La implementación de la profilaxis preexposición podría evitar la mayoría de las nuevas infecciones por el VIH en hombres que tienen sexo con hombres y mujeres transexuales / Implementing pre-exposure prophylaxis could prevent most new HIV infections in transsexual women and men who have sex with men

Introducción: La profilaxis preexposición (PrEP) consiste en administrar fármacos antirretrovirales a personas seronegativas para el VIH con prácticas de alto riesgo, con el fin de reducir la probabilidad de adquirir la infección. A pesar de su eficacia y seguridad, en España, la PrEP aún no está disponible dentro del sistema sanitario público. El objetivo fue estimar el impacto preventivo que supondría añadir la PrEP junto al resto de medidas preventivas. Se estimó el número de seroconversiones al VIH que se hubieran podido evitar, entre los hombres que tienen sexo con hombres y mujeres transgénero inicialmente seronegativos, en caso de disponer de la PrEP. Métodos: Estudio descriptivo de los seroconvertidores recientes al VIH entre 2014-2016 en una clínica de VIH/ITS de referencia en Madrid. Se analizaron a las personas que tenían indicación de recibir la PrEP, según las guías de Grupo de Estudio del Sida 2016. El análisis estadístico para estimar las infecciones por el VIH que se hubieran podido evitar, en caso de disponer de la PrEP, se efectuó mediante Stata 14. Resultados: Se estimó que de los 228 hombres que tienen sexo con hombres y mujeres transgénero, con seroconversión documentada al VIH, 195 tenían la indicación de PrEP. Teniendo en cuenta la eficacia preventiva descrita en estudios europeos, se estimó que se hubieran podido evitar 168 seroconversiones al VIH, lo que supone el 73,7% de las infecciones diagnosticadas. Conclusiones: Los resultados confirman la necesidad de impulsar programas preventivos combinados frente al VIH que integren todas las medidas posibles incluyendo la PrEP

Background: Pre-exposure prophylaxis (PrEP) consists of administering antiretroviral drugs to HIV-seronegative individuals who engage in high-risk practices, with the aim of reducing the probability of acquiring the infection. Despite its safety and efficacy, PrEP is still not available within Spain's public healthcare system. The aim of this study was to estimate the preventive impact of adding PrEP to the other preventive measures. We estimated the number of HIV seroconversions that could have been prevented (if PrEP had been available) among initially seronegative transsexual women and men who have sex with men. Methods: We conducted a descriptive study of recent HIV seroconverters between 2014-2016 in a reference HIV/sexually transmitted infection clinic in Madrid. We analysed the individuals who were indicated PrEP, according to the guidelines of the 2016 AIDS Study Group. The statistical analysis to estimate the HIV infections that could have been prevented (if PrEP had been available) was conducted using Stata 14. Results: We estimated that 195 of the 228 men who have sex with men and transsexual women, with documented HIV seroconversion, were indicated for PrEP. Considering the preventive efficacy reported in European studies, we estimated that 168 HIV seroconversions could have been prevented, which represents 73.7% of the diagnosed infections. Conclusions: The results confirm the need to promote combined preventive programs against HIV that integrate all possible measures, including PrEP

[Hepatitis C: New diagnosis and seroconversions in a Madrid sexually transmitted diseases clinic]. / Hepatitis C: nuevos diagnósticos y seroconversiones en una clínica de infecciones de transmisión sexual en Madrid.

OBJECTIVE: The aim of this study was to evaluate the incidence of new hepatitis C virus (HCV) infections, based on their sexual orientation, human immunodeficiency virus (HIV) status, geographical regions and coinfection with other sexually transmitted diseases (STDs). METHODS: This study was carried out at the Sandoval Health Center, reference clinic of Sexually Transmitted Diseases (STDs) in Madrid. All HCV seronegative individuals who were reanalyzed for this virus were included, between January 2010 and December 2016. RESULTS: A total of 59 new diagnoses of HCV were diagnosed. The proportion of men who have sex with men (MSM) diagnosed with HCV was 37% in 2010 and 75% in 2016 and was even higher in the group of coinfected with HIV/HCV (94%). A total of 67 seroconverters for HCV were detected (1.2%) of which 100% were MSM. The proportion of HCV seroconverters with HIV was 89%. CONCLUSIONS: HCV infection continues to be a current health problem, especially in HIV-positive MSM.

Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor-positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.

BACKGROUND: Randomised trials comparing the efficacy of standard endocrine therapy (ET) versus experimental ET + bevacizumab (Bev) in 1st line hormone receptor-positive patients with metastatic breast cancer have thus far shown conflicting results. PATIENTS AND METHODS: We pooled data from two similar phase III randomised trials of ET ± Bev (LEA and Cancer and Leukemia Group B 40503) to increase precision in estimating treatment effect. Primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety. Exploratory analyses were performed within subgroups defined by patients with recurrent disease, de novo disease, prior endocrine sensitivity or resistance and reported grades III-IV hypertension and proteinuria. RESULTS: The pooled sample consisted of 749 patients randomised to ET or ET + Bev. Median PFS was 14.3 months for ET versus 19 months for ET + Bev (unadjusted hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.66-0.91; p < 0.01). ORR and CBR with ET and ET + Bev were 40 versus 61% (p < 0.01) and 64 versus 77% (p < 0.01), respectively. There was no difference in OS (HR 0.96; 95% CI 0.77-1.18; p = 0.68). PFS was superior for ET + Bev for endocrine-sensitive patients (HR 0.68; 95% CI 0.53-0.89; p = 0.004). Grade III-IV hypertension (2.2 versus 20.1%), proteinuria (0 versus 9.3%), cardiovascular (0.5 versus 4.2%) and liver events (0 versus 2.9%) were significantly higher for ET + Bev (all p < 0.01). Hypertension and proteinuria were not predictors of efficacy (interaction test p = 0.33). CONCLUSION: The addition of Bev to ET increased PFS overall and in endocrine-sensitive patients but not OS at the expense of significant additional toxicity. TRIALS REGISTRATION: ClinicalTrial.Gov NCT00545077 and NCT00601900.

Implementing pre-exposure prophylaxis could prevent most new HIV infections in transsexual women and men who have sex with men. / La implementación de la profilaxis preexposición podría evitar la mayoría de las nuevas infecciones por el VIH en hombres que tienen sexo con hombres y mujeres transexuales.

BACKGROUND: Pre-exposure prophylaxis (PrEP) consists of administering antiretroviral drugs to HIV-seronegative individuals who engage in high-risk practices, with the aim of reducing the probability of acquiring the infection. Despite its safety and efficacy, PrEP is still not available within Spain's public healthcare system. The aim of this study was to estimate the preventive impact of adding PrEP to the other preventive measures. We estimated the number of HIV seroconversions that could have been prevented (if PrEP had been available) among initially seronegative transsexual women and men who have sex with men. METHODS: We conducted a descriptive study of recent HIV seroconverters between 2014-2016 in a reference HIV/sexually transmitted infection clinic in Madrid. We analysed the individuals who were indicated PrEP, according to the guidelines of the 2016 AIDS Study Group. The statistical analysis to estimate the HIV infections that could have been prevented (if PrEP had been available) was conducted using Stata 14. RESULTS: We estimated that 195 of the 228 men who have sex with men and transsexual women, with documented HIV seroconversion, were indicated for PrEP. Considering the preventive efficacy reported in European studies, we estimated that 168 HIV seroconversions could have been prevented, which represents 73.7% of the diagnosed infections. CONCLUSIONS: The results confirm the need to promote combined preventive programs against HIV that integrate all possible measures, including PrEP.

