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1.
J Infect Chemother ; 29(1): 67-71, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36162643

RESUMO

INTRODUCTION: BK virus associated hemorrhagic cystitis(BKV-AHC) is a serious complication observed after allogeneic stem cell transplantation and the current therapeutic options are scarce with substantial renal side effects. Although the guidelines recommend intravenous cidofovir application with caution to nephrotoxicity, there are few studies which investigated intravesical administration and reported similar therapeutic results with less renal side effects. METHODS: We administered low dose, daily and consecutive (75 mg/day, for 5 days) intravesical cidofovir to 25 patients with BKV-AHC that developed after (ASCT). RESULTS: The response rate in our cohort was 92% and relapse was not encountered in 84% of the patient population during one year of follow-up. The median BK urine viral load significantly decreased from 260,000,000 IU/mL to 53,000,000 IU/mL after a week of treatment (p = 0.0001). Rise in serum creatinine was observed in 5 patients during treatment and post-treatment nephrotoxicity was seen in only 1 patient. CONCLUSIONS: Daily low dose intravesical cidofovir might be an effective treatment option for BKV-AHC after ASCT with favorable less systemic side effects.


Assuntos
Vírus BK , Cistite , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Transplante de Células-Tronco Hematopoéticas , Organofosfonatos , Infecções por Polyomavirus , Insuficiência Renal , Infecções Tumorais por Vírus , Humanos , Cidofovir/uso terapêutico , Cidofovir/farmacologia , Infecções por Polyomavirus/tratamento farmacológico , Infecções Tumorais por Vírus/tratamento farmacológico , Organofosfonatos/efeitos adversos , Citosina/efeitos adversos , Antivirais/efeitos adversos , Cistite/tratamento farmacológico , Cistite/etiologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/métodos , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Insuficiência Renal/etiologia
2.
Sci Total Environ ; 857(Pt 2): 159501, 2023 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-36265616

RESUMO

Human diseases and health concerns caused by environmental pollutants are globally emerging. Therefore, rapid and efficient evaluation of the effects of environmental pollutants on human health is essential. Due to the significant differences between humans and animals and the lack of physiologically related environments, animal models and two-dimensional (2D) culture cannot accurately describe toxicological effects and predict actual in vivo responses. To make up for the limitations of traditional environmental toxicology screening, three-dimensional (3D) culture has been developed. The 3D culture could provide a good organizational structure comparable to the complex internal environment of humans and produce a more realistic response to environmental pollutants, which has been used in drug development, toxicity evaluation, personalized therapy and biological mechanism research. The goal of environmental toxicology is to provide clues and support for the risk assessment and management of environmental pollutants. With the development of 3D culture that can reproduce specific physiological aspects loaded with specific cells that reflect human biology, interactions between pollutants and target tissues and organs can be explored to assess the acute and chronic adverse health effects of exposure to various environmental toxins. The 3D culture with great potential shows broad prospects in toxicology research and is expected to bridge the gap between 2D culture and animal models eventually. In this sense, we strongly recommend that 3D culture be used to identify and understand environmental toxins, which will greatly facilitate the public's comprehensive understanding of environmental toxins.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Poluentes Ambientais , Animais , Humanos , Ecotoxicologia , Técnicas de Cultura de Células em Três Dimensões , Modelos Animais , Poluentes Ambientais/toxicidade
3.
Ann Pharmacother ; 57(1): 36-43, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35587124

