Naslov
Assessment of adverse drug reaction reports : metformin and metformin fixed drug combinations

Autori
Larsen Matić, Ina

Vrsta, podvrsta i kategorija rada
Ocjenski radovi, diplomski rad, diplomski

Fakultet
Medicinski fakultet

Mjesto
Split

Datum
17.07

Godina
2019

Stranica
47

Mentor
Božić, Joško

Ključne riječi
Metformin, Drug-Related Side Effects and Adverse Reactions, Pharmacovigilance, Adverse Drug Reaction Reporting Systems

Sažetak
Objectives: The aim of the present study was to compare adverse drug reaction reports of metformin and metformin in fixed combination in Croatia from 2007 to 2018. Materials and Methods: The data of adverse drug reaction reports received from 1 January 2007 to 31 December 2018 was analyzed in this retrospective study. Metformin reports were categorized into two main groups: single‐drug formulations and fixed‐dose combinations of drugs. The data of the year of the adverse drug reaction report, reporter qualification, patient age and gender, adverse drug reaction seriousness and other medication in therapy was included. Results: During the examined period the number of the metformin adverse drug reactions reports was 377 (70.3%) and metformin in combinations had 159 (29.7%) reported adverse drug reactions. Overall, this accounts for 536 adverse drug reaction reports included in this study. Majority of all the reports were provided by physicians. Female consumers reported a largest proportion of adverse drug reactions when compared to male consumers. Most of the reports were obtained by elderly, and included concomitant drug in therapy, other than suspected metformin or metformin in combination. Most commonly reported drug combination was metformin and vildagliptin, which were included in 55 of the reports. Majority of the reports, 87.1 %, included adverse drug reaction classified as non-serious and lactic acidosis was reported in 1% of the cases. Conclusion: Metformin was more frequently reported than metformin in combinations during the examined period. However, as the market of hypoglycemic drug combinations will probably rise in the future, the education of all the interested parties should be proposed in order to monitor safety of newly introduced drugs.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA