natgillin/translations-raw huggingface dataset:
- Diabetic coma
- diabetični komi
- Diabetic ketoacidosis
- diabetični ketoacidozi
- Severe renal function disorders
- hudih motnjah ledvičnega delovanja
- Pregnancy
- nosečnosti
- Lactation
- dojenju
There is no clinical trial experience of other oral anti-hyperglycaemic agents added to treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.
Kliničnih izkušenj s Tandemactom v kombinaciji z drugimi peroralnimi antihiperglikemičnimi učinkovinami ali s sočasnim jemanjem glimepirida in pioglitazona ni.
When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to hypoglycaemia due to the sulphonylurea component.
Pri nerednih ali izpuščenih obrokih lahko zdravljenje s Tandemactom zaradi sulfonilsečnine povzroči hipoglikemijo.
Treatment with Tandemact requires regular monitoring of glycaemic control.
Pri zdravljenju s Tandemactom je potrebno redno spremljati glikemični nadzor.
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose of pioglitazone and increase the dose gradually.
Pri zdravljenju bolnikov z vsaj enim dejavnikom tveganja za razvoj kongestivnega srčnega popuščanja (tj. pred miokardnim infarktom ali simptomatsko boleznijo koronarnih arterij), mora zdravnik začeti z najnižjim možnim odmerkom pioglitazona in ga postopoma zviševati.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema, particularly those with reduced cardiac reserve.
Bolnike je treba opazovati glede znakov in simptomov srčnega popuščanja, povišanja telesne mase ali edemov, posebno tiste z zmanjšano srčno rezervo.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin. or in patients with a history of cardiac failure.
Poročali so o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih z anamnezo srčnega popuščanja.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Pri bolnikih z diabetesom mellitusom tipa 2 in obstoječo težjo makrovaskularno boleznijo, starih manj kot 75 let, so izvajali študijo kardiovaskularnega izida.
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Obstoječi antidiabetični in kardiovaskularni terapiji so 3, 5 leta dodajali pioglitazon ali placebo.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Pri bolnikih, starih več kot 75 let, je zaradi omejenih izkušenj pri tej skupini bolnikov potrebna previdnost.
There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone and glimepiride (see section 4.8).
V postmarketinških izkušnjah s pioglitazonom in glimepiridom so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4. 8).
It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of liver enzymes.
Zato je priporočeno, da pri bolnikih, zdravljenih s Tandemactom, redno spremljate vrednosti jetrnih encimov.
Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja s Tandemactom.
Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi vrednostmi jetrnih encimov (ALT > 2, 5- kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni zdravljenja s Tandemactom ne smemo začeti.
3 Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
3 Po uvedbi zdravljenja s Tandemactom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
If ALT levels are increased to 3 X upper limit of normal during Tandemact therapy, liver enzyme levels should be reassessed as soon as possible.
Če se med zdravljenjem s Tandemactom ravni ALT zvišajo do 3- kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čim prej ponovno kontrolirati.
The decision whether to continue the patient on therapy with Tandemact should be guided by clinical judgement pending laboratory evaluations.
Odločitev o tem, ali zdravljenje bolnika s Tandemactom nadaljevati, naj do laboratorijskih vrednotenj temelji na klinični presoji.
If jaundice is observed, therapy with Tandemact should be discontinued.
Če se pojavi zlatenica, je treba zdravljenje z zdravilom Tandemact prekiniti.
Rare changes in haematology have been observed with glimepiride treatment (see section 4.8).
Pri zdravljenju z glimepiridom so bile opažene redke spremembe v hematologiji (glejte poglavje 4. 8).
Treatment with Tandemact therefore requires regular haematological monitoring (especially leucocytes and platelets).
Zato je pri zdravljenju s Tandemactom potrebno redno hematološko spremljanje (predvsem levkocitov in trombocitov).
During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Med zdravljenjem s pioglitazonom se je pojavljalo majhno znižanje povprečne vrednosti hemoglobina (4% relativno znižanje) in hematokrita (4, 1% relativno znižanje), skladno s hemodilucijo.
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia.
Ker sodi glimepirid kemijsko v skupino zdravil, ki so derivati sulfonilsečnine, je potrebna pri bolnikih s pomanjkanjem G6PD previdnost.
