The results of the questionnaire analysis in physicians as well as the prevalence of potentially inappropriate medication demonstrate that Slovak clinicians are aware of the risk of certain treatments in elderly patients.
Background: In the past few years, COVID-19 became the leading cause of morbidity and mortality worldwide. Although the World Health Organization has declared an end to COVID-19 as a public health emergency, it can be expected, that the emerging new cases at the top of previous ones will result in an increasing number of patients with post-COVID-19 sequelae. Despite the fact that the majority of patients recover, severe acute lung tissue injury can in susceptible individuals progress to interstitial pulmonary involvement. Our goal is to provide an overview of various aspects associated with the Post-COVID-19 pulmonary fibrosis with a focus on its potential pharmacological treatment options.Areas covered: We discuss epidemiology, underlying pathobiological mechanisms, and possible risk and predictive factors that were found to be associated with the development of fibrotic lung tissue remodelling. Several pharmacotherapeutic approaches are currently being applied and include anti-fibrotic drugs, prolonged use or pulses of systemic corticosteroids and non-steroidal anti-inflammatory and immunosuppressive drugs. In addition, several repurposed or novel compounds are being investigated. Fortunately, clinical trials focused on pharmacological treatment regimens for post-COVID-19 pulmonary fibrosis have been either designed, completed or are already in progress. However, the results are contrasting so far. High quality randomised clinical trials are urgently needed with respect to the heterogeneity of disease behaviour, patient characteristics and treatable traits.Conclusion: The Post-COVID-19 pulmonary fibrosis contributes to the burden of chronic respiratory consequences among survivors. Currently available pharmacotherapeutic approaches mostly comprise repurposed drugs with a proven efficacy and safety profile, namely, corticosteroids, immunosuppressants and antifibrotics. The role of nintedanib and pirfenidone is promising in this area. However, we still need to verify conditions under which the potential to prevent, slow or stop progression of lung damage will be fulfilled.
Introduction: The COVID-19 pandemic has resulted in more than 6.5 million deaths worldwide yet. Vaccination against the SARS-CoV-2 virus is a reliable way out of the pandemic, however, vaccination rate reaches only 58% in the Slovak Republic. Concerns about the adverse reactions of vaccines are one of the reasons for the low vaccination rate.Objective: The aim of our analysis was to review reported suspicions of adverse reactions (ARs) of registered COVID-19 vaccines (Comirnaty, Vaxzevria, Spikevax), which State Institute for Drug Control received from healthcare professionals and patients in the period from 1 January 2021 to 31 May 2021.Methods: Data were collected from the State Institute for Drug Control database, a retrospective analysis was carried out focusing on trends in the number of all reports of suspicions of adverse reactions sent to the State Institute for Drug Control during the previously mentioned period. We analysed the Retrieved data were analysed with the usage of descriptive statistics and comparison to historical data on drug adverse reactions in Slovakia was performed.Results: During the evaluation period, 5,763 reported suspicions of adverse reactions were analysed, overall, there was a significant (p < 0.0001) increase in the number of reported adverse reactions fivefold. 93% of ARs (n = 5,346) were reported for COVID-19 vaccines. In comparison of the extentof all adverse reactions, there is clearly a statistically significant difference between all types of vaccines administered at that time (p ≤ 0.0001). No statistically significant difference (p ≤ 0.238) was identified between Spikevax and Comirnaty in the proportion of serious adverse reactions. However, a significantly higher (p ≤ 0.00001) proportion of reported suspicions of serious adverse reactions was observed after the administration of Vaxzevria.Conclusion: This is the first analysis conducted in Slovakia aimed to reported adverse reactions in relation to the administration of COVID-19 vaccines. The rate of spontaneously reported suspected adverse reactions has been insufficient in the past for a long time; during the period from January to May 2021 the reporting rate increased due active calls for adverse reactions reporting. In concordance with European data, Vaxzevria had a significantly higher ratio of reported suspicions of serious adverse reactions.
OBJECTIVES: Biopharmaceuticals improved the prognosis and quality of life of patients with chronic diseases. The aim of our study was to analyse the total reported suspected adverse drug reactions (ADR) and ADRs of reference biologicals and their biosimilars in Slovakia. METHODS: Using data from the State Institute for Drug Control database, we analysed the trends of suspected ADR submitted between 2001-2017 including the registered biosimilars and their reference biologicals: erythropoietin, fi lgrastim and infl iximab. RESULTS: Severe suspected ADR represented 42.95 % from all the reported cases (n = 13,462) over the time period 2006-2017 and 54.98 % over 2015-2017 respectively. Reports from 2015-2017 were further analysed. From 4,364 cases, 27 were associated with infl iximab and one with erythropoietin. 75 % of these ADR were severe including one death. The difference between the suspected ADR for infl iximab reference biological compared to the biosimilar was not statistically signifi cant (p = 0.171) after adjustment to the number of prescribed drug units. CONCLUSION: We did not fi nd any evidence of increased risks associated with biosimilars compared to reference biologics. The spontaneous reporting system represents an inexpensive tool of reporting ADRs and should be utilized more frequently by health professionals, but even more importantly, by patients (Tab. 3, Fig. 2, Ref. 30).
No abstract
Pandémia vyvolaná novým koronavírusom SARS-CoV-2 predstavuje globálnu hrozbu pre zdravie svetovej populácie. Najčastejšou príčinou hospitalizácie kvôli ochoreniu COVID-19 je intersticiálna pneumónia, ktorá môže byť komplikovaná rozvojom syndrómu akútnej respiračnej tiesne (ARDS). Sledovanie pacientov po prekonaní pneumónie v dôsledku COVID-19 poukazuje na významnú redukciu difúznej kapacity pľúc spojenú s fibrotickými zmenami v pľúcnom parenchýme, čo sa odzrkadľuje v ich nepriaznivej prognóze. Preto sú dlhodobé následky ochorenia COVID-19 kľúčové. Rizikové faktory, histopatologické charakteristiky a prevalencia, ako aj manažment post-COVID-19 pľúcnej fibrózy sú zatiaľ nedostatočne objasnené. V našom prehľade sa venujeme aj patobiologickým mechanizmom a možným prediktorom vedúcim k rozvoju fibrotickej prestavby pľúc. Potenciálne sa v terapii môžu uplatniť antifibrotiká, dlhodobejšie liečebné režimy s kortikosteroidmi, iné protizápalové a imunosupresívne lieky, spironolaktón, azitromycín spolu s ďalšími inovatívnymi liečivami vo vývoji.Kľúčové slová: SARS-CoV-2, intersticiálna pneumónia, post-COVID-19 pľúcna fibróza, antifibrotiká. COVID-19 and the lung: from interstitial pneumonia to pulmonary fibrosisThe novel coronavirus-induced disease led to a pandemic that poses a global threat to human health. The most common cause of hospitalisation for COVID-19 is interstitial pneumonia that may be complicated by Acute Respiratory Distress Syndrome (ARDS). The monitoring of patients who have recovered from COVID-associated pneumonia demonstrates that the significant reduction in diffuse lung capacity and associated fibrotic signs in the lung parenchyma are factors associated with a negative prognosis. Thus, the long-term consequences of COVID-19 appear crucial. Risk factors, histopathological characterization, prevalence, and management of post-COVID-19 pulmonary fibrosis are poorly understood. This review addresses underlying pathobiological mechanisms and the possible predictors which might lead to the development of fibrotic lung remodeling. Potential therapeutic modalities include anti-fibrotic drugs, prolonged use of corticosteroids, other anti-inflammatory and immunosuppressive drugs, spironolactone, azithromycine, with further multiple novel compounds under investigation.
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