FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, as a precaution, the use of rosiglitazone is not recommended in these patients, particularly those with myocardial ischaemic symptoms.
Danish: For en sikkerheds skyld bør rosiglitazon derfor ikke anvendes til disse patienter, specielt ikke til patienter med symptomer på iskæmisk hjertesygdom.
English: The RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) trial was a large (4,447 subjects), open-label, prospective, controlled study (mean follow-up 5.5 years) in which patients with type 2 diabetes inadequately controlled with metformin or sulphonylurea were randomised to add-on rosiglitazone or metformin or sulphonylurea.
Danish: RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) var en stor (4.447 patienter), open-labelled, prospektiv, kontrolleret undersøgelse (gennemsnitlig opfølgning i 5,5 år), hvor patienter med type 2-diabetes, som ikke var tilstrækkeligt regulerede på metformin eller sulfonylurinstof (SU), blev randomiserede til at få lagt rosiglitzon eller metformin eller SU oveni.
English: Always take Avandamet tablets exactly as your doctor has told you.
Danish: Tag altid Avandamet nøjagtigt efter lægens anvisning.
English: For a full list of excipients, see section 6.1.
Danish: Alle hjælpestoffer er anført under afsnit 6.1.
English: The usual starting dose is one combined tablet (2 mg rosiglitazone and 1000 mg metformin), taken twice a day, morning and evening.
Danish: Den sædvanlige startdosis er en tablet (2 mg rosiglitazon og 1000 mg metformin) to gange dagligmorgen og aften.
English: Fluid retention and cardiac failure
Danish: Væskeretention og hjerteinsufficiens
English: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Kombinationer, som kræver særlige forsigtighedsregler Glukokortikoider (indgivet systemisk og lokalt), beta-2-agonister og diuretika har intern hyperglykæmisk aktivitet.
English: This translates to a cumulative incidence of treatment failure of 10.3% for rosiglitazone, 14.8% for metformin and 23.3% for glibenclamide treated patients.
Danish: Dette betyder, at akkumulerede tilfælde af behandlingssvigt hos rosiglitazon-, metformin- og glibenclamidbehandlede patienter er henholdsvis 10,3 %, 14,8 % og 23,3 %.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: Long-term studies show an increased incidence of bone fractures in patients, particularly female patients, taking rosiglitazone (see section 4.8).
Danish: Langtidsforsøg viser en øget forekomst af frakturer hos især kvindelige patienter, der blev behandlet med rosiglitazon (se afsnit 4.8).
English: Erythema
Danish: Erytem
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Danish: Analyser af resultaterne for overvægtige patienter, behandlet med metformin, da diæt havde vist sig utilstrækkelig: - en signifikant reduktion i den absolutte risiko for enhver diabetes-relateret komplikation i metformingruppen (28,9 tilfælde/1.000 patientår) versus diæt alene (43,3 tilfælde/1.000 patientår), p=0,0023, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (40,1 tilfælde/1.000 patientår), p=0,0034 - en signifikant reduktion i den absolutte risiko for diabetes-relateret mortalitet: metformin (7,5 tilfælde/1.000 patientår), diæt alene (12,7 tilfælde/1.000 patientår), p=0,017 - en signifikant reduktion i den absolutte risiko for overordnet mortalitet: metformin (13,5 tilfælde/1.000 patientår) versus diæt alene (20,6 tilfælde/1.000 patientår), p=0,011, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (18,9 tilfælde/1.000
English: Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Danish: Ældre: I den farmakokinetiske analyse med poolet population havde alder ikke nogen signifikant indflydelse på farmakokinetikken.
English: 4 Long-term studies show an increased incidence of bone fracture in patients, particularly female patients, taking rosiglitazone.
Danish: Langtidsundersøgelser viser en øget forekomst af fraktur hos især kvindelige patienter, der tager rosiglitazon.
English: You must look out for certain symptoms while you are taking Avandamet, to reduce the risk of any problems.
