine percent of respondents began to refer incidentalomas larger than 4 cm for surgical treatment, and 46% referred all tumors larger than 6 cm for surgical treatment. With regard to hormonal function, patients with pheochromocytoma, Cushing's syndrome, hyperaldosteronism with poorly controlled blood pressure or sex hormoneproducing tumors were more frequently referred for surgery. Seventy-six percent of endocrinologists performed clinical follow-up in adrenal incidentalomas larger than 4 cm, preferably through computerized tomography (81%), and repeated studies for hormonal hypercortisolism (97%), primary hyperaldosteronism (42%) and pheochromocytoma (76%) over a 4-5 year period (67%).Clinical practice varied among the endocrinologists surveyed, although a certain uniformity in relation to the main guidelines was observed. A tendency to request a greater number of diagnostic tests for initial hormone assessment and clinical follow-up was detected. Assessment, decision-making and medical monitoring in adrenal incidentalomas remain unclear and consequently further studies are required.

Secondary amyloidosis is generally caused by malignant tumors or chronic inflammatory diseases. Most cases of secondary amyloidosis are discovered due to proteinuria or nephrotic syndrome caused by renal amyloidosis. Clinically significant thyroid involvement is found in only a small percentage of cases, although a finding of amyloid deposit in autopsies is not infrequent. We present a case of amyloid goiter. The patient was diagnosed with Crohn's disease 7 years previously and had kidney failure of unknown cause. She was referred to our department for a goiter discovered incidentally. The patient finally underwent thyroidectomy due to progressive growth of the thyroid gland with compressive symptoms. The histologic analysis showed thyroid amyloidosis.

To assess the role of the adrenal cortical scintigraphy with 131-I Norcholesterol (I-COL) in the diagnosis and characterization of silent adrenal masses.We selected 57 patients who underwent an adrenal scintigraphy with I-COL, 36 women and 21 men (mean aged: 62.5 years), and who were classified into two groups: Group I or Incidentalomas, 39 patients without signs or symptoms of adrenal disease in whom an adrenal mass is incidentally discovered during a CT or ultrasound scan; and a second group or Group II, 18 patients with history of cancer in whom an adrenal mass is discovered. We defined the following Scintigraphic patterns in relationship with the CT: Normal, concordant unilateral (CU) or exclusive; discordant unilateral (DU); concordant asymmetrical (CA) or prevalent; discordant asymmetrical (DA) and nonvisualization (NV). The final diagnosis was obtained with clinical, analytical, and radiological evaluation and in some cases surgery.In Group I, the diagnoses were: 17 adrenal masses without criteria of malignancy or hormonal overproduction (the Scintigraphic patterns were 10 CA, 5 normal and 2 CU), 9 Subclinical Cushing's syndrome (4 CU, 4 CA and 1 normal), 5 adenomas (all CU), 3 adrenal primary carcinomas, with no uptake in the scintigraphy, and 5 were other diagnoses. In group II, 14 patients had benign masses (all patterns were normal or concordant) and 4 patients metastases (3 discordant and 1 NV patterns). The follow-up time was at least one year.The adrenal cortical scintigraphy with I-COL provides us information on the functional status of silent adrenal masses and it is an useful tool to distinguish benign from malignant lesions; for this reason we considered that it must be integrated in the diagnostic algorithm as a complement to other techniques.

The question of when to begin and when to stop therapy with antiepileptic agents is one of the most widely discussed matters among specialists in epilepsy, due to the potential risks of such pharmacological therapy in the long term. In this paper we review the most suitable way of beginning the administration of antiepileptic drugs and the reasons behind such a decision, as well as examining the motives that can lead to their being withdrawn. We pay special attention to the treatment of children and to the information received by parents.The aim of the therapy must be to improve patients' quality of life, and therefore treating the epileptic seizures only makes sense if by doing so an improvement in their quality of life is accomplished.

In this paper we review and bring up to date non-epileptic paroxystic motor disorders, since knowledge of these is necessary to avoid confusion with epileptic crises.Particular attention has been paid to the etiopathogenesis, classification and treatment of tics, including Tourette syndrome. Familial paroxystic choreoathetosis and alterations of movement induced by drugs are considered in the light of new etiopathogenic concepts, such as hyperekplexy, spasmus nutans and Sandifer syndrome. We also mention the clinical aspects of shudders, paroxystic vertigo, continuous muscle activity, transitory cerebral ischemia and masturbation which should be remembered to avoid confusion with epileptic crises.

House dust mites constitute the major etiologic factor causing sensitization and asthma its geographical distribution map is quite well known, although it is not yet complete. Home environments world-wide show mites that mainly belong to the Piroglyphidae family, the D. pteronyssinus specie being the predominant one. However others have also been considered of interest.The aim of this work was to study the species and to determine the levels of Der p I, Der f I and group II of allergens of Dermatophagoides. Present in houses from Tenerife, Canary Islands (Spain).Dust samples were collected in 130 houses.D. pteronyssinus was found in 121 (95.3%) homes, being the predominant species in 113 (89%). In 69 (55%) homes, Dermatophagoides spp. were found together with other species from other generus. Mean values for Der p I were 13.7 +/- 13.88 (mean +/- SD), for Der f 1 1.05 +/- 1.83 and for the Group I of allergens 7 +/- 6.77.Although D. pteronyssinus is the predominant species in our area, there are others that may be off importance and should be taken into consideration in the diagnostic, home disallergenization and later treatment of patients.