natgillin/translations-raw huggingface dataset:
Efficacy and safety of Tredaptive in combination with simvastatin > 40 mg were not included in this study. 
Učinkovitosti in varnosti zdravila Tredaptive v kombinaciji s simvastatinom > 40 mg v tej študiji niso preučevali.
Other medicines and Tredaptive 
Druga zdravila in zdravilo Tredaptive
MARKETING AUTHORISATION NUMBER(S) EU/1/08/459/012 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/459/012
• medicines used to lower blood pressure. 
• zdravila za zniževanje krvnega tlaka.
Safety and effectiveness of Tredaptive in paediatric patients under the age of 18 years have not been established. 
Varnost in učinkovitost zdravila Tredaptive pri pediatričnih bolnikih, mlajših od 18 let, nista bili dokazani.
Therefore, Tredaptive should not be used during pregnancy unless clearly necessary. 
Zato se zdravila Tredaptive ne sme uporabljati pri nosečnicah, razen če to ni nujno.
INFORMATION IN BRAILLE Tredaptive 
PODATKI V BRAILLOVI PISAVI Tredaptive
• Take Tredaptive with food. 
• Vzemite ga s hrano.
Weeks on Treatment 
Tedni zdravljenja
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Tredaptive to the woman. 
Odločiti se je treba med nadaljevanjem/prenehanjem dojenja in nadaljevanjem/prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Tredaptive za mater.
Side effects of Tredaptive are: 
Neželeni učinki zdravila Tredaptive so:
It is not known if Tredaptive will harm your unborn baby. 
Ni znano, ali zdravilo Tredaptive škoduje nerojenemu otroku.
Therefore, Tredaptive should not be used in children and adolescents under 18 years of age. 
Zato se zdravila Tredaptive ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
In particular, tell your doctor or pharmacist if you are taking any of the following: 
Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil:
Tredaptive is used in addition to diet 
Zdravilo Tredaptive se uporablja poleg diete za:
If you forget to take Tredaptive 
Če ste pozabili vzeti zdravilo Tredaptive
Patients with hepatic or renal insufficiency 
Bolniki z jetrno ali ledvično insuficienco
The frequencies of adverse reactions are ranked according to the following: 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). 
Neželeni učinki so po pogostnosti razvrščeni takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000),
What Tredaptive is and what it is used for What you need to know before you take Tredaptive How to take Tredaptive 
Kaj je zdravilo Tredaptive in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tredaptive Kako jemati zdravilo Tredaptive
If you get dizzy, you should avoid driving or operating machines after taking Tredaptive. 
Če postanete omotični, se med jemanjem zdravila Tredaptive izogibajte vožnji ali upravljanju strojev.
Tredaptive is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia: 
Zdravilo Tredaptive se uporablja poleg diete in telesne vadbe pri odraslih bolnikih s primarno hiperholesterolemijo ali z mešano dislipidemijo:
Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. 
Zdravilo Tredaptive morate previdno uporabljati pri bolnikih, ki uživajo velike količine alkohola in/ali imajo anamnezo bolezni jeter.
In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Tredaptive), flushing was reported in 12.3 % of patients taking Tredaptive. 
V štirih z učinkovino ali s placebom kontroliranih kliničnih preskušanjih (N=4.747, n = 2.548 jih je jemalo zdravilo Tredaptive) so o zardevanju poročali pri 12,3 % bolnikov,
• Take Tredaptive once a day, in the evening or at bedtime. 
• Zdravilo Tredaptive vzemite enkrat na dan, zvečer ali pred spanjem.
The effect on lipids was similar whether Tredaptive was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe. 
Učinek na lipide je bil podoben, naj je bilo zdravilo Tredaptive uporabljeno v monoterapiji ali dodano že vpeljanemu statinskemu zdravljenju, z ezetimibom ali brez njega.
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Tredaptive with or without a statin (see section 4.4). 
Klinično pomembno zvišanje CK (≥ 10 x ZNM) so opazili pri 0,3 % bolnikov, ki so dobivali zdravilo Tredaptive s statinom ali brez njega (glejte poglavje 4.4).
