FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP agrees that excluding females from the indication would deprive an important sub-group of the population of atorvastatin treatment if their CV risk warrants this treatment, and believes the above findings in the female subgroup of ASCOTLLA should be reflected in section 5.1 of the SPC.
Danish: CHMP kan derfor tilslutte sig, at man ved at undtage kvinder fra indikationen ville fratage en vigtig undergruppe i befolkningen muligheden for at blive behandlet med atorvastatin, når den kardiovaskulære risiko gør sådan behandling nødvendig, og finder, at ovenstående resultater i den kvindelige undergruppe af ASCOT-LLA bør afspejles i afsnit 5.1 af produktresuméet.
English: Uncommon: impotence.
Danish: Ikke almindelig: Impotens.
English: 100 vs. 154
Danish: 100 mod 154
English: CHD = coronary heart disease; MI = myocardial infarction.
Danish: CHD = koronar hjertesygdom; MI = myokardieinfarkt.
English: Therefore, special caution should be exercised when atorvastatin is used in combination with such medicinal agents (see section 4.4).
Danish: Der bør derfor udvises særlig forsigtighed, når atorvastatin gives sammen med sådanne præparater (se pkt.
English: Common: myalgia, arthralgia.
Danish: Almindelig: Myalgi, artralgi.
English: There was a 36.4% mean reduction in CRP in the atorvastatin group compared to a 5.2% reduction in the pravastatin group (p<0.0001).
Danish: Der er 36,4% gennemsnits reduktion i CRP i atorvastatingruppen sammenlignet med 5,2% reduktion i pravastatingruppen (p<0,0001).
English: This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with evidence of myocardial ischaemia (p=0.018).
Danish: Dette skyldes primært en risikoreduktion på 26% i genindlæggelse for angina pectoris med tegn på myokardieiskæmi (p=0,018).
English: - It is proposed to add the following indication in section 4.1: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Danish: - Følgende indikation foreslås tilføjet i afsnit 4.1: Forebyggelse af kardiovaskulære hændelser hos patienter, der skønnes at have en høj risiko for en første kardiovaskulær hændelse (se punkt 5.1), som supplement til korrektion af andre risikofaktorer.
English: He/she will decide on the further steps needed.
Danish: Lægen vil bestemme hvad der skal ske.
English: The effect of inducers of cytochrome P450 3A4 (e.g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Danish: Effekten af induktorer af cytokrom P450 3A4 (f.eks. rifampicin eller fenytoin) på {(Sær)navn} kendes ikke.
English: • The MAH has implemented the text proposed by the CHMP in the SPC:
Danish: • indehaveren af markedsføringstilladelsen har i produktresuméet anvendt den af CHMP foreslåede tekst:
English: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Danish: Atorvastatin er en selektiv, kompetitiv HMG-CoA-reduktasehæmmer, det hastighedsbegrænsende enzym, som er ansvarlig for omdannelsen af 3-hydroxy-3-methyl-glutaryl-coenzym A til mevalonat, et forstadium til sterol, herunder kolesterol.
English: The trial results show that for some low risk subgroups included in the studies, corresponding to large populations, treatment is probably not justified with current knowledge, and approving such an indication would result in the treatment of many patients that have no benefit from lipid lowering therapy.
Danish: Forsøgenes resultater viser, at den aktuelle viden formodentlig ikke giver grundlag for at behandle visse af forsøgenes lavrisikoundergrupper, der repræsenterer store populationer, hvorfor godkendelse af en sådan indikation ville føre til behandling af mange patienter, der ikke vil få gavn af lipidsænkende behandling.
English: In animal studies atorvastatin had no effect on male or female fertility at doses up to 175 and 225 mg/kg/day, respectively, and was not teratogenic.
Danish: I dyreforsøg havde atorvastatin ingen effekt på hanners eller hunners fertilitet i doser op til henholdsvis 175 og 225 mg/kg dagligt; atorvastatin havde ingen teratogen virkning.
English: Other less common side effects have been seen in some patients taking {PRODUCT NAME} or other medicines of this kind.
Danish: Andre ikke almindelige bivirkninger er set hos nogle patienter, som tager {(Sær)navn} eller anden medicin af samme type.