RESUMO

BACKGROUND: Acetaminophen overdose is a leading cause of liver failure, and a leading cause of pediatric poisoning requiring hospital admission. The antidote, N-acetylcysteine (NAC), is traditionally administered as a three-bag intravenous infusion. Despite its efficacy, NAC is associated with high incidence of nonallergic anaphylactoid reactions (NAARs). Adult evidence demonstrates that alternative dosing regimens decrease NAARs and medication errors (MEs). OBJECTIVES: To compare NAARs and MEs associated with two- versus three-bag NAC for acetaminophen overdose in a pediatric population. METHODS: This is a retrospective observational cohort study comparing pediatric patients who received three- versus two-bag NAC for acetaminophen toxicity. The primary outcome was incidence of NAARs. Secondary outcomes were rates of MEs and relevant hospital outcomes (length of stay [LOS], intensive care unit (ICU) admission, liver transplant, death). RESULTS: Two hundred forty-three patients met inclusion criteria (median age of 15 years): 150 (62%) three-bag NAC and 93 (38%) two-bag NAC. There was no difference in overall NAARs (p = 0.54). Fewer cutaneous NAARs were observed in the two-bag group, three-bag: 15 (10%), two-bag: 2 (2%), p = 0.02. MEs were significantly decreased with the two-bag regimen, three-bag: 59 (39%), two-bag: 21 (23%), p = 0.01. No statistical differences were observed in LOS, ICU admissions, transplant, or death. CONCLUSION AND RELEVANCE: A significant decrease in cutaneous NAARs and MEs was observed in pediatric patients by combining the first two bags of the traditional three-bag NAC regimen. In pediatric populations, a two-bag NAC regimen for acetaminophen overdose may improve medication tolerance and safety.


Assuntos
Analgésicos não Narcóticos , Overdose de Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adulto , Criança , Humanos , Adolescente , Acetilcisteína/uso terapêutico , Acetaminofen/uso terapêutico , Antídotos/uso terapêutico , Estudos de Coortes , Overdose de Drogas/tratamento farmacológico , Estudos Retrospectivos , Analgésicos não Narcóticos/uso terapêutico
4.
BMC Health Serv Res ; 22(1): 424, 2022 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-35361211

RESUMO

BACKGROUND: The "4 + 7" volume-based procurement is a "large group purchase" led by the Chinese government, with the aim of reducing the price of medicines by trading volume for price. Although the "4 + 7" drugs had passed the national consistency evaluation, the adverse drug reactions need to be further evaluated to ensure the safety of the "4 + 7" drugs with low prices. We aimed to analyze the occurrence characteristics and related influencing factors of adverse reactions of psychiatric drugs under the chinese drug volume-based procurement policy(4 + 7 policy), and provide references for clinical medication. METHODS: 137 cases of adverse drug reactions of four psychotropic drugs reported under the "4 + 7" policy in Wuxi Mental Health Center in 2020 were collected. The gender and age of patients, related "4 + 7" drugs, involving organs / systems, clinical manifestations, distribution of new / serious adverse reactions, clinic outcomes were analyzed. RESULTS: Among the 137 cases of adverse drug reactions, the incidence of adverse drug reactions was the highest in patients aged 61-70 (25.38%). Mainly involved 4 "4 + 7" psychiatric drugs, of which olanzapine tablets caused the most adverse reactions (54, 39.24%). The adverse reactions mainly involved the digestive system, nervous system, cardiovascular system, blood and lymphatic system, among which the digestive system was the most common (61, 44.53%). A total of 8 cases (6.16%) of new and 26 cases of serious adverse reactions were reported, all of which led to the prolongation of disease course. Except for the transient side effects, most of that were improved or cured with no death, disability or teratogenicity after stopping or reducing the dose with symptomatic treatment. CONCLUSION: Since more and more drugs will be included in "4 + 7" for clinic, clinical pharmacists should strengthen the publicity and training of the knowledge of "4 + 7" drugs, strengthen the monitoring of adverse drug reactions, and provide timely feedback to the clinic, in order to achieve early prevention, early identification, timely diagnosis and reasonable intervention of the adverse drug reactions under the context of "4 + 7" policy.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Idoso , China/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Incidência , Pessoa de Meia-Idade , Psicotrópicos/efeitos adversos , Política Pública
5.
Front Public Health ; 10: 996179, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36339230

