Kardiovaskularna sigurnost oralnih antidijabetika. (Croatian)

Cardiovascular Safety of Oral Antidiabetic Drugs. (English)

Croatia belongs to a group of European countries with a high cardiovascular risk and growing prevalence of diabetes mellitus type 2 (DMT2). According to data of the National Diabetes Registry (CroDiab registry), a total of 254,296 individuals aged >18 suffering from diabetes were registered in 2014 (7.9%). Along with hypertension and hyperlipidemia, DMT2 is one of the leading cardiovascular risk factors. Prompted by adverse cardiovascular effects of rosiglitazone, demonstrated in the RECORD study and subsequent meta-analyses, the main drug regulatory agencies require clinical trials of the effect on cardiovascular outcomes and safety evidence for all antidiabetic drugs. On assessing the effects of antidiabetic drugs on cardiovascular risk, the two-sided confidence interval upper borderline value of 95% (95% CI) is highly relevant for the estimated risk ratio. Additional safety testing is required for all antidiabetic drugs with the risk ratio upper limit ≥1.3. Cardiovascular safety of oral antidiabetic drugs is of special importance in patients with heart failure. Considering the great number of antidiabetic drugs on the market, decision on optimal DMT2 therapy should be made in dependence of specific characteristics of each individual patient and cardiovascular risk assessment. [ABSTRACT FROM AUTHOR]

Hrvatska pripada skupini europskih zemalja s visokim kardiovaskularnim rizikom i rastućom prevalencijom šećerne bolesti tipa 2 (DMT2). Prema podatcima Nacionalnog registra osoba sa šećernom bolešću (CroDiab registar), u Hrvatskoj je 2014. godine bilo evidentirano ukupno 254 296 osoba oboljelih od dijabetesa starijih od 18 godina (7,9 %). DMT2 je, uz hipertenziju i hiperlipidemiju, jedan od vodećih čimbenika kardiovaskularnog rizika. Glavne regulatorne agencije za lijekove, potaknute štetnim kardiovaskularnim učincima rosiglitazona u RECORD studiji i kasnijim metaanalizama, zahtijevaju za sve antidijabetike kliničke pokuse o utjecaju na kardiovaskularne ishode i dokaze o sigurnosti. U procjeni učinka antidijabetika na kardiovaskularni rizik važna je gornja granična vrijednost dvostranog intervala pouzdanosti od 95 % (95 % CI) za procijenjeni omjer rizika. Svi antidijabetici s gornjom granicom omjera rizika ≥ 1,3 zahtijevaju dodatne sigurnosne provjere. Kardiovaskularna sigurnost oralnih antidijabetika posebno je važna u bolesnika sa zatajivanjem srca. S obzirom na veliki broj antidijabetika na tržištu, odluka o optimalnom liječenju DMT2 treba ovisiti o svim individualnim karakteristikama bolesnika i procijenjenom kardiovaskularnom riziku. [ABSTRACT FROM AUTHOR]

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