natgillin/translations-raw huggingface dataset:
Ingestion of vorapaxar with a high-fat meal resulted in no meaningful change in AUC with a small (21%) decrease in Cmax and delayed tmax (45 minutes).
Uzimanje vorapaksara uz obrok s visokim udjelom masnoća nije dovelo do značajne promjene AUC-a, uz malo (21%) snižavanje Cmax i produljeni tmax (45 minuta).
Acetylsalicylic acid, vorapaxar, and clopidogrel in combination produced significant prolongation of bleeding time.
Kombinacija acetilsalicilatne kiseline, vorapaksara i klopidogrela značajno je produljila vrijeme krvarenja.
Zontivity is contraindicated in patients with severe hepatic impairment (Child Pugh, 10 to 15 points) (see sections 4.3 and 4.4).
Zontivity je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh: 10-15 bodova) (vidjeti dijelove 4.3 i 4.4).
Based on population pharmacokinetic analysis using data from healthy subjects and patients with atherosclerotic disease, vorapaxar mean AUC is estimated to be higher in patients with mild (17%) and moderate (34%) renal impairment compared to those with normal renal function; these differences are not considered to be clinically relevant.
Na temelju populacijske farmakokinetičke analize podataka prikupljenih u zdravih ispitanika i bolesnika s aterosklerotskom bolešću, procjenjuje se da je srednja vrijednost AUC-a vorapaksara veća u bolesnika s blagim (17%) i umjerenim (34%) oštećenjem funkcije bubrega nego u ispitanika s normalnom funkcijom bubrega; te se razlike ne smatraju klinički značajnima.
Phase 3 data suggest that co-administration of a weak or moderate CYP3A inhibitor with vorapaxar does not increase bleeding risk or alter the efficacy of vorapaxar.
Podaci iz ispitivanja faze 3 upućuju na to da istodobna primjena slabog ili umjerenog inhibitora CYP3A s vorapaksarom ne povećava rizik od krvarenja i ne mijenja djelotvornost vorapaksara.
• having another heart attack or stroke
• ponovnog srčanog udara ili moždanog udara,
HR 95% CI p-value (Z) vs (P) 0.83 (0.76, 0.90) <.001
HR 95% CI p-vrijednost Zontivity naspram placeba 0,83 (0,76; 0,90) <0,001
Zontivity prevents platelets from sticking together.
Zontivity sprječava da se krvne pločice zalijepe jedna za drugu.
Concomitant use of Zontivity with strong (potent) inducers of CYP3A (e.g., rifampin, carbamazepine and phenytoin) should be avoided.
Treba izbjegavati istodobnu primjenu lijeka Zontivity s potentnim induktorima CYP3A (npr. rifampinom, karbamazepinom i fenitoinom).
Elderly No dose adjustment is necessary in the elderly (see sections 4.4 and 5.2).
Nije potrebno prilagođavati dozu u starijih osoba (vidjeti dijelove 4.4 i 5.2).
Vorapaxar exposure (AUC and Cmax) in patients of African descent is estimated to be 17-19% lower compared to that of Caucasians.
Procjenjuje se da je izloženost vorapaksaru (AUC i Cmax) u bolesnika afričkog podrijetla 17-19% niža nego u bijelaca.
Vorapaxar did not increase bleeding time in non-human primates when administered alone at 1 mg/kg.
Vorapaksar nije produljio vrijeme krvarenja u nečovjekolikih primata kada se primjenjivao samostalno u dozi od 1 mg/kg.
• unexpected bleeding or bleeding that lasts a long time
• neočekivano ili dugotrajno krvarenje,
Due to the unknown potential for adverse reactions in breast-feeding infants from Zontivity, discontinue breast-feeding or discontinue Zontivity; taking into account the importance of the medicinal product to the mother.
Budući da nije poznato može li Zontivity uzrokovati nuspojave u dojenčadi, potrebno je prekinuti ili dojenje ili primjenu lijeka Zontivity, uzimajući u obzir važnost lijeka za majku.
Co-administration of an aluminium hydroxide/magnesium carbonate antacid or proton pump inhibitor (pantoprazole) did not affect vorapaxar AUC with only small decreases in Cmax.