RESUMO

Background: Semaglutide was approved for treatment of type 2 diabetes mellitus (T2DM) and chronic weight management in obesity or overweight adults. However, real-world data regarding its long-term gastrointestinal safety and tolerability in large sample population are incomplete. We evaluated semaglutide-associated gastrointestinal safety signals by data mining of the FDA pharmacovigilance database. Methods: Reporting odds ratio (ROR) was employed to quantify the signals of semaglutide-related gastrointestinal adverse events (AEs) from 2018 to 2022. Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (χ2) test, and signals were prioritized using a rating scale. Results: We identified 5,442 cases of semaglutide-associated gastrointestinal AEs, with 45 signals detected, ranging from a ROR025 of 1.01 (hypoaesthesia oral) to 42.03 (eructation), among which 17 AEs were identified as new and unexpected signals. Patient age (p < 0.001) and body weight (p = 0.006) rather than sex (p = 0.251) might be associated with an increased risk of gastrointestinal AEs severity. Notably, the association between semaglutide and gastrointestinal disorders remained when stratified by age, body weight, sex and reporter type. One strong, 22 moderate and 22 weak clinical priority signals were defined. The median time-to-onset (TTO) for strong clinical priority signal was 23 days, while for moderate and weak, they were 6 and 7 days, respectively. All of the disproportionality signals had early failure type features, suggesting that the risk of gastrointestinal AEs occurrence gradually decreased over time. Conclusion: Our study provided a deeper and broader understanding of semaglutide's gastrointestinal safety profiles, which would help healthcare professionals to mitigate the risk of gastrointestinal AEs in clinical practice.


Assuntos
Diabetes Mellitus Tipo 2 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adulto , Humanos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Peso Corporal
6.
Sci Rep ; 12(1): 19409, 2022 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-36371467

RESUMO

Drug information centers (DICs) are institutions dedicated to provide objective, independent, and up-to-date information on drugs and their rational use. To overcome the lack of recent DIC reports from central Europe, we analyzed all queries (n = 594) submitted to the DIC run by the Institute for Clinical Pharmacology of Hannover Medical School between October 2018 and April 2022. Approximately one in three queries (31.1%; 185/594) was submitted by internists. 82.8% (492/594) of the queries were patient-specific, while the remaining 17.2% (102/594) were general queries. Adverse drug reactions (ADRs), indications/contraindications, and pharmacodynamic interactions (PDIs) represented the three most frequently addressed query categories, being involved in 44.8% (266/594), 43.3% (257/594), and 34.3% (204/594) of all queries, respectively (assignment of more than one category per query was possible). As compared to general queries, patient-specific queries were statistically significantly more often related to ADRs, PDIs, and pharmacokinetic interactions (PKIs) (ADRs: 35.3% vs. 46.7%, P = 0.034; PDIs: 14.7% vs. 38.4%, P < 0.001; PKIs: 20.6% vs. 31.5%, P = 0.028). To demonstrate the complexity of queries submitted to the clinical-pharmacological DIC, we present and comment on an illustrative selection of queries.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Faculdades de Medicina , Humanos , Atenção Terciária à Saúde , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Centros de Informação , Hospitais , Dacarbazina
7.
Neurol India ; 70(5): 2031-2038, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36352605

RESUMO

Background: Although epilepsy is a common neurological condition, there is paucity of nationwide data on treatment patterns and sociodemographic and clinical factors affecting treatment decisions in India. Objective: To assess clinical profiles, usage pattern of antiepileptic drugs (AEDs), and seizure control among patients with epilepsy in India. Methods: This was a cross-sectional, observational, multicenter study on adult patients with epilepsy who were on AEDs for at least six months before enrollment. Data were collected from patient interviews and medical records. Results: Out of 800 enrolled patients, a majority (69.0%) had generalized onset seizure in the six months before enrollment. The median age at epilepsy onset was 20.0 (1.0-64.0) years; 40.0% of the patients were females, 48.5% were married, 99.1% were literate, and 67.0% belonged to the lower or upper-middle socioeconomic class. Overall, 459 patients (57.4%) received AEDs as combination therapy. Most patients received levetiracetam (37.0%), sodium valproate (18.5%), carbamazepine (17.3%), or phenytoin (13.8%) as monotherapy, and clobazam (59.7%), levetiracetam (52.9%), carbamazepine (26.4%), sodium valproate (24.8%), or phenytoin (24.0%) in combination therapy. Quality of life was comparable for first- and third-generation AEDs. Adverse drug reactions were mostly attributed to dose modification or switching between drugs. No serious adverse drug reactions or new safety concerns were identified. Conclusions: Findings from this large, cross-sectional, observational, multicenter study indicate that first-generation AEDs sodium valproate and phenytoin continued to be used in a substantial number of patients on monotherapy and combination therapy in India, even though an increasing trend toward use of second-generation AEDs was noted in clinical practice.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Epilepsia , Adulto , Feminino , Humanos , Adulto Jovem , Pessoa de Meia-Idade , Masculino , Fenitoína/uso terapêutico , Levetiracetam/uso terapêutico , Ácido Valproico/uso terapêutico , Estudos Transversais , Qualidade de Vida , Epilepsia/tratamento farmacológico , Epilepsia/epidemiologia , Anticonvulsivantes/efeitos adversos , Carbamazepina/uso terapêutico , Convulsões/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológico
8.
Sci Rep ; 12(1): 19555, 2022 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-36380085

