natgillin/translations-raw huggingface dataset:
Clopidogrel should therefore be used with caution in this population (see section 4.2).
Zato moramo pri tej skupini bolnikov klopidogrel uporabljati previdno (glejte poglavje 4. 2).
This product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Zdravilo vsebuje hidrogenirano ricinusovo olje, ki lahko razdraži želodec in povzroči drisko.
Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Peroralni antikoagulanti: sočasna uporaba klopidogrela s peroralnimi antikoagulanti ni priporočljiva, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4. 4).
Glycoprotein IIb/ IIIa inhibitors: clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions that receive concomitant glycoprotein IIb/ IIIa inhibitors (see section 4.4).
Zaviralci glikoproteina IIb/ IIIa: klopidogrel moramo uporabljati previdno pri bolnikih, ki imajo lahko tveganje za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj, ko prejemajo sočasno zaviralce glikoproteina IIb/ IIIa (glejte poglavje 4. 4).
ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
ASA ni spremenila s klopidogrelom dosežene inhibicije z ADP- jem sprožene agregacije trombocitov, vendar klopidogrel ojača učinek ASA na s kolagenom sproženo agregacijo trombocitov.
Therefore, concomitant use should be undertaken with caution (see section 4.4).
Zato moramo k sočasni uporabi pristopiti previdno (glejte poglavje 4. 4).
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Vendar pa so klopidogrel in ASA uporabljali sočasno do enega leta (glejte poglavje 5. 1).
The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8)
Incidenca klinično pomembnih krvavitev je bila podobna tisti, ki so jo opazili pri uporabi trombolitikov in heparina sočasno z ASA (glejte poglavje 4. 8).
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Nesteroidna protivnetna zdravila (NSAIDs; “ Non- Steroidal Anti- Inflammatory Drugs ”): v klinični študiji, izvedeni pri zdravih prostovoljcih, je sočasna uporaba klopidogrela in naproksena povečala okultno izgubo krvi iz prebavil.
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Zaradi tega moramo NSAIDs, vključno s COX2 inhibitorji, in klopidogrel sočasno uporabljati previdno (glejte poglavje 4. 4).
Other concomitant therapy: a number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Drugo sočasno zdravljenje: številne druge klinične študije so izvedli s klopidogrelom in drugimi sočasno danimi zdravili, da bi proučili potencial za farmakodinamične in farmakokinetične interakcije.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co- administration of phenobarbital, cimetidine, or oestrogen.
Poleg tega na farmakodinamično aktivnost klopidogrela ni pomembno vplivala sočasna uporaba fenobarbitala, cimetidina ali estrogena.
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are
To lahko potencialno vodi do povečanja plazemskih ravni zdravil, kot so fenitoin in tolbutamid ter NSAIDs, ki se presnavljajo s citokromom P450 2C9.
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
4 Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid sočasno s klopidogrelom varno uporabljata.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/ IIIa antagonists without evidence of clinically significant adverse interactions.
Vendar pa so bolniki, ki so bili vključeni v klinično preskušanje klopidogrela, prejemali sočasno različna zdravila, vključno z diuretiki, zaviralci adrenergičnih receptorjev beta, zaviralci angiotenzinske konvertaze (ACEI), kalcijevimi antagonisti, učinkovinami za zniževanje holesterola, koronarnimi vazodilatatorji, antidiabetiki (vključno z insulinom), antiepileptičnimi učinkovinami in antagonisti glikoproteina IIb/ IIIa, brez dokazov o klinično pomembnih neželenih interakcijah.
Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 42. 000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 9. 000 bolniki, ki so se zdravili 1 leto ali več.
Overall, clopidogrel 75 mg/ day was comparable to ASA 325 mg/ day in CAPRIE regardless of age, gender and race.
V celoti je bil klopidogrel v odmerku 75 mg/ dan v študiji CAPRIE, primerljiv z ASA v odmerku 325 mg/ dan, ne glede na starost, spol ali raso.
In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
V CAPRIE je bila pri bolnikih, zdravljenih bodisi s klopidogrelom ali ASA, celokupna incidenca kakršnihkoli krvavitev 9, 3%.