▲ Tredaptive  nicotinic acid (laropiprant withdrawn at Week 21) 
▲ Tredaptive  nikotinska kislina (ukinitev laropipranta v 21. tednu)
If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor. 
Ne nehajte jemati zdravila Tredaptive, ne da bi se posvetovali s svojim zdravnikom.
Flushing is the most common adverse reaction of Tredaptive. 
Zardevanje je najpogostejši neželeni učinek zdravila Tredaptive.
Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4). 
Redko so poročali o izrazitem in stalnem porastu serumskih transaminaz (glejte poglavje 4.4).
In an interim analysis of an ongoing clinical outcome study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking Tredaptive and simvastatin 40 mg. 
V vmesni analizi trenutno potekajoče preživetvene študije je neodvisen odbor za spremljanje varnosti odkril višjo pojavnost miopatije pri kitajskih bolnikih, ki so jemali zdravilo Tredaptive in simvastatin
Tredaptive is not recommended in pregnancy unless clearly necessary. 
Nosečnost in dojenje Zdravila Tredaptive v nosečnosti ne priporočamo, razen če je nujno potrebno.
However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive. 
Če pa se zgodi, da zdravila Tredaptive niste vzeli 7 ali več dni zapored, se pred ponovnim začetkom jemanja posvetujte z zdravnikom.
Tredaptive contains a sugar called lactose. 
Tredaptive vsebuje sladkor, imenovan laktoza.
Like other nicotinic acid medicinal products, Tredaptive is contraindicated in patients with significant or unexplained hepatic dysfunction. 
Tako kot druga zdravila z nikotinsko kislino je tudi zdravilo Tredaptive kontraindicirano pri bolnikih s pomembno ali nepojasnjeno motnjo delovanja jeter.
Tredaptive has not been studied in children and adolescents who are under 18 years of age. 
Zdravilo Tredaptive ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Tredaptive is recommended. 
Če zvišanje vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST) na ≥ 3 x ZMN (zgornja meja normalne vrednosti) vztraja, je priporočljivo zmanjšati odmerek zdravila Tredaptive ali pa zdravilo Tredaptive prenehati uporabljati.
The European Medicines Agency has deferred the obligation to submit the results of studies with Tredaptive in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Tredaptive pri pediatričnih bolnikih s heterozigotno družinsko hiperholesterolemijo, starih od 7-18 let (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tredaptive contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1). 
Zdravilo Tredaptive vsebuje nikotinsko kislino, ki v terapevtskih odmerkih vpliva na lipide, in laropiprant, močan, selektiven antagonist receptorja prostaglandina D2 (PGD2) podvrste 1 (DP1).
Each modified-release tablet contains 128.4 mg of lactose monohydrate. 
Ena tableta s prirejenim sproščanjem vsebuje 128,4 mg laktoze monohidrata.
If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose. 
Če bolnik zdravila Tredaptive ne vzame manj kot 7 dni zapored, ga lahko znova začne jemati v nazadnje uporabljanem odmerku.
Nicotinic acid causes a relative shift in the distribution of LDL subclasses from small, dense (most atherogenic) LDL particles to larger LDL particles. 
Nikotinska kislina povzroči relativen premik porazdelitve podskupin LDL od majhnih, gostih (najbolj aterogenih) delcev LDL proti večjim delcem LDL.
Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive. 
Dodatki, ki vsebujejo nikotinsko kislino: Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Tredaptive ni raziskana.
Also tell your doctor if you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese. 
Zdravniku povejte tudi, če jemljete simvastatin (statin) ali zdravilo, ki vsebuje simvastatin, in ste
Tredaptive is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial). 
Zdravilo Tredaptive je indicirano za zdravljenje dislipidemije, zlasti pri odraslih bolnikih s kombinirano mešano dislipidemijo (za katero so značilni zvišani LDL holesterol in trigliceridi in nizek HDL holesterol), in pri odraslih bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in nedružinsko).
• Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone. 
• Jemanje acetilsalicilne kisline pred zaužitjem zdravila Tredaptive ne bo bolj zmanjšalo zardevanja, kot če vzamete samo zdravilo Tredaptive.
