FrancophonIA/ELRC3.0 huggingface dataset:
English: On 28 June 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je dne 28. junija 2013 z večino podprla nova priporočila za varno uporabo zdravil, ki vsebujejo diklofenak in se dajejo na primer v obliki kapsul, tablet, svečk ali injekcij, ki naj bi učinkovale na celotno telo (t. i. sistemski učinek).
English: Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
Slovenian: Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials (Učinki nesteroidnih protivnetnih zdravil na ožilje in zgornja prebavila: meta analize podatkov o posameznikih, ki so sodelovali v randomiziranih preskušanjih).
English: If 1,000 patients at moderate risk took diclofenac for a year, there would be about 3 extra cases of heart attack among them, compared with patients not taking diclofenac.
Slovenian: Če bi 1.000 bolnikov, pri katerih obstaja zmerno tveganje, eno leto jemalo diklofenak, bi se med njimi pojavili približno 3 primeri srčne kapi več kot med bolniki, ki ne jemljejo diklofenaka.
English: • Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
Slovenian: • Uporaba diklofenaka je kontraindicirana pri bolnikih z ugotovljenim kongestivnim srčnim popuščanjem (II.-IV. razred po NYHA), ishemično boleznijo srca, periferno arterijsko boleznijo ali cerebrovaskularnim obolenjem.
English: • The PRAC has further reviewed available data including several new case-control and cohort studies, a post-hoc analysis of data from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme,1 and a meta-analysis2 by the Coxib and traditional NSAID Trialists Collaboration which involved over 600 clinical trials.
Slovenian: • PRAC je podrobneje pregledal razpoložljive podatke, vključno s podatki iz več novih študij „primerkontrola“ in kohortnih študij, post hoc analizo podatkov iz programa MEDAL (Mednarodni program vrednotenja dolgotrajne uporabe etorikoksiba in diklofenaka pri zdravljenju artritisa)1 in meta analizo2, ki jo je opravila kolaborativna skupina preskuševalcev koksibov in neselektivnih nesteroidnih protivnetnih zdravil (Coxib and Traditional NSAID Trialists Collaboration) in v katero so vključili več kot 600 kliničnih preskušanj.
English: The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs.
Slovenian: Pregled diklofenaka, ki ga je odbor PRAC opravil na zahtevo regulativne agencije Združenega kraljestva za zdravila (MHRA), se je začel oktobra 2012, po tem, ko so postale znane ugotovitve pregleda nesteroidnih protivnetnih zdravil iz leta 2012.
English: • Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150 mg daily) and for long periods.
Slovenian: • Na splošno so koristi tega zdravila večje od z njim povezanih tveganj, vendar obstaja majhno tveganje za srčno ali možgansko kap pri bolnikih, ki redno jemljejo sistemski diklofenak, zlasti če ga jemljejo v velikih odmerkih (150 mg na dan) in dlje časa.
English: However, data from previous reviews carried out in 2005, 2006 and 2012 suggested an increased relative risk of arterial thromboembolic events which was sometimes greater than for other commonly prescribed NSAIDs and in some cases as great or greater than that seen with certain COX-2 inhibitors.
Slovenian: Vendar pa so podatki iz preteklih pregledov, opravljenih v letih 2005, 2006 in 2012, pokazali povečano relativno tveganje za arterijske trombembolične dogodke, ki je bilo včasih večje kot pri drugih pogosto predpisanih nesteroidnih protivnetnih zdravilih, v nekaterih primerih pa tudi enako veliko ali večje kot pri uporabi nekaterih zaviralcev COX-2.
English: Most formulations are for systemic use (given as treatment throughout the body, such as oral and injectable medicines), which are covered by the current review.
Slovenian: Večina farmacevtskih oblik se uporablja za sistemsko zdravljenje (dajejo se kot zdravila, ki delujejo na celotno telo, na primer zdravila za peroralno uporabo ali injiciranje) in so obravnavane v tem pregledu.
English: • In the light of the above, all patients receiving regular diclofenac therapy should be reviewed at the next scheduled appointment.
Slovenian: • V skladu z zgoraj navedenim je treba pri vseh bolnikih, ki redno uporabljajo diklofenak, ob naslednjem obisku pri zdravniku ponovno oceniti zdravljenje.