Istodobna primjena antacida koji sadrži aluminijev hidroksid/magnezijev karbonat ili inhibitora protonske pumpe (pantoprazola) nije utjecala na AUC vorapaksara, uz tek neznatno snižavanje Cmax.
CV Death
Smrt zbog KV uzroka
Vorapaxar does not inhibit platelet aggregation induced by other agonists such as adenosine diphosphate (ADP), collagen or a thromboxane mimetic.
Vorapaksar ne inhibira agregaciju trombocita induciranu drugim agonistima kao što su adenozin difosfat (ADP), kolagen ili tromboksanski mimetici.
Bleeding was the most common adverse reaction leading to study drug discontinuation for both treatments (3.0% for Zontivity and 1.8% for placebo).
Kod oba je liječenja krvarenje bila najčešća nuspojava koja je dovodila do prekida primjene ispitivanoga lijeka (3,0% uz Zontivity te 1,8% uz placebo).
Patients with events
Bolesnici s događajima
If you are not sure, talk to your doctor or pharmacist before taking Zontivity.
Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Zontivity.
When Zontivity was co-administered with warfarin, there were no alterations in the pharmacokinetics or pharmacodynamics of warfarin.
Kada se Zontivity primjenjivao istodobno s varfarinom, nije bilo promjena u farmakokinetici ili farmakodinamici varfarina.
Patients with events*
Bolesnici s događajima*
No dose adjustment is necessary (see section 4.4).
Nije potrebno prilagođavati dozu (vidjeti dio 4.4).
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava anemija
Zontivity increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
Zontivity povećava rizik od krvarenja proporcionalno bolesnikovu već postojećem riziku od krvarenja.
In repeat dose oral toxicity studies in rodents and monkeys, the principal treatment-related findings were urinary bladder and ureter hyperplasia in mice, hepatic vascular thrombi, lymphoid necrosis and retinal vacuolation in rats and phospholipidosis in all species.
U ispitivanjima toksičnosti ponovljenih doza u glodavaca i majmuna, osnovni nalazi povezani s terapijom bili su hiperplazija mokraćnog mjehura i uretera u miševa, trombi u jetrenim krvnim žilama, limfoidna nekroza i retinalna vakuolizacija u štakora te fosfolipidoza u svih vrsta.
• vomiting blood or your vomit looks like ‘coffee grounds'
• povraćanje krvi ili povraćanje sadržaja koji nalikuje talogu kave,
Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
Pokazalo se da Zontivity smanjuje stopu mjere kombiniranog ishoda - smrti zbog kardiovaskularnog uzroka te nastupa IM-a, moždanog udara i hitne koronarne revaskularizacije (engl. urgent coronary revascularization, UCR).
Bleeding time was prolonged slightly with administration of acetylsalicylic acid alone or in combination with vorapaxar.
Vrijeme krvarenja bilo je blago produljeno nakon primjene acetilsalicilatne kiseline same ili u kombinaciji s vorapaksarom.
The overall no effect level for the pre- and postnatal development effects was 5 mg/kg/day (6.8-times [female animals] the human steady-state exposure at 2.5 mg/day).
Ukupna razina pri kojoj nisu primijećeni učinci na prenatalni i postnatalni razvoj iznosila je 5 mg/kg/dan (izloženost 6,8 puta veća [ženke životinja] od izloženosti u ljudi u stanju dinamičke ravnoteže nakon primjene doze od 2,5 mg/dan).
Pharmacokinetics of vorapaxar are similar between patients with mild (Child Pugh, 5 to 6 points) to moderate (Child Pugh, 7 to 9 points) hepatic impairment and healthy patients.
Farmakokinetika vorapaksara slična je u bolesnika s blagim (Child-Pugh: 5-6 bodova) do umjerenim (Child-Pugh: 7-9 bodova) oštećenjem funkcije jetre i zdravih ispitanika.
Phospholipidosis occurs at acceptable human to animal safety margins and was reversible.
Pojava fosfolipidoze bila je unutar prihvatljivih sigurnosnih margina s obzirom na omjer izloženosti između životinja i ljudi, te je bila reverzibilna.