Danish: For at mindste risikoen for problemer, skal du være særlig opmærksom på visse symptomer, mens du tager Avandamet.
English: • ACE inhibitors (used to treat high blood pressure), such as enalapril or captopril
Danish: • ACE-hæmmere (anvendes til at behandle højt blodtryk) såsom enalapril eller captopril
English: Metabolism and nutrition disorders lactic acidosis
Danish: Metabolisme og ernæring Lactacidose
English: The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Danish: Forekomsten af hjerteinsufficiens var 2,4 % ved kombinationsbehandling med insulin (rosiglitazon givet for at understøtte insulinbehandling), sammenlignet med 1,1 % ved behandling med insulin alene.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Avandamet til dig personligt.
English: New or worse cases of macular oedema have occurred on rare occasions in people taking Avandamet and similar medicines.
Danish: Nye tilfælde eller forværring af maculaødem er i enkelte tilfælde set hos patienter i behandling med Avandamet og tilsvarende lægemidler.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking AVANDAMET should have their renal function monitored regularly (see sections 4.3 and 4.4).
Danish: Da metformin udskilles via nyrerne, og ældre har tendens til forringet nyrefunktion, bør ældre patienter, som behandles med AVANDAMET, have deres nyrefunktion monitoreret regelmæssigt.
English: There was a significant increase in heart failure (fatal and nonfatal) (HR 2.10, CI 1.35-3.27) and bone fractures (Risk Ratio 1.57, CI 1.26-1.97) in rosiglitazonecontaining treatments compared to active control (see sections 4.4 and 4.8).
Danish: Der sås en signifikant stigning i hjerteinsufficiens (fatal og ikkefatal) (HR 2,10, CI 1,35-3,27) og frakturer (risikoratio 1,57, CI 1,26-1,97) i forbindelse med de behandlinger, der indeholdt rosiglitazon sammenlignet med den aktive kontrolgruppe (se afsnit 4.4 og 4.8).
English: Iron oxide red (E172).
Danish: Rød jernoxid (E172).
English: Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Danish: Der har ikke været inkluderet patienter med AKS i kontrollerede kliniske forsøg med rosiglitazon.
English: • if you are very dehydrated or have a severe infection (see ‘While you take
Danish: • hvis du er meget dehydreret eller har en alvorlig infektion (se ”Når du tager Avandamet, skal din læge vide” senere i afsnit 2)
English: Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Danish: Immunsystemet (se Hud og subkutane væv) Anafylaktisk reaktion
English: Therefore, liver enzymes should be checked prior to the initiation of therapy with AVANDAMET in all patients and periodically thereafter based on clinical judgement.
Danish: Derfor bør leverenzymer kontrolleres forud for indledning af terapi med AVANDAMET hos alle patienter.
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Danish: Rosiglitazons plasmaproteinbinding er høj (cirka 99,8 %) og påvirkes ikke af koncentration eller alder. Proteinbindingen af den hyppigst forekommende metabolit (para-hydroxy-sulfat) er meget høj (> 99,99 %).
English: In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)].
Danish: I en anden langtidsundersøgelse sås der øget forekomst af fraktur hos patienter i den kombinerede rosiglitazongruppe i sammenligning med den aktive kontrolgruppe [8,3 % versus 5,3 %, risikoratio 1,57 (95 % CI 1,26 - 1,97)].
English: AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Danish: AVANDAMET kombinerer to antidiabetiske stoffer med komplementære virkningsmekanismer til forbedring af den glykæmiske kontrol hos patienter med type 2-diabetes: rosiglitazonmaleat, hørende til thiazolidinedionerne og metforminhydrochlorid, hørende til biguaniderne.
English: Rosiglitazone
Danish: Rosiglitazon
English: There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of AVANDAMET (see section 4.4).
Danish: Der er øget risiko for lactacidose ved akut alkoholforgiftning (særligt i tilfælde af faste, fejlernæring eller leverinsufficiens) på grund af indholdet af metformin i AVANDAMET (se afsnit 4.4) Undgå indtagelse af alkohol og lægemidler indeholdende alkohol.
