| Abstract | Cilj istraživanja: Cilj ovog rada je pregledno prikazati klinička ispitivanja lijekova odobrena u
Republici Hrvatskoj u razdoblju od 1. siječnja 2013. do 31. prosinca 2015. Radi se o lijekovima s
novim mehanizmima djelovanja, a s kojima će se ljekarnici uskoro susresti u svakodnevnoj kliničkoj
praksi.
Ispitanici i metode: U tu svrhu pretražena je znanstvena i stručna literatura, publikacije stručnih
udruga i institucija, popis odobrenih kliničkih ispitivanja objavljen na stranici Ministarstva zdravstva
Republike Hrvatske, baza lijekova Agencije za lijekove i medicinske proizvode, baza lijekova
Europske agencije za lijekove, te drugi raspoloživi izvori.
Rezultati: U 2013. godini je odobreno 76, u 2014. godini 52, a u 2015. godini 56 kliničkih ispitivanja
lijekova. U razdoblju od 1. siječnja 2013. do 31. prosinca 2015. godine odobreno je najviše ispitivanja
iz područja neoplazmi (n=31), bolesti živčanog sustava (n=29), endokrinih, nutricijskih i metaboličkih
bolesti (n=28), bolesti probavnog sustava (n=16), bolesti mišićno-koštanog sustava i vezivnog tkiva
(n=15), bolesti cirkulacijskog (krvožilnog) sustava (n=14), te bolesti dišnog (respiracijskog) sustava
(n=13). Najviše se ispituju lijekovi u sljedećim indikacijama: šećerna bolest tipa 2 (n=19), reumatoidni
artritis (n=11), multipla skleroza (n=10), Alzheimerova bolest (n=8), Crohnova bolest (n=7), te
ulcerozni kolitis (n=7). U razdoblju koje je obuhvaćeno ovim radom najviše su se ispitivali lijekovi za
liječenje zloćudnih bolesti i imunomodulatori.
Zaključak: Novi lijekovi imaju kompliciranije, ciljane mehanizme djelovanja, veću mogućnost za
terapijski uspjeh no također i neželjene nuspojave. Ljekarnici trebaju razumjeti nove načine djelovanja
lijekova i biti u tijeku s ubrzanim razvojem novih terapijskih mogućnosti, kako bi mogli pomoći u
zbrinjavanju terapijskih problema i poboljšanju ishoda liječenja bolesnika. |
| Abstract (english) | Aim: The aim of this paper is to do a review of clinical trials on medicinal products approved in the
Republic of Croatia since 1st January 2013 till 31st December 2015. These clinical trials are
investigating medicinal products with the new mechanisms of action, and with which pharmacists will
soon meet in everyday clinical practice.
Subjects and method: For this purpose scientific articles and expert perspectives, publications of
professional associations and institutions, Ministry of Health's list of approved clinical trials, Croatian
Agency for Medicinal Products and Medical Devices' database of medicinal products, European
Medicines Agency's database of medicinal products, and other available resources were searched.
Results: Seventy-six clinical trials on medicinal products have been approved in 2013, 52 in 2014,
and 56 in 2015. In time period since 1st January 2013 till 31st December 2015, the greatest number of
clinical trials was in the field of neoplasms (n=31), diseases of the nervous system (n=29), endocrine,
nutritional and metabolic diseases (n=28), diseases of the digestive system (n=16), diseases of the
musculoskeletal system and connective tissue (n=15), diseases of the circulatory system (n=14),
diseases of the respiratory system (n=13). The medicinal products are mostly investigated in the
following indications: diabetes mellitus type II (n=19), rheumatoid arthritis (n=11), multiple sclerosis
(n=10), Alzheimer disease (n=8), Crohn disease (n=7), and ulcerative colitis (n=7). In the period
covered by this paper, antineoplastic and immunomodulating agents are medicinal products that are
mostly investigated.
Conclusion: New medicinal products have more complicated and targeted mechanisms of action,
greater possibility for therapeutic success but also unwanted side effects. The pharmacists need to
understand new mechanism of action of medicinal products and be up to date with the rapid
development of new therapeutic options, in order to help in the management of therapeutic issues and
improvement of treatment outcomes of patients. |
