We investigated in ninety Caucasian pediatric patients the impact of the main polymorphisms occurring in CYP3A, CYP2D6, ABCB1 and ABCG2 genes on second-generation antipsychotics plasma concentrations, and their association with the occurrence of adverse drug reactions. Patients with the CA/AA ABCG2 genotype had a statistically significant lower risperidone plasma concentration/dose ratio (Ct/ds) (P-value: 0.007) and an higher estimated marginal probability of developing metabolism and nutrition disorders as compared to the ABCG2 c.421 non-CA/AA genotypes (P-value: 0.008). Multivariate analysis revealed that the ABCG2 c.421 CA/AA genotype was found associated to a higher hazard (P-value: 0.004) of developing adverse drug reactions classified as metabolism and nutrition disorders. The ABCB1 2677TT/3435TT genotype had a statistically significant lower aripiprazole Ct/ds if compared with patients with others ABCB1 genotypes (P-value: 0.026). Information obtained on ABCB1 and ABCG2 gene variants may result useful to tailor treatments with these drugs in Caucasian pediatric patients.
COVID‐19 is a complex disease, and many difficulties are faced today especially in the proper choice of pharmacological treatments. The role of antiviral agents for COVID‐19 is still being investigated and evidence for immunomodulatory and anti‐inflammatory drugs is quite conflicting, whereas the use of corticosteroids is supported by robust evidence. The use of heparins in hospitalized critically ill patients is preferred over other anticoagulants. There are conflicting data on the use of convalescent plasma and vitamin D. According to the World Health Organization (WHO), many vaccines are in Phase III clinical trials, and some of them have already received marketing approval in European countries and in the United States. In conclusion, drug repurposing has represented the main approach recently used in the treatment of patients with COVID‐19. At this moment, analysis of efficacy and safety data of drugs and vaccines used in real‐life context is strongly needed.
Background Allopurinol can induce severe cutaneous adverse reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Aims and Methods We analyzed the Individual Case Safety Reports (ICSRs) sent from January 2001 until April 2019 to the Campania regional Center of Pharmacovigilance (Southern Italy) that reported allopurinol as suspected, with a focus on those reporting at least one serious cutaneous adverse drug reaction (ADR). This study was aimed to describe the main characteristics of all ADRs associated with allopurinol, analyze the proportion of serious cutaneous ADRs of total ICSRs related to allopurinol and to compare the main features (age, sex, seriousness and outcome) of ICSRs that reported serious cutaneous ADRs with those that did not. Results The Campania regional Center of Pharmacovigilance received 108 ICSRs that reported allopurinol as suspected. ADRs occurred more frequently in the elderly (median age: 71 years) and female patients (53.7%). Fifty-seven percent of all ADRs were classified as serious and 58% had a favorable outcome. Fifty-six ICSRs reported at least one serious cutaneous ADR; among these ICSRs, 37 cases of SCARs were found [DRESS syndrome (n = 3; 5.4%), SJS (n = 8; 14.3%) and TEN (n = 26; 46.4%)]. Serious cutaneous ADRs commonly occurred in the elderly (median age: 73 years) and female patients (62.5%). They frequently required hospitalization (75%) and had an unfavorable outcome (46%). No statistically significant differences were found between ICSRs that reported serious cutaneous ADRs and ICSRs that did not report serious cutaneous ADRs except for the seriousness degree "Hospitalization or its prolongation" and the outcome degrees "Unfavorable" and "Favorable". Conclusion This study found that 52% (56/108) of all ICSRs having allopurinol as a suspected drug were serious cutaneous ADRs. Serious cutaneous ADRs associated with allopurinol frequently required hospitalization or prolonged hospitalization, and almost half had an unfavorable outcome.
COVID-19 is a complex disease and many difficulties are faced today especially in the proper choice of pharmacological treatments. The role of antiviral agents for COVID-19 is still being investigated. The evidence for immunomodulatory and anti-inflammatory drugs is quite conflicting, while the use of corticosteroids is supported by robust evidence. The use of heparins in hospitalized critically ill patients is preferred over other anticoagulants. Lastly, conflicting data were found regarding to the use of convalescent plasma and vitamin D. According to data shared by the WHO, many vaccines are under phase 3 clinical trials and some of them already received the marketing approval in EU countries and in the US. In conclusion, drugs repurposing has represented the main approach recently used in the treatment of patients with COVID-19. At this moment, the analysis of efficacy and safety data of drugs and vaccines used in real life context is strongly needed.
Antimicrobial resistance (AMR) represents a major issue in healthcare being correlated to global inappropriate use of antibiotics. The aim of this study was to compare the data on hospital antibiotic consumption in 2020–2021 with those related to 2019 in order to evaluate the impact of the COVID-19 pandemic on antibiotic prescriptions and appropriate use at national level and in the different geographical areas. To estimate the consumption of antibiotics, two indicators were calculated: “number of DDD per 1000 inhabitants per day” and “number of DDD per 100 hospitalisation days”. Consumption data on antibiotics dispensed in public health facilities were based on the Italian “traceability of medicines” information flow. Data on hospitalisation days were extracted from the Italian “hospital discharge form” flow. Pearson correlation analysis was performed between the number of patients hospitalised for COVID-19 and the consumption of antibiotics in public healthcare facilities. During 2020, about 1.7 DDD/1000 inhabitants per day (12.3% of the overall consumption of reimbursed antibiotics) were dispensed exclusively in Italian hospitals (+0.8% compared to 2019). Considering the number of DDD per 100 hospitalisation days, consumption increased by 19.3% in 2020 compared to 2019. Comparing the first semester of 2020 and 2019, a decrease of DDD/1000 inhabitants per day was observed (−1.6%) at national level, with opposite trends in the different geographical areas; an increase in the use of azithromycin and carbapenems was also observed, with a stable consumption of third-generation cephalosporins. The use of antibiotics in the second semester of 2020 compared to the same period of 2019 showed a clear reduction at national level (−8.5%), appreciable to a similar extent in all geographic areas. In the first semester of 2021 compared to the same period of 2020, there was a huge reduction (−31.4%) in consumption at national level. However, the variations were heterogeneous between different geographical areas. To our knowledge, this study represents the most comprehensive analysis performed on antibiotic consumption data in hospital settings in Italy during the COVID-19 pandemic to date. Despite international and national guideline recommendations, a substantial overall increase in antibiotic prescriptions was observed during the COVID-19 pandemic, with variability in terms of geographical distribution and prescription strategies. These findings may be related to the dichotomy between perceived and real significance of guidelines, expert panels, or consensus. Therefore, new approaches or strategies to antimicrobial stewardship should be proposed.
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