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Danish: Bivirkninger fra hvert behandlingsregime er listet under organklasse og absolutte frekvens.
English: headache*
Danish: Hovedpine*
English: HR and CI for key secondary endpoints were: all-cause death (HR 0.86, CI 0.68-1.08), MACE (Major Adverse Cardiac Events - cardiovascular death, acute myocardial infarction, stroke) (HR 0.93, CI 0.74-1.15), cardiovascular death (HR 0.84, CI 0.59-1.18), acute myocardial infarction (HR 1.14, CI 0.80-1.63) and stroke (HR 0.72, CI 0.49-1.06).
Danish: HR og CI vedrørende sekundære endepunkter var: Død uanset årsag (HR 0,86, CI 0,68-1,08), MACE (Major Adverse Cardiac Events - kardiovaskulær død, akut myokardieinfarkt, apopleksi) (HR 0,93, CI 0,741,15), kardiovaskulær død (HR 0,84, CI 0.59-1,18), akut myokardieinfarkt (HR 1,14, CI 0,80-1,63) og apopleksi (HR 0,72, CI 0,49-1,06).
English: Check your weight regularly; if it goes up rapidly, tell your doctor.
Danish: Hvis den pludselig stiger, skal du fortælle det til din læge.
English: AVANDAMET 1 mg/500 mg film-coated tablets AVANDAMET 2 mg/500 mg film-coated tablets AVANDAMET 2 mg/1000 mg film-coated tablets AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
Danish: AVANDAMET 1 mg/500 mg filmovertrukne tabletter AVANDAMET 2 mg/500 mg filmovertrukne tabletter AVANDAMET 2 mg/1000 mg filmovertrukne tabletter AVANDAMET 4 mg/1000 mg filmovertrukne tabletter rosiglitazon/metformin HCl
English: Nervous system disorders metallic taste
Danish: Nervesystemet Metalsmag
English: In a prospective cardiovascular outcomes study (mean follow-up 5.5 years) the primary endpoint events of cardiovascular death or hospitalisation were similar between rosiglitazone and active comparators [HR 0.99 (95% CI 0.85 - 1.16)].
Danish: I en prospektiv undersøgelse af forekomsten af hjerte-kar-sygdomme (gennemsnitlig opfølgning i 5,5 år) var de primære endepunkter, død eller indlæggelse pga. hjerte-kar-sygdomme, lige hyppige hos de patienter, der fik rosiglitazon, og de patienter, der fik aktive komparatorer [HR 0,99 (95 % CI 0,85 - 1,16)].
English: Cardiac disorders congestive heart failure/pulmonary oedema
Danish: Hjerte Kongestiv hjerteinsufficiens /lungeødem
English: The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.
Danish: Den maksimalt anbefalede daglige dosis af AVANDAMET er 8 mg rosiglitazon plus 2000 mg metforminhydrochlorid.
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
English: Avandamet tablets come in different strengths.
Danish: Avandamet findes i forskellige styrker.
English: Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Danish: Samtidig administration af rosiglitazon og gemfibrozil (en hæmmer af CYP2C8) resulterede i en tofoldig stigning i plasmakoncentrationen af rosiglitazon.
English: Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Danish: Øget overvågning af patienten og en reduktion i dosis af enten sulfonylurinstof eller insulin kan være nødvendig.
English: Excipients: Each tablet contains lactose (approximately 6 mg).
Danish: Hver tablet indeholder lactose (ca. 6 mg).
English: Patients with renal impairment
Danish: Patienter med nedsat nyrefunktion:
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Danish: Post-marketing-rapporter har beskrevet nye tilfælde samt forværring af diabetisk maculaødem med synsforstyrrelser hos patienter i behandling med thiazolider, herunder rosiglitazon.