Motivo de consulta: pérdida de peso / Reason for consultation: Weight loss

Antecedentes y objetivo: La pérdida de peso es un motivo frecuente de consulta que abarca múltiples posibilidades diagnósticas. El objetivo de este trabajo es estudiar las características de los pacientes que acuden a consulta por pérdida de peso y establecer la relación de esta con las neoplasias. Método: Se analizaron datos demográficos, pérdida de peso cuantificada, sintomatología acompañante y diagnóstico de los pacientes que acuden a consulta por este motivo, durante el año 2015. Resultados: Se incluyeron 226 pacientes, de los cuales el 44,2% presentaba una pérdida de peso≥5% en los 6 meses previos. El diagnóstico más frecuente en este grupo fueron las neoplasias, mientras que en el resto de los pacientes fueron las enfermedades digestivas. Se establece relación entre una pérdida de peso≥5% y la presencia de neoplasias. Conclusión: Una pérdida de peso superior al 5% en los 6 meses previos se asocia con la presencia de enfermedades neoplásicas, lo que exige un estudio diagnóstico exhaustivo

Background and objective: Unintentional weight loss is frequent reason to visit a doctor and it has multiple diagnostic possibilities. The objective of this study is to examine the background of the patients who seek consultation for weight loss and to establish the relationship between weight loss and neoplasia. Method: An analysis was performed on the demographic data, quantified weight loss, accompanying symptomatology, and diagnosis of patients who sought medical advice for unintentional weight loss during the year 2015. Results: A total of 226 patients were included, of whom 44.2% of them had an intentional weight loss ≥ 5% in 6 months. The most frequent diagnosis in this group was a neoplasia, whereas in the rest of patients the most common diagnosis was a gastrointestinal disease. In light of this study we can conclude that there is a relationship between unintentional weight loss≥5% and the presence of neoplasia. Conclusion: An unintentional weight loss greater than 5% in the previous 6 months is associated with the presence of neoplastic diseases, and therefore requires further diagnostic study

[Reason for consultation: Weight loss]. / Motivo de consulta: pérdida de peso.

BACKGROUND AND OBJECTIVE: Unintentional weight loss is frequent reason to visit a doctor and it has multiple diagnostic possibilities. The objective of this study is to examine the background of the patients who seek consultation for weight loss and to establish the relationship between weight loss and neoplasia. METHOD: An analysis was performed on the demographic data, quantified weight loss, accompanying symptomatology, and diagnosis of patients who sought medical advice for unintentional weight loss during the year 2015. RESULTS: A total of 226 patients were included, of whom 44.2% of them had an intentional weight loss ≥ 5% in 6 months. The most frequent diagnosis in this group was a neoplasia, whereas in the rest of patients the most common diagnosis was a gastrointestinal disease. In light of this study we can conclude that there is a relationship between unintentional weight loss≥5% and the presence of neoplasia. CONCLUSION: An unintentional weight loss greater than 5% in the previous 6 months is associated with the presence of neoplastic diseases, and therefore requires further diagnostic study.

Síndrome antisintetasa / Anti-synthetase syndrome

No disponible

Metástasis cutánea y cáncer de pulmón / Cutaneous metastasis and lung cancer

No disponible

Reflexiones sobre el infradiagnóstico y la primoinfección por VIH / Reflections on underdiagnosis and primary HIV infection

No disponible

Diferencias entre las recomendaciones y la práctica clínica en la infección por Clostridium difficile / Identifying gaps between guidelines and clinical practice in Clostridium difficile infection

