[Proportion of patients with heart failure in a specialized clinic eligible for novel therapies]. / Pacientes elegibles para las nuevas terapias de la insuficiencia cardíaca en un policlínico especializado.

BACKGROUND: Pharmacological treatment improves survival in patients with heart failure with reduced ejection fraction. The use of sacubutril/valsartan and ivabradine has been recently approved and incorporated in the latest guidelines. AIM: To identify candidates eligible for these therapies among patients treated in a heart failure clinic, considering the inclusion criteria for the PARADIGM-HF and SHIFT trials. MATERIAL AND METHODS: Cross-sectional study on 158 patients aged 62 ± 11 years (67% male) with heart failure and reduced ejection fraction, with at least three months of follow-up and without decompensation. The percentage of patients complying for the inclusion criteria for the PARADIGM-HF y SHIFT trials was determined. RESULTS: In 37%, the etiology of heart failure was ischemic, 49% were in functional class I, their ejection fraction was 33 ± 11% and their median Pro-brain natriuretic peptide was 800 pg/mL. Ninety five percent were treated with vasodilators, 97% with beta-blockers and 82% with aldosterone antagonists. Using PARADIGM-HF and SHIFT criteria, 11 patients (7%) were eligible for sacubitril / valsartan and 21 patients (13.3%) for ivabradine. Among the main causes of non-eligibility for sacubitril / valsartan were being functional class I (48.7%) and not achieving a stable dose of enalapril ≥ 20 mg / day or losartan ≥ 100 mg / day (24.7%). In the case of ivabradine, apart from those in functional class I, the absence of sinus rhythm and a heart rate < 70 / min when receiving a maximal tolerated dose of beta-blockers, were present in 22%. CONCLUSIONS: A low percentage of our patients were eligible for these therapies. Among the causes that explain these results were clinical stability, a high percentage of patients in functional class I and being in a disease modifying treatment.

Using social media listening and data mining to understand travellers' perspectives on travel disease risks and vaccine-related attitudes and behaviours.

BACKGROUND: Travellers can access online information to research and plan their expeditions/excursions, and seek travel-related health information. We explored German travellers' attitude and behaviour toward vaccination, and their travel-related health information seeking activities. METHODS: We used two approaches: web 'scraping' of comments on German travel-related sites and an online survey. 'Scraping' of travel-related sites was undertaken using keywords/synonyms to identify vaccine- and disease-related posts. The raw unstructured text extracted from online comments was converted to a structured dataset using Natural Language Processing Techniques. Traveller personas were defined using K-means based on the online survey results, with cluster (i.e. persona) descriptions made from the most discriminant features in a distinguished set of observations. The web-scraped profiles were mapped to the personas identified. Travel and vaccine-related behaviours were described for each persona. RESULTS: We identified ~2.6 million comments; ~880 k were unique and mentioned ~280 k unique trips by ~65 k unique profiles. Most comments were on destinations in Europe (37%), Africa (21%), Southeast Asia (12%) and the Middle East (11%). Eight personas were identified: 'middle-class family woman', 'young woman travelling with partner', 'female globe-trotter', 'upper-class active man', 'single male traveller', 'retired traveller', 'young backpacker', and 'visiting friends and relatives'. Purpose of travel was leisure in 82-94% of profiles, except the 'visiting friends and relatives' persona. Malaria and rabies were the most commented diseases with 12.7 k and 6.6 k comments, respectively. The 'middle-class family woman' and the 'upper-class active man' personas were the most active in online conversations regarding endemic disease and vaccine-related topics, representing 40% and 19% of comments, respectively. Vaccination rates were 54%-71% across the traveller personas in the online survey. Reasons for vaccination reluctance included perception of low risk to disease exposure (21%), price (14%), fear of side effects (12%) and number of vaccines (11%). CONCLUSIONS: The information collated on German traveller personas and behaviours toward vaccinations should help guide counselling by healthcare professionals.

One-week intramuscular or intradermal pre-exposure prophylaxis with human diploid cell vaccine or Vero cell rabies vaccine, followed by simulated post-exposure prophylaxis at one year: A phase III, open-label, randomized, controlled trial to assess immunogenicity and safety.

