Avtor/Urednik		Barbič-Žagar, Breda
Naslov		Učinkovitost in varnost Vasilipa pri bolnikih s hiperholesterolemijo
Prevedeni naslov		The efficacy and safety of Vasilip in patients with hypercholesterolemia
Tip		članek
Vir		Krka Med Farm
Vol. in št.		Letnik 23, št. 33
Leto izdaje		2002
Obseg		str. 33-49
Jezik		slo
Abstrakt		Vasilip (simvastatin) belongs to the group of HMG CoA reductase inhibitors, the primary effect of which is lowering of the total cholesterol and LDL cholesterol blood levels. In addition to this primary effect, simvastatin lowers the triglyceride and increases the HDL cholesterol blood levels. It prevents disease-related complications and reduces mortality in patients with ischemic heart disease. Contributing to this action is its slowing effect on the process of atherosclerosis. Namely, in addition to their effects on the blood lipid levels, HMG CoA reductase inhibitors were shown to possess other, non-lipid (pleiotropic) effects that may contribute to the stabilisation of the atherosclerotic plaque, improve endothelial function, influence the process of platelet aggregation and reduce inflammation. Krka launched Vasilip (simvastatin tablets) in Slovenia in the summer of 1999. At present, Vasilip is successfully marketed in all Krka's traditional markets (Poland, the Czech Republic, Slovakia, Russia, Croatia, the Baltic republics, Ukraine, Romania and Macedonia). In addition to a bioequivalence study which furnished evidence that the bioavailability of Vasilip produced by Krka is completely comparable to that of the original simvastatin, a few comparable and open clinical trials (in 470 patients) have already been concluded. Postmarketing studies including more than 700 patients are currently under way. Treatment with Vasilip (in daily doses of 10-20 mg administered to patients included in primary prevention, and in daily doses of 20-40 mg administered to patients included in secondary prevention) resulted in favourable, statistically significant changes in the serum levels of atherogenic and protective lipoproteins. (Abstract truncated at 2000 characters).
Izvleček		Vasilip (simvastatin) spada v skupino zaviralcev reduktaze HMG CoA, katerih osnovni učinek je zmanjševanje skupnega holesterola in holesterola LDL v krvi. Zdravilo zmanjša tudi koncentracijo trigliceridov in povečuje koncentracijo holesterola HDL v krvi. Preprečuje bolezenski zaplet pri bolnikih z ishemično boleznijo srca in zmanjšuje njihovo smrtnost. K temu prispeva njegov učinek na upočasnjevanje procesa ateroskleroze. Zaviralci reduktaze HMG CoA ne vplivajo samo na vsebnost lipidov v krvi, temveč delujejo tudi nelipidno (pleiotropno), kar prispeva k stabilizaciji aterosklerotične lehe; izboljšajo tudi endotelno funkcijo, vplivajo na agregacijo trombocitov in zmanjšujejo vnetje. Krka je Vasilip (tablete, ki vsebujejo simvastatin) slovenskemu trgu ponudila poleti 1999. Danes se Vasilip uspešno trži že na vseh Krkinih tradicionalnih trgih (Poljska, Češka, Slovaška, Rusija, Hrvaška, pribaltske države, Ukrajina, Romunija, Makedonija). Poleg bioekvivalenčne raziskave, s katero smo dokazali, da je Krkin Vasilip glede biološke uporabnosti popolnoma primerljiv z originalnim simvastatinom, smo že končali nekaj kliničnih primerjalnih in odprtih raziskav (470 bolnikov). Trenutno potekajo poregistracijske klinične raziskave, v katere je vključenih več kot 700 bolnikov. Ob zdravljenju z Vasilipom (v dnevnih odmerkih po 10 do 20 mg v skupini bolnikov, vključenih v primarno preprečevanje, in po 20 do 40 mg v skupini bolnikov, vključenih v sekundarno preprečevanje) je prišlo do ugodnih statistično pomembnih sprememb serumskih vrednostih aterogenih in varovalnih lipoproteinov. Koncentracija skupnega holesterola se je relativno zmanjšala za 24 do 27%, holesterola LDL za 33,4 do 37%, trigliceridov za 5,4 do 17%, koncentracija holesterola HDL pa se je relativno povečala za 5 do 9%. (Izvleček skrajšan pri 2000 znakih).
Deskriptorji		HYPERCHOLESTEROLEMIA HMG-COA REDUCTASE INHIBITORS CHOLESTEROL LIPOPROTEINS, HDL CHOLESTEROL LIPOPROTEINS, LDL CHOLESTEROL TREATMENT OUTCOME DRUG EVALUATION CLINICAL TRIALS CORONARY DISEASE VASODILATION BRACHIAL ARTERY