natgillin/translations-raw huggingface dataset:
I APC- forsøget ses en dosisrelateret stigning i det sammensatte endepunkt af kardiovaskulær død, myokardieinfarkt eller slagtilfælde (bekræftet) med celecoxib sammenlignet med placebo over en behandlingsperiode på 3 år.
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.
PreSAP- forsøget viser ikke statistisk signifikant øget risiko for samme sammensatte endepunkt.
The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint.
I APC- forsøget er de relative risici sammenlignet med placebo for det sammensatte endepunkt (bekræftet) af kardiovaskulær død, myokardieinfarkt eller slagtilfælde 3, 4 (95% konfidensinterval 1, 4 - 8, 5) med celecoxib 400 mg 2 gange dagligt og 2, 8 (95% konfidensinterval 1, 1- 7, 2) med celecoxib 200 mg 2 gange dagligt.
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.
Kumulative procenter for det sammensatte endepunkt over 3 år er henholdsvis 3% (20/ 671 forsøgspersoner) og 2, 5% (17/ 685 forsøgspersoner) sammenlignet med 0, 9% (6/ 679 forsøgspersoner) for placebo.
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.
I PreSAP- forsøget er den relative risiko sammenlignet med placebo for det samme sammensatte endepunkt (bekræftet) 1, 2 (95% konfidensinterval 0, 6- 2, 4) med celecoxib 400 mg 1 gang dagligt.
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.
Kumulative procenter for det sammensatte endepunkt over 3 år er henholdsvis 2, 3% (21/ 933 forsøgspersoner) og 1, 9% (12/ 628 forsøgspersoner.
Cumulative rates for this composite endpoint over 3 years were 2.3% (21/ 933 subjects) and 1.9% (12/ 628 subjects), respectively.
Hyppigheden af myokardieinfarkt (bekræftet) er 1, 0% (9/ 933 forsøgspersoner) med celecoxib 400 mg 1 gang dagligt og 0, 6% (4/ 628 forsøgspersoner) med placebo.
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.
Data fra et tredje langtidsforsøg, ADAPT (The Alzheimer’ s Disease Anti- inflammatory Prevention Trial), viser ikke signifikant øget kardiovaskulær risiko med celecoxib 200 mg 2 gange dagligt sammenlignet med placebo.
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.
Den relative risiko sammenlignet med placebo for lignende sammensatte endepunkter (kardiovaskulær død, myokardieinfarkt, slagtilfælde) er 1, 14% (95% konfidensinterval 0, 61- 2, 12) med celecoxib 200 mg 2 gange dagligt.
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.
Hyppigheden af myokardieinfarkt er 1, 1% (8/ 717 patienter) med celecoxib 200 mg 2 gange dagligt og 1, 2% (13/ 1070 patienter) med placebo.
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.
Det tyder på, at forskelle i risko hænger sammen med celecoxibdosis.
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.
Onsenal er godkendt under ” særlige omstændigheder ”.
This medicinal product has been authorised under “ Exceptional Circumstances”.
Det Europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende Onsenal, og dette produktresumé vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
2- 3 timer.
Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Indtagelse sammen med føde (fedtrigt måltid) forsinker absorptionen omkring 1 time og øger den totale absorption (AUC) med 10- 20%.
Dosing with food (high fat meal) delays absorption by about 1 hour with an increase in total absorption (AUC) of 10 to 20%.
Den interindividuelle variation i plasmakoncentrationen af celecoxib er ca.
The inter-subject variability in the exposure of celecoxib is about 10-fold.
Inden for det terapeutiske dosisområde har celecoxib dosis - og tidsuafhængig farmakokinetik.
Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
97% ved terapeutiske plasmakoncentrationer, og celecoxib har ikke præference for binding til erytrocytter.
Plasma protein binding is about 97% at therapeutic plasma concentrations and celecoxib is not preferentially bound to erythrocytes.
Halveringstiden er 8- 12 timer.
Elimination half-life is 8-12 hours.
Hovedmetabolitterne, som findes i cirkulationen, har ingen målelig COX- 1 - eller COX- 2- aktivitet.
The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
3 metabolitter, inaktive som COX- 1 - eller COX- 2- hæmmere, er identificeret i humant plasma, dvs. en primær alkohol, den
Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i. e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Cytokrom P450 CYP2C9- aktivitet er nedsat hos personer med genetisk polymorfisme, som fører til nedsat enzymaktivitet, som f. eks. homozygot ved CYP2C9* 3- polymorfisme.
Cytochrome P450 CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
I et farmakokinetisk forøg med celecoxib 200 mg indgivet 1 gang dagligt til raske frivillige forsøgspersoner med genotype CYP2C9* 1 / * 1, CYP2C9* 1 / * 3 eller CYP2C9* 3 / * 3 er median Cmax og AUC0- 24 for celecoxib på dag 7 henholdsvis ca. firedoblet og syvdoblet hos personer med genotype CYP2C9* 3 / * 3 sammenlignet med andre genotyper.
11 In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/ *1, CYP2C9*1/ *3, or CYP2C9*3/ *3, the median Cmax and AUC 0-24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/ *3 compared to other genotypes.
3 gange sammenlignet med personer med normal metabolisme.
In three separate single dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/ *3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolizers.
Det anslås, at hyppigheden af homozygot * 3 / * 3 genotype er 0, 3- 1, 0% i forskellige etniske grupper.
It is estimated that the frequency of the homozygous *3/ *3 genotype is 0.3-1.0% among different ethnic groups.
4. 2).
Patients who are known or suspected to be CYP2C9 poor metabolizers based on previous history/ experience with other CYP2C9 substrates should be administered celecoxib with caution (see Section 4.2).
Celecoxibs plasmakoncentration er øget ca.
No clinically significant differences were found in pharmacokinetic parameters of celecoxib between African-Americans and Caucasians.
100% hos ældre kvinder (> 65 år).
The plasma concentration of celecoxib is approximately 100% increased in elderly women (> 65 years).
Hos FAP- patienter med moderat nedsat leverfunktion (serum - albumin 25- 35 g/ l) bør den daglige anbefalede dosis af celecoxib reduceres med 50%.
In FAP patients with moderate hepatic impairment (serum albumin of 25-35 g/ l), the daily recommended dose of celecoxib should be reduced by 50%.
Patienter med svært nedsat leverfunktion (serum- albumin < 25 g/ l) er ikke undersøgt, hvorfor celecoxib er kontraindiceret til denne patientgruppe.
Patients with severe hepatic impairment (serum albumin < 25 g/ l) have not been studied and celecoxib is contraindicated in this patient group.
3 gange (rotter) og 2 gange (kaniner) højere end opnået ved behandling med den maksimalt anbefalede daglige dosis til mennesker (800 mg).
Conventional embryo-foetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat foetuses and of cardiovascular malformations in rabbit foetuses at systemic exposures to free celecoxib approximately 3 times (rat) and 2 times (rabbit) higher than those achieved at the recommended daily human dose (800 mg).
I et peri- post natalt forsøg med rotter, som inkluderede behandling i den organdannende periode, blev diafragmabrok også set.
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Dyreforsøg med celecoxib i den tidlige fosterudvikling medførte abort i præ - og postimplantations - perioden.
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
I et peri- postnatalt rotteforsøg er der set toksicitet i afkommet.
In a peri-post natal study in rats, pup toxicity was observed.
I et 2- årigt toksicitetsforsøg er der set øget nonadrenal thrombose hos han- rotter ved høje doser.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Kapslerne indeholder: lactosemonohydrat natriumlaurilsulfat povidon K30 croscarmellosenatrium magnesiumstearat
Capsules contain: lactose monohydrate sodium lauryl sulphate povidone K30 croscarmellose sodium
Må ikke opbevares over 30°C.
Do not store above 30oC.
Klar eller uigennemsigtig PVC/ Aclar/ aluminiumfolieblister.
Clear or opaque PVC/ Aclar/ Aluminium foil blisters.
17. oktober 2003.
17 October 2003
Hjælpestoffer: lactosemonohydrat 99, 6 mg.
Excipients:
6. 1.
Lactose Monohydrate 99.6 mgFor a full list of excipients, see section 6.1.
Hvide, uigennemsigtige kapsler med 2 grønne bånd mærket 7767 og 400.
White, opaque capsules with two gold bands marked 7767 and 400.
16 4. 3 Kontraindikationer
4.3 Contraindications
4. 6 og 5. 3). • Svær leverdysfunktion (serumalbumin < 25 g/ l eller Child- Pugh score > 10) (klasse C). • Patienter med nyreinsufficiens med estimeret kreatinclearance < 30 ml/ min. • Inflammatorisk tarmsygdom. • Kronisk venstresidig hjerteinsufficiens (NYHA II- IV). • Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller cerebrovaskulær sygdom.
14 • Hypersensitivity to the active substance or to any of the excipients (see section 6.1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3) • Breast feeding (see sections 4.6 and 5.3) • Severe hepatic dysfunction (serum albumin< 25 g/l or Child-Pugh score > 10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance < 30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Der er ikke blevet fastslået nogen signifikant forskel i den gastrointestinale sikkerhed mellem selektive COX- 2- hæmmere + acetylsalicylsyre vs.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
5. 1).
