Clinical drug investigation
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Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) reduces the incidence of thrombotic events but increases the risk of bleeding, which is associated with a substantial and durable risk of death and could offset the benefits of a reduction in thrombotic events. P2Y12 inhibitor monotherapy after short-term DAPT could be an option to reduce the risk of bleeding. We carried out a meta-analysis comparing P2Y12 inhibitor monotherapy after short-term DAPT with standard-term DAPT in patients undergoing PCI. ⋯ This meta-analysis showed a significantly lowered risk of major bleeding and similar benefits of P2Y12 inhibitor monotherapy after short-term DAPT compared with standard-term DAPT in patients undergoing PCI.
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Schizophrenia is a severe public health problem and one of the top ten causes of disability, affecting about 1.1% of the world's population. Paliperidone is a new atypical antipsychotic used to treat schizophrenia. Several case reports about unexpected adverse drug reactions of paliperidone have been consistently reported around the world. The purpose of this study was to detect signals of adverse events (AEs) after paliperidone treatment using the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System database (KIDS-KD). ⋯ We detected new AE signals of paliperidone that were not listed on the drug labels of six countries, and many that were related to psychotic symptoms, metabolic problems, and endocrine disorders.
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Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines. ⋯ Our study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.
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Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine. ⋯ Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.
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Comparative Study
An Economic Evaluation of Pembrolizumab Versus Other Adjuvant Treatment Strategies for Resected High-Risk Stage III Melanoma in the USA.
Over the past 5 years, adjuvant treatment options for surgically resected stage III melanoma have expanded with the introduction of several novel immune checkpoint inhibitors and targeted therapies. Pembrolizumab, a programmed cell death protein 1 inhibitor, received US Food and Drug Administration approval in 2019 for resected high-risk stage III melanoma based on significantly longer recurrence-free survival versus placebo. This study evaluated the cost-effectiveness of pembrolizumab versus other adjuvant treatment strategies for resected high-risk stage III melanoma from a US health system perspective. ⋯ As adjuvant treatment for resected stage III melanoma, pembrolizumab was found to be dominant and therefore cost-effective compared with the active comparators ipilimumab and dabrafenib + trametinib. Pembrolizumab increased costs relative to observation in the overall population, with sufficient incremental benefit to be considered cost-effective based on typical willingness-to-pay thresholds.