Current medical research and opinion
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Soft-tissue sarcomas (STSs) are rare malignant tumors arising from tissues of mesenchymal origin throughout the body with poor prognosis in advanced disease. This commentary describes the current treatment landscape for patients with advanced STS undergoing chemotherapy as well as how pazopanib, a newer multitargeted tyrosine kinase inhibitor, has been incorporated into treatment for different subtypes of STS in our clinical practice. ⋯ Use of pazopanib increases the treatment options available to control advanced STS, with management of adverse events through close monitoring, patient education and treatment as necessary.
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This study was designed to understand the level of familiarity of US rheumatologists, gastroenterologists and dermatologists with biosimilar therapies, their experience with non-medical switching (switching medications for reasons unrelated to patient health) of patients between biologics and their attitudes towards switching from a biologic to a biosimilar. ⋯ The majority of physicians had concerns regarding non-medical switching to biosimilars and the impact such switching would have on patient care and physician practice.
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The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)-licensed reference product. FDA released the draft guidance for industry on Demonstrating Interchangeability with a Reference Product (hereafter referred to as the Draft Interchangeability Guidance) in January 2017. ⋯ Here we discuss interchangeability, as well as substitution of biological products, with a focus on the US. Additionally, the separate topic of physician-mediated switching is covered and distinguished from interchangeability and substitution.
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Case Reports
Management of a patient with heart failure by sacubitril/valsartan: improvement of functional capacity.
The main objectives of the treatment of heart failure (HF) are to improve patient clinical status, functional capacity and quality of life, as well as reducing re-hospitalization rate and mortality. A new compound, consisting of an angiotensin-receptor blocker (ARB) (valsartan) and a neprilysin (NEP) inhibitor (sacubitril), belonging to the newly established class of angiotensin receptor-neprilysin inhibitors (ARNIs) showed marked efficacy, without any relevant safety issue, in the treatment of patients with HF. ⋯ Therapy with sacubitril/valsartan was initiated after some years of other treatments, which did not lead to any positive outcome in HF, quality of life and clinical functions. After only 1 month of sacubitril/valsartan therapy, the patient reported a significant improvement in quality of life, and in 6 months his NYHA class switched from III to I.
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We evaluated the role of sacubitril/valsartan in heart rate variability, T-peak to T-end index, external cell mass, internal cell mass and total body water in elderly patients with heart failure with reduced ejection fraction (HFrEF). ⋯ Based on our preliminary results, sacubitril/valsartan could be a new effective approach in the treatment of elderly patients with chronic HFrEF. However, further studies are necessary to confirm these preliminary findings.