| Abstract | Cilj istraživanja: Cilj ovog rada bio je utvrditi ukupni broj prijavljenih sumnji na nuspojave
montelukasta u Republici Hrvatskoj u promatranom periodu od 1. siječnja 2005. do 1. srpnja 2021.
godine te utvrditi prema klasifikaciji po organskim sustavima (MedDRA) koji organski sustavi su
bili najzastupljeniji prilikom prijava.
Materijali i metode: Zabilježene prijave sumnji na nuspojave na montelukast, analizirane su s
obzirom na spol, dob i zanimanje prijavitelja, kao i s obzirom na ozbiljnost prijavljene nuspojave i
tip nuspojave prema klasifikaciji organskih sustava prema Medicinskom rječniku za regulatorne
poslove. Dodatno promatrane su sumnje na interakcije istovremeno primijenjenih lijekova i
montelukasta u zaprimljenim prijavama. Upotrebnom programa Microsoft Excel 2016 (One
Microsoft Way, Redmond, Washington, U.S.) napravljena je deskriptivna statistička analiza te su
rezultati prikazani kao cijeli brojevi i postoci.
Rezultati: Prva zabilježena prijava sumnje na nuspojavu montelukasta u Hrvatskoj bila je
2005.godine, a do 2021. je sveukupno zabilježeno 125 prijava. Od ukupnog broja prijava na sumnju
nuspojave montelukasta HALMED-u 50 posto ih je kod ženskog spola. Najčešće su u djece, u dobi
od 2 do 11 godina (42%). Najviše prijava zabilježeno je od strane liječnika (66% ), a najmanje od
strane pacijenata, odnosno nezdravstvenog osoblja. U navedenom razdoblju od 2005. do 2021.
godine, najviše nuspojava prijavljeno je 2014. (14%). Od ukupno prijavljenih 125 nuspojava,
najveći udio nije zadovoljavao uvjete ozbiljnosti, međutim, 35 nuspojava zadovoljilo je kriterije
ozbiljnosti, a zabilježen je i jedan smrtni slučaj. Deset najčešće prijavljenih sumnji na nuspojave
bili su bolovi u trbuhu, umor, glavobolja, noćne more (9%), nesanica, agresivnost, hiperaktivnost,
kašalj, dijareja i poremećaj spavanja. Prema klasifikaciji po organskim sustavima (MedDRA),
najveći broj prijava sumnji na nuspojavu pripada skupini XIX. Psihijatrijski poremećaji (33%).
Djelatne tvari za koje je uočeno da su se najčešće primjenjvale istovremeno s montelukastom u
situacijama kada su zabilježene prijave sumnji na nuspojave su salbutamol (6%) i loratadin (6%).
Zaključak: U promatranom periodu prijavljeno je 125 sumnji na nuspojave montelukasta. Najviše
prijava zabilježeno je u pacijenata dječje dobi. S obzirom na klasifikaciju po organskim sustavima,
najčešće prijavljene nuspojave bile su vezane uz psihijatrijske poremećaje i živčane poremećaje. |
| Abstract (english) | Objectives: The aim of this study was to assess the total number of adverse reactions on
montelukast in the Republic of Croatia from 1st of January 2005. to 1st of July 2021. Additionally,
the goal was to determine which organic system (MedDRA) was the most represented one in the
reports.
Respondents and methods: The recorded adverse reactions were analysed in view of the gender,
age and profession of the reporter, while also taking into consideration the seriousness of the
adverse reaction and the type of adverse reaction by the classification of the organic systems in the
Medical Dictionary for Regulatory Activities. Additionally, interactions of concurrently applied
medications were studied in the reports. Descriptive statistical analysis was preformed by using
Microsoft Excel 2016 (One Microsoft Way, Redmond, Washington, U. S.). The results were
presented as whole numbers and percentages.
Results: First reported adverse reaction in Croatia was in 2005. and by 2021. there were 125
reported cases. 50 % of reported cases were noted in females. They are most common in children,
aged 2 to 11 (42 %). Medical doctors were the most common reporters (66 %). The least common
reporters were patients, or rather non-medical personel. The highest number of reports were noted
in 2014. (14 %). 35 reported cases complied with conditions of seriousness and there was one case
of death. 10 most commonly reported adverse reactions were stomach aches, tiredness, headache,
nightmares (9 %), insomnia, aggression, hyperactivity, cough, diarrhea and sleep disorders.
According to MedDra, the largest number of reported cases is in group XIX. psychiatric disorders
(33 %). Active substances which were most commonly in interaction with montelukast with
adverse reactions were salbutamol (6 %) and loratadine (6 %).
Conclusion: In the observed period, 125 suspected adverse reactions on montelukast were
reported. Most reports were noted in children. Regarding the classification by organ systems, the
most frequently reported adverse reactions were related to psychiatric disorders and nervous
disorders. |
