FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Dronedarone displays indirect antiadrenergic effects and partial antagonism to adrenergic stimulation.
Croatian: Dronedaron ima neizravno antiadrenergičko djelovanje i iskazuje djelomični antagonizam na adrenergičku stimulaciju.
English: The clinical relevance of this observation is not known (see sections 4.4 and 5.2).
Croatian: Klinički značaj ovog opažanja nije poznat (vidjeti dio 4.4 i 5.2).
English: In the event of overdose, monitor the patient's cardiac rhythm and blood pressure.
Croatian: U slučaju predoziranja, potrebno je pratiti bolesnikov srčani ritam i krvni tlak.
English: MULTAQ does not usually affect your ability to drive or use machine.
Croatian: MULTAQ najčešće ne utječe na Vašu sposobnost upravljanja vozilima i strojevima.
English: The N-debutyl metabolite exhibits pharmacodynamic activity but is 3 to 10-times less potent than dronedarone.
Croatian: N-debutil metabolit iskazuje farmakodinamičko djelovanje, ali je 3 do 10 puta manje potentan od dronedarona.
English: If you forget to take MULTAQ
Croatian: Ako ste zaboravili uzeti MULTAQ
English: • Patients in unstable hemodynamic conditions
Croatian: • Bolesnici u nestabilnom hemodinamičkom stanju
English: It is recommended to swallow the tablet whole with a drink of water during a meal.
Croatian: Preporučuje se progutati cijelu tabletu s vodom tijekom obroka.
English: What MULTAQ contains
Croatian: Što MULTAQ sadrži
English: • Diarrhoea, vomiting when excessive as it can lead to kidney problems.
Croatian: • Proljev, povraćanje kad je pretjerano jer može dovesti do bubrežnih tegoba.
English: • It is not known if MULTAQ passes into your breast milk.
Croatian: • Nije poznato prelazi li MULTAQ u majčino mlijeko.
English: The usual dose is one 400 mg tablet twice a day.
Croatian: Uobičajena doza je jedna tableta od 400 mg dvaput na dan.
English: Forty seven percent (47%) of patients were female and a majority was Caucasian (89%).
Croatian: Četrdeset i sedam posto (47%) bolesnika bilo je ženskog spola, a većina je bila bijele rase (89%).
English: • If you are taking some medicines against blood clot formation such as warfarin, your doctor will order a blood test called INR to check how well your medicine is working.
Croatian: • Ako uzimate lijekove za sprječavanje stvaranja krvnih ugruška kao što je varfarin, Vaš liječnik će naručiti krvnu pretragu koja se zove INR da bi provjerio djelovanje lijeka
English: It is predicted that dronedarone could also increase the exposure of lovastatin within the same range as simvastatin acid.
Croatian: Predviđa se da bi dronedaron također mogao povećati izloženost lovastatinu u istom rasponu kao i simvastatinskoj kiselini.
English: The most common co-morbidities were hypertension (56.8%) and structural heart disease (41.5%) including coronary heart disease (21.8%).
Croatian: Najčešće popratne bolesti bile su hipertenzija (56,8%) i strukturna bolest srca (41,5%), uključujući koronarnu srčanu bolest (21,8%).
English: MULTAQ prevents repetition of your problem of irregular heart rhythm.
Croatian: MULTAQ sprječava ponovnu pojavu nepravilnog srčanog ritma.
English: Patients had at least one ECG-documented AF/AFL episode during the last 3 months and were in sinus rhythm for at least one hour and were followed for 12 months.
Croatian: Bolesnici su u posljednja tri mjeseca imali barem jednu EKG-om potvrđenu epizodu FA/UA i bili su u sinusnom ritmu najmanje jedan sat, a praćeni su 12 mjeseci.
English: Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary.
Croatian: Potrebno je nadzirati istodobnu primjenu lijekova poput digoksina i antikoagulansa.
English: Hemangiomas are not precancerous changes and do not transform into malignant hemangiosarcomas in either animals or man. None of these observations was considered relevant for humans.
Croatian: Hemangiomi nisu prekancerozne promjene i ne pretvaraju se u zloćudne hemangiosarkome ni u životinja ni u ljudi.
English: If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je djelovanje lijeka prejako ili preslabo, obratite se svom liječniku ili ljekarniku.
English: Similar results were obtained on the incidence of cardiovascular hospitalisation with a risk reduction of 25.5% (p <0.0001).
Croatian: Slični rezultati dobiveni su i za incidenciju hospitalizacije zbog kardiovaskularnih razloga, sa smanjenjem rizika od 25,5% (p <0,0001).