Objetivos. Primero, valorar la adherencia a las recomendaciones de la guía de práctica clínica de manejo de la infección por Clostridium difficile de las sociedades americanas de enfermedades infecciosas y epidemiología de 2010 y evaluar su influencia en la evolución de los pacientes. Segundo, identificar las recomendaciones no aplicadas en la práctica para su posterior implementación. Material y métodos. Estudio retrospectivo, descriptivo, de pacientes con síntomas clínicos compatibles y positividad para toxinas A y/o B de C. difficile en heces, en un servicio de medicina interna de un hospital de tercer nivel, en un período de 36 meses. Se recogieron datos clínicos, demográficos, evolutivos, factores de riesgo y la adherencia a las recomendaciones de la guía de práctica clínica. Resultados. Se identificaron 77 pacientes con infección por C. difficile (87 episodios). La estratificación por gravedad mostró un 49,3% de pacientes leves-moderados, 35,1% graves y 15,6% graves-complicados. La adherencia completa a las recomendaciones terapéuticas se observó en 40,2% de pacientes y fue significativamente mejor en los leves-moderados (71,0%), que en los graves (7,4%) o graves complicados (16,6%) (p < 0,003). La adherencia se asoció significativamente a una mayor probabilidad de curación (57% vs 42%) y menor de recurrencia (22,2% vs 77,7%) y mortalidad (25% vs 75%) (p < 0,01). Las recomendaciones no implementadas fueron la estratificación de la gravedad de los pacientes y la adecuación del tratamiento antibiótico a la categoría de gravedad clínica. Conclusiones. La adherencia a las recomendaciones terapéuticas de las guías es baja, especialmente en pacientes graves y graves complicados, asociándose a un peor curso evolutivo. Se precisan intervenciones educacionales para mejorar su aplicación (AU)

Objectives. The first aim was to determine whether patients are being treated in accordance with the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America (IDSA/SHEA) Clostridium difficile guidelines and whether adherence impacts patient outcomes. The second aim was to identify specific action items in the guidelines that are not being translated into clinical practice, for their subsequent implementation. Material and methods. A retrospective, descriptive study was conducted over a 36 month period, on patients with compatible clinical symptoms and positive test for C. difficile toxins A and/or B in stool samples, in an internal medicine department of a tertiary medical centre. Patient demographic and clinical data (outcomes, comorbidity, risk factors) and compliance with guidelines, were examined. Results. A total of 77 patients with C. difficile infection were identified (87 episodes). Stratified by disease severity criteria, 49.3% of patients were mild-moderate, 35.1% severe, and 15.6% severe-complicated. Full adherence with the guidelines was observed in only 40.2% of patients, and was significantly better for mild-moderate (71.0%), than in severe (7.4%) or severe-complicated patients (16.6%) (P < .003). Adherence was significantly associated with clinical cure (57% vs 42%), fewer recurrences (22.2% vs 77.7%), and mortality (25% vs 75%) (P < .01). The stratification of severity of the episode, and the adequacy of antibiotic to clinical severity, need improvement. Conclusions. Overall adherence with the guidelines for management of Clostridium difficile infection was poor, especially in severe and severe-complicated patients, being associated with worse clinical outcomes. Educational interventions aimed at improving guideline adherence are warranted (AU)

Neuralgia del nervio laríngeo superior: a propósito de un caso de difícil control / Refractory neuralgia of the superior laryngeal nerve: A case study

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[Identifying gaps between guidelines and clinical practice in Clostridium difficile infection]. / Diferencias entre las recomendaciones y la práctica clínica en la infección por Clostridium difficile.

OBJECTIVES: The first aim was to determine whether patients are being treated in accordance with the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America (IDSA/SHEA) Clostridium difficile guidelines and whether adherence impacts patient outcomes. The second aim was to identify specific action items in the guidelines that are not being translated into clinical practice, for their subsequent implementation. MATERIAL AND METHODS: A retrospective, descriptive study was conducted over a 36 month period, on patients with compatible clinical symptoms and positive test for C. difficile toxins A and/or B in stool samples, in an internal medicine department of a tertiary medical centre. Patient demographic and clinical data (outcomes, comorbidity, risk factors) and compliance with guidelines, were examined RESULTS: A total of 77 patients with C. difficile infection were identified (87 episodes). Stratified by disease severity criteria, 49.3% of patients were mild-moderate, 35.1% severe, and 15.6% severe-complicated. Full adherence with the guidelines was observed in only 40.2% of patients, and was significantly better for mild-moderate (71.0%), than in severe (7.4%) or severe-complicated patients (16.6%) (P<.003). Adherence was significantly associated with clinical cure (57% vs 42%), fewer recurrences (22.2% vs 77.7%), and mortality (25% vs 75%) (P<.01). The stratification of severity of the episode, and the adequacy of antibiotic to clinical severity, need improvement. CONCLUSIONS: Overall adherence with the guidelines for management of Clostridium difficile infection was poor, especially in severe and severe-complicated patients, being associated with worse clinical outcomes. Educational interventions aimed at improving guideline adherence are warranted.

