FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Orkambi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Orkambi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Orkambi's side effects mainly affected the gut and breathing and were generally considered mild to moderate and manageable.
Slovenian: Neželeni učinki zdravila Orkambi so prizadeli predvsem črevesje in dihanje ter so bili večinoma ocenjeni za blage do zmerne in obvladljive.
English: Serious side effects include liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Slovenian: Resni neželeni učinki so vključevali težave z jetri, kot so povišane vrednosti jetrnih encimov, holestatski hepatitis (kopičenje žolča, ki privede do vnetja jeter) in hepatično encefalopatijo (možgansko bolezen, ki jo povzročajo težave z jetri).
English: The children's growth (measured in terms of the body mass index, weight and height) also improved.
Slovenian: Izboljšala se je tudi rast (izmerjena v obliki indeksa telesne mase, telesne mase in višine).
English: What is Orkambi and what is it used for?
Slovenian: Kaj je zdravilo Orkambi in za kaj se uporablja?
English: In total, these serious side effects occurred in more than 1 in 200 people during the clinical studies.
Slovenian: Skupaj so se ti resni neželeni učinki v kliničnih študijah pojavili pri več kot 1 osebi od 200.
English: The most common side effects with Orkambi (which may affect more than 1 in 10 people) are dyspnoea (shortness of breath), diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Orkambi (ki lahko prizadenejo več kot 1 osebi od 10) so dispneja (zasoplost), driska in navzeja (siljenje na bruhanje).
English: Patients with cystic fibrosis have high levels of chloride in sweat due to CFTR not working properly.
Slovenian: Bolniki s cistično fibrozo imajo visoko vsebnost klorida v znoju, ker beljakovina CFTR ne deluje pravilno.
English: After 24 weeks of treatment, LCI2.5 decreased by 1.01 in patients treated with Orkambi compared with an increase of 0.08 in patients treated with placebo.
Slovenian: Po 24 tednih zdravljenja se je vrednost LCI2.5 pri bolnikih, zdravljenih z zdravilom Orkambi, zmanjšala za 1,01 odstotne točke, v primerjavi z 0,08 pri bolnikih, ki so prejemali placebo.
English: The mutations reduce the amount of CFTR protein on the cell surface or affect the way the protein works.
Slovenian: Te mutacije zmanjšujejo število beljakovin CFTR na celični površini ali pa vplivajo na način delovanja beljakovine.
English: It affects the cells that produce mucus and digestive juices.
Slovenian: Prizadene celice, ki proizvajajo sluz in prebavne sokove.
English: In the study in children aged 6 to 11 years, the main measure of effectiveness was a decrease in the lung clearance index (LCI2.5), which indicates an improvement in lung ventilation.
Slovenian: V študiji pri otrocih, starih od 6 do 11 let, je bilo glavno merilo učinkovitosti znižanje indeksa pljučnega očistka (LCI2.5), ki kaže boljšo predihanost pljuč.
English: Orkambi can only be prescribed by a doctor with experience in the treatment of cystic fibrosis.
Slovenian: Zdravilo Orkambi smejo predpisovati le zdravniki z izkušnjami z zdravljenjem cistične fibroze.
English: Orkambi improved lung function in two main studies involving 1,108 cystic fibrosis patients aged 12 years and above, and one study involving 204 children aged from 6 to 11 years.
Slovenian: Zdravilo Orkambi se je izkazalo za učinkovito pri izboljševanju delovanja pljuč v dveh glavnih študijah, ki sta zajeli 1 108 bolnikov s cistično fibrozo, starejših od 12 let, in v eni študiji, ki je zajela 204 otroke, stare od 6 do 11 let.
English: One of the active substances in Orkambi, lumacaftor, increases the amount of CFTR protein on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein.
Slovenian: Ena od učinkovin v zdravilu Orkambi, lumakaftor, poveča število beljakovin CFTR na celični površini, druga, ivakaftor, pa poveča delovanje okvarjene beljakovine CFTR.
English: A further long-term study in children aged 2 to 5 years with cystic fibrosis is also required to compare those who have the F508del mutation in the CFTR gene and are treated with Orkambi with those who have not been treated with Orkambi.