English: Nevertheless, patients receiving warfarin should be closely monitored when {PRODUCT NAME} is added to their therapy.
Danish: Ikke desto mindre bør patienter i warfarinbehandling monitoreres omhyggeligt, når {(Sær)navn} tillægges behandlingen.
English: The risk of atorvastatin-induced myopathy may be increased with the concomitant use of fibric acid derivatives.
Danish: Risiko for atorvastatin-induceret myopati kan øges ved samtidig brug af fibrater.
English: − Geriatric: Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations.
Danish: Ældre: Plasmakoncentrationer af atorvastatin og dets aktive metabolitter er højere hos raske ældre end hos yngre, mens virkningen på lipiderne er sammenlignelige med dem, som ses hos yngre patientgrupper.
English: Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Danish: Samtidig anvendelse af {(Sær)navn} og warfarin førte til et lille fald i protrombintid i de første dage efter indgift; dette normaliseredes inden for 15 dage.
English: − If symptoms resolve and CPK levels return to normal, then re-introduction of atorvastatin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring.
Danish: Hvis symptomerne forsvinder og CK-værdien normaliseres, bør re-introduktion eller introduktion af anden statinbehandling overvejes, idet der gives laveste dosis og med tæt monitorering.
English: Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.
Danish: CK bør ikke måles efter kraftig fysisk anstrengelse, eller hvis der er en alternativ grund til at CK er forhøjet, da det vanskeliggør fortolkningen af værdien.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Sealed for your protection.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Forseglet af sikkerhedshensyn.
English: Atorvastatin significantly reduced the frequency of coronary and CV events, strokes and revascularisation procedures in the entire study cohort, but a beneficial effect in the female subgroup could not be established, and overall mortality and CV mortality were numerically higher (not significant) in female patients.
Danish: Atorvastatin mindskede signifikant frekvensen af koronare og kardiovaskulære hændelser, slagtilfælde og revaskulariseringsprocedurer i hele forsøgskohorten, men en gavnlig virkning i den kvindelige undergruppe kunne ikke påvises, og den samlede dødelighed og kardiovaskulære dødelighed var numerisk større (ikke signifikant) hos kvindelige patienter.
English: Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Danish: Samlet mortalitet og kardiovaskulær mortalitet var numerisk højere hos kvinder (38 vs. 30 og 17 vs. 12), men det var ikke statistisk signifikant.
English: − Paediatric: Pharmacokinetic data in the paediatric population are not available.
Danish: Børn: Der findes ikke farmakokinetiske data hos børn.
English: − Atorvastatin must be discontinued if clinically significant elevation of CPK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
Danish: Atorvastatin skal seponeres ved klinisk signifikant stigning i CK-værdien (>10 gange den øvre referenceværdi), eller hvis der er mistanke om eller rhabdomyolyse diagnosticeres.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME, MÆRKNING PÅ EMBALLAGE OG INDLÆGSSEDDEL
English: Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
Danish: Niveauer mere end 10 gange den øvre referenceværdi er set hos 0,4% af de {(Sær)navn}-behandlede patienter (se pkt.
English: {PRODUCT NAME} is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed.
Danish: {(Sær)navn} anvendes til at sænke fedtstoffer (lipider) som kolesterol og triglycerider i blodet, når fedtfattig diæt og livsstilsændringer ikke er tilstrækkelig.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Mean volume of distribution of atorvastatin is approximately 381 l. Atorvastatin is ≥ 98% bound to plasma proteins.
Danish: Det gennemsnitlige fordelingsvolumen af atorvastatin er ca. 381 l. Atorvastatin er bundet ≥98% eller mere til plasmaproteiner.
English: 21 vs. 39
Danish: 21 mod 39
English: Very rare: angioneurotic oedema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
Danish: Meget sjælden: Angioneurotisk ødem, bulløs hududslæt (herunder erythema multiforme, Stevens Johnsons syndrom og toksisk epidermal nekrolyse).
