Drugs
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Ocriplasmin (JETREA(®)) is a recombinant human serine protease plasmin with proteolytic activity against the protein components (e.g. laminin, fibronectin and collagen) of the vitreous and vitreoretinal interface, thereby facilitating vitreous liquefaction and separation of vitreous from the retina. Intravitreal ocriplasmin is indicated for the treatment of symptomatic vitreomacular adhesion (USA) and vitreomacular traction including when associated with a macular hole of diameter ≤400 μm in adult patients (EU). The efficacy of ocriplasmin at the recommended dose of a single 125 μg intravitreal injection was demonstrated in two well-designed pivotal phase III trials of virtually identical design (TG-MV-006 and TG-MV-007) in patients with symptomatic vitreomacular adhesion. ⋯ At day 28, the proportion of eyes achieving total posterior vitreous detachment or nonsurgical closure of macular holes was also significantly greater with ocriplasmin than with placebo. Ocriplasmin was generally well tolerated in these trials, with most ocular adverse events being mild in severity and transient in nature. Current evidence suggests that ocriplasmin is a useful treatment option for patients with symptomatic vitreomacular adhesion.
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The inactivated quadrivalent split-virus seasonal influenza vaccine [Fluarix® quadrivalent, manufactured in Dresden (D-QIV)] contains 15 μg haemagglutinin from each of the four influenza virus strains expected to circulate in the upcoming influenza season. Unlike seasonal trivalent influenza vaccines (TIVs), which have been used previously, quadrivalent influenza vaccines (QIVs) contain two influenza A subtype viruses and two B type viruses. As two different B viruses have co-circulated in recent years, incorporating both B lineages reduces the risk of the dominant B strain not being included in the vaccine. ⋯ D-QIV was generally well tolerated in all age groups studied and, overall, reactogenicity and tolerability were generally similar to observations with TIVs. Quadrivalent influenza vaccines are expected to offer substantial cost-effectiveness benefits in seasons where the B lineage selected for inclusion in TIVs does not match the dominant circulating strain. Thus, by incorporating both circulating influenza B lineages, vaccination with D-QIV is likely to reduce the risk of the dominant circulating B type virus not matching the strain selected for the vaccine and, therefore, more effectively protect target populations from influenza than TIVs.
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Most prescribed opioids exert their analgesic effects via activation of central μ-opioid receptors. However, μ-opioid receptors are also located in the gastrointestinal (GI) tract, and activation of these receptors by opioids can lead to GI-related adverse effects, in particular opioid-induced constipation (OIC). OIC has been associated with increased use of healthcare resources, increased healthcare costs, and decreased quality of life for patients. ⋯ In this review, currently available pharmacologic therapies for the treatment and prevention of OIC are summarized briefly, with a primary focus on the administration of the peripheral μ-opioid receptor antagonist methylnaltrexone bromide in patients with OIC and advanced illness who are receiving palliative care. Also, clinical trial data of methylnaltrexone treatment in patients with OIC and other pain conditions (i.e., chronic noncancer pain and pain after orthopedic surgery) are reviewed. Data support that methylnaltrexone is efficacious for the treatment of OIC and has a favorable tolerability profile.
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A fixed-dose combination of sumatriptan/naproxen sodium (Treximet(®)) has been approved in the US for the acute treatment of migraine in adults. In two randomized trials, sumatriptan/naproxen sodium demonstrated significantly better efficacy than sumatriptan alone, naproxen sodium alone, or placebo as late-intervention therapy for a single migraine episode in adults, as assessed by co-primary efficacy endpoints evaluating pain and other migraine-related symptoms, as well as health-related quality of life (HR-QOL) endpoints. In four other randomized trials, the drug combination was also effective as early intervention in adults with migraine (including those with menstrual migraine and dysmenorrhoea, or those with poor response or intolerance to triptan therapy) according to various pain-related primary efficacy and HR-QOL endpoints. ⋯ In clinical trials, sumatriptan/naproxen sodium was generally well tolerated, with an overall tolerability profile similar to that of sumatriptan. The most common adverse events were in line with those expected for sumatriptan and naproxen sodium. Current data indicate that sumatriptan/naproxen sodium is a useful option in the treatment of adult migraine.
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Lenalidomide (Revlimid(®)), a thalidomide analogue, is an orally administered second generation immunomodulator with anti-angiogenic, antineoplastic, anti-inflammatory and pro-erythropoietic properties. It is approved for the treatment of patients with transfusion-dependent anaemia due to International Prognostic Scoring System low- or intermediate-1-risk myelodysplastic syndrome (MDS) associated with either chromosome 5q deletion [del(5q)] with or without additional cytogenetic abnormalities (US, Japan and Switzerland etc.), or with an isolated del(5q) cytogenetic abnormality when other therapeutic options are insufficient or inadequate (EU) [featured indication]. In a randomized, double-blind, multicentre, registrational trial (MDS-004; n = 205) in this patient population, a significantly higher proportion of lenalidomide recipients than placebo recipients achieved red blood cell transfusion independence for ≥26 consecutive weeks (primary endpoint for efficacy) and cytogenetic responses. ⋯ Lenalidomide had a manageable safety profile in the registrational trials, with ≤20 % of patients discontinuing treatment because of adverse events. The most common adverse events (incidence ≥20 %) occurring in lenalidomide recipients were thrombocytopenia and neutropenia, which were generally managed by dosage reductions and/or interruptions, and/or pharmacotherapy. Thus, lenalidomide is a useful option for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk del(5q) MDS, with or without additional cytogenetic abnormalities.