The tablets should be taken whole, with food, in the evening or at bedtime. 
Tablete Tredaptive mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
It is not known if Tredaptive will pass into your breast milk. 
Ni znano, ali zdravilo Tredaptive prehaja v materino mleko.
Warnings and precautions Tell your doctor about all of your medical conditions. 
Zdravniku morate povedati za vse svoje zdravstvene težave.
The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI. 
Drug Project, ki se je končala leta 1975, je pokazala, da nikotinska kislina statistično značilno pripomore k zmanjšanju števila neusodnih ponovnih miokardnih infarktov (MI) pri moških od 30. do 64. leta starosti z anamnezo MI.
Other abnormal laboratory values reported were elevations in LDH, fasting glucose, uric acid, total bilirubin, and amylase, and reductions in phosphorus and platelet counts (see section 4.4). 
Druge nenormalne laboratorijske vrednosti, o katerih so poročali, so bile zvišanje LDH, glukoze na tešče, sečne kisline, celotnega bilirubina in amilaze ter znižanje fosforja in števila trombocitov (glejte poglavje 4.4).
• After 4 weeks, your doctor may raise your dose to two tablets a day. 
Po 4 tednih vam zdravnik lahko odmerek poveča na dve tableti zdravila Tredaptive na dan.
Additional explanations that do not invoke plasma FFA reduction as the central driver of lipid profile modification include nicotinic acid-mediated inhibition of de novo lipogenesis or esterification of fatty acids into TG in the liver. 
Dodatne razlage, ki ne zajemajo znižanja PMK v palzmi kot glavnega gonila sprememb sestave lipidov, vključujejo z nikotinsko kislino posredovano zavrtje de novo lipogeneze ali esterifikacijo maščobnih kislin v trigliceride v jetrih.
The glycine conjugation pathway is not saturated across the clinically relevant dose range, based on the dose-proportional increase in the plasma concentrations of NUA from 1,000 mg to 2,000 mg. 
Pot konjugacije z glicinom pa se v celotnem razponu klinično pomembnih odmerkov ne nasiti, če presojamo na podlagi odmerku sorazmernega porasta koncentracije nikotinurične kisline v plazmi od odmerka 1.000 mg do 2.000 mg.
• Your doctor should do a blood test before you start taking Tredaptive to check how well your liver is working. 
• Pred začetkom uporabe zdravila Tredaptive vas mora zdravnik poslati na preiskavo krvi, da bo preveril delovanje vaših jeter.
Do not take Tredaptive if any of the above apply to you. 
Ne vzemite zdravila Tredaptive, če kaj od naštetega velja za vas.
Based on these data, laropiprant is not expected to cause interactions with substrates of CYP isozymes 3A4, 2C9, 2C8 and human P-glycoprotein (P-gp). 
Glede na te podatke ni pričakovati medsebojnega delovanja laropipranta s substrati izoencimov 3A4, 2C9 in 2C8 CYP ali humanega glikoproteina P (P-gp).
When Tredaptive is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product. 
Če zdravilo Tredaptive uporabljate skupaj s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4). 
Izmed statinov, so farmakokinetične interakcije zdravila Tredaptive raziskali samo s simvastatinom (glejte poglavje 4.4).
As with other nicotinic acid medicinal products, caution should be used when Tredaptive is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents. 
Akutni koronarni sindrom Tako kot velja za druga zdravila z nikotinsko kislino, je tudi pri zdravilu Tredaptive potrebna previdnost, če ga uporabljate pri bolnikih z nestabilno angino pektoris ali med akutno fazo MI, zlasti kadar takšni bolniki dobivajo tudi vazoaktivna zdravila, kot so nitrati, zaviralci kalcijevih kanalov ali adrenergični zaviralci.
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Tredaptive experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2,000 mg titration) (p< 0.001). 
