natgillin/translations-raw huggingface dataset:
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal.
Bolnikom, pri katerih pride do zvišanja vrednosti aminotransferaz, je treba za potrditev opraviti še drugo preiskavo delovanja jeter, nato pa jih je treba spremljati s pogostimi pregledi jetrnih testov, dokler se nenormalni izvid( i) ne normalizira( jo).
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Eucreas therapy is recommended.
Če zvišanje AST ali ALT na ali nad 3- kratno zgornjo mejo normalnih vrednosti (ULN - upper limit of normal) vztraja, je priporočena prekinitev zdravljenja z zdravilom Eucreas.
Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.
Srčno popuščanje Pri bolnikih s kongestivnim srčnim popuščanjem funkcijskih razredov I- II po klasifikaciji Združenja za srce iz New Yorka (New York Heart Association - NYHA) je malo izkušenj z uporabo vildagliptina, zato je potrebna previdnost pri uporabi vildagliptina pri teh bolnikih.
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class III-IV and therefore use is not recommended in these patients.
Iz kliničnih preskušanj ni nobenih izkušenj z uporabo vildagliptina pri bolnikih iz funkcijskih razredov III- IV po klasifikaciji NYHA, zato uporaba pri teh bolnikih ni priporočena.
Metformin is contraindicated in patients with heart failure, therefore Eucreas is contraindicated in this patient population (see section 4.3).
Metformin je kontraindiciran pri bolnikih s srčnim popuščanjem, zato je tudi zdravilo Eucreas kontraindicirano za to skupino bolnikov (glejte poglavje 4. 3).
Skin disorders Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Kožne spremembe V nekliničnih toksikoloških študijah z vildagliptinom so poročali o kožnih spremembah, med drugim o mehurčastem izpuščaju in razjedah na okončinah opic (glejte poglavje 5. 3).
Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
V kliničnih študijah niso opažali zvišane incidence kožnih sprememb, vendar je pri bolnikih s kožnimi obolenji kot diabetičnim zapletom obseg izkušenj omejen.
Surgery As Eucreas contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Operacijski poseg Zdravilo Eucreas vsebuje metformin, zato je treba zdravljenje z njim prekiniti 48 ur pred načrtovanim operacijskim posegom s splošno anestezijo, ponovno pa se ga sme uvesti šele 48 ur po posegu.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Aplikacija jodiranega kontrastnega sredstva Intravaskularna aplikacija jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic.
Therefore, due to the metformin active substance, Eucreas should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ker zdravilo Eucreas vsebuje zdravilno učinkovino metformin, ga je treba ukiniti pred preiskavo ali v času preiskave, ponovno pa se ga sme uvesti šele 48 ur po preiskavi in sicer samo v primeru, da ponovno vrednotenje pokaže normalno delovanje ledvic (glejte poglavje 4. 5).
4 Vildagliptin Vildagliptin has a low potential for interactions with co-administered medicinal products.
Vildagliptin Vildagliptin ima le majhno možnost medsebojnega delovanja z drugimi sočasno uporabljenimi zdravili.
Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population.
Rezultati kliničnih študij s peroralnimi antidiabetiki pioglitazonom, metforminom in gliburidom v kombinaciji z vildagliptinom niso pokazali nobenih klinično pomembnih farmakokinetičnih interakcij pri ciljni populaciji.
Drug-drug interaction studies with digox in (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co- administration with vildagliptin.
Študije medsebojnega delovanja z digoksinom (substratom P- glikoproteina) in z varfarinom (substratom CYP2C9) na zdravih prostovoljcih niso pokazale nobenih klinično pomembnih farmakokinetičnih interakcij pri sočasni uporabi vildagliptina.
However, this has not been established in the target population.
Vendar pa le- teh niso ugotavljali pri ciljni populaciji.
Metformin Combinations not recommended There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Eucreas (see section 4.4).
Metformin Kombinacije, ki niso priporočene Zaradi metformina, zdravilne učinkovine v zdravilu Eucreas, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience), povečano tveganje za laktacidozo (glejte poglavje 4. 4).
A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
V študiji na zdravih prostovoljcih se je pokazalo, da je uporaba cimetidina v odmerku 400 mg dvakrat na dan povečala sistemsko izpostavljenost metforminu (AUC) za 50%.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Zato je pri sočasni uporabi kationskih zdravil, ki se izločajo preko ledvic s tubulno sekrecijo, treba skrbno spremljati urejenost glikemije, ustrezno prilagajati odmerke v okviru priporočenega odmerjanja in pretehtati možnost spremembe zdravljenja diabetesa (glejte poglavje 4. 4).
