Background: Vonoprazan, a novel acid-suppressive drug, is non-inferior to proton pump inhibitors (PPIs) for the management of gastric acid-related diseases. However, the safety of vonoprazan has not been systematically evaluated yet. Objectives: To elucidate the incidence and type of adverse events (AEs) in patients taking vonoprazan. Design: Systematic review and meta-analysis. Data sources and methods: PubMed, EMBASE, and Cochrane Library databases were searched for all studies reporting the safety of vonoprazan. The incidences of any AEs, drug-related AEs, serious AEs, AEs leading to drug discontinuation, and common AEs were pooled. Odds ratios (ORs) were calculated to compare the incidence of AEs between patients taking vonoprazan and PPIs. Results: Seventy-seven studies were included. The pooled incidences of any AEs, drug-related AEs, serious AEs, and AEs leading to drug discontinuation were 20, 7, 1, and 1%, respectively. The incidences of any AEs (OR = 0.96, p = 0.66), drug-related AEs (OR = 1.10, p = 0.44), serious AEs (OR = 1.14, p = 0.36), and AEs leading to drug discontinuation (OR = 1.09, p = 0.55) were not significantly different between patients taking vonoprazan and PPIs. In subgroup analyses, patients with peptic ulcer disease (PUD) had higher incidences of any AEs, serious AEs, and AEs leading to drug discontinuation than those with gastroesophageal reflux disease (GERD), Helicobacter pylori ( H. pylori) infection, and artificial ulcer after gastric endoscopic submucosal dissection (ESD), but patients with H. pylori infection had a higher incidence of drug-related AEs than those with PUD, GERD, and artificial ulcer after gastric ESD. The incidence of AEs was higher in patients taking long-term use of vonoprazan than those taking short-term use of vonoprazan. Conclusion: Vonoprazan is well tolerated and shows similar safety compared to PPIs. The safety of vonoprazan may be primarily influenced by its indications and duration. Registration: PROSPERO CRD42022314982.
Objectives: Surgical site complications (SSC) represent a major problem in Surgery Departments, affecting the management costs of patients and prolonging their hospitalisation, with consequences in terms of wound healing outcomes and perceived quality of life. The study aimed at estimating the budget impact of an innovative portable device for negative pressure wound therapy introduction, compared with the historical situation based on the administration of pharmacological therapies alone, for the prevention of SSC in patients undergoing general, cardiac, ob-gyn or orthopaedic surgical procedures. MethOds: Activity based costing and budget impact analyses were implemented, assuming the Hospital's perspective and estimating the healthcare expenditure changes related to the innovation introduction. 8,566 patients undergoing the surgical procedures in 2015 were investigated considering: the infection risk index, SSC rates, drug therapies, surgical, diagnostic, specialist procedures and haematological exams (evaluated in accordance with the 2015 Italian outpatient hospital admissions Reimbursement Tariffs and NHS official drugs price list). Results: Patients developing SCC absorbed i) 64.27% more of economic resources, considering the length of stay (€ 8,269±2,096 vs € 5,034±2,9010, p< 0.05) and ii) 42.43% more related to haematological and diagnostic procedures (€ 639±117 vs € 449±72, p< 0.05). The innovation could decrease the risk to develop SSC, and hospitals would face a reduction in healthcare expenditure, ranging from a minimum of -0.27% (€ 189,414.95) to a maximum of -1.22% (-€ 860,631.51), with an average saving equal to -0.69% (-€ 483,787.92), depending on the number of patients eligible to the innovation and on the SSC rate. cOnclusiOns: The results provided a significant scientific contribution, demonstrating the importance of prevention strategies for SCC and emphasising: i) the relevance of the entire clinical pathway evaluation of a patient, not considering the "purchasing cost" of a technology in itself, and ii) the need of versatile investment and disinvestment strategies, useful for treating a wider population and reducing waiting lists.
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