Slovenian: Potrebna je tudi nadaljnja dolgoročna študija pri otrocih s cistično fibrozo, starih od 2 do 5 let, da bi se lahko primerjali tisti, ki imajo F508del mutacijo v genu CFTR in se zdravijo z zdravilom Orkambi, s tistimi, ki niso bili zdravljeni s tem zdravilom.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system.
Slovenian: Cistična fibroza je dedna bolezen, ki ima resne učinke na pljuča in prebavila.
English: Orkambi is available as tablets and granules.
Slovenian: Zdravilo Orkambi je na voljo v obliki tablet in zrnc.
English: For the full list of all side effects and restrictions with Orkambi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Orkambi glejte navodilo za uporabo.
English: Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation.
Slovenian: Zdravilo Orkambi se uporablja pri bolnikih z gensko mutacijo (spremembo), imenovano mutacija F508del.
English: Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV1 of 2.41 percentage points more than those who took placebo; this figure was 2.65 in the second study.
Slovenian: Rezultati prve študije so pokazali, da se je bolnikom, ki so jemali zdravilo Orkambi, po 24 tednih zdravljenja vrednost FEV1 povprečno izboljšala za 2,41 odstotne točke več kot bolnikom, ki so jemali placebo.
English: The company that markets Orkambi is required to conduct a 5-year study in patients with cystic fibrosis to evaluate the long-term effects of the medicine.
Slovenian: Družba, ki trži zdravilo Orkambi, mora za oceno dolgoročnih učinkov zdravila izvesti petletno študijo pri bolnikih s cistično fibrozo.
English: In the two studies in patients aged 12 years and above, the main measure of effectiveness was based on improvement in patients' predicted FEV1 which is a measure of how well the lungs work.
Slovenian: Glavno merilo učinkovitosti v obeh študijah pri bolnikih, starejših od 12 let, je temeljilo na izboljšanju odstotka napovedane vrednosti FEV1, kar je merilo, kako dobro pljuča delujejo.
English: A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene.
Slovenian: V dodatno študijo je bilo vključenih 60 otrok s cistično fibrozo, starih od 2 do 5 let, ki so imeli mutacijo F508del v genu CFTR.
English: This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices.
Slovenian: Ta mutacija prizadene gen za beljakovino, imenovano regulator transmembranske prevodnosti pri cistični fibrozi (CFTR), ki sodeluje pri uravnavanju nastajanja sluzi in prebavnih sokov.
English: All patients had the F508del mutation in the CFTR gene.
Slovenian: Vsi bolniki so imeli mutacijo F508del v genu CFTR.
English: Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above.
Slovenian: Orkambi je zdravilo za zdravljenje cistične fibroze pri bolnikih, starejših od dveh let.
English: It should be prescribed only to patients confirmed to have the F508del mutation in both copies of the CFTR gene.
Slovenian: Predpisovati se sme le bolnikom, ki imajo potrjeno mutacijo F508del v obeh kopijah gena CFTR.
English: These actions make mucus and digestive juices less thick.
Slovenian: S tem postanejo sluz in prebavni sokovi manj gosti.
English: The effects of Orkambi in children aged 2 to 5 years were considered to be similar to those in older children and a long-term study will be carried out to confirm this.
Slovenian: Učinki zdravila Orkambi pri otrocih, starih od 2 do 5 let, so se šteli podobni učinkom pri starejših otrocih.
English: How is Orkambi used?
Slovenian: Kako se zdravilo Orkambi uporablja?
English: How does Orkambi work?
Slovenian: Kako zdravilo Orkambi deluje?
English: This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices.
Slovenian: Ta gen proizvaja beljakovino CFTR, ki sodeluje pri uravnavanju nastajanja sluzi in prebavnih sokov.
English: Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age.
Slovenian: Dokazali so, da zdravilo Orkambi izboljšuje delovanje in predihanost pljuč pri bolnikih s cistično fibrozo, starejših od šest let.
English: In cystic fibrosis, the secretions become thick and cause blockage.
Slovenian: Pri cistični fibrozi se izločki zgostijo in povzročajo zaporo.
English: In the studies, Orkambi was compared with placebo (a dummy treatment), both added to patients' usual therapy.
Slovenian: V študijah so zdravilo Orkambi primerjali s placebom (zdravilom brez učinkovine).
English: Orkambi contains the active substances lumacaftor and ivacaftor.
Slovenian: Zdravilo Orkambi vsebuje učinkovini lumakaftor in ivakaftor.
English: 22 March 2013 EMA/402540/2013
Slovenian: 22. marec 2013 EMA/402540/2013
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Slovenian: Stopite v stik z našimi tiskovnimi predstavniki Monika Benstetter ali Martin Harvey Allchurch
English: Patients were followed for a median of 3.9 years.
Slovenian: Mediani čas spremljanja bolnikov je bil 3,9 leta;
English: Of those enrolled, 14,741 were from Europe and 10,932 were from China.
Slovenian: 14 741 sodelujočih je bilo iz Evrope, 10 932 pa s Kitajske.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Slovenian: Tel: +44 (0)20 7418 8427 Elektronski naslov: press@ema.europa.eu
English: Healthcare professionals should follow these recommendations:
Slovenian: Zdravstveni delavci naj upoštevajo naslednja priporočila:
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Slovenian: Podrobnejše informacije o priporočilu odbora PRAC in ozadju tega pregleda so na voljo na spletni strani agencije.
English: The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania.
Slovenian: Zdravilo je pod enim od naštetih trgovskih imen tržila družba Merck Sharp & Dohme Ltd v vseh državah članicah EU, razen v Bolgariji, Franciji in Romuniji.
English: • A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: • Pregled teh podatkov je najprej izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: • The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC.
Slovenian: • Pregled zdravil Tredaptive, Pelzont in Trevaclyn se je začel na zahtevo Evropske komisije dne 19. decembra 2012 v skladu s členom 20 Uredbe (ES) št. 726/2004 in po postopkovnih pravilih, opredeljenih v členih 107(j) in 107(k) Direktive 2001/83/ES.
English: The European Commission asked the Agency to assess the impact of the new data from the HPS2-THRIVE study, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Evropska komisija je zahtevala, da agencija oceni vpliv novih podatkov iz študije HPS2-THRIVE in poda mnenje o tem, ali je treba dovoljenja za promet s temi zdravili v EU ohraniti, spremeniti, začasno umakniti ali preklicati.
English: These included bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes.
Slovenian: Med njimi so bile krvavitve (intrakranialne in gastrointestinalne), miopatija, okužbe in novonastala sladkorna bolezen.
English: They were available as modified release tablets (meaning that the two active substances are released at different rates over a few hours).
Slovenian: Na voljo so bila v obliki tablet s prirejenim sproščanjem (to pomeni, da se zdravilni učinkovini sproščata z različno hitrostjo v obdobju nekaj ur).
English: The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available.
Slovenian: Pregled zdravil Tredaptive, Pelzont in Trevaclyn se je začel decembra 2012, potem ko so postali na voljo novi podatki iz obsežne dolgoročne študije z imenom HPS2-THRIVE.
English: The Agency's recommendations are based on the new data from the HPS2-THRIVE study:
Slovenian: Priporočila agencije temeljijo na novih podatkih iz študije HPS2-THRIVE:
English: It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
Slovenian: Kot zdravilo za zmanjševanje koncentracij maščob v krvi so jo prvič uporabili sredi 50. let prejšnjega stoletja, vendar so uporabo omejili zaradi njenih neželenih učinkov, še zlasti zardevanja (pordelosti kože).
English: • The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease.
Slovenian: • študija HPS2-THRIVE je bila obsežna dolgoročna študija, v katero je bilo vključenih 25 673 bolnikov, pri katerih naj bi zaradi okluzivne žilne bolezni v preteklosti obstajalo visoko tveganje za kardiovaskularne dogodke.
English: • The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013.
Slovenian: • Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 22. marca 2013 izdala končno pravno zavezujočo odločbo.
English: More information on the HPS2-THRIVE study is available below.
Slovenian: Podrobnejše informacije o študiji HPS2-THRIVE so na voljo v nadaljevanju.
English: Such treatment is ultimately aimed to reduce the risk of heart attacks, strokes and other conditions affecting the heart and blood vessels.
Slovenian: Končni cilj zdravljenja je zmanjšati tveganje za srčno in možgansko kap ter druge bolezni, ki prizadenejo srce in krvne žile.
English: Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo.
Slovenian: Bolnike so zdravili s simvastatinom 40 mg ali simvastatinom 40 mg v kombinaciji z ezetimibom 10 mg, da bi raven skupnega holesterola znižali na manj kot 3,5 mmol/l, nato pa so jih randomizirali v skupino z nikotinsko kislino/laropiprantom ali s placebom;
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013.
Slovenian: CHMP je mnenje posredoval Evropski komisiji, ki se je z njim strinjala in dne 22. marca 2013 izdala končno pravno zavezujočo odločbo.
English: • The two active substances, nicotinic acid and laropiprant, have different functions.
Slovenian: • Zdravilni učinkovini, nikotinska kislina in laropiprant, imata različni funkciji.
English: • You should make a non-urgent appointment with your doctor to review your treatment.
Slovenian: • Naročite se na nenujen obisk pri zdravniku, ki bo ponovno ocenil vaše zdravljenje.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines authorised throughout the EU on 3 July 2008 for the treatment of dyslipidaemia in combination with a statin when statin treatment alone is not sufficient, or alone in patients unable to take statins.
Slovenian: • Tredaptive, Pelzont in Trevaclyn so identična zdravila, ki so bila dne 3. julija 2008 po vsej EU odobrena za zdravljenje dislipidemije bodisi v kombinaciji s statini, kadar monoterapija s statini ni dovolj učinkovita, bodisi samostojno pri bolnikih, ki ne smejo jemati statinov.
English: Laropiprant has no effect on cholesterol but it reduces flushing, by blocking the receptors for a substance called ‘prostaglandin D2' which is released when nicotinic acid is taken and which dilates (widens) the blood vessels in the skin.
Slovenian: Laropiprant nima učinka na holesterol, vendar pa zmanjšuje zardevanje, tako da zavira receptorje za snov, imenovano „prostaglandin D2“, ki se sprosti ob zaužitju nikotinske kisline in razširi krvne žile v koži.
English: • Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg).
Slovenian: • Zdravila Tredaptive, Pelzont in Trevaclyn vsebujejo dve zdravilni učinkovini: nikotinsko kislino (1 000 mg) in laropiprant (20 mg).
English: • Doctors should review their patients' treatment in order to discontinue treatment with these medicines, which are no longer available in the EU.
Slovenian: • zdravniki morajo zdravljenje bolnikov ponovno oceniti in prekiniti zdravljenje s temi zdravili, ki v EU niso več na voljo;
English: The CHMP encouraged patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment.
Slovenian: CHMP je bolnikom, ki jemljejo ta zdravila, svetoval, naj se naročijo na nenujen obisk pri zdravniku in se z njim pogovorijo o zdravljenju.
English: Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended.
Slovenian: Potem ko je pregledal rezultate študije, je CHMP zaključil, da koristi zdravil Tredaptive, Pelzont in Trevaclyn niso več večje od tveganj in da je treba dovoljenja za promet z njimi začasno umakniti.
English: On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je 17. januarja 2013 potrdil priporočilo o začasnem umiku dovoljenj za promet z zdravili Tredaptive, Pelzont in Trevaclyn (nikotinska kislina/laropiprant), ki se uporabljajo za zdravljenje odraslih z dislipidemijo (nenormalno visokimi koncentracijami maščob, kot so trigliceridi in holesterol, v krvi).
English: • If you are taking Tredaptive, Pelzont or Trevaclyn you will have to discontinue treatment, as these medicines are no longer available in the EU.
Slovenian: • Če jemljete zdravilo Tredaptive, Pelzont ali Trevaclyn, boste morali prekiniti zdravljenje, saj ta zdravila v EU niso več na voljo.
English: Doctors should no longer prescribe these medicines and should review patients' treatment options
Slovenian: Zdravniki ne smejo več predpisovati teh zdravil in morajo ponovno proučiti možnosti zdravljenja bolnikov.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Slovenian: • Tredaptive, Pelzont in Trevaclyn so identična zdravila, ki se uporabljajo za zdravljenje odraslih z dislipidemijo (nenormalno visokimi koncentracijami maščob, kot so trigliceridi in holesterol, v krvi).
English: • Pharmacists should refer patients on new or repeated prescriptions for Tredaptive, Pelzont and Trevaclyn to the treating doctor.
Slovenian: • farmacevti morajo bolnike z novimi ali obnovljivimi recepti za zdravila Tredaptive, Pelzont in Trevaclyn napotiti k lečečemu zdravniku.
English: Tredaptive, Pelzont and Trevaclyn suspended across the EU
Slovenian: Zdravila Tredaptive, Pelzont in Trevaclyn začasno umaknjena s trgov EU
English: As taking Tredaptive, Pelzont and Trevaclyn together with a statin has no additional benefit in reducing the risk of major vascular events compared with statin therapy alone and taking into account the increased risk of serious side effects, the CHMP recommended the suspension of these medicines.
Slovenian: Ker jemanje zdravil Tredaptive, Pelzont in Trevaclyn v kombinaciji s statini ni prineslo dodatnih koristi v smislu zmanjšanja tveganja za pomembnejše vaskularne dogodke v primerjavi z monoterapijo s statini in ob upoštevanju povečanega tveganja za resne neželene učinke, je CHMP priporočil, da se ta zdravila začasno umaknejo s trga.
English: • An increase in the incidence of non-fatal but serious adverse events was seen.
Slovenian: • opazili so večjo pojavnost neželenih učinkov, ki so se končali brez smrtnega izida, vendar so bili resni.
English: The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines.
Slovenian: Mnenje odbora CHMP je temeljilo na priporočilu o začasnem umiku teh zdravil, ki ga je izdal Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients' treatment options.
Slovenian: Zdravniki ne smejo več predpisovati zdravil Tredaptive, Pelzont in Trevaclyn ter morajo možnosti zdravljenja bolnikov ponovno proučiti.
English: • In light of the unfavourable benefit-risk balance of Tredaptive, Pelzont and Trevaclyn, doctors should no longer prescribe these medicines to their patients.
Slovenian: • zaradi neugodnega razmerja med tveganji in koristmi zdravil Tredaptive, Pelzont in Trevaclyn jih zdravniki bolnikom ne smejo več predpisovati;
English: The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone.
Slovenian: Rezultati študije, ki so še vedno preliminarni, so pokazali, da jemanje nikotinske kisline/laropipranta skupaj s statini ne prinese pomembnih dodatnih koristi v smislu zmanjšanja tveganja za pomembnejše vaskularne dogodke, kot sta srčna in možganska kap, v primerjavi z monoterapijo s statini.
English: • The study was designed to assess the effect of adding nicotinic acid / laropiprant to statins on a composite endpoint of major vascular events, which included the combination of coronary death, non-fatal heart attack, stroke and revascularisation.
Slovenian: • študija je bila zasnovana za oceno učinka nikotinske kisline/laropipranta kot dodatnega zdravljenja k statinom na sestavljen opazovani dogodek, tj. pomembnejše vaskularne dogodke, ki so vključevali koronarno smrt, srčno kap brez smrtnega izida, možgansko kap in revaskularizacijo.
English: In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines.
Slovenian: Poleg tega so pri bolnikih, ki so jemali ta zdravila, pogosteje opazili neželene učinke, ki so se končali brez smrtnega izida, vendar so bili resni.
English: In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
Slovenian: Pri večjih odmerkih prek mehanizma, ki še ni povsem pojasnjen, zmanjšuje koncentracije maščobe v krvi.
English: • Treatment with nicotinic acid / laropiprant together with a statin did not result in a statistically significant reduction in major vascular events such as heart attack and stroke compared with statin therapy alone.
Slovenian: • zdravljenje z nikotinsko kislino/laropiprantom v kombinaciji s statini ni povzročilo statistično pomembnega zmanjšanja pomembnejših vaskularnih dogodkov, kot sta srčna in možganska kap, v primerjavi z monoterapijo s statini;