Lancet neurology
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of arimoclomol for inclusion body myositis: a multicentre, randomised, double-blind, placebo-controlled trial.
Inclusion body myositis is the most common progressive muscle wasting disease in people older than 50 years, with no effective drug treatment. Arimoclomol is an oral co-inducer of the cellular heat shock response that was safe and well-tolerated in a pilot study of inclusion body myositis, reduced key pathological markers of inclusion body myositis in two in-vitro models representing degenerative and inflammatory components of this disease, and improved disease pathology and muscle function in mutant valosin-containing protein mice. In the current study, we aimed to assess the safety, tolerability, and efficacy of arimoclomol in people with inclusion body myositis. ⋯ US Food and Drug Administration Office of Orphan Products Development and Orphazyme.
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Migraine is an evolving, and sometimes lifelong disorder. The prevalence of episodic migraine peaks among individuals aged in their late 30s, implying a tendency for the disorder to remit with increasing age thereafter, whereas chronic migraine is more likely to persist into later life. Diagnosis and treatment of migraine in older adults, defined as individuals aged 60 years or older, is rendered more complex by increasing probabilities of atypical clinical features and comorbidities, with patients' comorbidities sometimes limiting their therapeutic options. ⋯ Long-term longitudinal studies of individuals with migraine would be particularly informative, with the potential not only to suggest new research directions, but also to lead to the identification of novel therapeutic agents. Although several novel migraine medications are becoming available, their effectiveness, tolerability, and safety often remain uncertain in older adults, who have commonly been excluded from the evaluation of these agents in randomised controlled trials, or who constitute only a small proportion of study populations. There is a need to recognise these limitations in the available evidence, and the specific, and often unmet, clinical needs of older adults with migraine, not least because older adults constitute an increasing proportion of populations worldwide.
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About 300 million adults undergo non-cardiac surgery annually. Although, in this setting, the incidence of perioperative stroke is low, the absolute number of patients experiencing a stroke is substantial. Furthermore, most patients with this complication will die or end up with severe disability. ⋯ Evidence shows that traditional stroke risk factors including older age, hypertension, and atrial fibrillation are also associated with perioperative stroke; previous stroke is the strongest risk factor for perioperative stroke. Increasing evidence also suggests the pathogenic role of perioperative events, such as hypotension, new atrial fibrillation, paradoxical embolism, and bleeding. Clinicians involved in perioperative care should be aware of this evidence on prevention strategies to improve patient outcomes after non-cardiac surgery.