Combinations requiring precautions for use Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Kombinacije, pri katerih je potrebna previdnost pri uporabi Glukokortikoidi, beta- 2 agonisti in diuretiki imajo intrinzično hiperglikemično aktivnost.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
5 Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko znižujejo koncentracije glukoze v krvi.
For metformin, studies in animals have not
Za metformin študije na živalih niso pokazale vpliva na sposobnost razmnoževanja.
Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3).
Študije na živalih, ki so jih izvajali z vildagliptinom in metforminom, niso pokazale teratogenosti, pokazali pa so se toksični učinki za plod pri odmerkih, ki so bili toksični za mater (glejte poglavje 5. 3).
It is not known whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts.
Ni znano, ali se vildagliptin izloča v materino mleko pri človeku, se pa v materino mleko pri človeku v majhnih količinah izloča metformin.
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Eucreas should not be used during lactation (see section 4.3).
Tako zaradi potencialnega tveganja, da bi pri novorojenčku zaradi metformina prišlo do hipoglikemije, kot tudi zaradi pomanjkanja podatkov o vildagliptinu pri ljudeh, se zdravila Eucreas ne sme uporabljati v obdobju dojenja (glejte poglavje 4. 3).
Patients who may experience dizziness as an undesirable effect should avoid driving vehicles or using machines.
Bolniki, pri katerih prihaja do neželenega učinka v obliki omotičnosti, naj se izogibajo vožnji ali upravljanju s stroji.
There have been no therapeutic clinical trials conducted with Eucreas.
Terapevtskih kliničnih študij z zdravilom Eucreas niso izvajali.
However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Dokazali pa so bioekvivalenco zdravila Eucreas s sočasno uporabljanima vildagliptinom in metforminom (glejte poglavje 5. 2).
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations ≥ 3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
V podatkih iz kontroliranih preskušanj z monoterapijo in iz tistih z dodanim zdravilom, ki so trajala do 24 tednov, so bile incidence zvišanj ALT ali AST na ali nad 3- kratnik zgornje meje normalnih vrednosti (zvišanje opredeljeno kot prisotno na vsaj dveh zaporednih izvidih ali na zadnjem obisku v času zdravljenja) 0, 2% za vildagliptin 50 mg enkrat dnevno, 0, 3% za vildagliptin 50 mg dvakrat dnevno in 0, 2% za vsa primerjalna zdravila.
Adverse reactions reported in patients who received vildagliptin in double-blind studies as add-on therapy to metformin (Table 1) and as monotherapy (Table 2) are listed below by system organ class and absolute frequency.
Neželeni učinki, o katerih so poročali pri bolnikih, ki so v dvojno slepih študijah prejemali vildagliptin kot dodatno terapijo k metforminu (preglednica 1) in v monoterapiji (preglednica 2), so navedeni po organskih sistemih in po absolutni pogostnosti.
Adverse reactions listed in Table 3 are based on information available from the metformin Summary of Product Characteristics available in the EU.
Neželeni učinki, ki so navedeni v preglednici 3, temeljijo na podatkih iz Povzetka glavnih značilnosti zdravila, ki se za metformin uporablja v Evropski skupnosti.
Frequencies are defined as very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pogostnosti so definirane kot: zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1. 000, < 1/ 100), redki (≥1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), neznana (ni mogoče
6 Table 1
Preglednica 1
Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)
Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 100 mg vildagliptina dnevno kot dodatno terapijo k metforminu, v primerjavi s tistimi, ki so z metforminom prejemali placebo v dvojno slepih študijah (N=208)
Common Common Common Uncommon
pogosti pogosti pogosti občasni Bolezni prebavil
Nausea
navzea
In controlled clinical trials with the combination of vildagliptin 100 mg daily plus metformin, no withdrawal due to adverse reactions was reported in ei ther the vildagliptin 100 mg daily plus metformin or the placebo plus metformin treatment groups.
V kontroliranih kliničnih preskušanjih s kombinacijo 100 mg vildagliptina dnevno in metforminom niso poročali o nobenem izstopu iz preskušanja zaradi neželenih učinkov niti v skupini, ki je skupaj z metforminom prejemala 100 mg vildagliptina dnevno, niti v skupini, ki je skupaj z metforminom prejemala placebo.
