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001-es BibID:	BIBFORM122638
035-os BibID:	(scopus)85200837955 (wos)001285058800001
Első szerző:	Girgis, Michael Magdy Fahmy (Gyógyszerész)
Cím:	Seriousness and outcomes of reported adverse drug reactions in old and new antiseizure medications : a pharmacovigilance study using EudraVigilance database / Michael Magdy Fahmy Girgis, Gergely Farkasinszky, Klára Fekete, István Fekete, Miklos Vecsernyes, Ildikó Bácskay, László Horváth
Dátum:	2024
Megjegyzések:	Introduction Epilepsy is a widespread disease requiring long-term drug treatment. The aim of this study was to collect information on reported suspected adverse drug reactions (sADRs) of antiseizure medications (ASMs) and study their seriousness and outcomes in various system organ classifications (SOCs). We intended to compare old and new ASMs' ADRs. Methods Using EudraVigilance (EV) database, we extracted line listings of reported sADRs with different ASMs over the period from January 2012 to December 2021. The list of ASMs was compiled according to the Anatomical therapeutic chemical classification system. The Medical Dictionary for Regulatory Activities version 24.0 was used for determining the SOCs of individual reported preferred terms (PTs) sADRs. In addition, we calculated the Reporting Odds Ratio (ROR), 95% confidence interval (95% CI), p-value (statistically significant if p<0.05) and chi-square statistics. Results A total of 276,694 reports were contained in the exported line listings which included 1,051,142 individual sADRs reported as PTs such as seizure (3.49%), drug ineffective (2.46%), somnolence (1.32%), dizziness (1.29%) and represented four SOCs: nervous system disorders (19.26%), general disorders and administration site conditions (14.39%), psychiatric disorders (11.29%) and injury, poisoning and procedural complications (9.79). Among patients, the age group between 18 and 64 years had the highest percentage (52.40%), followed by those aged over 64 years (18.75%). Of all the reported PTs, 882,706 (83.98%) had reported seriousness. Old ASMs had a significant positive association with ♭caused/prolonged hospitalisation', ♭congenital anomaly', ♭disabling', ♭life threatening' and ♭results in death', while new ASMS with ♭other medically important condition'. There were 386 (0.04%) PTs related to Sudden Unexpected Death in Epilepsy (SUDEP). Conclusion In our study, we examined 10 years' reported sADRs of ASMs in the EV international database. The majority of PTs were serious. Old ASMs were generally more commonly associated with undesired outcomes and seriousness. Considering their expected seriousness and outcomes, the safety profile of the different ASMs, can play a cardinal role in the selection of ASMs.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Epilepsy Seizure treatment Antiseizure medications (ASMs) Adverse events Adverse drug reactions Pharmacovigilance EudraVigilance (EV) System Organ Classifications (SOCs) Outcomes Seriousness Sudden Unexpected Death in Epilepsy (SUDEP)
Megjelenés:	Pharmacology Pharmacoepidemiology. - 15 (2024), p. 1-17. -
További szerzők:	Farkasinszky Gergely (1990-) (gyógyszerész) Fekete Klára (1978-) (neurológus) Fekete István (1951-) (neurológus, pszichiáter) Vecsernyés Miklós (1959-) (gyógyszertechnológus, endokrinológus) Bácskay Ildikó (1969-) (gyógyszerész, gyógyszertechnológus) Horváth László (1973-) (gyógyszerész)
Pályázati támogatás:	TKP2021-EGA-18 Egyéb
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM099581
035-os BibID:	(WoS)000748044100001 (Scopus)85123453367
Első szerző:	Girgis, Michael Magdy Fahmy (Gyógyszerész)
Cím:	Use of complementary and alternative medicine among patients with epilepsy and diabetes mellitus, focusing on the outcome of treatment / Michael Magdy Fahmy Girgis, Klára Fekete, Nóra Homoródi, Sándor Márton, István Fekete, László Horváth
Dátum:	2022
ISSN:	1662-453X
Megjegyzések:	Introduction Millions all over the world live with epilepsy and they may require long-term drug treatment. The use and interest in complementary and alternative medicine (CAM) have grown over the previous years. Co-administration of herbal products with medicines may result in adverse drug reactions (ADR) and/or unfavourable interactions. The aims of this study were to determine the prevalence of CAM use among patients with epilepsy and, also, to compare the results to those of the patients with diabetes mellitus (DM); to reveal factors that may drive the use of CAM; and to measure outcomes and adherence. It was also our intent to have state-of-art information of CAM use in our region among patients with the two diseases above. Methods We conducted a non-interventional study using a self-developed questionnaire. It was distributed among adult patients with either epilepsy or diabetes mellitus who also suffered from cardiovascular consequences. A database was compiled from the anonymous questionnaires, filled in voluntarily by the patients. Basic statistics were used to analyse this database. Results A total of 227 questionnaires were filled in by 127 patients (55.9%) with epilepsy and 100 patients (44.1%) with diabetes mellitus. Mean age was 54.54?17.33 years. Of the patients, 50.2% were male. Average body weight was 80.3?17.3 kg. Of the patients, 22 (9.7%) used CAM because they believed in CAM. Two of them reported ADR. Among the patients with epilepsy, the ratio was only 7.9% compared to 12% among those with diabetes mellitus. While the number of CAM users was higher among younger patients with epilepsy, it was the elderly patients with diabetes mellitus who tended to use CAM. Conclusion Attention should be paid to reliance on CAM during the follow-up. Our finding that health-conscious patients tend to use CAM more often (than the general population) may indicate it is necessary to discuss CAM usage sincerely. CAMs modulating CYPs enzymes were the most common, leading to interactions with medication used and resulting in ADR. This shows the importance of educating patients and treating team including clinical pharmacist in this field is essential.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Frontiers in Neuroscience. - 15 (2022), p. 1-12. -
További szerzők:	Fekete Klára (1978-) (neurológus) Homoródi Nóra (1974-) (kardiológus) Márton Sándor (1965-) (matematikus) Fekete István (1951-) (neurológus, pszichiáter) Horváth László (1973-) (gyógyszerész)
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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