natgillin/translations-raw huggingface dataset:
Examples of medicines which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmics, etc.
Primeri zdravil, ki se presnavljajo s CYP2D6, so antidepresivi (triciklični in selektivni zaviralci
In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone / 35 microg ethinylestradiol).
V študiji medsebojnega delovanja celekoksib ni klinično pomembno vplival na farmakokinetiko peroralnih kontraceptivov (1 mg noretisterona/ 35 mikrogramov etinilestradiola).
5 In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Pri bolnikih z revmatoidnim artritisom celekoksib ni statistično značilno vplival na farmakokinetiko (plazemski ali ledvični očistek) metotreksata (v revmatoloških odmerkih).
In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium.
Pri zdravih preiskovancih je sočasna uporaba 200 mg celekoksiba dvakrat na dan in 450 mg litija dvakrat na dan povzročila povprečno zvečanje Cmax litija za 16% in njegove AUC za 18%.
In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors could result in further increases in celecoxib exposure.
Pri posameznikih, ki slabopresnavljajo s CYP2C9 in imajo večjo sistemsko izpostavljenost celekoksibu, lahko sočasno zdravljenje z zaviralci CYP2C9 dodatno poveča izpostavljenost celekoksibu.
Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2).
Pri bolnikih, za katere je znano, da slabopresnavljajo s CYP2C9, ne uporabljajte takšnih kombinacij (glejte poglavji 4. 2 in 5. 2).
Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%.
Sočasna uporaba enkratnega odmerka 200 mg celekoksiba in 200 mg flukonazola, ki je močan zaviralec CYP2C9, enkrat na dan je povzročila povprečno zvečanje Cmax celekoksiba za 60% in njegove AUC za 130%.
For celecoxib no clinical data on exposed pregnancies are available..
Kliničnih podatkov o izpostavljenosti celekoksibu med nosečnostjo ni.
Studies in animals (rats and rabbits) have shown reproductive toxicity (see sections 4.3 and 5.3).
Študije na živalih (podganah in kuncih) so pokazale učinke na sposobnost razmnoževanja (glejte poglavji 4. 3 in 5. 3).
Celecoxib is contraindicated in pregnancy and in women who can become pregnant unless using an effective method of contraception (see section 4.3).
Celekoksib je kontraindiciran med nosečnostjo in pri ženskah, ki bi lahko zanosile, če ne bi uporabljale učinkovite kontracepcijske zaščite (glejte poglavje 4. 3).
Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources:
Podatki so iz naslednjih virov:
- Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates
- Neželeni učinki, opisani pri bolnikih z osteoartritisom in revmatoidnim artritisom z incidenco nad
greater than 0.01% and greater than those reported for placebo during 12 placebo- and/ or active- controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg.
0, 01% in večjo kot pri placebu v 12 s placebom in/ ali učinkovino kontroliranih kliničnih preskušanjih, v katerih so do 12 tednov prejemali od 100 do 800 mg celekoksiba.
- Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in
- Neželeni učinki zdravila med pomarketinškim spremljanjem, spontano prijavljeni v obdobju, med
which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and
katerim je celekoksib po ocenah dobivalo > 70 milijonov bolnikov (različni odmerki, trajanje in indikacije).
6 indications).