V drugi študiji (16 tednov), v kateri je bilo dovoljeno uporabljati acetilsalicilno kislino, so bolniki, ki so prejemali zdravilo Tredaptive, doživljali zmerno ali izrazitejše zardevanje značilno manj dni na teden kot bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem, uporabljen v 12-tedenski večstopenjski titraciji od 500 mg do 2.000 mg) (p < 0,001).
Increases in serum alanine aminotransferase (ALT) levels were observed in all dog studies, at systemic exposure levels at least 14 times the human exposure based on the AUC of the recommended daily human dose. 
Zvišanje serumske alanin-aminotransferaze (ALT) so opažali v vseh študijah na psih pri izpostavljenosti, ki je bila vsaj 14-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
HMG-CoA reductase inhibitors: When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance. 
Zaviralci reduktaze HMG Co-A: Med uporabo simvastatina v kombinaciji z nikotinsko kislino sta se AUC in Cmax simvastatinske kisline (aktivne oblike simvastatina) zmerno zvišali, kar je lahko klinično nepomembno.
Effects of nicotinic acid on other medicinal products Antihypertensive therapy: Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive medicinal products such as nitrates, calcium channel blockers, and adrenergic receptor blocking agents, resulting in postural hypotension. 
Učinki nikotinske kisline na druga zdravila Antihipertenzivna zdravila: Nikotinska kislina lahko poveča učinke ganglijskih zaviralcev in vazoaktivnih zdravil, kot so nitrati, zaviralci kalcijevih kanalov ali adrenergični zaviralci, in tako povzroči posturalno hipotenzijo.
A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Tredaptive experienced significantly more flushing than patients who continued taking Tredaptive in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2. 
Multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana 32-tedenska študija za oceno učinka prenehanja jemanja laropipranta je pokazala, da je bilo pri bolnikih z dislipidemijo, ki so po 20 tednih zdravljenja z zdravilom Tredaptive prenehali jemati laropiprant, bistveno več zardevanja kot pri bolnikih, ki so nadaljevali z jemanjem zdravila Tredaptive, kar je bilo izraženo s številom dni v tednu z zmernim ali izrazitejšim zardevanjem, p<0,001, Slika 2.
This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia. 
Preobčutljivostne reakcije Poročali so o (< 1 %) očitni preobčutljivostni reakciji, za katero so značilni različni simptomi, ki lahko vključujejo: angioedem, srbenje, eritem, parestezije, izgubo zavesti, bruhanje, urtikarijo, zardevanje, dispnejo, navzeo, inkontinenco urina in blata, hladno znojenje, drgetanje, mrzlico, zvišan krvni tlak, otekanje ustnic, pekoč občutek, medikamentozen izpuščaj, artralgijo, otekanje nog in tahikardijo.
Laropiprant was not carcinogenic in 2 year studies in mice and rats at the highest doses tested, which represents at least 218 to 289 times the human exposure based on the AUC of the recommended daily human dose. 
Laropiprant ni bil kancerogen v 2-letnih študijah pri miših in podganah v največjih testiranih odmerkih, ki pomenijo vsaj 218- oz. 289-krat tolikšno izpostavljenost, kot je (na podlagi AUC)
Use of Tredaptive in patients with hepatic or renal insufficiency has not been studied. 
Uporaba zdravila Tredaptive pri bolnikih z jetrno ali ledvično insuficienco ni raziskana.
4.9 Overdose 
4.9 Preveliko odmerjanje Tredaptive
• laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid. 
• laropiprant, ki zmanjša simptome zardevanja, pogostega neželenega učinka nikotinske kisline.
In healthy subjects receiving Tredaptive, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Tredaptive alone (see section 4.8). 
Pri zdravih preiskovancih, ki so dobivali zdravilo Tredaptive, predhodna uporaba 325 mg acetilsalicilne kisline ni dodatno ublažila simptomov zardevanja zaradi nikotinske kisline v primerjavi s samim zdravilom Tredaptive (glejte poglavje 4.8).
Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive should be used with caution in patients with renal dysfunction. 
Nikotinska kislina in njeni presnovki se izločajo skozi ledvice, zato morate pri bolnikih z motenim delovanjem ledvic zdravilo Tredaptive uporabljati previdno.
