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1.
J Pers Med ; 14(2)2024 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-38392605

RESUMO

There are currently no established methods to predict quantitatively whether the start of a drug with the potential to prolong the QTc interval poses patients at risk for relevant QTc prolongation. Therefore, this retrospective study aimed to pave the way for the development of models for estimating QTc prolongation in patients newly exposed to medications with QTc-prolonging potential. Data of patients with a documented QTc prolongation after initiation of a QTc-prolonging drug were extracted from hospital charts. Using a standard model-building approach, general linear mixed models were identified as the best models for predicting both the extent of QTc prolongation and its absolute value after the start of a QTc-time-prolonging drug. The cohort consisted of 107 adults with a mean age of 64.2 years. Patients were taking an average of 2.4 drugs associated with QTc prolongation, with amiodarone, propofol, pipamperone, ondansetron, and mirtazapine being the most frequently involved. There was a significant but weak correlation between measured and predicted absolute QTc values under medication (r2 = 0.262, p < 0.05), as well as for QTc prolongation (r2 = 0.238, p < 0.05). As the developed models are based on a relatively small number of subjects, further research is necessary to ensure their applicability and reliability in real-world scenarios. Overall, this research contributes to the understanding of QTc prolongation and its association with medications, providing insight into the development of predictive models. With improvements, these models could potentially aid healthcare professionals in assessing the risk of QTc prolongation before adding a new drug and in making informed decisions in clinical settings.

2.
Swiss Med Wkly ; 149: w20085, 2019 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-31256417

RESUMO

AIMS OF THE STUDY: Although systemic drugs can exert local effects on the eye, ophthalmology is a medical specialty with perhaps the fewest assessed adverse drug reactions (ADRs), representing a particular challenge in pharmacovigilance. Our aim was to quantify ADRs in ophthalmology in Switzerland, with a focus on angiogenesis inhibitors. METHODS: Individual case safety reports (ICSRs) on suspected ADRs reported in Switzerland from January 1991 to June 2016 were extracted from the WHO Global ICSR database, VigiBase™. ICSRs were analysed in relation to treatment duration, patient age, route of administration, patient sex and reported symptoms. RESULTS: A total of 80,515 ICSRs were reported in Switzerland during the reference period. Reactions linked to eye disorders accounted for 2793 (3.5%) cases. The main Anatomic Therapeutic Chemical / Defined Daily Dose drug classes associated with eye disorders were drugs acting on the nervous system (27.7%) followed by drugs “acting on sensory organs” (20.2%) and antineoplastic agents (18.0%). Most cases involved adult patients (70.6%). Patients over 60 years accounted for 815 (29.2%) ICSRs, and reactions in children were significantly less frequent (8.2%). Older patients were exposed to a higher number of drugs, and the majority of serious reactions involved children and older patients. A significant positive correlation between polypharmacy and seriousness of reported reactions was observed. The reported drugs were categorised as “suspected” in 51.1%, “concomitant” in 43.3% and “interacting” in 2.6% of cases. “Visual impairment” was the most commonly reported adverse reaction, experienced by 635 (22.7%) of patients (7.2% of all reported eye-related symptoms). The majority of reactions were transient, as 4173 (47.1%) completely resolved. Severe reactions included fatal outcome in 18 patients (0.6%) and blindness in 78 patients (2.6%). Since 2000, the intravitreous vascular endothelial growth factor (VEGF) inhibitors bevacizumab, aflibercept and ranibizumab accounted for 99 ICSRs. Retinal haemorrhage (reporting odds ratio [ROR] 10.36, 95% confidence interval [95% CI] 2.65–40.50; p <0.001), blindness (ROR 3.73, 95% CI 1.08–12.96; p = 0.04) and uveitis (ROR 6.91, 95% CI 1.64–29.13; p = 0.01) were significantly more frequently reported for aflibercept than for bevacizumab and ranibizumab. CONCLUSIONS: ADRs that affect the eye represented 3.5% of all pharmacovigilance reports during the reporting period. Whereas retinal haemorrhage and uveitis are known adverse reactions to angiogenesis inhibitors, the reported cases of blindness and death should heighten awareness of potential safety issues associated with VEGF inhibitors for the treatment of proliferative eye disorders.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Oftalmologia , Farmacovigilância , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/uso terapêutico , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Suíça
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