RESUMO

Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. Reporting odds ratio (ROR) was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Totally, 9,704,33 reports were collected from the FAERS database, 10,804 reports of osimertinib were identified as the 'primary suspected (PS)' AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, venous thromboembolisms might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14-212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias Pulmonares , Estados Unidos/epidemiologia , Humanos , Farmacovigilância , United States Food and Drug Administration , Sistemas de Notificação de Reações Adversas a Medicamentos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Neoplasias Pulmonares/tratamento farmacológico
9.
Front Immunol ; 13: 1013186, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36341450

RESUMO

Objective: To study the incidence and distribution of adverse events in immune checkpoint inhibitors (ICI) for digestive system cancers and to provide a reference for the safe, rational, and effective use of immune detection site inhibitors. Methods: We searched for articles published in English between January 1, 2010, and May 18, 2022. All clinical trials of ICI-based therapies for digestive system cancers were investigated, including only randomized controlled trials that reported data on the overall incidence of treatment-related adverse events (trAEs) or immune-related adverse reactions (irAEs) or tables. Results: We searched 2048 records, of which 21 studies (7108 patients) were eligible for inclusion. The incidence of ICI trAEs of any grade was 82.7% (95% CI 73.9-90.0), and the incidence of grade 3 or higher trAEs was 27.5% (95% CI 21.3-34.1). The pooled rate of ICI irAEs of any grade was 26.3% (95% CI 11.8-44.0), and the incidence of grade 3 or higher irAEs was 9.4% (95% CI 1.1-24.6). In multivariate analysis, the incidence, characteristics, and distribution of AEs varied by cancer type, combination therapy modality (single/two-drug), and different agent types. Conclusion: Our meta-analysis summarizes AEs associated with ICI in digestive system cancers. The incidence, characteristics, and distribution of AEs vary by cancer type, combination therapy modality, and different agent types. These findings can be considered for the early identification of AEs and provide effective interventions to reduce the severity of these patients. It can provide a clinical reference and may contribute to clinical practice.


Assuntos
Neoplasias do Sistema Digestório , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Neoplasias do Sistema Digestório/tratamento farmacológico
10.
Curr Opin Support Palliat Care ; 16(4): 216-222, 2022 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-36349380

RESUMO

PURPOSE OF REVIEW: Androgen-deprivation therapy (ADT) is widely employed for treatment of advanced prostate cancer and it is considered the frontline therapy. However, the numerous adverse reactions associated with this treatment option are concerning and its potential association with cardiovascular diseases (CVD) should not be overlooked. In this review, we examine the literature on the cardiovascular side effects of ADT and the physiologic mechanisms underpinning the association with CVD. We will also specifically discuss the different findings regarding the interesting potential disparity in major cardiovascular events among GnRH agonist-treated patients compared with patients undergoing GnRH antagonist treatment. RECENT FINDINGS: Androgen-deprivation therapy increases the risk of developing CVD by altering the body composition, metabolism, vascular system, and cardiac physiology. GnRH agonists may pose a higher risk of cardiovascular mortality and morbidity than GnRH antagonists; however, this link remains to be determined. Furthermore, screening for cardiovascular risk factors before and during ADT treatment is a crucial step in preventing major adverse cardiac events in prostate cancer patients. Notably, preexisting CVD and comorbidities have been identified as major key elements predicting cardiovascular events. Early implementation of pharmacological and nonpharmacological treatment strategies is strongly suggested, and regular follow-up visits should be scheduled to continuously assess patients' cardiovascular risk under ADT. SUMMARY: ADT is a very powerful treatment option for advanced prostate cancer that improves survival outcomes but has the potential of considerably impacting patients' cardiovascular health. Medical optimization and close monitoring are crucial during treatment with ADT.