The effects of renal (end-stage renal disease undergoing haemodialysis) and hepatic impairment on the pharmacokinetics of vorapaxar were evaluated in specific pharmacokinetic studies and are summarized below:
Učinci oštećenja funkcije bubrega (bolesnici u terminalnoj fazi bubrežne bolesti na hemodijalizi) i oštećenja funkcije jetre na farmakokinetiku vorapaksara ocjenjivani su u specifičnim farmakokinetičkim ispitivanjima, a sažeto prikazani u nastavku:
Inhibition of TRAP-induced platelet aggregation at a level of ≥80% may last for 2 to 4 weeks after discontinuation of daily doses of vorapaxar sulfate 2.5 mg.
Inhibicija TRAP-om inducirane agregacije trombocita na razini od ≥ 80% može potrajati 2 do 4 tjedna nakon prekida primjene dnevne doze vorapaksarsulfata od 2,5 mg.
The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Sistemska farmakokinetika vorapaksara je linearna, uz kumulaciju (šesterostruku) koja se može predvidjeti na temelju podataka o primjeni jednokratne i višestrukih doza.
No vorapaxar-related tumours were observed in 2-year rat and mouse studies at oral doses up to 30 mg/kg/day in rats and 15 mg/kg/day in mice (8.9 and 30 times the recommended therapeutic exposures in humans based on plasma exposure to vorapaxar for rats and mice, respectively).
Nisu primijećeni tumori povezani s primjenom vorapaksara u 2-godišnjim ispitivanjima u štakora i miševa, u kojima su se primjenjivale peroralne doze do 30 mg/kg/dan u štakora odnosno do 15 mg/kg/dan u miševa (izloženost 8,9 odnosno 30 puta veća od preporučene terapijske izloženosti u ljudi na temelju izloženosti vorapaksaru u plazmi štakora odnosno miševa).
Zontivity increases the risk of bleeding, including ICH and sometimes fatal bleeding.
Zontivity povećava rizik od krvarenja, uključujući intrakranijalno krvarenje te ponekad krvarenje sa smrtnim ishodom.
Pre and postnatal studies in rats only showed some inconsistent developmental effects at exposures sufficiently in excess of human exposure at the RHD of 2.08 mg vorapaxar.
Prenatalna i postnatalna ispitivanja u štakora pokazala su samo neke nedosljedne učinke na razvoj pri razinama izloženosti dovoljno većima od izloženosti u ljudi nakon primjene preporučene doze vorapaksara od 2,08 mg.
The composite of cardiovascular death, MI, and stroke were assessed as secondary endpoint.
Smrt zbog kardiovaskularnog uzroka, IM i moždani udar objedinjeno su procjenjivani kao mjera sekundarnog ishoda.
In vitro metabolism studies demonstrate that vorapaxar is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
In vitro ispitivanja metabolizma pokazuju da nije vjerojatno da će vorapaksar uzrokovati klinički značajnu inhibiciju humanog CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6.
• itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
• itrakonazol, ketokonazol, posakonazol (koriste se za liječenje gljivičnih infekcija),
Severe hepatic impairment increases the risk of bleeding; therefore, the use of Zontivity in these patients is contraindicated (see sections 4.2 and 5.2).
Teško oštećenje funkcije jetre povećava rizik od krvarenja; stoga je primjena lijeka Zontivity u tih bolesnika kontraindicirana (vidjeti dijelove 4.2 i 5.2).
Strong CYP3A inducers
Potentni induktori CYP3A
No clinically relevant differences in vorapaxar pharmacokinetics were observed following daily co-administration of an aluminium hydroxide/magnesium carbonate antacid or pantoprazole (a proton pump inhibitor).
Nisu primijećene klinički značajne razlike u farmakokinetici vorapaksara nakon istodobne svakodnevne primjene antacida koji sadrži aluminijev hidroksid/magnezijev karbonat ili pantoprazola (inhibitora protonske pumpe).
When Zontivity was co-administered with prasugrel, no clinically significant pharmacokinetic interaction was demonstrated.
Kada se Zontivity primjenjivao istodobno s prasugrelom, nije primijećena klinički značajna farmakokinetička interakcija.
