natgillin/translations-raw huggingface dataset:
In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Za razliku od toga, post-hoc analize pokazale su statistički značajno povećanje rizika od krvarenja kod jačih inhibitora P2Y12, koje se većinom javljalo tijekom faze održavanja, nakon prvog mjeseca poslije ASC-a.
UNIQUE IDENTIFIER - 2D BARCODE
JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition.
Trebalo Vam je biti rečeno da su za ovo stanje „oralni antikoagulansi“ učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene klopidogrela i acetilsalicilatne kiseline.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
Ovo randomizirano, otvoreno ispitivanje uključivalo je 2.610 bolesnika s ACS-om pozitivnim na biomarkere nakon uspješnog PCI-ja.
Core:
Jezgra:
Secondary prevention of atherothrombotic events
Sekundarna prevencija aterotrombotičkih događaja
Marketing Authorisation Holder and Manufacturers:
Nositelj odobrenja za stavljanje lijeka u promet i proizvođači:
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years.
Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤75 godina.
• Your doctor may order blood tests.
• Liječnik će možda odrediti da Vam se naprave pretrage krvi.
TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Ispitivanja TOPIC i TROPICAL-ACS osmišljena su da ispitaju kako se pojava krvarenja može ublažiti uz zadržavanje djelotvornosti.
4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Klopidogrel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Clopidogrel Apotex contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel Apotex sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
Your doctor should have prescribed Clopidogrel plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik Vam treba propisati klopidogrela i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Farmakoterapijska skupina: inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Detalijne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies,and showed no genotoxic activity.
Klopidogrel je testiran u mnogim genotoksičnim studijama in vivo i in vitro i nije pokazao genotoksičnu aktivnost.
• Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
• Odrasli i starije osobe Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2 CYP2B6 and CYP3A4.
Aktivni metabolit nastaje većinom putem CYP2C19 uz sudjelovanje nekoliko drugih CYP enzima, uključujući CYP1A2, CYP2B6 i CYP3A4.
The de-escalated patients underwent high platelet reactivity (HPR) testing.
Deeskalirani bolesnici podvrgnuti su testiranju visoke reaktivnosti trombocita (HPR).
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Apotex.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Clopidogrel Apotexom.
If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Ako je HPR bio ≥46 jedinica, bolesnici su ponovno eskalirani na prasugrel od 5 ili 10 mg/dan tijekom 11,5 mjeseci; ako je HPR bio <46 jedinica, bolesnici su nastavili liječenje klopidogrelom od 75 mg/dan tijekom 11,5 mjeseci.
If you forget to take a dose of Clopidogrel Apotex, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu Clopidogrel Apotexa, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
If you become pregnant while taking Clopidogrel Apotex, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja Clopidogrel Apotexa, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
Apotex Polska Sp. z o.o.
Apotex Polska Sp. z o.o. Polsce
You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
imate nepravilne otkucaje srca, stanje koje se zove "fibrilacija atrija", a ne možete uzimati lijekove poznate kao 'oralni antikoagulansi' (antagonisti vitamina K), koji sprječavaju stvaranje novih ugrušaka te rast postojećih ugrušaka.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Apotex in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Clopidogrel Apotex u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
hipromeloza (E464) laktoza hidrat triacetin (E1518) titanijev dioksid (E171) željezov oksid, crveni (E172)
In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa slučajeva temeljena na metabolizatorskom statusu.
Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Prema tome, u grupi s kontroliranom deeskalacijom bili su bolesnici na prasugrelu (40 %) ili klopidogrelu (60 %).
Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Greece
Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Grčka
In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
U studiji CHARISMA i jednoj kohortnoj studiji (Simon), povećana stopa događaja bila je zapažena samo u slabih metabolizatora, u sporedbi s brzim metabolizatorima.
If you have any further questions, ask your doctor or your pharmacist.
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided de-escalation group versus 11% (137 events) in the control group (p=0.14).
Kumulativna učestalost svih događaja krvarenja (BARC kategorija od 1 do 5) bila je 9 % (114 događaja) u skupini s kontroliranom deeskalacijom u odnosu na 11 % (137 događaja) u kontrolnoj skupini (p=0,14).
Blisters of white PVC/PE/PVDC-aluminium foil or PA/ALL/PVC-aluminium foil.
Blisteri s bijelom PVC/PE/PVDC-aluminijskom folijom ili PA/ALL/PVC-aluminijskom folijom.
What Clopidogrel Apotex is and what it is used for
Što je Clopidogrel Apotex i za što se koristi
not known*
Vrlo rijetko, nepoznato*
If Clopidogrel Apotex is supplied in all aluminium blisters, it does not require any special storage conditions.