Since glimepiride belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Razmisliti je treba o možnosti zdravljenja z zdravili, ki niso derivati sulfonsilečnine.
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8. 100 s pioglitazonom in 7. 400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3, 5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunana incidenca zlomov je bila 1, 9 zlomov na 100 bolnik- let pri ženskah, zdravljenih s pioglitazonom in 1, 1 zlomov na 100 bolnik- let pri ženskah, zdravljenih s primerjalnim zdravilom.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0, 8 zlomov na 100 bolnik- let uporabe.
In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures
4 V 3, 5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/ 870 (5, 1%; 1, 0 zlom na 100 bolnik - let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/ 905 (2, 5%; 0, 5 zlomov na 100 bolnk- let) žensk, zdravljenih s primerjalnim zdravilom.
The tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Tablete vsebujejo laktozo monohidrat in se zato ne smejo dajati bolnikom z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorpcijo glukoze- galaktoze.
There have been no formal interaction studies for Tandemact, however, the concomitant use of the active substances in patients in clinical use has not resulted in any unexpected interactions.
Formalne raziskave o interakcijah za Tandemact niso bile narejene, vendar sočasno jemanje zdravilnih učinkovin pri bolnikih pri klinični uporabi ni povzročilo nobenih nepričakovanih interakcij.
The following statements reflect the information available on the individual active substances (pioglitazone and glimepiride).
Sledeče navedbe odražajo dostopne podatke o posameznih zdravilnih učinkovinah (pioglitazonu in glimepiridu).
Interactions with substances metabolised by these enzymes, e. g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Interakcij s snovmi, ki jih presnavljajo ti encimi, npr. s peroralnimi kontraceptivi, ciklosporinom, zaviralci kalcijevih kanalčkov in inhibitorji HMGCoA reduktaze, ni pričakovati.
Close monitoring of glycaemic control should be considered (see section 4.4).
Pretehtati je potrebno je skrbno spremljanje glikemičnega nadzora (glejte poglavje 4. 4).
For this reason, other medicinal products should only be taken with Tandemact with the knowledge (or at the prescription) of the doctor.
Zato se lahko druga zdravila jemljejo skupaj s Tandemactom zgolj ob vednosti (ali po navodilu) zdravnika.
Based on the experience with glimepiride and with other sulphonylurea the following interactions have to be mentioned.
Na podlagi izkušenj z glimepiridom in drugimi sulfonilsečninami, je treba omeniti naslednja medsebojna delovanja.
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following active substances is taken, for example:
5 Ob jemanju katere izmed naslednjih zdravilnih učinkovin se lahko poveča učinek na znižanje koncentracije glukoze v krvi, zato lahko v nekaterih primerih pride do hipoglikemije:
5 phenylbutazone, azapropazon and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol coumarin anticoagulants fenfluramine fibrates ACE inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro-and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines MAO-inhibitors quinolone antibiotics probenecid miconazol pentoxyfylline (high dose parenteral) tritoqualine fluconazole
fenilbutazon, azapropazon in oksifenbutazon insulin in peroralni antidiabetiki metformin salicilati in p- aminosalicilna kislina anabolni steroidi in moški spolni hormoni kloramfenikol kumarinski antikoagulansi fenfluramin fibrati zaviralci ACE fluoksetin alopurinol simpatikolitiki ciklo -, tro - in ifosfamidi sulfinpirazon nekateri dolgo delujoči sulfonamidi tetracikilini zaviralci MAO kinolonski antibiotiki probenecid mikonazol pentoksifilin (velik parenteralen odmerek) tritokalin flukonazol
Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following active substances is taken, for example:
Ob jemanju katere izmed naslednjih zdravilnih učinkovin se lahko zmanjša učinek na znižanje koncentracije glukoze v krvi, zato lahko v nekaterih primerih pride do hiperglikemije:
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives, laxatives (long-term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin. acetozolamide
estrogeni in progestageni, saluretiki, tiazidni diuretiki, sredstva, ki stimulirajo ščitnico, glukokortikoidi, fenotiazinski derivati, klorpromazin, adrenalin in simpatikomimetiki, nikotinska kislina (veliki odmerki) in derivati nikotinske kisline, odvajala (dolgotrajna uporaba), fenitoin, diazoksid, glukagon, barbiturati in rifampicin acetozolamid
Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Znaki adrenergične protiregulacije na hipoglikemijo se lahko pod vplivom simpatikolitičnih zdravilnih učinkovin kot so zaviralci beta, klonidin, gvanetidin in reserpin, zmanjšajo ali izginejo.
There are no adequate data from the use of pioglitazone and glimepiride in pregnant women.
Ni zadostnih podatkov o uporabi pioglitazona in glimepirida pri nosečnicah.
Studies of pioglitazone in animals have shown reproductive toxicity (see section 5.3).
Študije pioglitazona na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte Poglavje 5. 3).
Tandemact should not be used during pregnancy.
Tandemacta se med nosečnostjo ne sme uporabljati.
6 Sulphonylurea-derivatives like glimepiride pass into the breast milk.
6 Derivati sulfonilsečnin, kot je glimepirid, se izločajo v materino mleko.
Therefore, Tandemact must not be administered to breast-feeding women.
Zato se Tandemacta doječim ženskam ne sme dajati.
The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia from glimepiride or, for example, as a result of visual impairment.
Bolnikova zmožnost koncentracije in reagiranja se lahko poslabša zaradi hipoglikemije ali hiperglikemije povezane z glimepiridom, pa tudi npr. zaradi prizadetosti vida.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machines).
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
No therapeutic clinical trials have been conducted with Tandemact.
Klinična terapevstka preskušanja s Tandemactom niso bila opravljena.
However, bioequivalence of Tandemact with coadministered pioglitazone and glimepiride has been demonstrated (see section 5.2).
Vendar je bila bioekvivalenca Tandemacta dokazana s sočasno uporabo pioglitazona in glimepirida (glejte poglavje 5. 2).
Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies in combination with a sulphonylurea, including glimepiride, are listed below as MedDRA preferred term by system organ class and absolute frequency.
Neželeni učinki, o katerih so poročali večkrat (> 0, 5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v kombinaciji s sulfonilsečnino, vključno z glimperidom, v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA.
Frequencies are defined as: common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100; rare > 1/ 10000 ,< 1/1000; very rare < 1/10000; isolated reports: not known (cannot be estimated from the available data).
Pogostnosti so določene kot: pogosti > 1/ 100, < 1/ 10; občasni > 1/ 1. 000, < 1/ 100; redki > 1/ 10. 000, < 1/ 1. 000; zelo redki < 1/ 10. 000; posamezni primeri: neznani (jih ne moremo oceniti iz obstoječih podatkov).
Metabolism and nutritional disorders Uncommon:
Presnovne in prehranske motnje Občasni:
hypoglycaemia, appetite increased
hipoglikemija, povečan apetit
7 Renal and urinary disorders Uncommon:
7 Bolezni sečil Občasni:
In combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one year of 2.8 kg.
V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan sulfonilsečnini, povzročil povprečno povečanje telesne mase v enem letu za 2, 8 kg.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included in insulin.
V študiji izida pri bolnikih z obstoječo težjo makrovaskularno boleznijo je bila incidenca resnega srčnega popuščanja 1, 6% višja pri pioglitazonu kot pri placebu, ko je bil slednji dodan zdravljenju, ki je zajemalo insulin.
Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Pri tržni uporabi pioglitazona so redko poročali o srčnem popuščanju, a bolj pogosto, ko je bil pioglitazon uporabljen v kombinaciji z insulinom ali pri bolnikih z anamnezo srčnega popuščanja.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups.
V kontroliranih kliničnih preskušanjih je bila incidenca poročil o srčnem popuščanju ob zdravljenju s pioglitazonom enaka kot v skupinah zdravljenja s placebom, metforminom in sulfonilsečnino.
Heart failure has been reported rarely with marketing use of pioglitazone.
Pri tržni uporabi pioglitazona so redko poročali o srčnem popuščanju.
POST MARKETING DATA
POSTMARKETINŠKI PODATKI
Based on experience with glimepiride and with other sulphonylureas the following adverse reactions have to be mentioned.
Na podlagi izkušenj z glimepiridom in drugimi sulfonilsečninami, je treba omeniti naslednje neželene učinke.
8 Immune system disorders Very rare:
8 Bolezni imunskega sistema Zelo redki:
Allergic shock, allergic vasculitis
alergijski šok, alergijski vaskulitis
Changes in haematology
hematološke spremembe
Gastro-intestinal disorders Very rare:
Bolezni prebavil
Vomiting, diarrhoea, nausea, abdominal pressure, feeling of fullness in the stomach, abdominal pain
bruhanje, driska, slabost, napetost trebuha, občutek polnosti v želodcu, bolečine v
Hepato-biliary disorders Very rare:
Bolezni jeter, žolčnika in žolčevodov Zelo redki:
Hepatitis, impairment of liver function (with cholestasis and jaundice)
hepatitis, okvara delovanja jeter (npr. s holestazo in zlatenico)
Hypersensitivity to light
preobčutljivost na svetlobo
Decrease in sodium serum concentrations
znižanje natrija v serumu
In very rare cases mild hypersensivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
V zelo redkih primerih se lahko blage preobčutljivostne reakcije razvijejo v resne reakcije z dispnejo, padcem krvnega tlaka in včasih šokom.
Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, agranulocytopenia, agranulocytosis, haemolytic anemia and pancyto-penia may occur.
Lahko se pojavi zmerna do huda trombocitopenija, levkopenija, eritrocitopenija, agranulocitopenija, agranulocitoza, hemolitična anemija in pancitopenija.
These are in general reversible upon discontinuation of medication.
Po prekinitvi zdravljenja z zdravilom so ta stanja ponavadi reverzibilna.
Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
Bolezni prebavil so zelo redke in redko povzročijo prekinitev zdravljenja.
Elevation of liver enzymes may occur.
Jetrni encimi se lahko zvišajo.
In very rare cases, impairment of liver function (e. g. with cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure.
V zelo redkih primerih se lahko razvije okvara delovanja jeter (npr. s holestazo in zlatenico) ter hepatitis, ki lahko napreduje v odpoved jeter.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8. 100 bolnikov v skupini zdravljeni s pioglitazonom in 7. 400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3, 5 let.
Patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Bolniki so jemali pioglitazon v višjem od najvišjega priporočenega odmerka 45 mg na dan.
After ingestion of an overdosage of glimepiride, hypoglycaemia may occur, lasting from 12 to 72 hours, and may recur after initial recovery.
Po zaužitju prevelikega odmerka glimepirida se lahko pojavi hipoglikemija, ki traja od 12 do 72 ur in se lahko po navideznem okrevanju ponovi.
Nausea, vomiting and epigastric pain may occur.
Lahko se pojavijo slabost, bruhanje in
9 Treatment of overdosage of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Hipoglikemijo lahko spremljajo nevrološki simptomi kot so nemir, tremor, motnje vida, težave s koordinacijo, zaspanost, koma in konvulzije.
In case of (severe) overdosage hospitalization in an intensive care department is indicated.
V primeru (resnega) prevelikega odmerjanja je indicirana hospitalizacija v oddelku za intenzivno nego.
In particular when treating hypoglycaemia due to accidental intake of Tandemact in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia.
Zlasti pri zdravljenju hipoglikemije zaradi akcidentalnega zaužitja Tandemacta pri dojenčkih in majhnih otrocih, je treba odmerek glukoze skrbno nadzirati, da bi se izognili možnosti za pojav nevarne hiperglikemije.
Combinations of oral blood glucose lowering drugs; ATC code:
Farmakoterapevtska skupina: kombinacije peroralnih antidiabetikov, Oznaka ATC:
Tandemact combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: pioglitazone, a member of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class.
Tandemact je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: pioglitazona iz skupine tiazolidindionov in glimepirida iz skupine sulfonilsečnin.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolniki, ki so prejemali pioglitazon, so imeli povprečno znižan HbA1c za 0, 45% v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini, zdravljeni s pioglitazonom.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
10 V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično značilno znižal razmerje albumin/ kreatinin v primerjavi z izhodiščnimi vrednostmi.
10 The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18 - tedenskem preskušanju pri diabetikih tipa 2.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL- cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
V večini kliničnih preskušanj so opažali znižane skupne plazemske koncentracije trigliceridov in prostih maščobnih kislin ter povišane ravni HDL holesterola v primerjavi s placebom, in majhna, statistično neznačilna povišanja ravni LDL holesterola.