• clarithromycin, telithromycin (used to treat infections)
• klaritromicin, telitromicin (koriste se za liječenje infekcija),
Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).
Zbog ograničenog terapijskog iskustva i povišenog inherentnog rizika od krvarenja u bolesnika s teškim oštećenjem funkcije jetre, Zontivity je u tih bolesnika kontraindiciran (vidjeti dijelove 4.3, 4.4 i 5.2).
In the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, comprising patients with a NSTEACS (non-ST segment elevation acute coronary syndrome) who were largely antiplatelet naive, vorapaxar, with a loading dose of 40 mg and then maintained at 2.5 mg/day in addition to standard of care, initiated within 24 hours of NSTEACS, did not achieve its primary efficacy endpoint (cardiovascular death, MI, stroke, urgent coronary revascularization, and recurrent ischemia with rehospitalisation) and there was an increased risk of GUSTO moderate or severe bleeding.
Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome), u kojem su sudjelovali bolesnici s akutnim koronarnim sindromom bez elevacije ST-spojnice (engl. non-ST segment elevation acute coronary syndrome, NSTEACS) koji prethodno pretežno nisu primali antitrombocitne lijekove, liječenje vorapaksarom započeto udarnom dozom od 40 mg unutar 24 sata nakon NSTEACS-a i zatim nastavljeno dozom od 2,5 mg/dan uz standardnu terapiju nije postiglo primarnu mjeru ishoda za djelotvornost (smrt zbog kardiovaskularnog uzroka, IM, moždani udar, hitna koronarna revaskularizacija i rekurentna ishemija s rehospitalizacijom), a postojao je i povećan rizik od umjerenog ili teškog krvarenja prema GUSTO kriterijima.
In the cohort of post-MI or PAD patients with no history of stroke or TIA, the net clinical outcome analysis based on multiple occurrences of endpoints (CV Death/MI/Stroke/GUSTO Severe) is constant over time at each of the censoring times examined (12, 18, 24, 30, and 36 months) at cumulative 6-month intervals.
U kohorti bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIAu, rezultat analize neto kliničkog ishoda, temeljen na višestrukim nastupima ishoda (smrt zbog KV uzroka/IM/moždani udar/teško prema GUSTO kriterijima), tijekom vremena je konstantan za svaki ispitivani cenzurirajući interval (12, 18, 24, 30 i 36 mjeseci) u kumulativnim 6-mjesečnim intervalima. (Vidjeti Tablicu 5).
Based upon in vitro data, chronic administration of vorapaxar is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
In vitro podaci pokazuju da nije vjerojatno da će kronična primjena vorapaksara inducirati metabolizam lijekova koji se metaboliziraju posredstvom glavnih CYP izoformi.
The percentages of patients who underwent CABG surgery and had CABG-related bleeds are shown in Table 3.
Postotak bolesnika koji su bili podvrgnuti CABG-u i koji su imali krvarenje vezano uz CABG prikazan je u Tablici
It is not known whether vorapaxar is excreted in human breast milk.
Nije poznato izlučuje li se vorapaksar u majčino mlijeko.
Concomitant use of Zontivity with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) should be avoided.
Nužno je izbjegavati istodobnu primjenu lijeka Zontivity sa potentnim inhibitorima CYP3A (npr. ketokonazolom, itrakonazolom, posakonazolom, klaritromicinom, nefazodonom, ritonavirom, sakvinavirom, nelfinavirom, indinavirom, boceprevirom, telaprevirom, telitromicinom i konivaptanom).
In post-MI and PAD patients, the median duration of treatment with Zontivity in these patients was 2.5 years (up to 4 years).
U bolesnika koji su pretrpjeli IM i bolesnika s PAD-om, medijan trajanja liječenja lijekom Zontivity iznosio je 2,5 godine (najviše 4 godine).
• double vision
• dvoslike,
What Zontivity is
Što je Zontivity
• carbamazepine, phenytoin (anti-seizure medicines)
• karbamazepin, fenitoin (lijekovi protiv napadaja),
Effects of vorapaxar on other medicinal products
Učinci vorapaksara na druge lijekove
However, if a patient is to undergo elective surgery, if clinically feasible, Zontivity should be discontinued at least 30 days prior to surgery.