Pogostnost ni
TABLE 1
1
(≥ 1/ 100 to < 1/ 10)
(≥ 1/ 100 do <
(≥ 1/ 1000 to < 1/ 100)
(≥ 1/ 1000 do < 1/ 100)
(≥ 1/ 10,000 to
(≥ 1/ 10. 000 do <
Known
znana
< 1/ 1000)
1/ 1000)
(Post-marketing experience)1
(pomarketinške izkušnje) 1
Sinusitis, upper respiratory tract infection, urinary tract infection
parazitske boleznizgornjih dihal, okužbe sečil Bolezni krvi in limfatičnega sistema
Anemia
anemija
Allergy aggravated
poslabšanje
Serious allergic reactions, anaphylactic shock, anaphylaxis
resne alergijske
Psychiatric
imunskega sistema
Insomnia
alergije
Anxiety, depression, tiredness
reakcije, anafilaktični šok, anafilaksija
Confusion
Psihiatrične motnje Presnovne in prehranske motnje
Hallucinations
nespečnost
Metabolism and nutrition
anksioznost, depresija, zmedenost utrujenost hiperkaliemija
Hyperkaelemia
halucinacije
Headache, aggravated epilepsy, meningitis aseptic, ageusia, anosmia, fatal intracranial haemorrhage
glavobol, poslabšanje epilepsije, aseptični meningitis, agevzija, anozmija, intrakranialna krvavitev s smrtnim izidom
Eye
Očesne bolezni
Decreased hearing
miokardni infarkt2
Cardiac
poslabšanje sluha
Heart failure, palpitations, tachycardia
Srčne bolezni
Myocardial infarction2
srčno popuščanje,
Vascular
7
Hypertension, hypertension aggravate d
palpitacije, tahikardija Žilne bolezni
Flushing, vasculitis
hipertenzija, poslabšanje
Respiratory, thoracic, and mediastinal
zardevanje,
Pharyngitis, rhinitis, cough
hipertenzije
Dyspnoea
vaskulitis
Bronchospasm
Bolezni dihal,
Gastrointestinal
bronhospazem
Abdominal pain, diarrhoea,
prsnega koša in kašelj mediastinalnega prostora Bolezni prebavil bolečine v
Constipation, eructation, gastritis,
zaprtje, riganje, gastritis razjeda na
Duodenal, gastric, oesophageal,
navzea, akutni
Nausea, acute pancreatitis,
trebuhu, driska, stomatitis, bruhanje, dispepsija, poslabšanje
dyspepsia, flatulence
dvanajstniku, želodcu, požiralniku
stomatitis, vomiting, aggravation of gastrointestinal inflammation
pankreatitis, gastrointestinalna
intestinal, and colonic gastrointestinal ulceration; dysphagia, haemorrhage, intestinal perforation; colitis/ colitis oesophagitis, aggravated melaena; pancreatitis
tankem in debelem krvavitev, črevesu, disfagija, kolitis/ poslabšanje perforacija črevesa, kolitisa ezofagitis, melena, pankreatitis
Hepatobiliary
Bolezni jeter,
Abnormal hepatic function, increased
nenormalno delovanje zvišanje jetrnih
Elevation of hepatic Hepatitis, enzymes hepatic failure
hepatitis, jetrna
7
žolčnika in žolčevodov
SGOT and SGPT
jeter, zvišana SGOT in encimov SGPT
jaundice
odpoved, zlatenica
Skin and subcutaneous
Bolezni kože in izpuščaj, srbenje urtikarija podkožja
Rash, pruritus
alopecija, fotosenzitivnost
Alopecia, Ecchymosis, photosensitivity bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
ekhimoze, bulozen izpuščaj, eksfoliativni dermatitis, multiformni eritem, Stevens- Johnsonov sindrom, toksična epidermalna nekroliza, angioedem
Musculoskeletal and connective
krči v nogah Bolezni mišično - skeletnega sistema in vezivnega tkiva
Renal and urinary
zvišan kreatinin, Bolezni sečil
Increased creatinine, BUN increased
akutna odpoved
1
zvišana sečnina Motnje reprodukcije in dojk Splošne težave gripi podobni simptomi, periferni edemi/ zastajanje tekočine 1
Reproductive and breast General
ledvic, intersticijski nefritis, hiponatriemija menstruacijske motnje
Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and indications).
Neželeni učinki zdravila, spontano prijavljeni v podatkovno bazo za spremljanje varnosti v obdobju, med katerim je celekoksib po ocenah dobivalo > 70 milijonov bolnikov (različni odmerki, trajanje in indikacije).
2 In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Presežka možganskih kapi ni bilo.
The additional adverse reactions listed by system organ class and ranked by frequency in Table 2 were reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg to 800 mg daily in long-term polyp prevention trials of duration up to 3 years (the APC and PreSAP trials; see Section 5.1, Pharmacodynamic properties:
Dodatni neželeni učinki, navedeni po organskih sistemih in razvrščeni po pogostnosti v preglednici 2, so bili opisani z incidenco večjo kot pri placebu med preiskovanci, zdravljenimi s celekoksibom od 400 do 800 mg na dan v dolgoročnih preskušanjih preprečevanja polipov, ki so trajala do 3 leta
Cardiovascular Safety – Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps).
Srčnožilna varnost – dolgoročne študije pri bolnikih s sporadičnimi adenomatoznimi polipi).
(≥ 1/ 100 to < 1/ 10)
(≥ 1/ 100 do < 1/ 10)
Ear infection, fungal infection (fungal infections were primarily nonsystemic)
okužba ušesa, glivična okužba
Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection
okužba s Helicobactrom, herpes
Neoplasms Psychiatric Nervous system Eye
parazitske bolezni
Lipoma Sleep disorder Cerebral infarction Vitreous floaters; conjunctival hemorrhage
(glivične okužbe so bile
Ear and labyrinth
zoster, šen, okužba rane, okužbe
Hypoacusis
predvsem nesistemske)
Angina pectoris; myocardial infarction
nestabilna angina pektoris,
Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertropy
infarkt
8
insuficienca aortne zaklopke, ateroskleroza koronarnih arterij, sinusna bradikardija, prekatna hipertrofija
Hypertension *
hipertenzija *
Respiratory, thoracic, and mediastinal
Bolezni dihal, prsnega koša in mediastinalnega prostora
Diarrhoea*
driska *
Nausea, gastroesophageal reflux disease, diverticulum, vomiting, * dysphagia, irritable bowel syndrome
navzea, gastroezofagealna
Haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, stomatitis
hemoroidalna krvavitev, pogosto
Dermatitis allergic
iztrebljanje, razjeda v ustih, stomatiti alergijski dermatitis
Musculoskeletal nd connective
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Muscle spasms
spazmi mišic
Reproductive and breast
benigna hipertrofija prostate,
Benign prostatic hyperplasia, prostatitis, prostatic specific antigen increased
krvavitev iz nožnice, občutljivost
Vaginal haemorrhage, breast tenderness, dysmenorrhea, ovarian cyst, menopausal symptoms
prostatitis, zvišanje za prostato
General and administrative site
dojk, dismenoreja, cista jajčnika,
Edema
Splošne težave in spremembe na mestu aplikacije
Investigations
specifičnega antigena edemi
Weight increased
menopavzalni simptomi
Blood levels increased: potassium, sodium, hemoglobin Blood levels decreased: hematocrit, testosterone
Preiskave Poškodbe in zastrupitve, postopkovni zapleti
Injury, poisoning, procedural
povečanje telesne mase
Foot fracture, lower limb fracture, epicondylitis, tendon rupture, fracture
Zvišanje kalija, natrija, hemoglobina v krvi Znižanje hematokrita, testosterona v krvi zlom stopala, zlom spodnje okončine epikondilitis, pretrganje tetive, zlom
* Hypertension, vomiting and diarrhoea are included in Table 2 because they were reported more frequently in these studies, which were of 3-year duration, compared to Table 1, which includes adverse reactions from studies of 12-week duration.
* Hipertenzija, bruhanje in driska so vključeni v preglednico 2, ker so bili v teh, 3- letnih študijah zabeležen pogosteje, v primerjavi s preglednico 1, ki obsega neželene učinke 12- tedenskih študij.
In final data (adjudicated) from the APC trial in patients treated with celecoxib 800 mg daily for up to 3 years, the excess rates over placebo were 11 events per 1000 patients for myocardial infarction (common); and 5 events per 1000 patients for stroke (uncommon; types of stroke not differentiated).
Po oceni končnih podatkov () preskušanj APC in PreSAP pri bolnikih, zdravljenih z 800 mg celekoksiba na dan do 3 leta, je bil presežni delež miokardnih infarktov v primerjavi s placebom 11 dogodkov na 1000 bolnikov (pogosto) in možganskih kapi 5 dogodkov na 1000 bolnikov (občasno; kapi nerazvrščene po tipu).
4.9 Overdose
9 4. 9 Preveliko odmerjanje
Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events.
Zdravi preiskovanci so devet dni dobivali posamične odmerke do 1. 200 mg in večkratne odmerke do 1. 200 mg dvakrat na dan brez klinično pomembnih neželenih učinkov.
In the event of suspected overdose, appropriate supportive medical care should be provided e. g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Če obstaja sum na preveliko odmerjanje, je treba zagotoviti ustrezno podporno medicinsko oskrbo, npr. izpiranje želodca, kliničen nadzor in, če je treba, simptomatsko zdravljenje.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe.
Antineoplastic, ATC code:
Oznaka ATC:
Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e. g. thiazides, furosemide) but differing from arylamine sulfonamides (e. g. sulfamethoxizole and other sulfonamide antibiotics).
Celekoksib je diaril- substituiran pirazol, kemično podoben drugim nearilaminskim sulfonamidom (npr. tiazidom, furosemidu), a drugačen od arilaminskih sulfonamidov (npr. sulfametoksazola in drugih sulfonamidnih antibiotikov).
9 Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Celekoksib je peroralen, selektiven zaviralec ciklooksigenaze- 2 (COX- 2).
No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in healthy volunteers at the FAP therapeutic dose of 400 mg BID.
Pri zdravih prostovoljcih, ki so dobivali odmerek 400 mg dvakrat na dan, kot se terapevtsko uporablja pri FAP, niso opazili statistično značilnega zavrtja COX- 1 (ocenjenega z zavrtjem nastajanja tromboksana B2 [TxB2] ex vivo).