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]
Danish: <[Se bilag I - Udfyldes nationalt]> [For referral procedures]
English: The absolute and relative risk reduction effect of atorvastatin were as follows:
Danish: Den absolutte og relative risikoreducerende virkning af atorvastatin var som følger:
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Danish: Derefter kan dosis enten øges til maksimalt 80 mg dagligt eller kan kombineres med en galdesyrebinder og 40 mg {(Sær)navn} 1 gang dagligt.
English: Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours.
Danish: Den gennemsnitlige halveringstid i plasma hos mennesker er ca. 14 timer.
English: Other possible side effects with {PRODUCT NAME}:
Danish: Andre mulige bivirkninger med {(Sær)navn}:
English: However, large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites) HMG-CoA reductase inhibitors 1.3 fold.
Danish: Store mængder grapefrugtjuice (mere end 1,2 l dagligt i 5 dage) øger atorvastatins AUC med 2,5 gange og AUC af den aktive (atorvastatin og metabolitter) HMG-CoA-reduktasehæmmere med 1,3 gange.
English: − Occasionally, patients have developed muscle wasting or inflammation, and very rarely this has progressed to become a serious, potentially life-threatening condition (called ‘rhabdomyolysis').
Danish: Patienter kan lejlighedsvis opleve muskelsvind eller betændelsetilstand, som i meget sjældne tilfælde kan udvikle sig til en alvorlig, mulig, livstruende tilstand (rhabdomyolyse).
English: Coadministration of {PRODUCT NAME} with an oral antacid suspension containing magnesium and aluminium hydroxides decreased plasma concentrations of atorvastatin and its active metabolites approx. 35%; however, LDL-C reduction was not altered.
Danish: Samtidig anvendelse af {(Sær)navn} og en oral syreneutraliserende suspension med magnesium og aluminiumhydroxyd gav fald i plasmakoncentrationen af atorvastatin og dets aktive metabolitter med ca. 35%; LDL-kolesterol reduktionen var imidlertid ikke ændret.
English: Nonetheless, the CHMP thought it relevant to reflect this finding and include following factual statement in the pragraph summarising the results of ASCOT-LLA under section 5.1 of the SPC.
Danish: Dog har CHMP fundet det relevant, at disse resultater afspejler sig i nedenstående faktuelle udsagn, der indsættes i det afsnit, der sammenfatter resultaterne af ASCOT-LLA i afsnit 5.1 af produktresuméet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
English: In the Final Assessment report (1 November 2005) the Reference Member State proposed, and the MAH agreed to, the following indication : “Prevention of cardiovascular events in patients with type 2 diabetes and one additional risk factor with normal to mildly elevated cholesterol level without clinically evident coronary heart disease”.
Danish: I den endelige vurderingsrapport (1. november 2005) foreslog referencemedlemsstaten følgende indikation, som indehaveren af markedsføringstilladelsen tilsluttede sig: "Forebyggelse af kardiovaskulære hændelser hos patienter med type 2-diabetes og én yderligere risikofaktor samt normalt til let forhøjet kolesteroltal uden klinisk evident koronar hjertesygdom",
English: You should consult your doctor as soon as possible.
Danish: Kontakt straks lægen.
English: AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
Danish: AMI = akut myokardieinfarkt; CABG = koronar arterie bypass transplantat; CHD = iskæmisk hjertesygdom; MI = myokardieinfarkt; PTCA = perkutan transluminal koronar angioplastik.
English: Endocrine disorders
Danish: Endokrine lidelser
English: Calcium carbonate Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Polysorbate 80
Danish: Calciumcarbonat Mikrokrystallinsk cellulose Lactosemonohydrat Croscarmellosenatrium Polysorbat 80
English: Treatment with atorvastatin 80 mg/day increased the time to occurrence of the combined primary endpoint, defined as death from any cause, nonfatal MI, resuscitated cardiac arrest, or angina pectoris with evidence of myocardial ischaemia requiring hospitalization, indicating a risk reduction by 16% (p=0.048).
Danish: Behandling med atorvastatin 80 mg dagligt forlængede tiden til forekomst af kombineret primært endepunkt, defineret som død af enhver årsag, ikke-fatal MI, genoplivet efter hjertestop, eller angina pectoris med tegn på myokardieiskæmi, der kræver hospitalsindlæggelse, med en risikoreduktion på 16% (p=0,048).