Međutim, u slučaju elektivnog kirurškog zahvata, primjena lijeka Zontivity mora se prekinuti najkasnije 30 dana prije kirurškoga zahvata, ako je to klinički izvedivo.
Although the TRA 2°P - TIMI 50 trial was not designed to evaluate the relative benefit of Zontivity in individual patient subgroups, the benefit was most apparent in patients who were enrolled on the basis of a recent MI as indicated by a history of spontaneous MI ≥2 weeks but 12 months prior (post-MI or PAD patient population) with no history of stroke or TIA.
Iako ispitivanje TRA 2°P - TIMI 50 nije bilo dizajnirano da ocijeni relativnu korist lijeka Zontivity u pojedinačnim podskupinama bolesnika, korist je bila najizraženija u bolesnika koji su bili uključeni u ispitivanje na temelju nedavnog IM-a, definiranog kao spontani IM ≥2 tjedna, ali 12 mjeseci prije početka ispitivanja (populacija bolesnika koji su pretrpjeli IM ili imaju PAD), a koji u anamnezi nisu imali moždani udar ni TIA-u.
The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Filmom obložene tablete su žute, ovalne, veličine 8,48 mm x 4,76 mm, s oznakom "351" na jednoj i logotipom tvrtke MSD na drugoj strani.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza "Rok valjanosti" ili na blisteru iza "EXP".
• have ever had stomach ulcers or small growths in your gut (‘colon polyps')
• ste ikada imali vrijed (čir) na želucu ili malene izrasline u crijevima (polipe u debelom crijevu),
If you have a stroke, ‘mini-stroke', or bleeding in the brain while taking Zontivity, your doctor ought to stop your Zontivity.
Ako za vrijeme uzimanja lijeka Zontivity doživite moždani udar, mali moždani udar ili krvarenje u mozgu, liječnik bi morao prekinuti njegovu primjenu.
A history of bleeding disorders and use of certain concomitant medicinal products (e.g., anticoagulant and fibrinolytic therapy, and chronic nonsteroidal anti-inflammatory drugs (NSAIDS), selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) may also increase the risk of bleeding in patients taking Zontivity.
Poremećaji hemostaze u anamnezi te istodobna primjena određenih lijekova (npr. antikoagulantna i fibrinolitička terapija te trajna primjena nesteroidnih protuupalnih lijekova (NSAIL), selektivnih inhibitora ponovne pohrane serotonina ili inhibitora ponovne pohrane serotonina i noradrenalina) također mogu povećati rizik od krvarenja u bolesnika koji uzimaju Zontivity.
Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care.
Bolesnici koji uzimaju Zontivity moraju također uzimati acetilsalicilatnu kiselinu, s klopidogrelom ili bez njega, sukladno indikaciji ili standardima liječenja.
• antacids and pantoprazole (used to treat upset stomach)
• antacide i pantoprazol (koriste se za liječenje želučanih tegoba),
Hazard Ratio and p-value were calculated based on Andersen-Gill model with covariates treatment and stratification factor (planned thienopyridine use).
Omjer rizika i p-vrijednosti izračunate su temeljem Andersen-Gill modela s kovarijantama liječenja i stratifikacijskim faktorom (planirana uporaba tienopiridina).
In the TRA 2ºP-TIMI 50 trial, although CABG-related TIMI major bleeding was observed in patients taking vorapaxar (see section 4.8), patients who continued therapy with vorapaxar while undergoing CABG did not show an increased risk of major bleeding compared to placebo.
Iako je u ispitivanju TRA 2ºP - TIMI 50 u bolesnika liječenih vorapaksarom primijećeno obilno krvarenje vezano uz CABG prema TIMI kriterijima (vidjeti dio 4.8), bolesnici koji su nastavili liječenje vorapaksarom tijekom CABG-a nisu imali povećan rizik od obilnog krvarenja u usporedbi s bolesnicima koji su primali placebo.