Ako je Clopidogrel Apotex opremljen u aluminijske blistere, lijek ne zahtijeva posebne uvjete čuvanja.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Apotex.
Ako ste trudni ili sumnjate na trudnoću, obavjestite svog liječnika ili ljekarnika prije nego što uzmete Clopidogrel Apotex.
Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Greece
Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Grčka ili
The prasugrel-only patients were continued on prasugrel for 11.5 months.
Bolesnici koji su primali samo prasugrel nastavili su liječenje prasugrelom tijekom 11,5 mjeseci.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Apotex (4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Clopidogrel Apotexa (4 tablete od po 75 mg).
Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon "Rok valjanosti".
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka): reakcije preosjetljivosti s bolovima u prsnom košuištuma ili trbuhu, trajni simptomi niskog šećera u krvi).
Store below 25°C (for PVC/PE/PVDC/aluminium blisters)
Čuvati na temperaturi ispod 25°C (za PVC/PE/PVDC/aluminij blistere)
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
• Također, odmah obavijestite svog liječnika ukoliko se pojavi medicinsko stanje (koje se naziva trombotična trombocitopenična purpura ili "TTP") sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (pogledajte dio 4. "Moguće nuspojave").
Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT).
Bolesnici na aspirinu i jačem blokatoru P2Y12 bez nuspojava nakon mjesec dana raspoređeni su za prebacivanje na fiksnu dozu aspirina plus klopidogrel (deeskalirana dualna antitrombocitna terapija (DAPT)) ili za nastavak svog režima lijeka (neizmijenjeni DAPT).
In all aluminium blisters, this medicinal product does not require any special storage conditions.
Aluminijski blisteri: lijek ne zahtijeva posebne uvjete čuvanja.
In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
U studiji TRITON-TIMI 38 i 3 kohortne studije (Collet, Sibbing, Giusti), kombinirana skupina bolesnika sa statusom slabih ili umjerenih metabolizatora, imala je veću stopu kardiovaskularnih događaja (smrt, infarkt miokarda, i moždani udar) ili tromboze stenta, u usporedbi s brzim metabolizatorima.
The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the deescalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Kontrolirana deeskalacija nije dovela do povećanog kombiniranog rizika od ishemijskih događaja (2,5 % u skupini s deeskalacijom u odnosu na 3,2 % u kontrolnoj skupini; p neinferiornost=0,0115), niti do ključnog sekundarnog ishoda krvarenja kategorije ≥2 prema BARC-u ((5 %) u skupini s deeskalacijom u odnosu na 6 % u kontrolnoj skupini (p=0,23).
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
U randomiziranoj, dvostrukoslijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemskoplućnim arterijskim šantom, bilo je randomizirano da primaju klopidogrel u dozi od 0,2 mg/kg (n=467) ili placebo (n=439) zajedno s istodobnom popratnom terapijom sve do drugog operativnog zahvata.
The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Prevalencija CYP2C19 alela koji rezultiraju umjerenim i slabim CYP2C19 metabolizmom razlikuje seprema rasi/etničkoj skupini (vidjeti dio "Farmakogenetika").
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (pogledajte dio 4. "Moguće nuspojave").
Clopidogrel Apotex is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Apotex uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika.(vidjeti dio 2. "Upozorenja i mjere opreza").
In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen,and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Dodatno, vrijednost IPA iznosila je 32% (24 sata) i 61% (dan 5), što je više nego u slabih metabolizatora koji su primali režim doziranja od 300 mg/75 mg i slično je ostalim skupinama CYP2C19 metabolizatora koje su primale doze od 300 mg/75 mg.
Driving and using machines Clopidogrel Apotex is unlikely to affect your ability to drive or to use machines.
Upravljanje vozilima i strojevima: Clopidogrel Apotex ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Clopidogrel Apotex film-coated tablets are pink, round and biconvex.
Clopidogrel Apotex filmom obložene tablete su ružičaste, okrugle i bikonveksne.
For further information please refer to section 5.1.
Za dodatne informacije molimo vidjeti dio 5.1. 4.2 Doziranje i način primjene Doziranje
In patients suffering from acute coronary syndrome:
• odraslih bolesnika koji boluju od akutnog koronarnog sindroma:
Follow-up at one year was performed for 316 patients (98.1%) in the de-escalated DAPT group and 318 patients (98.5%) in the unchanged DAPT group.
Praćenje nakon godinu dana obavljeno je za 316 bolesnika (98,1 %) u skupini s deeskaliranim DAPT-om i 318 bolesnika (98,5 %) u skupini s neizmijenjenim DAPT-om.