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
V kliničnih preskušanjih je do hipoglikemije prišlo pogosto pri bolnikih, ki so prejemali vildagliptin v kombinaciji z metforminom (1%), in občasno pri bolnikih, ki so prejemali placebo v kombinaciji z metforminom (0, 4%).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Telesna masa se v kliničnih preskušanjih ni bistveno spremenila od izhodiščne: pri dodajanju 100 mg vildagliptina metforminu se je povečala za 0, 2 kg, pri kombinaciji metformina s placebom pa se je zmanjšala za 1, 0 kg.
Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 100 mg vildagliptina dnevno v monoterapiji v dvojno slepih študijah (N=1. 855)
Common Uncommon
pogosti občasni Bolezni prebavil
Infections and infestations
Infekcijske in parazitske bolezni Žilne
Very rare Very rare
zelo redki zelo redki bolezni občasni
Upper respiratory tract infection Nasopharyngitis
okužba zgornjih dihal nazofaringitis periferni edemi
Vascular disorders
Skupna
Uncommon
incidenca izstopov iz
Oedema peripheral
kontroliranih preskušanj z monoterapijo zaradi neželenih učinkov ni bila
The overall incidence of withdrawals from controlled monotherapy trials due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
večja pri bolnikih, ki so prejemali vildagliptin v odmerku 100 mg dnevno (0, 3%) v primerjavi z bolniki, ki so prejemali placebo (0, 6%) ali primerjalna zdravila (0, 5%).
In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
Poročil o resnih oziroma hudih epizodah ni bilo.
7 In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Telesna masa se v kliničnih preskušanjih ni bistveno spremenila od izhodiščne: pri jemanju 100 mg vildagliptina v monoterapiji se je zmanjšala za 0, 3 kg, pri uporabi vildagliptina skupaj s placebom pa se je zmanjšala za 1, 3 kg.
Known adverse reactions for metformin component
Znani neželeni učinki metformina
Very Rare
zelo redki
Decrease of vitamin B12 absorption and lactic acidosis*
zmanjšanje absorpcije vitamina B12 in laktacidoza *
Liver function test abnormalities or hepatitis**
nenormalne vrednosti jetrnih testov ali hepatitis **
*A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
* Pri bolnikih, ki so se dologtrajno zdravili z metforminom, so zelo redko opažali zmanjšanje absorpcije vitamina B12 in znižanje njegove koncentracije v serumu.
Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia. **Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported.
Priporočeno je, da se pri bolniku z megaloblastno anemijo pomisli na možnost take etiologije. ** Poročali so o posameznih primerih nenormalnih vrednosti jetrnih testov ali hepatitisa, ki so izzveneli po ukinitvi metformina.
Gastrointestinal undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Do gastrointestinalnih neželenih učinkov pride najpogosteje na začetku zdravljenja in v večini primerov spontano izzvenijo.
Vildagliptin Information regarding overdose with vildagliptin is limited.
Vildagliptin Podatki o prevelikem odmerjanju vildagliptina so omejeni.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Pri 600 mg je pri eni osebi prišlo do otekanja rok in stopal ter zvišanja koncentracij kreatin- kinaze (CK), aspartat - aminotransferaze (AST), C- reaktivnega proteina (CRP) in mioglobina.
Metformin A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital.
Metformin Zaradi znatno prevelikega odmerjanja metformina (ali sočasnega tveganja za laktacidozo) lahko pride do laktacidoze, ki je urgentno stanje in zahteva bolnišnično zdravljenje.
Management The most effective method of removing metformin is haemodialysis.
8 Obravnava Hemodializa je najučinkovitejši način odstranjevanja metformina.
Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Vildagliptin iz skupine spodbujevalcev Langerhansovih otočkov je močan in selektiven zaviralec dipeptidil peptidaze 4 (DPP- 4).
Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively).
Vildagliptin, ki so ga dodajali bolnikom, pri katerih glikemija ni bila zadovoljivo urejena kljub zdravljenju z metforminom v monoterapiji, je po 6- mesečnem zdravljenju povzročil dodatno statistično značilno povprečno znižanje HbA1c v primerjavi s placebom (razlika med skupinama - 0, 7% za odmerek 50 mg vildagliptina in - 1, 1% za odmerek 100 mg vildagliptina).
The proportion of patients who achieved a decrease in HbA1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%).
Delež bolnikov, pri katerih je prišlo do znižanja HbA1c za ≥ 0, 7% od izhodiščne vrednosti, je bil v obeh skupinah s kombinacijo vildagliptina in metformina statistično značilno večji (46% oziroma 60%) v primerjavi s skupino, ki je prejemala metformin in placebo (20%).
Vildagliptin Vildagliptin acts primarily by inhibiting DPP-4, the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
Vildagliptin Vildagliptin deluje predvsem z zaviranjem DPP- 4, encima, ki je odgovoren za razgradnjo hormonov inkretinov GLP- 1 (glukagonu podoben peptid 1) in GIP (od glukoze odvisni insulinotropni polipeptid).
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Uporaba vildagliptina povzroči hitro in popolno zaviranje delovanja DPP- 4, kar povzroča zvišanje endogenih koncentracij hormonov inkretinov GLP- 1 in GIP na tešče in po obroku.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA-β (Homeostasis Model Assessment–β), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Zdravljenje z vildagliptinom v odmerkih 50- 100 mg dnevno je pri bolnikih z diabetesom tipa 2 pomembno izboljšalo vrednosti kazalcev delovanja beta celic, vključno z modelom ocene homeostaze HOMA- β, razmerjem med proinsulinom in insulinom ter merjenjem odzivnosti beta celic po obroku s pogostim vzorčenjem.
By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion.
Z zviševanjem endogenih koncentracij GLP- 1 vildagliptin okrepi tudi občutljivost celic alfa za glukozo, kar povzroči ustreznejše izločanje glukagona glede na koncentracijo glukoze.
The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Pri hiperglikemiji zaradi zvišanih koncentracij hormonov inkretinov pride do dodatnega zvišanja razmerja insulin/ glukagon, kar povzroči zmanjšanje tvorbe glukoze v jetrih na tešče in po obroku, to pa zniža koncentracije glukoze v krvi.
The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Pri zdravljenju z vildagliptinom niso opažali počasnejšega praznjenja želodca, kar je sicer znan učinek pri zvišanih koncentracijah GLP- 1.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
9 Metformin Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
Metformin may exert its glucose -lowering effect via three mechanisms:
Metformin lahko deluje na zniževanje glukoze v krvi na tri načine:
- by reduction of hepatic glucose production through inhibition of gluconeogenesis and
- zmanjšuje tvorbo glukoze v jetrih, tako da zavira glukoneogenezo in glikogenolizo;
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
- v mišicah nekoliko poveča občutljivost za insulin, izboljša periferni privzem in koriščenje
utilisation;
glukoze;
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Metformin z delovanjem na glikogen- sintazo spodbuja znotrajcelično tvorbo glikogena, poleg tega pa povečuje transportno zmožnost specifičnih vrst membranskih glukoznih prenašalcev (GLUT- 1 in GLUT- 4).
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Metformin ima pri ljudeh neodvisno od delovanja na koncentracijo glukoze v krvi ugoden vpliv na presnovo lipidov, kar se je pokazalo pri uporabi terapevtskih odmerkov v srednje dolgih in dolgotrajnih kontroliranih kliničnih študijah.
- a significant reduction in the absolute risk of any diabetes-related complication in the metformin
- pomembno zmanjšanje absolutnega tveganja za katerikoli diabetični zaplet v skupini z
group (29.8 events/1,000 patient -ye ars) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034;
metforminom (29, 8 dogodkov/ 1. 000 bolnikov- let) v primerjavi s skupino bolnikov, zdravljenih samo z dieto (43, 3 dogodkov/ 1. 000 bolnikov- let), p=0, 0023, in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom (40, 1 dogodek/ 1. 000 bolnikov- let), p=0, 0034;
- a significant reduction in the absolute risk of diabetes-related mortality: metformin
- pomembno zmanjšanje absolutnega tveganja za umrljivost, povezano z diabetesom: metformin
7.5 events/1,000 patient -ye ars, diet alone 12.7 events/1,000 patient-years, p=0.017;
12, 7 dogodkov/ 1. 000 bolnikov- let, p=0, 017;
- a significant reduction in the absolute risk of overall mortality: metformin
- pomembno zmanjšanje absolutnega tveganja za splošno umrljivost: skupina z metforminom
13.5 events/1,000 patient -ye ars versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient- years (p=0.021);
13, 5 dogodkov/ 1. 000 bolnikov- let v primerjavi s skupino bolnikov, zdravljenih samo z dieto, 20, 6 dogodkov / 1. 000 bolnikov- let (p=0, 011) in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom, 18, 9 dogodkov/ 1. 000 bolnikov- let (p=0, 021);
- a significant reduction in the absolute risk of myocardial infarction: metformin
- pomembno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin