Frailty is a strong predictor of adverse post-implantation outcome in patients with non-ischaemic cardiomyopathy undergoing CRT-D.

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Background There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). Methods and results TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analyzed according to the intention-to-treat principle. Conclusion The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.

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A double-blind, placebo-controlled trial was carried out to assess the effectiveness of a new synthetic bioflavonoid, hidrosmin, in patients with chronic venous insufficiency of the lower limbs. Fifty-seven patients, showing varicose veins and ankle swelling and suffering from local pain and heaviness of the legs, were allocated at random to receive treatment for 45 days with 1 capsule 3-times daily of either 200 mg hidrosmin (30 patients) or placebo (27 patients). Pain and heavy legs were assessed using rating scales; swelling was assessed by a photographic method. The results showed that hidrosmin produced a significant clinical improvement in all of the parameters evaluated; compared with placebo, there was a marked reduction in the main subjective symptoms accompanied by a 10% reduction in swelling. Apart from 1 patient who complained of epigastric pain, there were no reports of adverse events during the study period.

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Certolizumab pegol is a new anti-TNF drug formed by the Fab' fragment of a humanized mouse monoclonal antibody bound to two molecules of polyethylene glycol. Certolizumab pegol recognizes and binds to human TNF-α, both in its soluble and membrane bound form, and has shown clinical efficacy in controlled trials for the treatment of RA and Crohns' disease. In this review we summarize the structural characteristics and clinical efficacy data, as well as safety data of this anti-TNF agent in patients with RA.

BackgroundFingolimod (Gilenya) is an immunomodulator which alters the immune system to reduce inflammation. It has been shown to benefit patients with relapsing forms of multiple sclerosis (MS). Progressive multifocal leukoencephalopathy (PML) is a serious brain infection caused by the John Cunningham (JC) virus.In August 2015, the US Food and Drug Administration (FDA) announced that a case of definite PML and a case of probable PML had been reported in MS patients taking fingolimod. One of these two cases is described here. It was reported to our reference pharmacovigilance centre and then to the US FDA.PurposeTo report a case of PML associated with fingolimod use.Material and methodsThe patient was a 54-year-old man diagnosed with MS in 2002 and treated with interferon beta-1b. In 2012, after neurological evaluation, he began a secondline of treatment with fingolimod 0.5 mg/24 h. He was also taking mesalazine and pitavastatine for ulcerative colitis; none of these drugs are linked to PML. In 2015, the patient was hospitalised with suspected PML after developing new symptoms, including gait instability, clumsiness, inattention, somnolence and mental sluggishness. Fingolimod was discontinued.ResultsHe was diagnosed with PML based on symptoms, MRI findings and positive JC virus test in CSF. Mefloquine, mirtazapine and cidofovir/probenecib were prescribed to treat PML.ConclusionThis is one of very few cases of PML reported worldwide in patients taking fingolimod with no prior exposure to an immunosuppressant drug for MS or any other medical condition. However, no definitive causal relation between  fingolimod and PML has been established. It was classified as conditional using the Karsch-Lasagna algorithm.No conflict of interest.