Among post-MI or PAD patients without a history of stroke or TIA, Zontivity appeared to reduce the rate of definite stent thrombosis (HR 0.71 (0.51-0.99 for adjudicated “definite”) vs. placebo in subjects receiving any stent before or during the study.
Među bolesnicima koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u, Zontivity je, čini se, smanjio stopu potpune tromboze stenta (HR 0,71 (0,51-0,99 za događaj ocijenjen kao "definitivan") naspram placeba u ispitanika kojima je bio ugrađen bilo kakav stent prije ili tijekom ispitivanja.
Table 1: Tabulated List of Adverse Reactions
Tablica 1: Tablični prikaz nuspojava
• have had recent bleeding from the stomach or gut
• ste nedavno imali krvarenje u želucu ili crijevima,
• bleeding that is severe or that you cannot control
• teško krvarenje ili krvarenje koje ne možete zaustaviti,
At a dose of 2.5 mg of vorapaxar sulfate (equivalent to 2.08 mg vorapaxar) daily, vorapaxar consistently achieves ≥80% inhibition of TRAP-induced platelet aggregation within one week of initiation of treatment.
Pri dozi vorapaksarsulfata od 2,5 mg na dan (što odgovara 2,08 mg vorapaksara), vorapaksar dosljedno ostvaruje inhibiciju TRAP-om inducirane agregacije trombocita od ≥ 80% unutar tjedana dana od početka liječenja.
No effects on fertility were observed in animal studies (see section 5.3).
U ispitivanjima na životinjama nisu primijećeni učinci na plodnost (vidjeti dio 5.3).
Co-administration of vorapaxar (40 mg) and digoxin (0.5 mg single-dose) increased digoxin Cmax and AUC by 54% and 5%, respectively.
Istodobna primjena vorapaksara (40 mg) i digoksina (jednokratna doza od 0,5 mg) povisila je Cmax digoksina za 54%, a njegov AUC za 5%.
After oral administration of a single vorapaxar sulfate 2.5 mg dose, vorapaxar is rapidly absorbed and peak concentrations occur at a median tmax of 1 hour (range: 1 to 2) under fasted conditions.
Nakon peroralne primjene jednokratne doze vorapaksarsulfata od 2,5 mg, vorapaksar se brzo apsorbira, a vršne se koncentracije postižu u medijanu tmax od 1 sata (raspon: 1 do 2) nakon primjene natašte.
Withholding Zontivity for a brief period will not be useful in preventing or managing an acute bleeding event because of its long half-life (see section 5.2).
Zbog dugog poluvijeka lijeka Zontivity, kratkotrajan prekid njegove primjene neće pridonijeti sprječavanju ni zbrinjavanju događaja akutnoga krvarenja (vidjeti dio 5.2).
Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.400.86]; P=0.007) than patients randomized to placebo.
Bolesnici koji u anamnezi imaju PAD, ali ne i moždani udar ili TIA-u, a koji su randomizirani da primaju vorapaksar imali su manji broj postupaka periferne revaskularizacije (15,4% naspram 19,3%, 3-godišnje stope po Kaplan-Meieru; HR 0,82 [0,71-0,94, 95% CI]; P=0,005) i manji broj hospitalizacija zbog akutne ishemije ekstremiteta (2,0% naspram 3,3%; HR 0,59 [0,40-0,86]; P=0,007) nego bolesnici randomizirani da primaju placebo.
Of these patients, 10,080 received Zontivity (8,458 post-MI and 1,622 PAD) and 10,090 received placebo (8,439 post-MI and 1,651 PAD) in addition to standard of care, including antiplatelet therapy with acetylsalicylic acid and thienopyridine.
Među tim je bolesnicima njih 10 080 primalo Zontivity (8458 pretrpjelo IM, a 1622 ima PAD), a njih 10 090 placebo (8439 pretrpjelo IM, a 1651 ima PAD) kao dodatak standardnoj terapiji, uključujući antitrombocitnu terapiju acetilsalicilatnom kiselinom i tienopiridinom.
Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Bolesnici koji uzimaju Zontivity moraju također uzimati acetilsalicilatnu kiselinu ili klopidogrel sukladno indikaciji ili standardima liječenja.
Randomization to 12 months Total Events
Randomizirano do 12 mjeseci