English: • one tablet with the evening meal.
Croatian: • jednu tabletu uz večernji obrok.
English: Cardiac clinical symptoms
Croatian: - srčani klinički simptomi
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical assistance
Croatian: Kod primjene ovog lijeka prijavljene su sljedeće nuspojave: Odmah obavijestite svog liječnika ako primjetite neku od sljedećih ozbiljnih nuspojava - možda ćete trebati hitnu medicinsku pomoć
English: Patients could be in AF/AFL or in sinus rhythm after spontaneous conversion or following any procedures.
Croatian: Bolesnici su mogli imati FA/UA ili biti u sinusnom ritmu nakon spontane konverzije ili nakon nekog terapijskog postupka.
English: Treatment should be initiated and monitored only under specialist supervision (see section 4.4).
Croatian: Liječenje se smije započeti i pratiti samo pod nadzorom specijaliste (vidjeti dio 4.4).
English: Signs include breathlessness or non-productive cough.
Croatian: Znakovi uključuju nedostatak zraka i neproduktivni kašalj.
English: Treatment should be supportive and based on symptoms.
Croatian: Liječenje treba biti potporno i simptomatsko.
English: MULTAQ contains an active substance named dronedarone.
Croatian: MULTAQ sadrži djelatnu tvar koja se zove dronedaron.
English: A total of 504 patients with documented AF were randomised, 249 received dronedarone and 255 received amiodarone.
Croatian: Randomizirano je ukupno 504 bolesnika s dokumentiranom fibrilacijom atrija, od kojih je njih 249 primalo dronedaron, a 255 amiodaron.
English: However, proarrhythmic effects may occur in particular situations such as concomitant use with medicinal products favouring arrhythmia and/or electrolytic disorders (see sections 4.4 and 4.5).
Croatian: Međutim, proaritmijski učinci mogu se javiti u specifičnim situacijama, npr. kod istodobne primjene lijekova koji potiču aritmiju i/ili poremećaja elektrolita (vidjeti dio 4.4 i 4.5).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Patients with symptoms of heart failure at rest or with minimal exertion within the previous month or who were hospitalised for heart failure during the previous month
Croatian: Bolesnici sa simptomima zatajenja srca u mirovanju ili pri minimalnom naprezanju u prethodnom mjesecu ili bolesnici koji su tijekom prethodnog mjeseca hospitalizirani zbog zatajenja srca.
English: Dronedarone and/or its metabolites also have been shown to inhibit transport proteins of the Organic Anion Transporter (OAT), Organic Anion Transporting Polypeptide (OATP) and Organic Cation Transporter (OCT) families in vitro.
Croatian: Također se pokazalo da dronedaron i/ili njegovi metaboliti in vitro inhibiraju transportne proteine iz porodice organskog anionskog transportera (OAT), organskog anionskog transportnog polipeptida (OATP) i organskog kationskog transportera (OCT).
English: Interaction with clopidogrel
Croatian: Interakcija s klopidogrelom
English: Figure 1 - Relative risk (dronedarone 400 mg twice daily versus placebo) - first cardiovascular hospitalisation or death from any cause.
Croatian: Slika 1 - Procjene relativnog rizika (dronedaron 400 mg dvaput na dan u usporedbi s placebom)prva hospitalizacija zbog kardiovaskularnih razloga ili smrt zbog bilo kojeg uzroka.
English: A potential pharmacodynamic interaction can also be expected with beta-blockers, calcium antagonists and digitalis.
Croatian: Može se očekivati i potencijalna farmakodinamička interakcija s beta-blokatorima, antagonistima kalcija i digitalisom.
English: • ritonavir (a medicine for AIDS infection),
Croatian: • ritonavir (lijek za AIDS infekciju),
English: EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets
Croatian: EU/1/09/591/001 20 filmom obloženih tableta EU/1/09/591/002 50 filmom obloženih tableta EU/1/09/591/003 60 filmom obloženih tableta EU/1/09/591/004 100x1 filmom obložena tableta
English: Very Common
Croatian: Vrlo česte
English: A number of patients had been previously exposed to amiodarone (see section 4.4).
Croatian: Određeni broj bolesnika prethodno je bio izložen amiodaronu (vidjeti dio 4.4).
English: In animal models, dronedarone reduces the heart rate.
Croatian: U životinjskim modelima dronedaron usporava srčani ritam.
English: It is recommended to measure plasma creatinine values prior to and 7 days after initiation of dronedarone.