English: AVANDAMET should not be used in patients with renal failure or renal dysfunction, e.g. serum creatinine levels > 135 μmol/l in males and > 110 μmol/l in females and/or creatinine clearance < 70 ml/min (see sections 4.3 and 4.4).
Danish: AVANDAMET må ikke anvendes til patienter med nyresvigt eller nedsat nyrefunktion, f.eks. serumkreatinin niveau > 135 µmol/l hos mænd og > 110 µmol/l hos kvinder og/eller kreatininclearance < 70 ml/min (se afsnit 4.3 og 4.4).
English: The risk of fracture should be considered in the care of patients, especially female patients, treated with rosiglitazone.
Danish: Der skal tages hensyn til risikoen for frakturer hos især kvindelige patienter ved behandling med rosiglitazon.
English: The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Danish: Frekvens af bivirkninger identificeret fra postmarketingdata med rosiglitazon Bivirkning
English: Blood and the lymphatic system disorders anaemia granulocytopaenia
Danish: Blod- og lymfesystem Anæmi
English: These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
Danish: Disse styrker findes i blisterpakninger indeholdende 14, 28, 56, 2x56, 3x56 eller 180 filmovertrukne tabletter.
English: Individual CL/F in the paediatric population was in the same range as individual adult data.
Danish: Hos patienterne mellem 10 og 18 år var den individuelle CL/F i samme størrelsesorden som hos voksne.
English: Î Contact a doctor immediately if you get these symptoms.
Danish: Kontakt straks en læge, hvis du får disse symptomer.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt [måned] [år].
English: Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4) - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Danish: Oral tripel-kombinationsbehandling (rosiglitazon, metformin og sulfonylurinstof) (se afsnit 4.4) - Patienter, der hidtil har fået metformin og sulfonylurinstof: Hvor det er hensigtsmæssigt kan AVANDAMET-behandlingen påbegyndes med en dosis af rosiglitazon på 4 mg pr. dag og en dosis metformin, som erstatter den dosis, der allerede indtages.
English: Î Contact a doctor immediately if you get any of these symptoms.
Danish: Kontakt straks en læge, hvis du får nogen af disse symptomer.
English: The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day.
Danish: Den maksimale dosis er 4 mg rosiglitazon og 1000 mg metformin 2 gange daglig.
English: If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Danish: Hvis du har taget for meget Avandamet Kontakt lægen eller apoteket, hvis du kommer til at tage for mange tabletter.
English: Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Danish: Rosiglitazons metabolisme er omfattende, og intet af det oprindelige stof udskilles uændret.
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h. There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Danish: Total plasmaclearance af rosiglitazon er omkring 3 l/time, og den endelige halveringstid er cirka 3-4 timer.
English: The risk of fracture appeared to be higher in females relative to control [11.5% vs 6.3%, Risk ratio 1.82 (95% CI 1.37 - 2.41)], than in males relative to control [5.3% vs 4.3%, Risk ratio 1.23 (95% CI 0.85 - 1.77)].
Danish: Risikoen for fraktur så ud til at være større hos kvinder i forhold til kontrolgruppen [11,5 % versus 6,3 %, risikoratio 1,82 (95 % CI 1,26 - 1,97)] end hos mænd i forhold til kontrolgruppen [5,3 % versus 4,3 % (95 % CI 0,85 - 1,77)].
English: Excipients: Each tablet contains lactose (approximately 11 mg)
Danish: Hver tablet indeholder lactose (ca. 11 mg).
English: These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Danish: Disse styrker findes i blisterpakninger indeholdende 28, 56, 112, 3x112 eller 360 filmovertrukne tabletter.
English: 6 Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: 6Gastrointestinale symptomer såsom kvalme, opkastning, diaré, mavesmerter og appetitløshed er meget almindelige.
English: and your dose of Avandamet may need to be changed.
Danish: Dit blodsukker vil blive tjekket, og din dosis af Avandamet skal måske ændres.
