natgillin/translations-raw huggingface dataset:
21%.
Atorvastatin was administered at doses up to 80 mg/ day.
Doseringen af atorvastatin til patienter med homozygot familiær hyperkolesterolæmi er 10- 80 mg dagligt.
The dosage of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily.
Atorvastatin gives som supplement til anden lipidsænkende behandling (f. eks.
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e. g.
LDL- aferese) eller hvis sådan behandling ikke er tilgængelig.
LDL apheresis) in these patients or if such treatments are unavailable.
I de primære forebyggelsesstudier var dosis 10 mg/ døgn.
In the primary prevention trials the dose was 10 mg/ day.
Højere dosis kan være nødvendigt for at opnå (LDL) - kolesterolniveauer i henhold til gældende guidelines.
Higher dosages may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Nyresygdomme har ingen indflydelse på atorvastatins plasmakoncentration eller {(Sær) navn} s effekt på lipiderne, hvorfor dosisjustering ikke er nødvendig.
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Ældre
Geriatric use
Børn
Pediatric use
Erfaring med brug hos børn er begrænset til et lille antal patienter (4- 17 år) med svær dyslipidæmi som f. eks. homozygot familiær hyperkolesterolæmi.
Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
14 4. 3 Kontraindikationer
4.3 Contraindications
- med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne i dette
14 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
mere end 3 gange den øvre referenceværdi
4.4 Special warnings and precautions for use
- med myopati
Liver effects
4. 8).
Should an increase in transaminases of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
{(Sær) navn} bør bruges med forsigtighed hos patienter, som indtager store mængder alkohol og/ eller med leversygdom i anamnesen.
{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/ or have a history of liver disease.
Atorvastatin kan som andre HMG- CoA- reduktasehæmmere i sjældne tilfælde have en effekt på skeletmuskulaturen og kan forårsage myalgi, myositis, og myopati som kan udvikle sig til rhabdomyolyse, en potentielt livstruende tilstand, som kendetegnes ved markant forhøjet CK- værdi (> 10 gange den øvre referenceværdi), myoglobinæmi og myoglobinuri, som kan føre til nyresvigt.
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Før behandlingen Atorvastatin bør gives med forsigtighed til patienter med prædisponerede faktorer for rhabdomyolyse.
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
- hos ældre (alder > 70 år), bør en sådan måling overvejes i overensstemmelse med tilstedeværelse af
A creatine phosphokinase (CPK) level should be measured before starting statin treatment in the following situations: − Renal impairment − Hypothyroidism − Personal or familial history of hereditary muscular disorders − Previous history of muscular toxicity with a statin or fibrate − Previous history of liver disease and/ or where substantial quantities of alcohol are consumed − In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis
andre prædisponerede faktorer for rhabdomyolyse.
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
I sådanne tilfælde bør risikoen ved behandlingen vurderes i forhold til mulig fordel, og klinisk monitorering anbefales.
Creatine phosphokinase measurement 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.
Hvis CK- værdien er signifikant forhøjet (> 5 gange den øvre referenceværdi) ved baseline, bør behandlingen ikke startes.
If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Hvis CK- værdien er signifikant forhøjet ved baseline (> 5 gange den øvre referenceværdi), bør den måles igen inden for 5- 7 dage for at bekræfte resultatet.
Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
15 Under behandlingen
15 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Hvis
If these levels are found to be significantly elevated (> 5 times ULN), treatment should be stopped. − 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. − 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. − Atorvastatin must be discontinued if clinically significant elevation of CPK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
4. 8).
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
Risiko for myopati under behandling med HMG- CoA- reduktasehæmmere øges ved samtidig anvendelse af ciclosporin, fibrater, niacin, makrolidantibiotika herunder erythromycin, azol- antimykotika og har ved sjældne lejligheder resulteret i rhabdomyolyse med nedsat nyrefunktion sekundært til myoglobinuri.
The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of ciclosporin, fibric acid derivatives, macrolide antibiotics including erythromycin, azole antifungals, or niacin and on rare occasions has resulted in rhabdomyolysis with renal dysfunction secondary to myoglobinuria.