Assuntos
Doenças Cardiovasculares , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias da Próstata , Masculino , Humanos , Antagonistas de Androgênios/efeitos adversos , Neoplasias da Próstata/tratamento farmacológico , Androgênios/uso terapêutico , Hormônio Liberador de Gonadotropina/uso terapêutico , Doenças Cardiovasculares/induzido quimicamente , Doenças Cardiovasculares/epidemiologia
11.
Sci Data ; 9(1): 699, 2022 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-36376331

RESUMO

The data currently described was generated within the EU/FP7 HeCaToS project (Hepatic and Cardiac Toxicity Systems modeling). The project aimed to develop an in silico prediction system to contribute to drug safety assessment for humans. For this purpose, multi-omics data of repeated dose toxicity were obtained for 10 hepatotoxic and 10 cardiotoxic compounds. Most data were gained from in vitro experiments in which 3D microtissues (either hepatic or cardiac) were exposed to a therapeutic (physiologically relevant concentrations calculated through PBPK-modeling) or a toxic dosing profile (IC20 after 7 days). Exposures lasted for 14 days and samples were obtained at 7 time points (therapeutic doses: 2-8-24-72-168-240-336 h; toxic doses 0-2-8-24-72-168-240 h). Transcriptomics (RNA sequencing & microRNA sequencing), proteomics (LC-MS), epigenomics (MeDIP sequencing) and metabolomics (LC-MS & NMR) data were obtained from these samples. Furthermore, functional endpoints (ATP content, Caspase3/7 and O2 consumption) were measured in exposed microtissues. Additionally, multi-omics data from human biopsies from patients are available. This data is now being released to the scientific community through the BioStudies data repository ( https://www.ebi.ac.uk/biostudies/ ).


Assuntos
Cardiotoxicidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Epigenômica , Metabolômica , Proteômica , Transcriptoma
12.
Am J Manag Care ; 28(11): 566-571, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36374614

RESUMO

OBJECTIVES: Drug-drug interactions (DDIs) are among the most common causes of adverse drug reactions and are further complicated by genetic variants of drug-metabolizing enzymes. The aim of this study is to quantify and describe potential DDIs, drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs) in a community-based population. STUDY DESIGN: This was an analysis of deidentified retail pharmacy prescription data for 4761 individuals. METHODS: Data were first assessed for DDIs, and individuals were stratified to a risk category using the logic of a commercially available digital DDGI tool. To calculate the frequency of potential DGIs and DDGIs, genotypes were imputed and randomly allocated to the cohort 100 times via Monte Carlo simulation according to each variant's frequency in the general population. RESULTS: The probability of a DDI of any impact was 26.0% and increased to 49.6% (95% CI, 48.4%-50.7%) when drug-metabolizing phenotypes were ascribed according to the distribution of variants of 11 genes as found in a Caucasian population. There was a 7.8% probability of major DDIs, which increased to a 10.1% (95% CI, 9.5%-10.8%) probability with the addition of genetic contributions. The probability of DDGIs of any impact was correlated with the number of medications. Antidepressants, antiemetics, blood products and modifiers, analgesics, and antipsychotics had the highest probability of DDGIs. CONCLUSIONS: The probability of drug interaction risk increased when phenotypes associated with genetic polymorphisms were attributed to the population. These data suggest that pharmacogenomic assessment may be useful in predicting drug interactions and severity when evaluating patient medication profiles.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmácias , Humanos , Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Genótipo
13.
BMC Geriatr ; 22(1): 841, 2022 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-36344918