The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Incidenca hujših primerov je bila 1, 4% za klopidogrel in 1, 6% za ASA.
In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
V CURE je bil delež dogodkov z velikimi krvavitvami za klopidogrel in ASA odvisen od odmerka ASA (< 100 mg:
4.9%) as was the major bleeding event rate for placebo+ASA (< 100mg:
4, 9%), kakor tudi delež velikih krvavitev za placebo in ASA (< 100 mg:
The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial:
Tveganje za krvavitev (življenje ogrožajoče, velike, manjše, druge) se je zmanjševalo tekom preskušanja:
0-1 months (clopidogrel:
0- 1 mesec (klopidogrel:
6.6%), 1-3 months (clopidogrel:
6, 6%), 1- 3 meseci (klopidogrel:
2.3%), 3-6 months (clopidogrel:
2, 3%), 3- 6 mesecev (klopidogrel:
1.6%), 6-9 months (clopidogrel:
1, 6%), 6- 9 mesecev (klopidogrel:
1.5%), 9-12 months (clopidogrel:
1, 5%), 9- 12 mesecev (klopidogrel:
5.3% placebo+ASA).
Število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot 5 dni pred kirurškim posegom (4, 4% klopidogrel in ASA proti 5, 3% placebo in ASA).
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel+ASA, and 6.3% for placebo+ASA.
Pri bolnikih, ki so ostali na zdravljenju do 5 dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9, 6% za klopidogrel in ASA in 6, 3% za placebo in ASA.
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%). The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev (17, 4%) v primerjavi s skupino s placebom in ASA (12, 9%).
This was
Incidenca večjih krvavitev je bila v
5 consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
To je veljalo tudi za podskupine bolnikov, opredeljene z določenimi izhodiščnimi značilnostmi in tipom fibrinolitičnega ali heparinskega zdravljenja.
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6% versus 0.5% in the clopidogrel + ASA and the placebo + ASA groups, respectively).
V študiji COMMIT je bil skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve nizek in podoben v obeh skupinah (0, 6% v skupini s klopidogrelom in ASA ter 0, 5% v skupini s placebom in ASA).
Their frequency is defined using the following conventions: common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000).
Blood and the lymphatic system disorders
Trombotična Trombocitopenija, Nevtropenija, Bolezni krvi in trombocitopenična vključno s hudo limfatičnega sistema
Thrombocytopenia, leucopenia, eosinophilia
levkopenija, eozinofilija
Neutropenia, including severe neutropenia
nevtropenijo
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
purpura (TTP) (glejte poglavje 4. 4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, granulocitopenija, anemija
Immune system disorders
Bolezni imunskega sistema Psihiatrične motnje
Serum sickness, anaphylactoid reactions
Serumska bolezen, anafilaktoidne reakcije Halucinacije, zmedenost Motnje okusa
Nervous system disorders
Intrakranialna
Intracranial bleeding (some cases were
krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica Očesne bolezni
Taste disturbances
Krvavitve v očesu (veznica, oko, mrežnica)
reported with fatal outcome), headache, paraesthesia, dizziness Eye disorders
Ušesne bolezni, vključno z motnjami labirinta
Eye bleeding (conjunctival, ocular, retinal)
Vrtoglavica
Ear and labyrinth disorders
Žilne bolezni
Vascular disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Haematoma
Epistaksa
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem, intersticijski pnevmonitis
Respiratory, thoracic and mediastinal disorders
Krvavitev v prebavila, driska, bolečine v trebuhu, dispepsija
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
System Organ Class
Organski sistem Bolezni jeter, žolčnika in žolčevodov
Retroperitoneal Gastrointestinal and
Zelo redki Akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
Hepato-biliary disorders
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Bulozen dermatitis (toksična epidermalna nekroliza, Stevens - Johnsonov sindrom, multiformni eritem), angioedem, eritematozen izpuščaj, urtikarija, ekcem, lihen planus Mišično- skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
Haematuria
Hematurija
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije Preiskave
Fever
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov
Investigations
Zvišana telesna temperatura
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code:
Zaviralci agregacije trombocitov brez heparina, oznaka ATC:
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the GPIIb/ IIIa complex, thereby inhibiting platelet aggregation.
Klopidogrel selektivno zavira vezavo adenozin difosfata (ADP) na njegov trombocitni receptor in tako preko z ADP posredovane aktivacije kompleksa glikoproteina IIb/ IIIa zavira agregacijo trombocitov.
Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the
Biotransformacija klopidogrela je nujna za dosego inhibicije agregacije trombocitov.
7 amplification of platelet activation by released ADP.
Klopidogrel prav tako zavira agregacijo trombocitov, sproženo z drugimi agonisti, z blokado ojačitve aktivacije trombocitov s sproščenim ADP.
Clopidogrel acts by irreversibly modifying the platelet ADP receptor.
Klopidogrel deluje tako, da ireverzibilno spremeni trombocitni ADP receptor.
Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Posledično so trombociti, ki so bili izpostavljeni klopidogrelu, prizadeti preostanek svoje življenske dobe in okrevanje trombocitov se pojavlja s hitrostjo, ki je v skladu s trombocitno premeno.
Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
To se progresivno povečuje in doseže stanje dinamičnega ravnovesja (“ steady state ”) med 3. in 7. dnem.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
7 zaviranja z odmerkom 75 mg na dan med 40% in 60%.
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Varnost in učinkovitost klopidogrela so vrednotili v 4 dvojno slepih študijah, v katere je bilo vključenih več kot 80. 000 bolnikov: študija CAPRIE je obsegala primerjavo klopidogrela in ASA, v študijah CURE, CLARITY in COMMIT pa so primerjali klopidogrel s placebom; oboje pa so bolniki dobivali v kombinaciji z ASA in drugo standardno terapijo.
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (< 35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Študija CAPRIE je vključevala 19. 185 bolnikov z aterotrombozo, ki se je odrazila z nedavnim miokardnim infarktom (< 35 dni), ishemično kapjo (med 7 dni in 6 meseci) ali razvito periferno arterijsko boleznijo (PAD).
Patients were randomised to clopidogrel 75 mg/ day or ASA 325 mg/ day, and were followed for 1 to 3 years.
Bolniki so bili naključno razdeljeni v skupine, ki so prejemale klopidogrel 75 mg/ dan ali ASA 325 mg/ dan, spremljali so jih od 1 do 3 let.
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI:
Pri analizi vključenih bolnikov (“ intention to treat analysis ”) so v skupini, ki je prejemala klopidogrel, opazili 939 dogodkov in v skupini, ki je prejemala ASA, 1. 020 dogodkov (zmanjšanje relativnega tveganja (RT) 8, 7%, [95% IZ:
0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI:
0, 2 do 16, 4]; p=0, 045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1. 000 bolnikov, zdravljenih 2 leti, dodatnim 10 [IZ:
0 to 20] additional patients being prevented from experiencing a new ischaemic event.
0 do 20] bolnikom.
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala pomembne razlike med klopidogrelom (5, 8%) in ASA (6, 0%).
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p = 0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI:
Pri analizi podskupin glede na vključitveni pogoj (miokardni infarkt, ishemična kap in periferna arterijska bolezen/ PAD /) je videti najmočnejšo korist (doseganje statistične značilnosti pri p=0, 003) pri bolnikih, vključenih zaradi PAD (zlasti pri tistih, ki so doživeli tudi miokardni infarkt) (zmanjšanje RT=23, 7%; IZ:
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
8, 9 do 36, 2), in šibkejšo (ni bila pomembno različna od ASA) pri bolnikih s kapjo (zmanjšanje RT=7, 3%; IZ: - 5, 7 do 18, 7 [p=0, 258]).
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
Pri bolnikih, ki so bili vključeni v preskušanje samo na podlagi nedavnega miokardnega infarkta, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT= - 4, 0%; IZ: - 22, 5 do 11, 7 [p=0, 639]).
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.
Razen tega analiza podskupin glede na starost nakazuje, da so koristi klopidogrela pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih ≤ 75 let.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
Študija CURE je vključevala 12. 562 bolnikov z akutnim koronarnim sindromom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, konsistentnih z ishemijo.
Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/ day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (začetni odmerek 300 mg, nato 75 mg/ dan, n=6. 259) ali skupino, ki je prejemala placebo (n=6. 303), oboje prejeto v kombinaciji z ASA (75- 325 mg enkrat na dan) in drugimi standardnimi terapijami.
In CURE, 823 (6.6%) patients received concomitant GPIIb/ IIIa receptor antagonist therapy.
V študiji CURE je 823 (6, 6%) bolnikov sočasno prejemalo terapijo z antagonisti receptorjev glikoproteinov IIb/ IIIa.
8 The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Delež bolnikov s primarnim opazovanim dogodkom [srčno- žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9, 3%) v skupini, zdravljeni s klopidogrelom, in 719 (11, 4%) v skupini, ki je prejemala placebo, to je 20% zmanjšanje relativnega tveganja (95% IZ od 10% - 28%; p=0, 00009) v skupini, zdravljeni s klopidogrelom (17% zmanjšanje relativnega tveganja, če so bili bolniki 8 zdravljeni konzervativno, 29% kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTCA) z ali brez stenta in 10%, če je bila izvedena premostitvena operacija koronarnih arterij (CABG).
New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI:
22% (IZ:
8.6, 33.4), 32% (CI:
8, 6, 33, 4), 32% (IZ:
12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
12, 8, 46, 4), 4% (IZ: - 26, 9, 26, 7), 6% (IZ: - 33, 5, 34, 3) in 14% (IZ: - 31, 6, 44, 2) tekom 0- 1, 1- 3, 3- 6, 6- 9 oziroma 9- 12 mesečnimi intrevali študije.
Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in ASA, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostala (glejte poglavje 4. 4).
The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR = 43.3%; CI:
Uporaba klopidogrela v CURE je bila povezana z zmanjšano potrebo po zdravljenju s trombolitiki (zmanjšanje RT= 43, 3%; IZ:
24.3%, 57.5%) and GPIIb/ IIIa inhibitors (RRR = 18.2%; CI:
24, 3%, 57, 5%) in inhibitorji glikoproteinov IIb/ IIIa (zmanjšanje RT =18, 2%; IZ:
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo- treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel- treated group.
Število bolnikov s primarnim opazovanim dogodkom (srčno- žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1. 035 (16, 5%) v skupini zdravljeni s klopidogrelom in 1. 187 (18, 8%) v skupini s placebom, to je 14% zmanjšanje relativnega tveganja (95% IZ od 6% - 21%, p=0, 0005) za skupino, zdravljeno s klopidogrelom.
This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Ta korist je bila v glavnem zaradi statistično pomembnega zmanjšanja incidence MI [287 (4, 6%) v skupini, zdravljeni s klopidogrelom, in 363 (5, 8%) v skupini s placebom].
The results obtained in populations with different characteristics (e. g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Rezultati, pridobljeni pri populacijah z različnimi karakteristikami (npr. nestabilna angina, MI brez Q zobca, visoka do nizka raven tveganja, diabetes, potreba po revaskularizaciji, spol, starost, itd), so skladni z rezultati primarne analize.
In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Zlasti post hoc analiza podatkov 2172 bolnikov (17% celotne populacije CURE), ki so jim namestili žilno opornico (Stent- CURE), je ob klopidogrelu v primerjavi s placebom pokazala značilno, 26, 2% zmanjšanje RT za sestavljen primarni opazovani dogodek (srčno - žilna smrt, miokardni infarkt, možganska kap) in tudi značilno, 23, 9% zmanjšanje RT za drug sestavljen primarni opazovani dogodek (srčno- žilna smrt, miokardni infarkt, možganska kap ali neodzivna ishemija).
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/ LMWH, GPIIb/ IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Koristi, ki so jih opazili s klopidogrelom, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin / nizkomolekularni heparin, antagonisti glikoproteina IIb/ IIIa, učinkovinami za zniževanje lipidov, zaviralci adrenergičnih receptorjev beta in zaviralci angiotenzinske konvertaze (ACEI)).