4. 4).
Therefore, the benefit and the risk of concurrent treatment should be carefully weighed (see section 4.4).
Cytokrom P450 3A4- hæmmere
Inhibitors of cytochrome P450 3A4
Interaktion kan opstå, når atorvastatin gives sammen med cytokrom P450 3A4- hæmmere (f. eks. ciclosporin, makrolidantibiotika, herunder erythromycin og clarithromycin, nefazodon, azol- antimykotika herunder itraconazol og HIV- proteasehæmmere).
Interaction may occur when {PRODUCT NAME} is administered with inhibitors of cytochrome P450 3A4 (e. g. ciclosporin, macrolide antibiotics including erythromycin and clarithromycin, nefazodone, azole antifungals including itraconazole and HIV protease inhibitors).
4. 4).
Therefore, special caution should be exercised when atorvastatin is used in combination with such medicinal agents (see section 4.4).
P- glycoprotein- hæmmere
Inhibitors of P-glycoprotein
Atorvastatin og atorvastatinmetabolitter er substrater for P- glycoprotein.
Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
P- glycoprotein- hæmmere (f. eks. ciclosporin) kan forhøje biotilgængeligheden af atorvastatin.
Inhibitors of the P- glycoprotein (e. g. ciclosporin) can increase the bioavailability of atorvastatin.
Erythromycin, clarithromycin
Erythromycin, clarithromycin
16 Proteasehæmmere
Protease inhibitors
Samtidig administration af atorvastatin og proteasehæmmere, kendte cytochrom P450 3A4- hæmmere, er forbundet med forhøjede plasmakoncentrationer af atorvastatin.
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Grapefrugtjuice
16 Grapefruit juice
Indtagelse af 1 glas på 240 ml grapefrugtjuice fører til en stigning på 37% af AUC for atorvastatin og en reduktion af AUC på 20, 4% for den aktive orthohydroxymetabolit.
Intake of one 240 ml glass of grapefruit juice resulted in an increase in atorvastatin AUC of 37% and a decreased AUC of 20.4% for the active orthohydroxy metabolite.
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.
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.
Cytokrom P450 3A4- induktorer
Inducers of cytochrome P450 3A4
Effekten af induktorer af cytokrom P450 3A4 (f. eks. rifampicin eller fenytoin) på {(Sær) navn} kendes ikke.
The effect of inducers of cytochrome P450 3A4 (e. g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Den mulige interaktion med andre substrater af dette isoenzym er ukendt, men bør overvejes for andre stoffer med snævert terapeutisk indeks, f. eks. klasse III antiarytmika herunder amiodaron.
The possible interaction with other substrates of this isozyme is unknown but should be considered for other medicinal products with a narrow therapeutic index, for example, antiarrhythmic agents Class III including amiodarone.
Gemfibrozil/ fibrater Risiko for atorvastatin- induceret myopati kan øges ved samtidig brug af fibrater.
Gemfibrozil / fibric acid derivatives The risk of atorvastatin-induced myopathy may be increased with the concomitant use of fibric acid derivatives.
(se punkt 4. 4).
This may possibly lead to increased plasma levels of atorvastatin (see section 4.4).
Digoxin Når flere doser af digoxin og 10 mg atorvastatin blev givet samtidigt, blev steady state plasmakoncentrationerne af digoxin ikke påvirket.
Digoxin When multiple doses of digoxin and 10 mg atorvastatin were coadministered, steady-state plasma digoxin concentrations were unaffected.
20%.
However, digoxin concentrations increased approximately 20% following administration of digoxin with 80 mg atorvastatin daily.
Denne interaktion kan forklares ved en hæmning af membrantransportproteinet P- glycoprotein.
This interaction may be explained by an inhibition of the membrane transport protein, P-glycoprotein.
Oral antikonception Samtidig anvendelse af {(Sær) navn} og et oralt antikonceptivum førte til forhøjede plasmakoncentrationer af norethindron og ethinylestradiol.
Oral contraceptives Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Cholestipol Plasmakoncentrationer af atorvastatin og dets aktive metabolitter var lavere (ca.