Shorter rabies pre-exposure prophylaxis (PrEP) regimens may offer improved convenience and feasibility over classic 3-week regimens, for example in regions with poor access to vaccines or for travelers to rabies-endemic regions. In this multicenter, open-label, controlled trial, 570 healthy participants aged 2-64 years were randomized to receive: 1-week PrEP (vaccination days [D]0 and 7; Group 1) or classic 3-week PrEP regimen (D0, D7, and D21; Group 2) with one 1.0 mL intramuscular [IM] dose of human diploid cell culture rabies vaccine (HDCV) at each visit; 1-week PrEP with two 0.1 mL intradermal (ID) HDCV doses at each visit (Group 3); or 1-week PrEP with one 0.5 mL IM dose (Group 4) or two 0.1 mL ID doses (Group 5) of Vero cell rabies vaccine (PVRV) at each visit. Participants received simulated post-exposure prophylactic (PEP) vaccination (two IM or ID doses of HDCV or PVRV three days apart) one year later. Rabies virus neutralizing antibody titers and seroconversion (titers ≥ 0.5 IU/mL) rates were assessed 14 days and up to 1 year post-PrEP, and pre- and post-PEP. Safety was assessed throughout the study. Seroconversion rates were high 14 days post-last PrEP injection (ranging from 96.7 % to 97.2 % across groups 1, 3-5; 1-week PrEP) and reached 100 % in Group 2 (3-week PrEP). Non-inferiority of Group 1 versus Group 2 in terms of seroconversion rates 14 days post-last PrEP injection (primary objective) was not demonstrated. After simulated PEP, all groups showed rapid and robust immune responses, with all but one participant achieving seroconversion (titers ≥ 0.5 IU/mL). There were no safety concerns, and the tolerability profiles of the vaccines were similar across the groups. A 1-week, IM or ID PrEP regimen with HDCV or PVRV provided efficacious priming, enabling rapid robust anamnestic responses to simulated PEP 1 year later across age groups. ClinicalTrials.gov number: NCT03700242. WHO Universal Trial Number (UTN): U1111-1183-5743.

Clinical experience with the inactivated hepatitis A vaccine, Avaxim 80U Pediatric.

INTRODUCTION: Hepatitis A, caused by hepatitis A virus (HAV), is primarily transmitted via the fecal/oral route either through ingestion of contaminated food and water or through direct contact with an infectious person. Prevalence of hepatitis A is strongly correlated with socioeconomic factors, decreasing with increased socio-economic development, access to clean water and sanitation. Vaccination against HAV should be part of a comprehensive plan for the prevention and control of viral hepatitis, either as part of regular childhood immunization programs or with other recommended vaccines for travelers. Areas covered: We present here evidence for the immunogenicity and safety of an inactivated HAV pediatric vaccine (Avaxim® 80U Pediatric, Sanofi Pasteur), indicated for use in children aged 12 months to 15 years. Data evaluated are from trials undertaken during the clinical development of this vaccine, a systematic literature review and post-market pharmacovigilance. Expert opinion: The pediatric HAV vaccine is highly immunogenic and generates long-lasting protection against hepatitis A disease in children. The safety and immunogenicity data presented in this review suggest that the pediatric HAV vaccine is a valuable option in the prevention of HAV infection in children in many areas of the world where the disease remains a healthcare issue.

Post-Marketing Surveillance of Hepatitis A Virus Vaccine (Avaxim® 160U) in South Korea from 2011 to 2015.

INTRODUCTION: Hepatitis A, caused by hepatitis A virus (HAV), is one of the leading causes of acute hepatitis in South Korea. Avaxim® 160U is an inactivated hepatitis A vaccine that has been proven to be highly effective and well tolerated. It is licensed for use in more than 90 countries, and was approved for use in South Korea in 2011. Clinical trial and approval processes may not fully assess the safety and efficacy of a vaccine. Post-marketing surveillance (PMS) aims to provide a complete safety profile of a vaccine in a real-life setting. PMS trials are mandatory in South Korea to retain drug licensure. METHODS: This post-marketing observational study (NCT01838070) was conducted over 4 years at 16 centres in South Korea, and aimed to observe and record all types of adverse events (AE) occurring in an adult population after vaccination with Avaxim® 160U. This included solicited events, unsolicited non-serious events, unexpected events and serious events. RESULTS: Case report forms were collected from 614 vaccinees, all of whom completed 30 days of follow-up post-vaccination, of whom 36 (5.9%) experienced 53 solicited and unsolicited AEs, 17 (2.8%) experienced 22 of the solicited AEs, while there were no reports of AEs of severe intensity. A total of 31 unsolicited AEs were reported in 22 patients (3.6%), and no unexpected adverse drug reactions were reported. CONCLUSION: No new safety issues were identified and the safety profile obtained from this study was comparable to that of previous studies for HAV vaccine. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01838070. FUNDING: Sanofi Pasteur.

