Current medical research and opinion
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LBSA0103 is a recently developed high-molecular-weight, cross-linked, non-animal hyaluronic acid (HA). The safety of LBSA0103 has been investigated only in a limited number of patients, therefore this prospective study was designed. This study sought to assess the safety including injection-site reactions and adverse drug reactions after a single intra-articular injection of LBSA0103 in patients with osteoarthritis (OA) of the knee joint. ⋯ A single intra-articular injection of LBSA0103 in patients with OA of the knee joint was safe, and no significant safety concerns were observed. As such, LBSA0103 could be safely applied as an intra-articular injection for the management of knee OA.
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Randomized Controlled Trial
The Efficacy of Cariprazine on Function in Patients With Bipolar Depression: A Post Hoc Analysis of a Randomized Controlled Trial.
Individuals with bipolar depression often experience functional impairment that interferes with recovery. These analyses examined the effects of cariprazine on functional outcomes in patients with bipolar I disorder. ⋯ At week 8, statistically significant improvements in FAST outcomes were observed for cariprazine versus placebo in patients with bipolar I depression; more consistent results were noted for 1.5 mg/d than 3 mg/d. In addition to improving bipolar depression symptoms, these results suggest that cariprazine may improve functional outcomes.
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Randomized Controlled Trial
A Medicine Adoption Model for Assessing the Expected Effects of Additional Real-World Evidence (RWE) at Product Launch.
The optimal launch and adoption of novel medicines require effective navigation of the commercial and regulatory landscape, including three key gatekeeper groups: regulators, payors, and prescribers. Traditionally, despite lacking generalisability, the pharmaceutical industry provides Phase III randomized controlled trial evidence to gatekeepers. Despite additional real-world evidence (RWE) improving the generalisability of evidence, the provision of RWE remains in its infancy. The industry may use a multiple stakeholder approach to RWE generation to address each group's priorities and expectations effectively. ⋯ The proposed model provides an intuitive temporal framework within which subsystem logic can be further researched to identify and address stakeholder groups' needs and weigh those needs. Preliminary results appear to support adopting a multiple stakeholder approach to RWE for augmenting the uptake of novel medicines.
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Observational Study
Costs of minor bleeds in atrial fibrillation patients using a non-vitamin K antagonist oral anticoagulant.
A very common side effect of non-vitamin K antagonist oral anticoagulant (NOAC) is (minor) bleeding. Data about impact and costs of minor bleeds in NOAC therapy is still limited or not present in current literature. In this patient orientated study, we aim to provide an estimate of the costs of minor bleeds in patients with atrial fibrillation (AF) treated with a NOAC. ⋯ Total costs of minor bleeds from a societal perspective, in AF patients using NOACs, are non-trivial and exceed the costs presented in existing literature.