RESUMO

BACKGROUND: Polypharmacy can be defined as using five or more medications simultaneously. "Medication-related problems", an extension of polypharmacy, includes inappropriate prescribing, poor adherence, overdosage, underdosage, inappropriate drug selection, inadequate monitoring, adverse drug effects, and drug interactions. Polypharmacy and the high risk of medication-related problems among older people are associated with adverse health consequences due to drug-drug interactions, drug-disease interactions, and adverse drug effects. This study aims to assess the factors associated with polypharmacy and the high risk of medication-related problems among community-dwelling older people in the Netherlands, Greece, Croatia, Spain, United Kingdom. METHOD: This longitudinal study used baseline and follow-up data from 1791 participants of the Urban Health Center European project. Polypharmacy and the risk of medication-related problems were evaluated at baseline and follow-up using the Medication Risk Questionnaire. We studied factors in the domains (a) sociodemographic characteristics, (b) lifestyle and nutrition, and (c) health and health care use. Hierarchical logistic regression analyses were used to examine the factors associated with polypharmacy and the high risk of medication-related problems. RESULTS: Mean age was 79.6 years (SD ± 5.6 years); 60.8% were women; 45.2% had polypharmacy, and 41.8% had a high risk of medication-related problems. Women participants had lower odds of polypharmacy (OR = 0.55;95%CI:0.42-0.72) and a high risk of medication-related problems (OR = 0.50; 95%CI:0.39-0.65). Participants with a migration background (OR = 1.67;95%CI:1.08-2.59), overweight (OR = 1.37; 95%CI:1.04-1.79) and obesity (OR = 1.78;95%CI:1.26-2.51) compared to 'normal weight', with lower physical HRQoL (OR = 0.96, 95%CI:0.95-0.98), multi-morbidity (OR = 3.73, 95%CI:2.18-6.37), frailty (OR = 1.69, 95%CI:1.24-2.30), visited outpatient services (OR = 1.77, 95%CI: 1.09-2.88) had higher odds of polypharmacy. The associations with the high risk of medication-related problems were similar. CONCLUSIONS: Multiple factors in demography, lifestyle, nutrition, and health care use are associated with polypharmacy and the high risk of medication-related problems. Polypharmacy is a single element that may reflect the number of medications taken. The broader content of medication-related problems should be considered to assess the context of medication use among older people comprehensively. These provide starting points to improve interventions to reduce polypharmacy and high risk of medication-related problems. In the meantime, health professionals can apply these insights to identify subgroups of patients at a high risk of polypharmacy and medication-related problems. TRIAL REGISTRATION: The intervention of the UHCE project was registered in the ISRCTN registry as ISRCTN52788952. The date of registration is 13/03/2017.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Polimedicação , Humanos , Feminino , Idoso , Masculino , Vida Independente , Estudos Longitudinais , Europa (Continente)/epidemiologia , Prescrição Inadequada , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
14.
Crit Care Nurs Clin North Am ; 34(4): 361-371, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36336427

RESUMO

Medications are a common cause of injury to the kidney and can contribute to the increased progression of disease, poorer outcomes, and increased health care costs. Improved prescribing practices can decrease the risk for the development of acute kidney injury and the progression to end-stage kidney disease. KDIGO Clinical Practice Guidelines recommend the use of caution when prescribing potentially nephrotoxic medications for patients with kidney disease. More than 50-72% of individuals across all stages of kidney disease utilized potentially nephrotoxic medications contributing to poorer outcomes. Annually, 1.5 million adverse drug events causing medication-induced nephrotoxicity occur in the US. Medication-induced nephrotoxicity accounts for 14-26% of cases of AKI in adults and 16% of hospitalized children. It is imperative that nurses and all health care providers are practicing nephrotoxic stewardship to prevent medication-induced nephrotoxicity.


Assuntos
Injúria Renal Aguda , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Falência Renal Crônica , Adulto , Criança , Humanos , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Estudos Retrospectivos , Progressão da Doença , Falência Renal Crônica/prevenção & controle , Revisão de Uso de Medicamentos
15.
Int J Mol Sci ; 23(21)2022 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-36362438

RESUMO

Mitochondria are central organelles in the homeostasis of the cardiovascular system via the integration of several physiological processes, such as ATP generation via oxidative phosphorylation, synthesis/exchange of metabolites, calcium sequestration, reactive oxygen species (ROS) production/buffering and control of cellular survival/death. Mitochondrial impairment has been widely recognized as a central pathomechanism of almost all cardiovascular diseases, rendering these organelles important therapeutic targets. Mitochondrial dysfunction has been reported to occur in the setting of drug-induced toxicity in several tissues and organs, including the heart. Members of the drug classes currently used in the therapeutics of cardiovascular pathologies have been reported to both support and undermine mitochondrial function. For the latter case, mitochondrial toxicity is the consequence of drug interference (direct or off-target effects) with mitochondrial respiration/energy conversion, DNA replication, ROS production and detoxification, cell death signaling and mitochondrial dynamics. The present narrative review aims to summarize the beneficial and deleterious mitochondrial effects of common cardiovascular medications as described in various experimental models and identify those for which evidence for both types of effects is available in the literature.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Mitocôndrias , Humanos , Espécies Reativas de Oxigênio/metabolismo , Mitocôndrias/metabolismo , Morte Celular , Homeostase , Transdução de Sinais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/metabolismo
16.
PLoS One ; 17(11): e0272022, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36318537

RESUMO

BACKGROUND: Treatment options for many cancers include immune checkpoint inhibitor (ICI) monotherapy and combination therapy with impressive clinical benefit across cancers. We sought to define the comparative cardiac risks of ICI combination and monotherapy. METHODS: We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac ADRs (cADRs), such as carditis, heart failure, arrhythmia, myocardial infarction, and valvular dysfunction, related to ICI therapy. To explore possible relationships, we used the reporting odds ratio (ROR) as a proxy of relative risk. A lower bound of a 95% confidence interval of ROR &gt; 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. RESULTS: We found 2278 cADR for ICI monotherapy and 353 for ICI combination therapy. Combination therapy was associated with significantly higher odds of carditis (ROR 6.9, 95% CI: 5.6-8.3) versus ICI monotherapy (ROR 5.0, 95% CI: 4.6-5.4). Carditis in ICI combination therapy was fatal in 23.4% of reported ADRs, compared to 15.8% for ICI monotherapy (P = 0.058). CONCLUSIONS: Using validated pharmacovigilance methodology, we found increased odds of carditis for all ICI therapies, with the highest odds for combination therapy. Given the substantial risk of severe ADR and death, clinicians should consider these findings when prescribing checkpoint inhibitors.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Miocardite , Neoplasias , Humanos , Inibidores de Checkpoint Imunológico , Cardiotoxicidade/tratamento farmacológico , Miocardite/tratamento farmacológico , Farmacovigilância , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológico , Neoplasias/tratamento farmacológico , Estudos Retrospectivos
17.
BMJ Open ; 12(11): e062853, 2022 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-36323472

RESUMO

INTRODUCTION: Adverse drug events (ADEs) among hospitalised older adults are common yet often preventable. Efforts to recognise ADEs using pharmacist review and electronic health record adaptations have had mixed results. Our health system developed and implemented a geriatric prescribing context designed to offer age-friendly dose and frequency defaults for hospitalised patients 75 years and older. The impact of this context on ADEs remains unknown. To measure its impact, our team created a list of ADE-related International Classification of Diseases (ICD) codes specific to 10 commonly used medications at our institution. This protocol paper presents the process of designing a screening tool for ADEs, validating the tool with manual chart reviews and measuring the impact of the context on ADEs. METHODS AND ANALYSIS: This retrospective cross-sectional study will assess our list of ICD-10 codes against manual chart review to determine its accuracy. An electronic health record report for patients aged 75 years and older admitted to the hospital for a minimum of two nights was generated to identify 100 test positives and 100 test negatives. Test positives need at least one code from each level of our ICD-10 code list. The first level of codes identifies any possible ADEs while the second level is more symptom based. Test negatives must not have any code from the list. Two physicians blinded to test status will complete a structured chart review to determine if a patient had an ADE during their hospitalisation. Acceptable inter-rater reliability will need to be met before proceeding with independent chart review. Positive predictive value and negative predictive value will be calculated once all the chart reviews are completed. ETHICS AND DISSEMINATION: The Oregon Health & Science University Institutional Review Board approved this study (#21385). The results of the study will be disseminated in peer-reviewed journals and conference presentations.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Classificação Internacional de Doenças , Humanos , Idoso , Estudos Transversais , Estudos Retrospectivos , Reprodutibilidade dos Testes , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle
18.
BMC Cancer ; 22(1): 1136, 2022 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-36335320