Síndrome de piernas inquietas e hipotiroidismo / Restless legs syndrome and hypothyroidism

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Monitorización ambulatoria de la presión arterial y actividad física en pacientes hipertensos / Ambulatory blood pressure monitoring and physical activity in hypertensive patients. Circadian pattern and physical activity

Objetivo: Analizar la relación entre el patrón circadiano de la presión arterial ambulatoria de 24h y la actividad física habitual en sujetos hipertensos. Material y métodos: Estudio transversal en el que se incluyeron 552 pacientes hipertensos del estudio EVIDENT (edad media 61 ± 55 años; 49,5% mujeres). La presión arterial ambulatoria se valoró con un tonómetro radial (dispositivo-B pro) y la actividad física se evaluó con un acelerómetro Actigraph GT3X (counts/minuto) durante 7días. Resultados: Los pacientes con patrón circadiano dipper realizaban mayor actividad física habitual que los no dipper. Las medidas de la actividad física (counts/minuto) presentaron correlación negativa con el ratio noche/día de las presiones arteriales sistólica y diastólica (ρ = -0,227 y ρ = -0,205; p < 0,001), respectivamente. Esta asociación se mantuvo en la regresión lineal múltiple después de ajustar por factores de confusión (β = -0,016; p < 0,001). En la regresión logística, considerando el patrón circadiano como variable dependiente (1: dipper; 0: no dipper), la odds ratio del tercer tertil de counts/minuto respecto del primero fue de 2,80 (IC95%: 1,73-4,51; p < 0,001) después de ajustar por las variables de confusión. Conclusiones: La actividad física evaluada con acelerómetro se asoció con un mayor descenso nocturno de la presión arterial y, en consecuencia, un menor ratio noche/día de la presión arterial sistólica y diastólica en sujetos hipertensos

Objective; To analyze the relationship between the circadian pattern of 24hour ambulatory blood pressure and regular physical activity in hypertensive patients. Material and methods: A cross-sectional study that included 552 hypertensive patients from EVIDENT study (mean age 61 ± 55 years, 49.5% women) was performed. Ambulatory blood pressure was measured with a radial tonometer (pro-B device) and physical activity was assessed with an accelerometer Actigraph GT3X (counts/min) for 7 days. Results: Patients with dipper circadian pattern performed more regular physical activity than non-dipper patients. The measures of physical activity (counts/min) showed negative correlation with the night/day systolic and diastolic blood pressures ratio (ρ = -.227 and ρ = -.205, P < .001), respectively. This association remained in the multiple linear regression after adjusting for confounders (β = -.016, P < .001). In the logistic regression, considering the circadian pattern as the dependent variable (1: dipper, 0: no dipper), the odds ratio for third tertile of counts/minute, compared to the first one was 2.80 (95% CI: 1.73-4.51, P < .001) after adjusting for confounding variables. Conclusions: Physical activity assessed by accelerometer was associated with increased nocturnal blood pressure and, consequently, a lower night/day systolic and diastolic blood pressure ratio in hypertensive patients

Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study).

INTRODUCTION: Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer. METHODS: Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method). RESULTS: The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ∼100%. The pathologic complete response was 50%. CONCLUSIONS: The combination allows the delivery of full-dose intensity, while efficacy seems promising.