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- Drug-associated acute kidney disease: data from a world pharmacovigilance databasePublication . Baptista, Alexandre; Marreiros, Ana; Macedo, Ana; Coelho, AndréBackground: Drugs are a frequent cause of nephrotoxicity, especially in the context of acute kidney disease (AKD), with a significant number of cases being drug-associated. The WHO's VigiBase is a powerful tool for identifying drugs described and associated with the development of AKD. Methods: We retrieved data from the period 1968 to 2022 regarding notifications of adverse drug reactions (ADR). The extracted medications were evaluated for their nephrotoxicity based on the bibliographic score (BS) developed through pre-selected references. The main medications involved were classified as 'non-nephrotoxic', 'potentially nephrotoxic', and 'nephrotoxic'. We utilized the IC025 and reporting odds ratio (ROR) disproportionality indexes to study the relationship between medications and the odds of being included in an AKD notification. Results: During the period, a total of 33,932,051 notifications were obtained, revealing 435,677 cases related to drug-associated AKD following MedDRA term filtering, predominantly affecting males aged 45-64. We identified 8,991 active ingredients or suspected combinations associated with AKD development, with the ATC class A - Alimentary Tract and Metabolism being the most frequently described. Among the medications most strongly associated with this phenotype, classes J and N stood out. Among the most notable medications collected, 8.3% were classified as "non-nephrotoxic," 16.7% as "potentially nephrotoxic," and 75% as "known nephrotoxic." Notable active ingredients included cobicistat + elvitegravir + emtricitabine + tenofovir disoproxil (IC025 8.7; ROR 786.96), inotersen (IC025 7.7; ROR 604.57), emtricitabine + tenofovir disoproxil (IC025 7.9; ROR 432.36), esomeprazole (IC025 6.8; ROR 184.23), and pantoprazole (IC025 6.3; ROR 109.86), with proton pump inhibitors dominating the top four positions among the most frequently involved medications. Conclusion: AKD is a frequent adverse reaction in VigiBase, with a significantly high reported mortality rate. Evaluation of the notifications revealed medications with a high disproportionality index and a strong association with AKD. We also highlight the potential nephrotoxic role of less suspected medications. This study emphasizes the need to consider AKD as a condition potentially associated with iatrogenic etiology, highlighting various medications and their respective involvement in the various possible manifestations of AKD.
- Drug-related glomerular phenotypes: a global pharmacovigilance perspectivePublication . Baptista, Alexandre; Macedo, Ana M.; Marreiros, Ana; Coelho, André; Perazella, Mark A.Introduction: Adverse drug reactions are a significant problem in modern society, stemming from the increase in prescribed medications, over-the-counter drugs, and overall polypharmacy. Glomerular disorders are one of the frequently reported renal conditions associated with medication use. VigiBase is a significant tool for evaluating events associated with drug use, and, to the authors’ knowledge, no study has yet assessed this database to identify the primary medications associated with glomerular disorders. Materials and Methods: We collected data from VigiBase for 54 years and evaluated data based on global frequencies, disproportionality (IC025 values), nephrotoxic potential, and physiopathological mechanisms. Results: Over the evaluation period, 33.932.051 spontaneous notifications of adverse drug reactions reported in VigiBase were assessed, from which 106.775 notifications of drug-associated glomerular disorders were extracted. The isolated medications were classified as ‘potential nephrotoxins’ (47.0%), with 40% of the medications lacking scientific references to report any association with the development of glomerular disorders. Among the evaluated medications, Inotersen (IC025 of 8.3), Penicillamine (IC025 6.8), Bevacizumab (IC025 5.9) and Lenvatinib (IC025 5.4) were identified as having the strongest association with these glomerular disorders. For medications classified as ‘non-nephrotoxic’, a high disproportionality index was observed, suggesting drugs that might be considered as new potential nephrotoxins. Conclusions: Drug-induced glomerular disorders were significantly associated with medications that had no established nephrotoxic role but demonstrated a high disproportionality index in VigiBase. These newly alleged nephrotoxic drugs warrant further evaluation in dedicated studies to assess their true nephrotoxic potential.
- Avaliação da adesão à terapêutica em doentes com diabetes tipo 2 e hipertensão arterial: adesão à medicação nas doenças crónicasPublication . Rosu, Amalia; Coelho, André; Camacho, PedroObjetivos: Avaliação da adesão à terapêutica em doentes recém-diagnosticados com Diabetes Mellitus tipo 2 e Hipertensão Arterial, nos Cuidados de Saúde Primários na Região Lisboa Vale Tejo. Metodologia: Estudo observacional de coorte retrospetivo. População composta pelos doentes recém-diagnosticados com Diabetes Mellitus tipo 2 e Hipertensão Arterial, em início de tratamento. Os dados foram extraídos do Sistema de Informação da Administração Regional de Saúde de Lisboa Vale Tejo. A adesão à terapêutica foi avaliada nas suas três componentes: se os doentes iniciaram a terapêutica prescrita (iniciação); através do Medication Possession Ratio (MPR) durante o período de seguimento (implementação) e a descontinuação da medicação, que marca o fim do tratamento (descontinuação). Resultados: A taxa de iniciação foi de 84.2% nos doentes com ambas as doenças (98% para a terapêutica antidiabética oral e 84.6% para a terapêutica anti-hipertensiva). A taxa de implementação (MPR) para ambas as doenças foi de, apenas 3.4% (4.2% foram considerados aderentes com a terapêutica antidiabética oral e 8.5% para a terapêutica anti-hipertensiva). A taxa de descontinuação foi de 3.4% (5.5% para a terapêutica antidiabética oral e 13.2% para terapêutica anti-hipertensiva). A maioria dos doentes iniciam a toma da medicação após a prescrição, mas poucos têm uma implementação suficiente para que a adesão seja considerada boa. Poucos doentes descontinuaram a medicação. Conclusão: Os doentes tiveram uma maior taxa de implementação à terapêutica anti-hipertensiva, mas, por outro lado, foram mais persistentes à terapêutica antidiabética oral. O padrão da adesão à terapêutica parece ser influenciado pelo doente e pela própria doença.