RESUMO

BACKGROUND: Immune checkpoint inhibitors (ICIs) has shown remarkable benefit in the treatment of a range of cancer types, although it may initiate immune related adverse events (irAEs) in patients. Some studies have shown that there is a close relationship between the occurrence of irAEs and prognosis. In present study, we have attempted to establish whether the occurrence of irAEs after the use of anti PD-1 antibodies is associated with treatment efficacy in people with advanced gastric cancer (AGC). METHODS: This study included patients treated with the anti-PD-1 antibodies for AGC patients at The Fourth Hospital of Hebei Medical University. IrAEs were identified clinically and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 4.03. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS). The analysis was performed to determine the association between irAEs and clinical outcomes. RESULT: Of the 74 AGC patients in our study, 24 developed irAEs. The DCR of the irAE displayed a trend better than that of non-irAE group but without statistical difference (41.70% VS 6.0%, p = 0.118). Median PFS in the irAE group was superior to that in the non-irAE group (176 days VS 94 days, p = 0.001). Median OS also showed this trend of difference at borderline statistical level (292 days VS 239 days, p = 0.057). Multivariate analysis also demonstrated irAE (HR = 0.269, 95%CI: 0.088 to 0.822, p = 0.021) were associated independently with the better prognosis for AGC patients. CONCLUSION: In advanced gastric cancer treated with anti PD-1 antibodies, the occourence of irAEs might contribute to the improved prognosis.


Assuntos
Antineoplásicos Imunológicos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias Gástricas , Humanos , Nivolumabe/uso terapêutico , Antineoplásicos Imunológicos/efeitos adversos , Neoplasias Gástricas/tratamento farmacológico , Estudos Retrospectivos , Prognóstico
20.
PLoS One ; 17(11): e0278039, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36413565

RESUMO

To determine the course of treatment while considering the patients' desires, we examined trends regarding patients' perception and expectations over the course of cancer pharmacotherapy. We retrospectively reviewed interview sheets filled in by patients with advanced urogenital cancers when they started a new pharmacotherapy regimen between 2014 and 2020. The responses to the following questions were analyzed: 1) How did your doctor explain the treatment objectives?; 2) Are you willing to receive treatment?; and 3) When the standard treatment becomes difficult to continue, would you like to try another treatment even if it may cause severe side effects? A total of 277 patients answered the interview sheet. The percentage of patients who accurately perceived the treatment objectives among patients receiving 1st, 2nd, and 3rd line regimens was 67%, 79%, and 93%, respectively. The percentage significantly improved over the course of pharmacotherapy (p = 0.0057). The percentage of patients who indicated that they were willing to receive treatment in 1st, 2nd, and 3rd line regimens was 80%, 83%, and 86%, respectively. The percentage of patients who indicated that they wanted to try another treatment when the standard treatment became difficult to continue in 1st, 2nd, and 3rd line regimens was 56%, 64%, and 59%, respectively. The percentage of patients who accurately perceived the objective of pharmacotherapy increased over the course of pharmacotherapy. The rate of patients who were willing to receive treatment and try other treatments when the standard treatment became too difficult to continue remained consistently high.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias Urogenitais , Humanos , Motivação , Estudos Retrospectivos , Neoplasias Urogenitais/tratamento farmacológico , Percepção
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