17 Colestipol Plasma concentrations of atorvastatin and its active metabolites were lower (by approx.
25%), når cholestipol blev indgivet sammen med {(Sær) navn}.
25%) when colestipol was coadministered with {PRODUCT NAME}.
Effekten på lipiderne var imidlertid større, når {(Sær) navn} og cholestipol blev indgivet samtidig, end hvis stofferne blev givet hver for sig.
However, lipid effects were greater when {PRODUCT NAME} and colestipol were coadministered than when either medicinal product was given alone.
Antacida 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.
Antacid 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%; LDL- kolesterol reduktionen var imidlertid ikke ændret.
35%; however, LDL-C reduction was not altered.
Warfarin 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.
Warfarin 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.
Ikke desto mindre bør patienter i warfarinbehandling monitoreres omhyggeligt, når {(Sær) navn} tillægges behandlingen.
Nevertheless, patients receiving warfarin should be closely monitored when {PRODUCT NAME} is added to their therapy.
17 Fenazon Samtidig anvendelse af gentagne doser {(Sær) navn} og fenazon viste kun lidt eller ingen synlig effekt på fenazon- clearance.
Phenazone Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Cimetidin Et interaktionsstudie med cimetidin og {(Sær) navn} viste ingen interaktion.
Cimetidine An interaction study with cimetidine and {PRODUCT NAME} was conducted, and no interaction was seen.
Amlodipin Atorvastatins farmakokinetik var uændret ved samtidig anvendelse af atorvastatin 80 mg og amlodipin 10 mg ved steady state.
Amlodipine Atorvastatin pharmacokinetics were not altered by the coadministration of atorvastatin 80 mg and amlodipine 10 mg at steady state.
Andre Der er ikke set klinisk signifikante interaktioner i kliniske studier, hvor {(Sær) navn} blev givet sammen med antihypertensiva eller hypoglykæmiske midler.
Other In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
{(Sær) navn} er kontraindiceret under graviditet og amning.
{PRODUCT NAME} is contraindicated in pregnancy and while breast feeding.
Kvinder i den fertile alder bør anvende sikker antikonception.
Women of child- bearing potential should use appropriate contraceptive measures.
Dyreforsøg viser tegn på, at HMG- CoA- reduktasehæmmere kan påvirke udviklingen af embryo og foster.
There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
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).
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).
{(Sær) navn} har ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
{PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Mindre end 2% af patienterne udgik af kliniske studier på grund af bivirkninger forbundet med {(Sær) navn}.
Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
På baggrund af data fra kliniske studier og omfattende erfaring efter markedsføring fremgår {(Sær) navn} s sikkerhedsprofil af nedennævnte tabel.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for {PRODUCT NAME}.
Almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1000 og < 1/ 100); sjælden (≥1/ 10. 000 og < 1/ 1000); meget sjælden (≤1/ 10. 000).
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (≤ 1/ 10,000).
Obstipation, flatulens, dyspepsi, kvalme, diarré.
Common: constipation, flatulence, dyspepsia, nausea, diarrhoea.
Anoreksi, opkastning.
Uncommon: anorexia, vomiting.
Thrombocytopeni.
Uncommon: thrombocytopenia.
18 Lidelser i immunsystemet
Immune system disorders
Allergiske reaktioner.
Common: allergic reactions.
Anafylaksi.
Very rare: anaphylaxis.
Alopeci, hyperglykæmi, hypoglykæmi, pancreatitis.
Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
Psykiske lidelser
Psychiatric
Almindelig:
Common: insomnia.
Søvnløshed.
Uncommon: amnesia.
Hovedpine, svimmelhed, paræstesi, hypæstesi Ikke almindelig:
Common: headache, dizziness, paraesthaesia, hypoesthesia.
Perifer neuropati.
Uncommon: peripheral neuropathy.
Lever - og galdevejslidelser
Hepato-biliary disorders
Hepatitis, kolestatisk icterus.
Rare: hepatitis, cholestatic jaundice.
Hud og adneks
Skin/ Appendages
Hududslæt, kløe.
Skin rash, pruritus.
Urticaria.