Botanic gardens are an untapped resource for studying the functional ecology of tropical plants.

Functional traits are increasingly used to understand the ecology of plants and to predict their responses to global changes. Unfortunately, trait data are unavailable for the majority of plant species. The lack of trait data is especially prevalent for hard-to-measure traits and for tropical plant species, potentially owing to the many inherent difficulties of working with species in remote, hyperdiverse rainforest systems. The living collections of botanic gardens provide convenient access to large numbers of tropical plant species and can potentially be used to quickly augment trait databases and advance our understanding of species' responses to climate change. In this review, we quantitatively assess the availability of trait data for tropical versus temperate species, the diversity of species available for sampling in several exemplar tropical botanic gardens and the validity of garden-based leaf and root trait measurements. Our analyses support the contention that the living collections of botanic gardens are a valuable scientific resource that can contribute significantly to research on plant functional ecology and conservation.This article is part of the theme issue 'Biological collections for understanding biodiversity in the Anthropocene'.

Pacientes elegibles para las nuevas terapias de la insuficiencia cardíaca en un policlínico especializado / Proportion of patients with heart failure in a specialized clinic eligible for novel therapies

Background: Pharmacological treatment improves survival in patients with heart failure with reduced ejection fraction. The use of sacubutril/valsartan and ivabradine has been recently approved and incorporated in the latest guidelines. Aim: To identify candidates eligible for these therapies among patients treated in a heart failure clinic, considering the inclusion criteria for the PARADIGM-HF and SHIFT trials. Material and Methods: Cross-sectional study on 158 patients aged 62 ± 11 years (67% male) with heart failure and reduced ejection fraction, with at least three months of follow-up and without decompensation. The percentage of patients complying for the inclusion criteria for the PARADIGM-HF y SHIFT trials was determined. Results: In 37%, the etiology of heart failure was ischemic, 49% were in functional class I, their ejection fraction was 33 ± 11% and their median Pro-brain natriuretic peptide was 800 pg/mL. Ninety five percent were treated with vasodilators, 97% with beta-blockers and 82% with aldosterone antagonists. Using PARADIGM-HF and SHIFT criteria, 11 patients (7%) were eligible for sacubitril / valsartan and 21 patients (13.3%) for ivabradine. Among the main causes of non-eligibility for sacubitril / valsartan were being functional class I (48.7%) and not achieving a stable dose of enalapril ≥ 20 mg / day or losartan ≥ 100 mg / day (24.7%). In the case of ivabradine, apart from those in functional class I, the absence of sinus rhythm and a heart rate < 70 / min when receiving a maximal tolerated dose of beta-blockers, were present in 22%. Conclusions: A low percentage of our patients were eligible for these therapies. Among the causes that explain these results were clinical stability, a high percentage of patients in functional class I and being in a disease modifying treatment.

Calcifilaxis y gabapentina / Calciphylaxis and gabapentin

La calcifilaxis es un trastorno severo, poco frecuente que afecta a los pacientes con insuficiencia renal crónica terminal en diálisis periódica. Es una vasculopatía que se caracteriza por la calcificación dela capa media de las arterias sistémicas, con la consecuente isquemia distal de los tejidos, principalmente piel y tejido subcutáneo, llevando finalmente a la formación de úlceras, necrosis y dolor crónico. El diagnóstico se confirma con histología.Entre los principales factores de riesgo destacan el hiperparatiroidismo secundario, un producto calcio / fósforo elevado (superior a 70), o ambas cosas, entre otros. La Calcifilaxis tiene mal pronóstico, con alta mortalidad en la mayoría de los casos antes de los 10 meses de diagnosticada, siempre por causa séptica.Se presenta el caso de un paciente con Insuficiencia Renal Crónica secundaria a nefropatía hipertensiva, en hemodiálisis, que desarrolló calcifilaxis, y secundario a ésta, dolor intratable. Se utilizaron diversos fármacos para el manejo del dolor, entre ellos antiinflamatorios no esteroidales, derivados de la morfina, antidepresivos tricíclicos y gabapentina. La eficacia del tratamiento fue evaluada mediante Escala Visual Análoga. Los objetivos del trabajo son replantear los valores aceptados de producto calcio / fósforo y la utilidad de gabapentina en el manejo del dolor. Se concluye que las acciones dirigidas contra la calcifilaxis deben estar orientadas principalmente hacia su prevención, manteniendo un producto calcio / fósforo en cifras inferiores a 55. Además la gabapentina parece ser el fármaco con mejores resultados en el manejo del dolor en pacientes con calcifilaxis.