Author/Editor		Markovič, Saša; Bogdanovič, Sanja; Mrhar, Aleš
Title		Klinični, epidemiološki in farmakoekonomski vidiki zdravljenja resnih gastrointestinalnih zapletov pri uporabi NSAR
Translated title		Clinical, epidemiological and pharmacoeconomical aspects of serious gastrointestinal adverse events related to NSAID therapy
Type		članek
Source		Farm Vestn
Vol. and No.		Letnik 55, št. Poseb št
Publication year		2004
Volume		str. 137-52
Language		slo
Abstract		NSAIDs are indicated in osteo- and rheumatoid-arthritis treatment. These diseases are classified as the second most chronic condition in Slovenia that demands the visit of general practitioner. Due to their mechanism of action, i.e. inhibition of prostaglandines, NSAIDs cause gastrointestinal, renal and hematological adverse effects. Gastrointestinal toxicity includes dyspepsia, ulceration, and bleeding. Bleeding can be viewed as a serious gastrointestinal adverse event and is therefore elaborated in this contribution from clinical, epidemiological and pharmacoeconomic aspect. In clinical part, efficacy and gastrointestinal safety among different types of NSAIDs (nonselective inhibitors COX-1 and COX-2, COX-2 specific inhibitors) were compared. Safety was evaluated by monitoring ulceration with bleeding, while effectiveness was assessed by establishing the reduction of pain intensity, the improvement of patients estimation of the disease and the improvement of doctors estimation of patients response to the therapy. Metaanalysis of selected clinical studies on gastrointestinal toxicity showed that COX-2 specific inhibitors exhibit better safety in comparison to nonselective inhibitors COX-1 and COX-2 because of causing significantly less ulcerations with bleeding. Metaanalysis on eficacy demonstrated that both groups of drugs are comparable in this criterion. Epidemiologic part presents the results of our epidemiologic study that was performed at the Department for Gastroenterology of the Clinical Centre in Ljubljana. We identified 81 patients in the three-months period that had to be hospitalized for ulceration with bleeding because of being treated by NSDAIDs. (Abstract truncated at 2000 characters).
Summary		Bolezni gibal so v Sloveniji drugi najpogostejši vzrok za obisk splošnega zdravnika, zato se NSAR veliko uporabljajo. Zaradi zaviranja sinteze fizioloških zaščitnih prostaglandinov, NSAR povzročajo neželene učinke na prebavilih, motnje v delovanju ledvic in strjevanju krvi. Najpogosteje se neželeni učinki pojavijo na prebavilih. Zdravljenje krvavitev, ki so najpogostejši resni zaplet v prebavilih pri uživanju NSAR, smo želeli predstaviti s kliničnega, epidemiološkega in farmakoekonomskega vidika. V kliničnem segmentu smo primerjali gastrointestinalno vamost in učinkovitost neselektivnih NSAR in visoko selektivnih zaviralcev COX-2. Varnost smo ovrednotili glede na nastanek klinično pomembnih peptičnih razjed, ki predstavljajo resne neželene učinke NSAR. Učinkovitost smo ovrednotili preko treh opazovanih ciljev: zmanjšanje intenzitete bolečine, izboljšanje preiskovančeve ocene bolezni ter izboljšanje preiskovalčeve ocene odziva bolnika na terapijo. Metaanaliza izbranih kliničnih študij o gastrointestinalni varnosti obeh skupin zdravil je pokazala, da so visoko selektivni zaviralci COX-2 v primerjavi z neselektivnimi NSAR varnejši za zgornja prebavila, saj povzročajo statistično pomembno manj razjed. Metaanaliza učinkovitosti pa je pokazala, da je učinkovitost NSAR in visoko selektivnih zaviralcev COX-2 med seboj primerljiva, in da med skupinama ni statistično pomembnih razlik. V epidemiološkem segmentu smo predstavili rezultate lastne epidemiološke raziskave, ki smo jo izvedli na Kliničnem oddelku za gastroenterologijo Kliničnega centra v Ljubljani. Po naših podatkih je bilo v obdobju treh mesecev zaradi gastrointestinalnih krvavitev, povezanih z uživanjem NSAR, hospitaliziranih 81 bolnikov. Na podlagi naših rezultatov smo ocenili, da se v Sloveniji zaradi tovrstnih zapletov zdravi 1073 bolnikov letno. (Izvleček skrajšan pri 2000 znakih).
Descriptors		ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL GASTROINTESTINAL HEMORRHAGE PEPTIC ULCER ANTI-ULCER AGENTS PEPTIC ULCER HEMORRHAGE SLOVENIA META-ANALYSIS