English: − If muscular symptoms are severe and cause daily discomfort, even if the CPK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered.
Danish: Hvis muskelsymptomer er svære og foranlediger daglig ubehag, selv hvis CK-værdien er forhøjet til ≤ 5 gange den øvre referenceværdi, bør seponering af behandlingen overvejes.
English: These results are consistent in patients with heterozygous familial hypercholesterolaemia, nonfamilial forms of hypercholesterolaemia, and mixed hyperlipidaemia, including patients with noninsulin-dependent diabetes mellitus.
Danish: Disse resultater er konsistente hos patienter med heterozygot familiær hyperkolesterolæmi, nonfamiliære former for hyperkolesterolæmi og kombineret hyperlipidæmi samt hos patienter med ikke-insulinkrævende diabetes mellitus.
English: Atorvastatin significantly reduced the frequency of coronary and CV events, strokes and revascularisation procedures in the entire study cohort.
Danish: Atorvastatin mindskede signifikant frekvensen af koronare og kardiovaskulære hændelser, slagtilfælde og revaskulariseringsprocedurer i hele forsøgskohorten.
English: In the Reversing Atherosclerosis with Aggressive Lipid- Lowering Study (REVERSAL), the effect of intensive lipid lowering with atorvastatin 80 mg and standard degree of lipid lowering with pravastatin 40 mg on coronary atherosclerosis was assessed by intravascular ultrasound (IVUS), during angiography, in patients with coronary heart disease.
Danish: I ”Reversing Atherosclerosis with Aggressive Lipid-Lovering Study” (REVERSAL) blev effekten af intensiv lipidsænkning med atorvastatin 80 mg og standard lipidsænkning med pravastatin 40 mg på koronar aterosclerose under angiografi vurderet ved hjælp af intravaskulær ultralyd (IVUS) hos patienter med koronarhjertesygdom.
English: In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina).
Danish: I MIRACL-studiet blev atorvastatin 80 mg vurderet i 3086 patienter (atorvastatin n=1538; placebo n=1548) med akut koronarsyndrom (non-Q-tak MI eller ustabil angina).
English: However, lipid effects were greater when {PRODUCT NAME} and colestipol were coadministered than when either medicinal products was given alone.
Danish: Effekten på lipiderne var imidlertid større, når {(Sær)navn} og cholestipol blev indgivet samtidig, end hvis stofferne blev givet hver for sig.
English: Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Danish: Atorvastatin sænker plasmakolesterol- og lipoproteinserumkoncentrationer ved at hæmme HMG-CoAreduktase og derefter kolesterolbiosyntese i leveren og øger antallet af lever LDL-receptorer på celleoverfladen, hvilket fører til øget optagelse og katabolisering af LDL.
English: Plasma concentrations of atorvastatin and its active metabolites were lower (by approx. 25%) when colestipol was coadministered with {PRODUCT NAME}.
Danish: Plasmakoncentrationer af atorvastatin og dets aktive metabolitter var lavere (ca. 25%), når cholestipol blev indgivet sammen med {(Sær)navn}.
English: Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Danish: Samtidig anvendelse af {(Sær)navn} og et oralt antikonceptivum førte til forhøjede plasmakoncentrationer af norethindron og ethinylestradiol.
English: Musculoskeletal disorders
Danish: Muskuloskeletale lidelser
English: As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
Danish: Som for andre HMG-CoA-reduktasehæmmere ses forhøjede serum-transaminaser hos patienter, der behandles med {(Sær)navn}.
English: Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Danish: Forhøjet serum-kreatininfosfokinase (CK) niveau på mere end 3 gange den øvre referenceværdi er set hos 2,5% af de patienter, som behandles med {(Sær)navn}, hvilket svarer til andre HMG-CoAreduktasehæmmere i kliniske studier.
English: Lowdensity lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Danish: Low-density lipoprotein (LDL) dannes fra VLDL og kataboliseres primært ved hjælp af LDL-receptorer med høj affinitet.
English: Higher dosages may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Danish: Højere dosering kan være nødvendig for at opnå (LDL-)kolesteroltal svarende til de nugældende guidelines.
