ADVERSE DRUG REACTIONS OF HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS REPORTED TO AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES
Autori:
Nikica Mirošević Skvrce, Nada Božina, Viola Macolić Šarinić, Siniša Tomić
Sažetak
Sažetak. Inhibitori 3-hidroksi-3-metil-glutaril koenzim A reduktaze (statini) lijekovi su koji se primjenjuju u liječenju kroničnih bolesti i često u istodobnoj terapiji s mnogim drugim lijekovima te je mogućnost nastanka nuspojava, posebice onih uzrokovanih interakcijama, velika. Cilj ovog istraživanja bio je analizirati sve nuspojave statina prijavljene Agenciji za lijekove i medicinske proizvode od ožujka 2005. godine do 31. 12. 2008. te istaknuti moguće razloge njihova nastanka. Prijavljeno je 136 slučaja nuspojava statina. 12% svih prijavljenih nuspojava statina bilo je uzrokovano interakcijama, što je više od postotka nuspojava (5,6%) uzrokovanih interakcijama svih lijekova prijavljenih u 2005. i 2006. godini. Udio ozbiljnih nuspojava koje su povezane s primijenjenom dozom i prema tome se mogu spriječiti bio je veći od udjela svih prijavljenih ozbiljnih nuspojava statina (p=0,003). Najveći broj ozbiljnih nuspojava statina mogao je biti spriječen boljim poznavanjem interakcija te primjenom farmakogenomike koja može identificirati bolesnike koji su zbog genske predispozicije osjetljiviji na standardne doze lijeka.
Summary
Summary. Hydroxymethylglutaryl-CoA reductase inhibitors (statins) are drugs used in the treatment of chronic diseases and frequently in concomitant therapy with many other drugs. Therefore, the risk of adverse drug reactions (ADRs), especially those caused by interactions is high. Aim of the study was to describe and analyze ADRs caused by statins reported to Croatian Agency from March 2005 to December 2008, and to emphasize reasons of their occurrence. 136 of statin ADRs were reported. 12 % of all reported statins’ ADRs were caused by interactions, which is higher than percent (5.6%) of interactions caused by all other drugs in 2005 and 2006. Proportion of serious ADRs related to administered dose and thus preventable was higher than proportion of all ADRs caused by statins (p=0.003). Most serious ADRs could have been prevented with better understanding of interactions and by use of pharmacogenomics in identifying patients that are because of genetic predisposition more sensitive to standard doses.