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Danish: In vitro-undersøgelser har vist, at rosiglitazon primært metaboliseres af CYP2C8, med CYP2C9 som en mindre metaboliseringsvej.
English: • constipation
Danish: • frysen
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Danish: Absolut biotilgængelighed af en 500 mg metfomin-tablet er cirka 50-60 % hos raske personer.
English: In the final analysis at 5 years, an adjusted mean reduction from baseline in HbA1c of 0.14% for patients on rosiglitazone added to metformin versus an increase of 0.17% for patients taking sulphonylurea added to metformin was seen during treatment with randomised dual-combination therapy (p<0.0001 for treatment difference).
Danish: I den endelige analyse efter 5 år sås en justeret gennemsnitsreduktion fra baseline i HbA1c på 0,14 % hos patienter på rosiglitazon lagt oven i metformin over for en stigning på 0,17 % hos de patienter, der fik SU lagt oven i metformin i den randomiserede tostofbehandling (p < 0,0001 mht. forskel i behandling).
English: 1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone
Danish: 1Hypercholesterolæmi var rapporteret hos op til 5,3 % af de patienter, der blev behandlet med rosiglitazon (oral monoterapi, dobbel- eller tripelterapi).
English: Eye problems: Swelling of the retina at the back of the eye which can cause blurred vision (macular oedema) can be a problem for people with diabetes.
Danish: Øjenlidelser: Diabetespatienter kan opleve problemer i form af hævelse af retina i det bagerste af øjet, hvilket kan medføre synsforstyrrelser (maculaødem).
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Danish: Når nyrefunktionen er nedsat, er renal clearance nedsat forholdsmæssigt som kreatininclearance, og dermed er eliminationshalveringstiden forlænget, førende til øgede plasmakoncentrationer af metformin.
English: Musculoskeletal and connective tissue disorders bone fractures4
Danish: Knogler, led, muskler og bindevæv Frakturer4
English: Î Tell your doctor as soon as possible if you get these symptoms.
Danish: Fortæl det til lægen så hurtigt så muligt, hvis du får disse symptomer.
English: If you have any unwanted tablets, don't put them in waste water or household rubbish.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: • rapid breathing
Danish: • hurtig vejrtrækning
English: Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
Danish: Kun metformingruppen opnåede statistisk signifikant forbedring i forhold til baseline.
English: The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Danish: Frekvens af bivirkninger identificeret under kliniske undersøgelser med metformin og fra postmarketingdata med metformin
English: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
Danish: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS Storbritannien
English: Two other long-term prospective randomised controlled clinical trials (9,620 patients, study duration >3 years in each study), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the potential risk of cardiac ischaemia.
Danish: To andre prospektive, randomiserede, kontrollerede kliniske langtidsundersøgelser (med 9.620 patienter, hver undersøgelse med en varighed på > 3 år), der sammenlignede rosiglitazon og andre godkendte orale antidiabetika eller placebo, hverken be- eller afkræftede den potentielle risiko for myokardieiskæmi.
English: The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride.
Danish: Den sædvanlige startdosis af AVANDAMET er 4 mg rosiglitazon/dag plus 2000 mg metforminhydrochlorid/dag.
English: In an update to this retrospective analysis that included 10 further studies that met the criteria for inclusion, but were not available at the time of the original analysis, the overall incidence of events typically associated with cardiac ischaemia was not statistically different for rosiglitazone containing regimens, 2.21% versus combined active and placebo comparators, 2.08% [HR 1.098 (95% CI 0.809 - 1.354)].
Danish: I en analyse opdateret med yderligere 10 undersøgelser, der opfyldte inklusionskriterierne, men som ikke var tilgængelige, da den oprindelige analyse blev foretaget, er der ikke statistisk forskel på forekomsten af hændelser, der typisk sættes i forbindelse med hjerteiskæmi, i behandlingsregimer med rosiglitazon, 2,21 %, og med kombinerede aktive og placebo-komparatorer, 2,08 [HR 1,098 (95 % CI 0,809 - 1,354)].