Croatian: Preporučuje se izmjeriti vrijednosti kreatinina u plazmi prije početka liječenja i 7 dana nakon uvođenja dronedarona.
English: Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists
Croatian: Interakcija s varfarinom i losartanom (supstratima CYP2C9) Varfarin i drugi antagonisti vitamina
English: You and your doctor should decide if you will take MULTAQ or breastfeed.
Croatian: Trebali biste odlučiti s Vašim liječnikom hoćete li uzimati MULTAQ ili dojiti.
English: Losartan and other Angiotensin II Receptor Antagonists (AIIRAs)
Croatian: Losartan i drugi antagonisti receptora angiotenzina II
English: The DIONYSOS study compared the efficacy and safety of dronedarone (400 mg twice daily) versus amiodarone (600 mg daily for 28 days, then 200 mg daily thereafter) over 6 months.
Croatian: Ispitivanje DIONYSOS uspoređivalo je djelotvornost i sigurnost dronedarona (400 mg dvaput na dan) i amiodarona (600 mg na dan tijekom 28 dana, a zatim 200 mg na dan) tijekom 6 mjeseci.
English: Dronedarone has vasodilatory properties, in coronary arteries (related to the activation of the nitric oxide pathway) and in peripheral arteries.
Croatian: Dronedaron ima vazodilatatorska svojstva u koronarnim arterijama (povezana s aktivacijom puta dušikova oksida) te u perifernim arterijama.
English: After intravenous administration the volume of distribution at steady state (Vss) ranges from 1,200 to 1,400 L.
Croatian: Nakon intravenske primjene volumen distribucije u stanju dinamičke ravnoteže (Vss) kreće se u rasponu od 1200 do 1400 l.
English: In patients, dronedarone and its metabolite are completely eliminated from the plasma within 2 weeks after the end of a 400 mg twice daily-treatment.
Croatian: U bolesnika se dronedaron i njegov metabolit u potpunosti eliminiraju iz plazme unutar 2 tjedna po završetku liječenja dozom od 400 mg dvaput na dan.
English: It is recommended to monitor renal function periodically and to consider further investigations as needed.
Croatian: Preporuča se periodično praćenje bubrežne funkcije te, prema potrebi, razmatranje daljnjih pretraga.
English: If no further increase in creatininaemia is observed, this value should be used as the new reference baseline taking into account that this may be expected with dronedarone.
Croatian: Ako se ne uoči daljnje povećanje kreatininemije, izmjerenu vrijednost treba uzeti kao novu referentnu početnu vrijednost s obzirom da se takav razvoj događaja može očekivati kod primjene dronedarona.
English: In the event of overdose, treatment should be supportive and directed toward alleviating symptoms.
Croatian: U slučaju predoziranja potrebno je uvesti potporno liječenje usmjereno prema ublažavanju simptoma.
English: Treatment with dronedarone should be stopped during the course of treatment, in case the patient develops any of the conditions which would lead to a contraindication as mentioned in section 4.3.
Croatian: Primjenu dronedarona treba prekinuti tijekom liječenja ako se u bolesnika razvije bilo koje stanje koje bi moglo dovesti do neke od kontraindikacija navedenih u dijelu 4.3.
English: Although plasma exposure in elderly females was increased in a pharmacokinetic study conducted in healthy subjects, dose adjustments are not considered necessary (see sections 5.1 and 5.2).
Croatian: Iako je u farmakokinetičkom ispitivanju provedenom u zdravih ispitanika utvrđena povećana izloženost u plazmi starijih žena, smatra se da nije potrebno prilagođavati dozu (vidjeti dio 5.1 i 5.2).
English: It can increase the blood levels of dronedarone and may increase your chance of getting side effects.
Croatian: On može povisiti razinu dronedarona u krvi i može povećati mogućnost nastanka nuspojava.
English: Effect of other medicinal products on dronedarone
Croatian: Učinak drugih lijekova na dronedaron
English: Assessment of intrinsic factors such as gender or age on the incidence of any treatment emergent adverse reactions showed an interaction for gender (female patients) for the incidence of any adverse reactions and for serious adverse reactions.
Croatian: Procjena utjecaja intrinzičnih faktora poput spola i dobi na incidenciju svih nuspojava povezanih s liječenjem pokazala je interakciju vezanu uz spol (ženski) i to s obzirom na incidenciju svih nuspojava te ozbiljnih nuspojava.
English: Pharmacotherapeutic group: cardiac therapy, antiarrhythmics class III, ATC code: C01BD07
Croatian: Farmakoterapijska skupina: pripravci koji djeluju na srce, antiaritmici skupine III, ATK oznaka: C01BD07.
English: • QTc Bazett interval ≥500 milliseconds
Croatian: • QTc-interval ≥ 500 milisekundi prema Bazettovoj formuli
English: Since antiarrhythmic medicinal products may be ineffective or may be arrhythmogenic in patients with hypokalaemia, any potassium or magnesium deficiency should be corrected before initiation and during dronedarone therapy.
Croatian: Budući da antiaritmici mogu biti nedjelotvorni ili aritmogeni u bolesnika s hipokalijemijom, bilo kakav nedostatak kalija ili magnezija treba korigirati prije početka i tijekom liječenja dronedaronom.
English: In the pooled data from EURIDIS and ADONIS as well as in the individual trials, dronedarone consistently delayed the time to first recurrence of AF/AFL (primary endpoint).
Croatian: Objedinjeni podaci iz ispitivanja EURIDIS i ADONIS, kao i iz pojedinačnih ispitivanja, pokazuju da dronedaron dosljedno odgađa vrijeme do prvoga recidiva FA/UA (primarna mjera ishoda).
English: In 2-year oral carcinogenicity studies, the highest dronedarone dose administered for 24 months was 70 mg/kg/day in rats and 300 mg/kg/day in mice.
Croatian: U dvogodišnjem ispitivanju kancerogenosti peroralnih doza najveća doza dronedarona primjenjivana tijekom 24 mjeseca bila je 70 mg/kg na dan u štakora i 300 mg/kg na dan u miševa.
English: The active substance is dronedarone.
Croatian: Djelatna tvar je dronedaron.
English: • Patients with liver and lung toxicity related to the previous use of amiodarone
Croatian: • Bolesnici s toksičnim oštećenjem jetre i pluća povezanim s prethodnom primjenom amiodarona
English: How to take MULTAQ
Croatian: Kako uzimati MULTAQ
English: Maintenance of sinus rhythm
Croatian: Održavanje sinusnog ritma
English: In patients who were taking amiodarone, an ECG was to be performed about 4 hours after the first administration to verify good tolerability.
Croatian: U bolesnika koji su uzimali amiodaron trebalo je napraviti EKG otprilike 4 sata nakon prve primjene kako bi se potvrdila dobra podnošljivost.
English: If serum creatinine continues to rise then consideration should be given to further investigation and discontinuing treatment.
Croatian: Ako razine kreatinina u serumu nastave rasti, treba razmotriti provođenje dodatnih pretraga i prekid liječenja.
English: Heart, lung and blood tests
Croatian: Pretrage srca, pluća i krvi
English: • other medicines for high blood pressure, for chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
Croatian: • druge lijekove za visoki krvni tlak, za bolove u prsištu uzrokovane bolešću srca ili za druge tegobe sa srcem, kao što su verapamil, diltiazem, nifedipin, metoprolol, propranolol ili digoksin,
English: MULTAQ is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek MULTAQ tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: • terfenadine (a medicine for allergies),
Croatian: • terfenadin (lijek za alergije),
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk.
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se dronedaron i njegovi metaboliti izlučuju u mlijeko.
English: Administration of dronedarone to patients receiving digoxin will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with digoxin toxicity.
Croatian: Primjena dronedarona u bolesnika koji primaju digoksin dovest će do povišenja koncentracija digoksina u plazmi te tako izazvati simptome i znakove povezane s toksičnošću digoksina.
English: White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side.
Croatian: Bijele, duguljaste tablete s utisnutom dvostrukom valovitom oznakom na jednoj i oznakom „4142” na drugoj strani.
English: Bradycardia (see sections 4.3 and
Croatian: bradikardija (vidjeti dijelove 4.3 i 4.4)
English: The median time from randomised to first AF/AFL recurrence in the dronedarone group was 116 days, i.e. 2.2-fold longer than in the placebo group (53 days).
Croatian: U skupini koja je primala dronedaron medijan vremena od randomizacije do prvog recidiva FA/UA iznosio je 116 dana, tj. bio je 2,2 puta dulji nego u skupini koja je primala placebo (53 dana).
English: Hepatotoxicity are concerned by the additional minimization measures.
Croatian: • hepatotoksičnost su obuhvaćeni dodatnim mjerama minimizacije rizika.
English: The digoxin dose should be reduced by approximately 50%, serum levels of digoxin should be closely monitored and clinical and ECG monitoring is recommended.
Croatian: Doza digoksina mora se smanjiti za približno 50%, moraju se pažljivo pratiti koncentracije digoksina u serumu, a preporučuje se i kliničko i EKG praćenje.
English: • dabigatran (a medicine for prevention of blood clot formation).
Croatian: • dabigatran (lijek za sprječavanje stvaranja krvnih ugrušaka).
English: In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
Croatian: U kliničkim je ispitivanjima bradikardija primijećena češće kada se dronedaron primjenjivao u kombinaciji s beta-blokatorima.
English: • change in the results of blood tests used to check your liver function.
Croatian: • promjene u nalazima krvnih pretraga kojima se ispituje funkcija jetre.
English: MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).
Croatian: MULTAQ je indiciran za održavanje sinusnog ritma nakon uspješne kardioverzije u odraslih, klinički stabilnih bolesnika s paroksizmalnom ili perzistentnom fibrilacijom atrija (FA).
English: No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.
Croatian: Nije opaženo smanjenje razine etinilestradiola ni levonorgestrela u zdravih ispitanika koji su dronedaron (800 mg dvaput na dan) primali istodobno s oralnim kontraceptivima.
English: Patients with permanent atrial fibrillation
Croatian: Bolesnici s permanentnom fibrilacijom atrija:
English: Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically.
Croatian: Pojava dispneje ili neproduktivnog kašlja može biti povezana s toksičnim djelovanjem na pluća pa treba učiniti pažljivu kliničku procjenu bolesnika.
English: Since dronedarone is a weak inhibitor of CYP 2D6 in humans, it is predicted to have limited interaction on antidepressant medicinal products metabolised by CYP 2D6.
Croatian: Budući da je dronedaron slab inhibitor CYP2D6 u ljudi, pretpostavlja se da će imati ograničenu interakciju s antidepresivima koji se metaboliziraju pomoću CYP2D6.
English: Observations were increased incidence of mammary gland tumors in female mice, histiocytic sarcomas in mice and hemangiomas at the mesenteric lymph node level in rats, all at the highest tested dose only (corresponding to an exposure of 5 to 10 times that of the human therapeutic dose).
Croatian: Primijećena je povećana incidencija tumora mliječne žlijezde u ženki miševa, histiocitnih sarkoma u miševa i hemangioma mezenterijskog limfnog čvora u štakora, i to samo pri najvećim ispitivanim dozama (što odgovara izloženosti 5 do 10 puta većoj od one koja se postiže primjenom terapijske doze u ljudi).
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: The mean exposure of the N-debutyl metabolite is decreased by 47% (see section 4.2).
Croatian: N-desbutil metabolitu manja je za 47% (vidjeti dio 4.2).
English: The Prescriber Guide should display information to help physician assess whether the patient is eligible for MULTAQ prescription and whether the patient remains within the prescribing information.
Croatian: Vodič za liječnike propisivače mora sadržavati informacije koje će liječniku pomoći ocijeniti je li bolesnik prikladan kandidat za liječenje lijekom MULTAQ i ostaje li unutar okvira informacija o lijeku.
English: EU/1/09/591/001 - cartons of 20 film-coated tablets EU/1/09/591/002 - cartons of 50 film-coated tablets EU/1/09/591/003 - cartons of 60 film-coated tablets EU/1/09/591/004 - cartons of 100 x 1 film-coated tablets
Croatian: EU/1/09/591/001 - kutija s 20 filmom obloženih tableta EU/1/09/591/002 - kutija s 50 filmom obloženih tableta EU/1/09/591/003 - kutija sa 60 filmom obloženih tableta EU/1/09/591/004 - kutija sa 100 x 1 filmom obloženom tabletom
English: Effect of dronedarone on other medicinal products
Croatian: Učinak dronedarona na druge lijekove
English: After oral administration, approximately 6% of the labelled dose is excreted in urine mainly as metabolites (no unchanged compound excreted in urine) and 84% are excreted in faeces mainly as metabolites.
Croatian: Nakon peroralne primjene približno 6% deklarirane doze izlučuje se mokraćom uglavnom u obliku metabolita (mokraćom se ne izlučuje spoj u neizmijenjenu obliku), a 84% doze izlučuje se fecesom uglavnom u obliku metabolita.
English: Calcium antagonists
Croatian: Antagonisti kalcija
English: The recommended dose is 400 mg twice daily in adults.
Croatian: Preporučena doza za odrasle je 400 mg dvaput na dan.
English: Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p<0.0001).
Croatian: Dronedaron je smanjio incidenciju hospitalizacije zbog kardiovaskularnih razloga odnosno smrti zbog bilo kojeg uzroka za 24,2% u usporedbi s placebom (p<0,0001).