Two isoforms, COX-1 and COX-2, have been identified.
COX- 2 izooblike ni najti v večini normalnih tkiv in je pod nadzorom inducibilnega promotorja, njegova izraženost pa je povezana z vnetjem.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever.
Koncentracija COX- 2 je zvečana v številnih predmalignih spremembah (npr. v adenomatoznih kolorektalnih polipih) in epitelijskih karcinomih.
Polyps with the APC mutation overexpress COX-2 and left untreated, these polyps continue to form and enlarge in the colon or rectum resulting in essentially a 100% chance of developing colorectal cancer.
Če polipi ostanejo nezdravljeni, v predelu kolona in danke še naprej nastajajo in se večajo, kar se izteče v dejansko 100- odstotno možnost za kolorektalni karcinom.
COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
COX- 2 je vpletena tudi v ovulacijo, ugnezdenje zarodka in zaprtje arterioznega duktusa, uravnavanje delovanja ledvic in funkcije centralnega živčnega sistema (indukcija zvišane telesne temperature, zaznavanje bolečine in kognitive funkcije).
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
COX- 2 so pri človeku našli v tkivu okoli želodčnih ulkusov, a njena vloga pri celjenju ulkusov ni ugotovljena.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Razlika v antitrombocitni aktivnosti med nekaterimi NSAID, ki zavirajo COX- 1, in selektivnimi zaviralci COX- 2 bi lahko bila klinično pomembna pri bolnikih, ki jih ogrožajo trombembolične reakcije.
COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Zaviralci COX- 2 zmanjšajo sistemsko (in tako morda tudi endotelijsko) nastajanje prostaciklina, ne da bi vplivali na trombocitni tromboksan.
Inhibition of COX-2 may have consequences on tumour viability that are unrelated to inflammation.
Zavrtje COX- 2 morda vpliva na viabilnost tumorjev z učinki, ki niso povezani z vnetjem.
Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation.
V predkliničnih modelih karcinoma na kolonu s prekomerno izraženo COX- 2 celekoksib zavira nastanek tumorjev, izzvanih s kemično (model podgan AOM) ali genetsko (model miši MIN) mutacijo.
Celecoxib has been shown to reduce the number and size of adenomatous colorectal polyps.
10 Ugotovljeno je, da celekoksib zmanjša število in velikost adenomatoznih kolorektalnih polipov.
The mean reduction in the number of colorectal polyps following six months of treatment was 28% (SD + 24%) for celecoxib 400 mg BID which was statistically superior to placebo (mean 5%, SD +16%).
Število kolorektalnih polipov se je po šestmesečnem zdravljenju s 400 mg celekoksiba dvakrat na dan v povprečju zmanjšalo za 28% (SD ± 24%), kar je statistično bolje kot s placebom (povprečje 5%, SD ±16%).
A meaningful reduction in duodenal adenoma area was also observed compared with placebo (14.5% celecoxib 400 mg BID versus 1.4% placebo), which however was not statistically significant.
V primerjavi s placebom so ugotovili tudi pomembno zmanjšanje števila adenomov na dvanajstniku (celekoksib 400 mg dvakrat na dan 14, 5%, placebo 1, 4%), kar pa ni bilo statistično značilno.
Pilot Study in Juvenile FAP Patients:
Pilotska študija pri bolnikih z juvenilno FAP:
A total of 18 children 10 to 14 years of age who had genotype or phenotype positive FAP were treated with celecoxib 4 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo), celecoxib 8 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo), or celecoxib 16 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo).
Skupno so 18 otrok, starih od 10 do 14 let in z genotipsko ali fenotipsko pozitivno FAP, zdravili s celekoksibom 4 mg/ kg/ dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo), 8 mg/ kg/ dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo) ali 16 mg/ kg/ dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo).
The greatest reduction was observed in patients treated with celecoxib 16 mg/ kg/ day, which corresponds to the recommended adult FAP dose of 800 mg daily.
Največje zmanjšanje so zabeležili pri bolnikih, ki so dobivali celekoksib v odmerku 16 mg/ kg/ dan, kar ustreza priporočenemu odmerku za odrasle s FAP, ki je 800 mg na dan.
Safety data were reviewed in detail by a Data Safety Monitoring Committee, which concluded that celecoxib 16 mg/ kg/ day was a safe dose to recommend for further studies in juvenile FAP patients.