English: LIST OF EXCIPIENTS Also contains lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat.
English: According to results of in vitro studies the metabolic pathway of atorvastatin via glucuronidation is inhibited by Gemfibrozil.
Danish: I overensstemmelse med resultaterne af in vitro forsøg hæmmes atorvastatins metabolisering via glucuronidering af gemfibrozil.
English: Common: insomnia.
Danish: Almindelig: Søvnløshed.
English: Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve.
Danish: Patienter, som udvikler forhøjede transaminaseniveauer, skal kontrolleres til tallene er normaliserede.
English: Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Danish: Samtidig anvendelse af gentagne doser {(Sær)navn} og fenazon viste kun lidt eller ingen synlig effekt på fenazon-clearance.
English: Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Danish: Dosis bør individualiseres i henhold til basisniveau for LDL-kolesterol, mål for behandlingen og behandlingseffekt.
English: No. of Events (Atorvastatin vs Placebo)
Danish: Antal hændelser (Atorvastatin vs. Placebo)
English: All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Danish: Alle patienterne havde mindst en af følgende risikofaktorer: hypertension, nuværende rygning, retinopati, mikroalbuminuri eller makroalbuminuri.
English: Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Danish: Nyresygdomme har ingen indflydelse på atorvastatins plasmakoncentration eller {(Sær)navn}s effekt på lipiderne, hvorfor dosisjustering ikke er nødvendig.
English: If these levels are found to be significantly elevated (> 5 times ULN), treatment should be stopped.
Danish: Hvis denne værdi findes signifikant forhøjet (>5 gange den øvre referenceværdi), bør behandlingen stoppes.
English: In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
Danish: Ved undergruppeanalyse efter køn (81 % mænd, 19 % kvinder) kunne en gavnlig virkning af atorvastatin kun påvises hos mænd, men ikke hos kvinder, antagelig på grund af det lave antal hændelser i den kvindelige undergruppe.
English: The development of rat offspring was delayed and post-natal survival reduced during exposure of the dams to atorvastatin at doses above 20 mg/kg/day (the clinical systemic exposure).
Danish: Udviklingen af rotteafkom var forsinket og postnatal overlevelse nedsat efter indgift af atorvastatin til moderdyr i doser over 20 mg/kg dagligt (den klinisk systemiske dosis).
English: Uncommon: amnesia.
Danish: Ikke almindelige: Amnesi.
English: − Hepatic insufficiency: Plasma concentrations of atorvastatin and its active metabolites are markedly increased (approx. 16-fold in Cmax and approx. 11-fold in AUC) in patients with chronic alcoholic liver disease (Childs-Pugh B).
Danish: Leverinsufficiens: Plasmakoncentrationerne af atorvastatin og dets aktive metabolitter er markant forhøjede (ca. 16 gange for Cmax og ca. 11 gange for AUC) hos patienter med kronisk alkoholisk leversygdom (Childs-Pugh B).
English: The CARDS study was conducted in 2,838 patients (40-75 years of age) with normal to mildly elevated cholesterol levels, with type 2 diabetes and 1 additional CV risk factor, and without clinically evident CHD.
Danish: CARDS-forsøget omfattede 2 838 patienter (i alderen 40-75 år) med normalt til let forhøjet kolesteroltal, type 2-diabetes og én yderligere kardiovaskulær risikofaktor, men uden klinisk evident koronar hjertesygdom.
English: The ASCOT-LLA study was carried out in 10,000 patients (40-79 years of age) with normal to mildly elevated cholesterol levels, no previous MI or treatment for angina but with hypertension and at least 3 other CV risk factors, to assess the effect of atorvastatin on fatal and non-fatal CHD.
Danish: ASCOT-LLA-forsøget omfattede 10 000 patienter (i alderen 40-79 år) med normalt eller let forhøjet kolesteroltal, uden tidligere myokardieinfarkt eller behandling for angina, men med hypertension og mindst tre andre kardiovaskulære risikofaktorer, og skulle vurdere virkningen af atorvastatin på dødelig og ikke-dødelig koronar hjertesygdom.