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1).
Samtidig behandling med celecoxib og et ikke- acetylsalicylsyreholdigt NSAID bør undgås.
The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
4. 2, 4. 3, 4. 8 og 5. 1).
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1).
Selektive COX- 2- hæmmere kan ikke erstatte acetylsalicylsyre som profylakse ved kardiovaskulær tromboembolisk sygdom på grund af manglende effekt på blodpladefunktionen.
15 COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
18 Onsenal 200 mg kapsler indeholder lactose (49, 8 mg).
Onsenal 400 mg capsules contain lactose (99.6 mg).
Farmakodynamiske interaktioner Størstedelen af interaktionsforsøgene er blevet udført med celecoxibdoser på 200 mg 2 gange dagligt (dvs. de doser, der anvendes ved osteoarthritis/ reumatoid artrit).
16 The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i. e. those used for osteoarthritis/ rheumatoid arthritis).
Samtidig behandling med NSAID og ciclosporin D- derivater eller tacrolimus synes at kunne øge den nyretoksiske effekt af ciclosporin og tacrolimus.
Co-administration of NSAIDs and cyclosporine D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
19 In vitro- forsøg har vist mulighed for, at celecoxib kan hæmme CYP2C19- katalyseret metabolisme.
In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Hos patienter med reumatoid artrit havde celecoxib ingen signifikant virkning på farmakokinetikken (plasma - eller renal clearance) af methotrexat (i reumatologiske doser).
17 In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Bivirkningerne i tabel 1 er anført efter organklasse og i henhold til frekvens og afspejler information fra følgende kilder:
4.8 Undesirable effects Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources:
periode, hvor det anslås, at > 70 millioner patienter er blevet behandlet med celecoxib (variable doser, varigheder og indikationer).
which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and indications).
TABEL 1.
18
Frekvens ikke
Frequency Not Known
< 1/ 100
(≥ 1/ 1000 to < 1/ 100)
< 1/ 1000
(≥ 1/ 10,000 to < 1/ 1000)
Infektioner og parasitære sygdomme
(Post-marketing experience)1
sinuitis, øvre luftvejsinfektion, urinvejsinfektion
Infections and infestations
På baggrund af dette kan hyppigheden af disse bivirkninger ikke bestemmes på pålidelig måde.
Sinusitis, upper respiratory tract infection, urinary tract infection
leukopeni, trombocytopeni
Leucopenia, thrombocytopeni a
Psykiske forstyrrelser Metabolisme og ernæring
Psychiatric
angst, depression, træthed hyperkaliæmi
Anxiety, depression, tiredness
myokardieinfarkt4
Myocardial infarction2
sår i tolvfingertarmen, mavesæk, spiserør, tyndtarmen og tyktarmen; dysfagi, intestinal perforation, esophagitis, melaena, pancreatitis
Duodenal, gastric, Nausea, acute oesophageal, pancreatitis, intestinal, and gastrointestinal colonic ulceration; haemorrhage, dysphagia, colitis/ colitis aggravated intestinal perforation; oesophagitis, melaena; pancreatitis
forhøjede leverenzymer
Elevation of Hepatitis, hepatic failure hepatic enzymes jaundice
hepatitis, leversvigt, icterus
19
urticaria
Urticaria
alopeci, foto - sensitivitet
Alopecia, photosensitivity
ekkymose, bulløs erruption, exfoliativ dermatitis, erythema multiforme, Stevens - Johnsons syndrom,
Ecchymosis, bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
4
Leg cramps
1000 patienter (sjælden) i forhold til placebo.
Arthralgia, myositis
Der ses ingen overrepræsentation af slagtilfælde.
Increased creatinine, BUN increased
22 toksisk epidermal nekrolyse, angioødem Knogler, led, muskler og bindevæv
Acute renal failure, interstitial nephritis, hyponatraemia
kramper i benene
Reproductive and breast
artralgi, myositis
Menstrual disorder
Nyrer og urinveje Det reproduktive system og mammae
1
forhøjet kreatinin, forhøjet serumcarbamid
General
akut nyresvigt, interstitial nefritis, hyponatriæmi menstruations - forstyrrelser
Flu-like symptoms, peripheral oedema/ fluid retention
Almene symptomer og reaktioner på adminitrationsste det
As a result, the frequencies of these adverse drug reactions cannot be reliably determined.
influenzalignende symptomer, peri - fere ødemer/ væske - retention
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.
5. 1, Farmakodynamiske egenskaber:
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:
Kardiovaskulær sikkerhed – langtidsforsøg hos patienter med sporadisk adenomatøs polypose).
Cardiovascular Safety – Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps).
TABEL 2 Organklasse
TABLE 2
øre infektion, svampe - infektion (svampeinfek - tionerne var primært ikke - systemiske)
Ear infection, fungal infection (fungal infections were primarily nonsystemic)
unstabil angina, aortaklapregur - gitation, aterosklerose af koro - nararterier, sinusbradykardi, ventrikulær hypertrofi
Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertropy
Luftveje, thorax og mediastinum
Respiratory, thoracic,
kvalme, gastroøsofageal reflukssygdom, divertikel, opkastning *, dysfagi, colon irritabile- syndrom
Nausea, gastroesophageal reflux disease, diverticulum, vomiting, * dysphagia, irritable bowel syndrome
Det reproduktive system og mammae Almene symptomer og reaktioner på adminitrations - stedet
Reproductive and breast General and administrative site
benign prostatahyperplasi, prostatitis, øget prostata - specifikt antigen ødemer
Benign prostatic hyperplasia, prostatitis, prostatic specific antigen increased Edema
fodfraktur, frakturer i underekstre - miteterne, epikondylit, seneruptuk, fraktur
Foot fracture, lower limb fracture, epicondylitis, tendon rupture, fracture
Celecoxib er en oral, selektiv cyclooxygenase- 2- hæmmer (COX- 2).
Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Cyclooxygenase er ansvarlig for dannelsen af prostaglandiner.
21 Cyclooxygenase is responsible for generation of prostaglandins.
Der er identificeret 2 isoformer, COX - 1 og COX- 2.
Two isoforms, COX-1 and COX-2, have been identified.
Det er vist at COX- 2 er isoformen af det enzym, som induceres af pro- inflammatoriske stimuli, og som man mener, hovedsagelig har ansvaret for syntese af prostanoide mediatorer af smerte, inflammation og feber.
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.
Der er set forhøjede COX- 2- niveauer i mange præmaligne læsioner (såsom adenomatøse colorektale polypper) og epitelcancer.
Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers.
Familiær adenomatøs polypose (FAP) er en genetisk sygdom, som skyldes en autosomal dominant genetisk forandring af et
Familial Adenomatous Polyposis (FAP) is a genetic disease resulting from an autosomal dominant genetic alteration of a tumor suppressor gene, the adenomatous polyposis coli (APC) gene.
Efter 6 måneders behandling med celecoxib 400 mg 2 gange dagligt var den gennemsnitlige reduktion i antallet af colorektale polypper på 28% (standardafvigelse + 24%), hvilket var signifikant bedre end for placebo (middelværdi 5%, standardafvigelse + 16%).
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%).
Der blev set en betydelig reduktion af det adenomatøse område i duodenum sammenlignet med placebo (14, 5% for celecoxib 400 mg 2 gange dagligt versus 1, 4% for placebo), hvilket dog ikke er statistisk signifikant.
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.
I alt 18 børn i alderen 10- 14 år med positiv FAP- geno - eller FAP - fænotype blev behandlet med celecoxib 4 mg/ kg dagligt (4 patienter sammenlignet med 2 behandlet med placebo) celecoxib 8 mg/ kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo), eller celecoxib 16 mg/ kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo).
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).
4. 4; kardiovaskulære lidelser).
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).
Kardiovaskulær sikkerhed – langtidsforsøg med patienter med sporadisk adenomatøs polypose:
Cardiovascular Safety – Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps:
Der er gennemført 2 forsøg på personer med sporadisk adenomatøs polypose med celecoxib, dvs.
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).
APC- forsøget (Adenoma Prevention with Celecoxib) og PreSAP- forsøget (Prevention of Spontaneous Adenomatous Polyps).
In the APC trial, there was a dose-related increase in the composite endpoint of cardiovascular
I APC- forsøget ses en dosisrelateret stigning i det sammensatte endepunkt af kardiovaskulær død, myokardieinfarkt eller slagtilfælde (bekræftet) med celecoxib sammenlignet med placebo over en behandlingsperiode på 3 år.
22 death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment.
Det tyder på at forskelle i risko hænger sammen med celecoxibdosis.
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.
Den farmakologiske virkning sidder i
Pharmacological activity resides in the parent substance.
3 metabolitter, inaktive som COX- 1 - eller COX- 2- hæmmere, er identificeret i humant plasma, dvs. en primær alkohol, den tilsvarende carboxylsyre og dets glucuronidkonjugat.
Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i. e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.