Factors such as hypertension and bleeding comorbidities during delivery and management of gestational age of less than 33 weeks were associated with the birth of VLBW newborns. This group of infants also showed higher RR for the occurrence of early neonatal death.

Aims To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. Methods and results Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF. Conclusions Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.

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Rationale:Necrotizing fasciitis is a destructive tissue infection with rapid progression and high mortality. Thus, it is necessary that high-performance dressings be introduced as possibilities of treatment.Patient concerns:Female patient, 44 years of age, admitted to hospital unit complaining of lesion in the gluteal region and drainage of purulent secretion in large quantity followed by necrosis.Diagnoses:The diagnosis of necrotizing fasciitis was carried out with the computerized tomography examination result and its association with the patient's clinical condition.Interventions:Initially, successive debridements were carried out in lower limbs as well as primary dressing with enzymatic debriding action until indication of negative pressure wound therapy, for the period of 2 weeks in the right lower limb and for 5 weeks in the left lower limb, with changes every 72 h. Dressing with saline gauze was used at the end of this therapy until hospital discharge.Outcomes:After the use of negative pressure wound therapy, we observed the presence of granulation tissue, superficialization and reduction of lesion extension. The patient presented good tolerance and absence of complications.Lessons:Negative pressure wound therapy constituted a good option for the treatment of necrotizing fasciitis, despite the scarcity of protocols published on the subject.

Rationale: Teriflunomide is an inhibitor of pyrimidine synthesis available as a first-line treatment for relapsing-remitting multiple sclerosis. Drug-induced liver damage is a relevant problem in clinical practice, representing a frequent cause of treatment discontinuation. This case report describes the occurrence of liver injury, with a 33.7-fold increase in the upper limit of normality of the liver enzyme alanine aminotransferase during treatment with teriflunomide 14 mg. Patient concern: A 44-year-old woman receiving teriflunomide 14 mg for the treatment of multiple sclerosis presented symptoms suggestive of liver dysfunction 54 days after starting treatment. The patient had no history of using disease-modifying therapy, neither previous liver disease nor other comorbidities. Diagnostics: The suggested diagnosis was drug-induced liver injury, classified as hepatocellular. Other possible hepatic and autoimmune etiologies were ruled out. Interventions: Replacement of teriflunomide treatment with glatiramer acetate and follow-up of the disease. Outcomes: Signs and symptoms regressed after treatment with teriflunomide 14 mg was discontinued, with normalization of liver enzyme activity in ∼5 months. The causality assessment of the adverse drug reaction was determined by the Naranjo scaling system, resulting in probable, with a final score of 7. Conclusions: Teriflunomide-induced liver injury in patients with multiple sclerosis is a serious adverse reaction. The report of this case contributes to updating knowledge about the safety aspects of treatment with teriflunomide and planning of monitoring strategies and patient risk management.

Objectives: to evaluate the maternalfetal outcomes of thromboprophylaxis with enoxa parin based on scoring system in women with serum markers for hereditary thrombophilia and previous obstetric complications. Methods: a retrospective study was undertaken based on data collected from clinical records. We included 54 pregnant women with serum markers for hereditary thrombophilia undergoing therapeutic intervention with enoxaparin in the period from November 2009 to December 2013. The initial dose of low molecular weight heparin was guided by a scoring system. The maternalfetal outcomes of previous pregnancies and, subsequently, the treatment were compared using the chisquare (χ2) test with the Yates correction and Fisher's Exact Test; p<0.05 was considered significant. Results: we observed significant reduction in fetal/perinatal deaths (p<0.05) and spontaneous abortions (p<0.001) after intervention. The live births at fullterm delivery (p<0.001) and live births at preterm delivery (p<0.05) increased significantly after intervention. Conclusions: the therapeutic intervention with enoxaparin based on scoring system during pregnancy seems to improve the fetal prognosis.