Medicinal products that are strong or moderate CYP2C19 inhibitors include for example omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Lijekovi koji su jaki ili umjereni inhibitori CYP2C19 uključuju, primjerice, omeprazol i esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, karbamazepin i efavirenz.
If you take more Clopidogrel Apotex than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Odmah morate kontaktirati liječnika ili najbliži odjel hitne medicinske pomoći zbog povećanog rizika od krvarenja.
The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2 at 12 months) was met showing non-inferiority.
Primarni ishod (kombinirana učestalost kardiovaskularne smrti, infarkta miokarda, moždanog udara i krvarenja kategorije ≥2 prema BARC-u nakon 12 mjeseci) ispunjen je uz dokaz o neinferiornosti.
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Fibrinolitike je primalo 99,7% bolesnika (fibrin-specifični: 68,7%, fibrinnespecifični: 31,1%), 89,5% heparin, 78,7% beta blokatore, 54,7% ACE inhibitore i 63% statine.
- In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
U odraslih bolesnika s fibrilacijom atrija koji imaju najmanje jedan faktor rizika za krvožilne događaje, nisu podobni za terapiju antagonistima vitamina K (VKA) te imaju nizak rizik od krvarenja, klopidogrel je indiciran u kombinaciji s ASK za prevenciju aterotrombotičkih i tromboembolijskih događaja, uključujući moždani udar.
What Clopidogrel Apotex looks like and contents of the pack
Kako Clopidogrel Apotex izgleda i sadržaj pakiranja
TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
TROPICAL-ACS (Testiranje responsivnosti inhibicije trombocita na kronično antitrombocitno liječenje za akutne koronarne sindrome [Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet
Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Kod 95 bolesnika (7 %) u skupini s kontroliranom deeskalacijom i kod 118 bolesnika (9 %) u kontrolnoj skupini (p neinferiornost=0,0004) zabilježen je događaj.
This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01).
Ova statistički značajna razlika bila je uglavnom posljedica manjim brojem krvarenja, bez zabilježene razlike u ishemijskim ishodima (p=0,36), dok se krvarenje kategorije ≥2 javljalo rjeđe u skupini s deeskaliranim DAPT-om (4,0 %) u odnosu na 14,9 % u skupini s neizmijenjenim DAPT-om (p<0,01).
Pink, round, biconvex, film-coated tablets.
Ružičasta, okrugla, bikonveksna filomom obložena tableta.
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome)
TOPIC (Vrijeme inhibicije trombocita nakon akutnog koronarnog sindroma [Timing Of Platelet
This randomized, open-label trial included ACS patients requiring PCI.
Ovo randomizirano, otvoreno ispitivanje uključivalo je bolesnike s ACS-om kojima je bila neophodna perkutana koronarna intervencija (PCI).
What you need to know before you take Clopidogrel Apotex
Što morate znati prije nego počnete uzimati Clopidogrel Apotex
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Akutni infarkt miokarda s elevacijom ST-segmenta, u kombinaciji s ASK u medikamentozno liječenih bolesnika pogodnih za liječenje trombolitičkom terapijom.
Therefore, concomitant use of clopidogrel with boosted ART should be discouraged.
Stoga istodobnu primjenu klopidogrela s pojačanim terapijama ARTa treba izbjegavati.
They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Dostupne su u PVC/PE/PVDC/Al blisterima ili PA/ALL/PVC-Al blisterima u pakiranjima koja sadrže: 7, 14, 28, 30, 50, 56, 84, 90 ili 100 filmom obloženih tableta.
Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Ukupno je analizirano 645 od 646 bolesnika s infarktom miokarda sa ST elevacijom (STEMI) ili infarktom miokarda bez ST elevacije (NSTEMI) ili nestabilnom anginom pektoris (deeskalirani DAPT (n=322); neizmijenjeni DAPT (n=323).
rash erythematous or exfoliative, urticaria, eczema, lichen planus
DRESS), eritematozni ili eksfolijativni osip, urtikarija, ekcem, lichen planus
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
U skladu s gore navedenim rezultatima, u metaanalizi koja je uključivala 6 studija sa 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazano je da je izloženost aktivnom metabolitu smanjena za 28% za umjerene metabolizatore te 72% za slabe metabolizatore, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena s razlikama za vrijednsoti IPA-e od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Primarni ishod, kompozit kardiovaskularne smrti, moždanog udara, urgentne revaskularizacije i krvarenja kategorije ≥2 prema BARC-u (Akademski istraživački konzorcij za krvarenje) nakon 1 godine poslije ASC-a, zabilježen je kod 43 bolesnika (13,4 %) u skupini s deeskaliranim DAPT-om i kod 85 bolesnika (26,3 %) u skupini s neizmijenjenim DAPT-om (p<0,01).