As with other nicotinic acid medicinal products, patients with a history of jaundice, hepato-biliary disorder or peptic ulcer should be observed closely (see sections 4.2 and 4.3). 
Tako kot velja za druga zdravila z nikotinsko kislino, morate bolnike z anamnezo zlatenice, bolezni jeter in žolčnika ali želodčne razjede pozorno spremljati (glejte poglavji 4.2 in 4.3).
Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine. 
Previdnost je potrebna, če zdravilo Tredaptive uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, kot je zidovudin.
What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “552” debossed on one side. 
Izgled zdravila Tredaptive in vsebina pakiranja Tablete s prirejenim sproščanjem so v obliki kapsul, bele do kremaste barve in imajo na eni strani vtisnjeno oznako "552".
TP plays a role in platelet function; however, therapeutic doses of laropiprant had no clinically relevant effect on bleeding time and collagen-induced platelet aggregation (see section 4.5). 
TP igra vlogo pri delovanju trombocitov; vendar terapevtski odmerki laropipranta niso klinično pomembno vplivali na čas krvavitve ali agregacijo trombocitov, izzvano s kolagenom (glejte poglavje 4.5).
Symptoms included fainting, shortness of breath, wheezing or trouble breathing, swelling of the face, lips, tongue, itching or hives on the skin. 
kratko sapo, piskanje ali težko dihanje, otekanje obraza, ustnic, jezika, srbenje ali koprivnico.
• If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Tredaptive a day. 
• Če prehajate z zdravila, ki vsebuje 2.000 mg nikotinske kisline s podaljšanim sproščanjem ali več, vam zdravnik lahko predpiše, da začnete jemati dve tableti zdravila Tredaptive na dan.
In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Tredaptive. 
Kot del alergijske reakcije na zdravilo Tredaptive so poročali še o enem ali večih od naslednjih simptomov:
• medicines used to lower cholesterol called ‘bile acid sequestrants', such as colestyramine. 
• zdravila za zniževanje holesterola, ki jih imenujemo "adsorbenti žolčnih kislin", npr.
Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. 
Zdravilo Tredaptive je treba uporabljati v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralcem reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Tredaptive. 
Biološka uporabnost peroralne nikotinske kisline se med moškimi in ženskami, ki so dobivali zdravilo Tredaptive, ni razlikovala.
●Tredaptive (1000 mg/20 mg to 2000 mg/40 mg at week 5) ▲Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) 
● Tredaptive (1.000 mg/20 mg do 2.000 mg/40 mg 5. teden)
Tredaptive (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Tredaptive (2000 mg/40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9 %, -37.0 %, -17.0 % respectively), TG (-33.3 %, -14.7 %, -21.6 % respectively), apo B (-41.0 %, -28.8 %, -17.1 % respectively), and TC (-29.6 %, -24.9 %, -9.1 % respectively), as well as LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % respectively), non-HDL-C (-45.8 %, -33.4 %, -18.1 % respectively), and TC:HDL-C (-43.0 %, -28.0 %, -24.9 % respectively), and significantly increased HDL-C (27.5 %, 6.0 %, 23.4 % respectively). 
Zdravilo Tredaptive 2.000 mg/40 mg, uporabljen sočasno s simvastatinom, je v primerjavi s samim simvastatinom ali samim zdravilom Tredaptive 2.000 mg/40 mg v 12 tednih bistveno znižal hLDL (-47,9 % oz. -37,0 % oz. -17,0 %), trigliceride (-33,3 % oz. -14,7 % oz.21,6 %), apo B (-41,0 % oz. -28,8 % oz. -17,1 %) in Ch (-29,6 % oz. -24,9 % oz. -9,1 %) kot tudi razmerje hLDL:hHDL (-57,1 % oz. -39,8 % oz. -31,2 %), ne-HDL-holesterol (-45,8 % oz. -33,4 % oz. -18,1 %) in razmerje Ch:hHDL (-43,0 % oz. -28,0 % oz. -24,9 %) ter bistveno zvišal hHDL (27,5 % oz. 6,0 % oz. 23,4 %).