| Sažetak | Cilj istraživanja: U ovom istraživanju napravljena je analiza sumnji na nuspojave vezane uz lijekove is skupine GLP-1 agonista, DPP-4 inhibitora i SGLT2 inhibitora koje su zaprimljene u Agenciji za lijekove i medicinske proizvode (HALMED) u vremenskom razdoblju od 1. siječnja 2010. do 31. prosinca 2018. godine.
Ispitanici i metode: Podatci o nuspojavama dobiveni su iz globalne baze podataka Svjetske zdravstvene organizacije - VigiBase. Od dobivenih podataka analizirano je sljedeće: godina prijave nuspojave, struka prijavitelja nuspojave, dob i spol pacijenta, ozbiljnost nuspojave, generički naziv lijeka te nuspojave navedene prema MedDRA klasifikaciji po organskim sustavima.
Rezultati: U promatranom vremenskom razdoblju prijavljeno je ukupno 217 sumnji na nuspojave. Nuspojave su u 58,1% slučajeva prijavile osobe ženskog spola. Lijekovi koji se u najvećem broju slučajeva povezuju s prijavom nuspojava su liraglutid (agonist GLP-1 receptora) i sitagliptin (DPP-4 inhibitor) svaki s 19,4% ukupnog broja prijava. Ukupan broj prijavljenih sumnji na nuspojave za skupinu DPP-4 inhibitora iznosi 92 slučaja (42,4%), za skupinu GLP-1 agonista 64 slučaja (29,5%), a za skupinu SGLT2 inhibitora 61 slučaj (28,2%). Najviše slučajeva sumnji na nuspojave prijavljeno je 2017. godine (24,4%). Od ukupno 217 prijavljenih sumnji na nuspojave, 38 (17,5%) je okarakterizirano kao ozbiljna nuspojava. Liječnici su prijavili 51,2%, farmaceuti 31,3%, a pacijenti 9,2% sumnji na nuspojave. Većina pacijenata pripadaju dobnoj skupini od 50 do 69 godina (66%). Najviše sumnji na nuspojavu, prema MedDRA klasifikaciji, odnosilo se na skupinu poremećaja probavnog sustava (20,3%), skupinu ozljeda, trovanja i proceduralnih komplikacija (12,1%) te skupinu poremećaja živčanoga sustava (8,7%).
Zaključci: Nuspojave najčešće prijavljuju zdravstveni djelatnici za pacijente ženskog spola. Najviše prijavljenih sumnji na nuspojave odnosilo se na pacijente u dobi od 60 do 69 godina. Lijekovi iz skupine DPP-4 inhibitora u najviše slučajeva su bili povezani s razvojem mogućih nuspojava. Korištenje lijekova iz skupine agonista GLP-1 receptora, DPP-4 inhibitora i SGLT2 inhibitora najčešće dovodi do razvoja gastrointestinalnih nuspojava. Potrebno je ispitati moguću povezanost korištenja linagliptina i razvoja karcinoma gušterače. Svi slučajevi poremećaja mokraćnog i spolnog sustava povezani su s upotrebom SGLT2 inhibitora. |
| Sažetak (engleski) | Objective: In this research we made analysis of suspected adverse reactions of GLP-1 agonists, DPP-4 inhibitors and SGLT2 inhibitors reported to the Agency for Medicinal Products and Medical Devices (HALMED) in Republic of Croatia in the period from 1 January 2010 to 31 December 2018.
Patients and Methods: Suspected adverse reactions data were obtained from a WHO global database – VigiBase. Following data were analyzed: year of report, qualifications of the person who reported adverse drug reaction, patient's age and sex, seriousness criteria, generic name of a drug and adverse drug reactions according to MedDRA system organ classification.
Results: In the observed period 217 suspected adverse drug reactions were reported. Adverse reactions were reported by female patients in 58.1% of cases. Liraglutide (GLP-1 receptor agonist) and sitagliptine (DPP-4 inhibitor) were both related to the highest number of adverse reactions, each representing 19.4% of total cases. The total number of adverse drug reactions for DPP-4 inhibitors group was 92 cases (42.4%), for GLP-1 agonists group 64 cases (29.5%) and for SGLT2 inhibitors group 61 cases (28.2%). The highest number of reported cases was in year 2017 (24.4%). Out of 217 reported suspected adverse drug reactions 38 (17.5%) were characterized as a serious. Doctors reported 51.2%, pharmacists 31.3% and patients 9.2% suspected adverse drug reactions. Most patients were in age group from 50 to 69 years (66%). The highest number of suspected adverse reactions, according to MedDRA classification, were reported for a gastrointestinal disorders group (20.3%), an injury, poisoning and procedural complications group (12.1%) and a nervous system disorders group (8.7%).
Conclusion: Adverse drug reactions are mostly being reported by health workers for female patients. The most of adverse drug reactions reports were for the patients from age group 60-69 years. The DPP-4 drugs group is mostly related to adverse drug reactions. Using GLP-1 receptor agonists, DPP-4 inhibitors and SGLT2 inhibitors in highest number of cases leads to gastrointestinal adverse reactions. Further research is needed to define the possible connection between the use of linagliptine and pancreatic cancer. Each case of urogenital disorder was related to SGLT2 inhibitors use. |