Uncommon: urticaria.
Angioneurotisk ødem, bulløs hududslæt (herunder erythema multiforme, Stevens Johnsons syndrom og toksisk epidermal nekrolyse).
Very rare: angioneurotic oedema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
Lidelser i øre
Ear and Labyrinth Disorders
Ikke almindelig:
Uncommon: tinnitus
Muskuloskeletale lidelser
19 Musculoskeletal disorders
Myalgi, artralgi.
Common: myalgia, arthralgia.
Myopati.
Uncommon: myopathy.
Myositis, rhabdomyolyse.
Rare: myositis, rhabdomyolysis.
Impotens.
Uncommon: impotence.
Generelle symptomer
General disorders
Asteni, brystsmerter, rygsmerter, perifert ødem, træthed.
Common: asthenia, chest pain, back pain, peripheral oedema.
Utilpashed, vægtøgning.
Uncommon: malaise, weight gain.
Som for andre HMG- CoA- reduktasehæmmere ses forhøjede serum- transaminaser hos patienter, der behandles med {(Sær) navn}.
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
Klinisk relevante (> 3 gange den øvre referenceværdi) forhøjelser i serum - transaminaser er set hos 0, 8% af de patienter, som behandles med {(Sær) navn}.
Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
19 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- CoA - reduktasehæmmere i kliniske studier.
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.
4. 4).
Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
Der findes ingen specifik behandling ved overdosering med {(Sær) navn}.
Specific treatment is not available for {PRODUCT NAME} overdosage.
Leverfunktionsmålinger og serum- CK- niveauet bør monitoreres.
Liver function tests should be performed and serum CPK levels should be monitored.
HMG- CoA- reduktasehæmmere, ATC kode C10AA05.
C10AA05
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.
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.
Low- density lipoprotein (LDL) dannes fra VLDL og kataboliseres primært ved hjælp af LDL- receptorer med høj affinitet.
Low- density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Atorvastatin sænker plasmakolesterol - og lipoproteinserumkoncentrationer ved at hæmme HMG- CoA - reduktase og derefter kolesterolbiosyntese i leveren og øger antallet af lever LDL- receptorer på celleoverfladen, hvilket fører til øget optagelse og katabolisering af LDL.
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.
Atorvastatin reducerer LDL- produktionen og antallet af LDL- partikler.
Atorvastatin reduces LDL production and the number of LDL particles.
Atorvastatin giver en væsentlig og vedvarende forøgelse af LDL- receptoraktiviteten forbundet med en fordelagtig ændring i kvaliteten af cirkulerende LDL- partikler.
Atorvastatin is effective in reducing LDL-C in patients with
Atorvastatin reducerer effektivt LDL- kolesterol hos patienter med homozygot familiær hyperkolesterolæmi, en patientgruppe, som ikke sædvanligvis responderer på lipidsænkende behandling.
20 homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid- lowering medication.
Atorvastatin reducerede koncentrationen af total- kolesterol (30- 46%), LDL- kolesterol (41- 61%), apolipoprotein B (34- 50%) og triglycerider (14- 33%), men forårsagede variable stigninger i HDL - kolesterol og apolipoprotein A1 i et dosis- respons- studie.
Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDL-C and apolipoprotein A1 in a dose response study.
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.
These results are consistent in patients with heterozygous familial hypercholesterolaemia, nonfamilial forms of hypercholesterolaemia, and mixed hyperlipidaemia, including patients with noninsulin-dependent diabetes mellitus.
Der er vist, at reduktion i total- kolesterol, LDL- kolesterol og apolipoprotein B reducerer risikoen for kardiovaskulære hændelser og kardiovaskulær mortalitet.
Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality.
Mortalitets - og morbiditets- studier med atorvastatin er endnu ikke afsluttede.
Mortality and morbidity studies with atorvastatin have not yet completed.
Aterosclerose
Atherosclerosis
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.
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.
I dette randomiserede, dobbelt- blinde, multicenter, kontrollerede kliniske studie blev IVUS udført ved baseline og ved 18 måneder hos 502 patienter.
In this randomized, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients.