Current medical research and opinion
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Randomized Controlled Trial
Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study.
In CAPTAIN, a double-blind, parallel-group, Phase IIIA study, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, symptoms and asthma control versus FF/VI in patients with inadequately controlled asthma. Here, we report efficacy and safety from a Japanese cohort in CAPTAIN. ⋯ FF/UMEC/VI is an effective option with a favorable risk-benefit profile in Japanese patients with uncontrolled moderate or severe asthma on ICS/LABA.
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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.