PURPOSE:To evaluate the effects of exposure of enoxaparin and unfractionated heparin (UFH) in prophylactic and therapeutic doses on the fertility rates of pregnant healthy Wistar rats. METHODS:Enoxaparin and UFH were administered in prophylactic doses 1 mg/Kg/day 72 UI/Kg/day, and in therapeutic doses at 2 mg/kg/day 400UI/Kg/day. The rats were divided into five groups. The number of live and dead foetuses was quantified. The uterine horns were dissected and the presence of early and late reabsorptions (abortions) was determined. A p<0.05 was considered statistically significant. RESULTS:We did not observe statistically significant differences between groups when comparing the average weight of the foetuses and placentas, rate of female VS males, rates of pre-implantation loss (RPL), rates of efficiency implantation (REI), rates of postimplantation loss (RPIL) and rates of foetal viability (RFV). CONCLUSIONS:There was no significant effect on fertility with the use of anticoagulant drugs in pregnant healthy Wistar rats.

ResumoOBJETIVO: Avaliar se a intervenção com heparina de baixo peso molecular (HBPM) -enoxaparina sódica -foi eficaz na melhora dos desfechos perinatais de mulheres com trombofillias com base em sistema de pontuação. MÉTODOS: Estudo prospectivo, não randomizado, não controlado, realizado em um Ambulatório de Gestação de Alto Risco, durante o período de novembro de 2009 a novembro de 2011. Foram incluídas gestantes com diagnóstico e intervenção terapêutica para trombofilias adquiridas e/ou hereditárias na gestação atual. Os dados obstétricos e perinatais das gestantes anteriores à intervenção foram comparados com os desfechos subsequentes à intervenção, sendo analisados estatisticamente através do teste do χ 2 , com correção de Yates, considerando significativos quando p<0,05. A dosagem inicial de HBPM foi norteada por sistema de pontuação, baseado no histórico clínico e gestacional das pacientes, além de exames de rastreamento de trombofilias adquiridas e/ou hereditárias. RESULTADOS: Foram incluídas 84 mulheres grávidas com 175 gestações anteriores ao diagnóstico, das quais 20,0% resultaram em morte fetal ou perinatal, 40,0% resultaram em abortamento, 17,7% desenvolveram pré-eclâmpsia ou eclâmpsia, 10,3% foram partos a termo e 29,7% partos pré-termo. Nas 84 gestações após a intervenção, 6,0% resultaram em morte fetal ou perinatal, 1,2% em abortamento, 4,8% desenvolveram pré-eclâmpsia/eclâmpsia, 22,6% em parto prematuro e 70,2% parto a termo. Observou-se redução significativa na taxa de óbito fetal ou perinatal (p<0,05) e abortos (p<0,0001), e aumento significativo (p<0,05) no número de nascidos vivos após a intervenção. CONCLUSÃO: A intervenção baseada na enoxaparina utilizando um sistema de pontuação em gestantes com trombofilia mostrou-se eficaz na melhora do desfecho perinatal. Abstract PURPOSES:To assess whether an enoxaparin-based intervention using a score system was effective in improving perinatal outcome in women with thrombophilia. METHODS: Study Design: Prospective, not randomized, uncontrolled, performed at a Clinic of High-Risk Pregnancy from November 2009 to November 2011. We included women with a diagnosis and therapeutic intervention for thrombophilia acquired and/or inherited in the current pregnancy. The obstetric and perinatal outcomes of pregnant women before the intervention were compared with outcomes after the intervention, and statistically analyzed using the χ 2 test with Yates correction, considered significant when p<0.05. The initial dose of low-molecular-weight Heparin (LMWH) was guided by a scoring system based on the clinical and gestational history of the patients and screening tests for acquired and/or inherited thrombophilia. RESULTS: We included 84 pregnant women with 175 pregnancies before diagnosis, 20.0% of which resulted in fetal ou perinatal death, 40.0% resulted in abortion, 17.7% developed preeclampsia/eclampsia, 10.3% resulted in full-term births, and 29.7% in premature births. In the 84 pregnancies after intervention, 6.0% resulted in fetal ou perinatal death, 1.2% in ...