Current medical research and opinion
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Randomized Controlled Trial
Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study.
Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) is a new long-acting injectable antipsychotic formulation for administration every 2 months. A 32-week trial evaluated the safety, tolerability, and pharmacokinetics of Ari 2MRTU 960 in clinically stable adults with schizophrenia or bipolar I disorder (BP-I) (per DSM-5 criteria). This secondary analysis evaluated the safety and efficacy of Ari 2MRTU 960 in the subpopulation of patients with BP-I. ⋯ Ari 2MRTU 960 was well tolerated in patients with BP-I, with efficacy similar to AOM 400.
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Review
A systematic literature review of the economic and healthcare resource burden of cytomegalovirus.
Cytomegalovirus (CMV) can infect individuals at any age, including infants, who may contract it from infected mothers (congenital CMV [cCMV]). Whereas CMV infection is typically asymptomatic or causes mild illness in healthy individuals, infection can result in severe outcomes in immunocompromised individuals and in infants with cCMV. This systematic review aims to characterize the economic impact of CMV and cCMV infections. ⋯ CMV and cCMV infections impose a considerable economic impact on different countries, populations, and outcomes. There are substantial evidence gaps where further research is warranted.
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Review
Patient-reported outcomes validated in Phase 3 clinical trials: a targeted literature review.
Regulatory guidance advises validation of patient-reported outcome (PRO) instruments prior to use in pivotal clinical studies, which may then be used to generate critical patient-centered evidence and support labelling claims. This targeted literature review aimed to determine if PRO instruments psychometrically validated in a phase 3 trial setting could support label claims from the same phase 3 study (i.e. PRO data were generated as an endpoint). ⋯ These results suggest that quantitative validation of novel PRO instruments, and existing PROs for new indications, can occur within the context of phase 3 trials, and these PROs can also support label claims.
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Elevated Lipoprotein(a) [Lp(a)] has not been firmly established as a risk factor for recurrent coronary heart disease (CHD). The present analysis explored this relationship in senior citizens. ⋯ Elevated Lp(a) is an independent and significant predictor of recurrent CHD in senior citizens. Upper reference Lp(a) levels of 500 mg/L (≈125nmol/L) or 300 mg/L (≈75nmol/L) both appear to be appropriate. The clinical benefit of therapy to reduce elevated Lp(a) remains to be confirmed.
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Review Meta Analysis
Meta-analysis and GRADE assessment of randomized controlled trials on the efficacy and safety of bimekizumab in psoriatic arthritis patients.
A persistent immune-mediated inflammatory disorder called psoriatic arthritis affects about 25% of persons with psoriasis. Bimekizumab, a humanized monoclonal IgG1 antibody, is a novel therapeutic approach that inhibits homodimers and heterodimers of IL-17A and IL-17F by binding to comparable locations in these molecules. Bimekizumab was the subject of a meta-analysis to assess its efficacy and safety in psoriatic arthritis patients. ⋯ In comparison to a placebo, bimekizumab treatment significantly improved joint and skin efficacy outcomes. Also, its safety results were acceptable.