Ta je presodil, da je odmerek celekoksiba 16 mg/ kg/ dan mogoče varno priporočiti za nadaljnje študije bolnikov z juvenilno FAP.
The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects.).
Tako ni znano, ali je dolgoročno tveganje morda podobno, kot je ugotovljeno pri odraslih osebah, izpostavljenih celekoksibu ali drugim COX- 2 selektivnim in neselektivnim nesteroidnim protivnetnim zdravilom (glejte poglavje 4. 4, Srčnožilni učinki).
10 Cardiovascular Safety – Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps:
Srčnožilna varnost – dolgoročne študije preiskovancev s sporadičnimi adenomatoznimi polipi:
Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i. e., the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).
S celekoksibom sta bili izvedeni dve študiji preiskovancev s sporadičnimi adenomatoznimi polipi: preskušanje APC (Adenoma Prevention with Celecoxib) in preskušanje PreSAP (Prevention of Spontaneous Adenomatous Polyps).
In theAPC trial, there was a dose-related increase in the composite endpoint of cardiovascular death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment.
V preskušanju APC so med 3- letnim zdravljenjem pri celekoksibu v primerjavi s placebom ugotovili z odmerkom povezan porast sestavljenega opazovanega dogodka srčnožilne smrti, miokardnega infarkta ali možganske kapi (presojeno).
In the APC trial, the relative risks compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 - 8.5) with celecoxib 400 mg twice daily and 2.8 (95% CI 1.1 - 7.2) with celecoxib 200 mg twice daily.
1, 1 – 7, 2.
Cumulative rates for this composite endpoint over 3 years were 3.0% (20/ 671 subjects) and 2.5% (17/ 685 subjects), respectively, compared to 0.9% (6/ 679 subjects) for placebo.
Kumulativna deleža za ta sestavljeni opazovani dogodek v 3- letnem obdobju sta bila 3, 0% (20/ 671 preiskovancev) in 2, 5% (17/ 685 preiskovancev) v primerjavi z 0, 9% (6/ 679 preiskovancev) pri placebu.
In the PreSAP trial, the relative risk compared to placebo for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 - 2.4) with celecoxib 400 mg once daily compared to placebo.
0, 6– 2, 4).
Cumulative rates for this composite endpoint over 3 years were 2.3% (21/ 933 subjects) and 1.9% (12/ 628 subjects), respectively.
Kumulativna deleža za ta sestavljeni opazovani dogodek v 3- letnem obdobju sta bila 2, 3% (21/ 933 preiskovancev) in 1, 9% (12/ 628 preiskovancev).
The incidence of myocardial infarction (adjudicated) was 1.0% with (9/ 933 subjects) with celecoxib 400 mg once daily and 0.6% (4/ 628 subjects) with placebo.
Incidenca miokardnega infarkta (presojeno) je bila 1, 0% (9/ 933 preiskovancev) pri celekoksibu 400 mg enkrat na dan in 0, 6% (4/ 628 preiskovancev) pri placebu.
Data from a third long-term study, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), did not show a significantly increased cardiovascular risk with celecoxib 200mg BID compared to placebo.
Podatki tretje dolgoročne študije, ADAPT (The Alzheimer' s Disease Anti- inflammatory Prevention Trial), med uporabo celekoksiba 200 mg dvakrat na dan niso pokazali statistično pomembno večjega srčnožilnega tveganja kot s placebom.
The relative risk compared to placebo for a similar composite endpoint (CV death, MI, stroke) was 1.14 (95% CI 0.61 - 2.12) with celecoxib 200 mg twice daily.
Relativno tveganje za podoben sestavljeni opazovani dogodek (srčnožilna smrt, miokardni infarkt, možganska kap) je bilo za celekoksib 200 mg dvakrat na dan v primerjavi s placebom 1, 14 (95% IZ:
The incidence of myocardial infarction was 1.1% (8/ 717 patients) with celecoxib 200 mg twice daily and 1.2% (13/ 1070 patients) with placebo.
Incidenca miokardnega infarkta je bila z 200 mg celekoksiba dvakrat na dan 1, 1% (8/ 717 bolnikov) in s placebom 1, 2% (13/ 1070) bolnikov.
Data from pooled analysis of controlled randomized trials also suggest that cardiovascular risk may be associated with the use of celecoxib compared to placebo, with evidence for differences in risk based on celecoxib dose.
11 Podatki kumulativne analize kontroliranih randomiziranih preskušanj tudi kažejo, da je lahko srčnožilno tveganje povezano z uporabo celekoksiba v primerjavi s placebom, z dokazi za različno tveganje glede na odmerek celekoksiba.