English: Traditional NSAIDs act by blocking the effects of the two cyclo-oxygenase (COX) enzymes, known as COX-1 and COX-2, resulting in a reduced production of substances called prostaglandins.
Slovenian: Običajna nesteroidna protivnetna zdravila delujejo tako, da zavirajo učinke obeh encimov ciklooksigenaze (COX), ki ju imenujemo COX-1 in COX-2, zaradi česar se zmanjša nastajanje snovi, imenovanih prostaglandini.
English: • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Slovenian: • Bolnike s pomembnimi dejavniki tveganja za srčno-žilne dogodke (npr. hipertenzija, hiperlipidemija, sladkorna bolezen ali kajenje) se lahko zdravi z diklofenakom šele po temeljitem razmisleku.
English: The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied.
Slovenian: Skupina CMDh se je strinjala z ugotovitvijo odbora PRAC, da so kljub dejstvu, da so koristi sistemskega diklofenaka še vedno večje od z njim povezanih tveganj, omenjena tveganja podobna kot pri uporabi zaviralcev COX-2, in podprla priporočilo, da se uvedejo podobni previdnostni ukrepi.
English: The cardiovascular risk with any NSAID depends on a person's underlying risk factors, such as high blood pressure and cholesterol levels and also any underlying heart or circulatory conditions.
Slovenian: Srčno-žilno tveganje pri uporabi nesteroidnih protivnetnih zdravil je odvisno od obstoječih dejavnikov tveganja pri posamezniku, kot so visok krvni tlak in visoke ravni holesterola, ter tudi od obstoječih bolezni srca in ožilja.
English: This followed a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) which found that the effects of systemic diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers.
Slovenian: Do tega je prišlo po tem, ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila po pregledu ugotovil, da so učinki sistemskega diklofenaka na srce in ožilje podobni učinkom selektivnih zaviralcev COX-2, ki so prav tako skupina zdravil proti bolečinam.
English: Diclofenac is a widely used medicine for relieving pain and inflammation, particularly in painful conditions such as arthritis.
Slovenian: Diklofenak je zdravilo, ki se pogosto uporablja za lajšanje bolečine in vnetja, še zlasti pri bolečih bolezenskih stanjih, kot je artritis.
English: Diclofenac is authorised for the relief of pain and inflammation in a wide range of conditions, including arthritic conditions and acute musculoskeletal disorders.
Slovenian: Diklofenak je odobren za lajšanje bolečine in vnetja pri različnih bolezenskih stanjih, vključno z artritičnimi obolenji in akutnimi mišično-skeletnimi okvarami.
English: Reviews of these medicines carried out in 2005, 2006 and 2012 have confirmed that NSAIDs as a class are associated with a small increased risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, which in some cases has led to heart attack or stroke, particularly if used at high dose and for long periods.
Slovenian: Pregledi teh zdravil, ki so jih opravili v letih 2005, 2006 in 2012, so potrdili, da je skupina nesteroidnih protivnetnih zdravil povezana z rahlo povečanim tveganjem za arterijske trombembolične dogodke (krvni strdki v arterijah), ki se pojavi zlasti pri bolnikih z obstoječimi boleznimi srca in ožilja ali z določenimi srčnožilnimi dejavniki tveganja in je v nekaterih primerih povzročilo srčno ali možgansko kap, še zlasti kadar so se zdravila uporabljala pri velikih odmerkih in dlje časa.
English: A subgroup of NSAIDs, called ‘selective COX-2 inhibitors' (also known as ‘coxibs'), acts by blocking the COX-2 enzyme rather than both.
Slovenian: Podskupina nesteroidnih protivnetnih zdravil, imenovanih „selektivni zaviralci COX-2“ (poznamo jih tudi pod imenom „koksibi“), deluje tako, da zavira samo encim COX-2, in ne obeh.
English: As the risk is known to be somewhat higher with the subgroup of NSAIDs known as selective COX-2 inhibitors, increased measures to minimise risk are recommended in their product information.
Slovenian: Ker je znano, da je tveganje nekoliko večje pri podskupini nesteroidnih protivnetnih zdravil, imenovanih selektivni zaviralci COX-2, so v informacijah o teh zdravilih priporočeni strožji ukrepi za zmanjšanje tveganja.
English: The PRAC therefore recommended that the same precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should be applied to diclofenac.
Slovenian: PRAC je zato priporočil, naj se previdnostni ukrepi, ki so bili sprejeti za zmanjšanje tveganj za nastanek krvnih strdkov v arterijah pri uporabi selektivnih zaviralcev COX-2, uvedejo tudi za diklofenak.
English: • Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.
Slovenian: • Podatki iz kliničnega preskušanja in epidemiološki podatki dosledno kažejo na povečano tveganje za arterijske trombotične dogodke (na primer za srčni infarkt ali možgansko kap), povezane z uporabo diklofenaka, še zlasti pri zdravljenju z velikimi odmerki (150 mg na dan) in za dalj časa.
English: In addition to diclofenac, widely used NSAIDs also include ibuprofen and naproxen.
Slovenian: Poleg diklofenaka med pogosto uporabljana nesteroidna protivnetna zdravila sodita še ibuprofen in naproksen.
English: However, considering that the cardiovascular risk with systemic diclofenac appears similar to that of selective COX-2 inhibitors, it was considered that any risk minimisation in place for COX-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Slovenian: Vendar je glede na to, da vse kaže, da je srčno-žilno tveganje pri uporabi sistemskega diklofenaka podobno tveganju pri uporabi selektivnih zaviralcev COX-2, treba vse ukrepe za zmanjšanje tveganja, sprejete za zaviralce COX-2 glede srčnožilnega tveganja, vpeljati tudi za diklofenak.
English: The latter identified a small increased risk of these cardiovascular side effects with diclofenac compared with other NSAIDsan increase similar to that seen with the COX-2 inhibitors.
Slovenian: Ta je razkril rahlo povečano tveganje za srčnožilne neželene učinke diklofenaka v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili - podobno večje, kot so ga opazili pri zaviralcih COX-2.
English: Diclofenac is an NSAID.
Slovenian: Diklofenak je nesteroidno protivnetno zdravilo.
English: Blood pressure and cardiovascular outcomes in patients taking nonsteroidal antiinflammatory drugs.
Slovenian: Krum H, Swergold G, Gammaitoni A, et al. Blood pressure and cardiovascular outcomes in patients taking nonsteroidal antiinflammatory drugs (Vplivi na krvni tlak ter srce in ožilje pri bolnikih, ki jemljejo nesteroidna protivnetna zdravila).
English: Speak to your prescriber at your next scheduled appointment.
Slovenian: Ob naslednjem obisku pri zdravniku se o tem posvetujte z zdravnikom, ki vam je predpisal zdravljenje.
English: EU number
Slovenian: Številka EU dovoljenja za promet
English: Ask about ways to prevent dehydration.
Slovenian: Vprašajte o tem, kako preprečevati dehidracijo.
English: Possible signs of severe allergic reaction may include:
Slovenian: Možni znaki hude alergijske reakcije lahko vključujejo:
English: Possible signs are listed in section 4 under ‘dehydration'.
Slovenian: Možni znaki so našteti v poglavju 4 pod “dehidracija”.
English: Severe allergic reaction, seen with unknown frequency (frequency cannot be estimated from the available data )
Slovenian: Huda alergijska reakcija, pojavi se z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: Appropriate diet and exercise help your body use its blood sugar better.
Slovenian: Ustrezna dieta in vadba vašemu telesu pomagata bolje porabiti krvni sladkor.
English: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Slovenian: Če bolnik odmerek izpusti, ga mora vzeti takoj, ko se spomni, vendar v istem dnevu ne sme vzeti dvojnega odmerka.
English: Possible signs of losing too much fluid from your body are listed in section 4.
Slovenian: Možni znaki pretirane izgube tekočine iz telesa so našteti v poglavju 4.
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)*
Slovenian: nekrotizirajoči fasciitis presredka (Fournierova gangrena)*
English: Co-treatment with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Slovenian: Sočasni uporabi z znanimi induktorji encimov UGT se je treba izogniti zaradi možnega tveganja za zmanjšano učinkovitost.
English: • if you are taking medicines that increase urine production (diuretics).
Slovenian: • če uporabljate zdravila, ki spodbujajo izločanje urina (diuretiki).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 22. maj 2014 Datum zadnjega podaljšanja: 14. februar 2019
English: If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Slovenian: Če imate sladkorno bolezen tipa 2, vaša trebušna slinavka ne tvori dovolj insulina za uravnavo ravni glukoze v krvi, vaše telo pa lastnega insulina ne more učinkovito uporabiti.
English: • swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Slovenian: • otekanje obraza, ustnic, ust, jezika ali žrela, kar lahko povzroči oteženo dihanje ali požiranje
English: Thereby Jardiance lowers the amount of sugar in your blood.
Slovenian: S tem zdravilo Jardiance znižuje količino sladkorja v krvi.
English: • if you have serious kidney or liver problems - your doctor may ask you to take a different medicine.
Slovenian: • če imate resne težave z ledvicami ali jetri - zdravnik vam bo morda svetoval uporabo drugega zdravila.
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but they can also be signs of urinary tract infection.
Slovenian: Potreba po uriniranju ali pogostejše uriniranje so lahko tudi posledica načina delovanja zdravila Jardiance, vendar so lahko tudi znak okužbe sečil.
English: If Fournier´s gangrene is suspected, Jardiance should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Slovenian: Če obstaja sum na Fournierovo gangreno, je treba zdravilo Jardiance ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
English: • might be at risk of dehydration, for example: o if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure o if you are over 75 years old.
Slovenian: • če pri vas morda obstaja nevarnost dehidracije, na primer: o če vam je slabo, imate drisko ali povišano telesno temperaturo ali ne morete jesti ali piti, o če jemljete zdravila, ki spodbujajo izločanje urina (diuretiki) ali znižujejo krvni tlak, o če ste starejši od 75 let.
English: Therefore assessment of renal function is recommended as follows: - Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly (see sections 4.2, 5.1 and 5.2).
Slovenian: Zato se priporoča spremljanje delovanja ledvic kot sledi: - Pred uvedbo empagliflozina in nato redno med zdravljenjem, tj. vsaj enkrat letno (glejte poglavja 4.2, 5.1 in 5.2).
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Slovenian: Ob pojavu teh simptomov je potrebno pri bolnikih nemudoma preveriti, ali gre za ketoacidozo, ne glede na raven glukoze v krvi.
English: • blood tests may show an increase in blood fat (cholesterol) levels in your blood
Slovenian: • krvni testi lahko pokažejo povišane ravni maščob (holesterola) v krvi
English: This causes blood sugar (glucose) to be removed in your urine.
Slovenian: To povzroči izločanje krvnega sladkorja (glukoze) v urin.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with active substances that are P-gp substrates.
Slovenian: Na podlagi študij in vitro ni verjetno, da bi empagliflozin povzročil medsebojno delovanje z učinkovinami, ki so substrati P-gp.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot-care.
Slovenian: Kot pri vseh bolnikih s sladkorno boleznijo je pomembno, da jih podučimo o rutinski preventivni negi stopal.
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BK03
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje sladkorne bolezni, druga zdravila za zniževanje glukoze v krvi, brez insulinov, oznaka ATC: A10BK03
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Slovenian: Ti simptomi so lahko znak “diabetične ketoacidoze”, redke, vendar resne in včasih življenjsko nevarne težave, ki se lahko pojavi pri sladkorni bolezni zaradi povišanih ravni “ketonskih teles” v urinu ali krvi, kar je razvidno iz laboratorijskih preiskav.
English: • blood tests may show a decrease in kidney function (creatinine or urea)
Slovenian: • krvni testi lahko pokažejo zmanjšano delovanje ledvic (kreatinin ali sečnina)
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Slovenian: • nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom
English: Jardiance works by blocking the SGLT2 protein in your kidneys.
Slovenian: Zdravilo Jardiance deluje tako, da zavira beljakovino SGLT2 v vaših ledvicah.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Slovenian: • če jemljete druga zdravila, ki zmanjšujejo količino krvnega sladkorja, kot so insulin ali
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (see end of section 2 under ‘Jardiance contains sodium'), colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Slovenian: • Druge sestavine zdravila so: - jedro tablete: laktoza monohidrat (glejte na koncu poglavja 2 pod »Zdravilo Jardiance vsebuje laktozo«), mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat (glejte konec poglavja 2 »Zdravilo Jardiance vsebuje natrij«), koloidni, brezvodni silicijev dioksid, magnezijev stearat - filmska obloga: hipromeloza, titanov dioksid (E171), smukec, makrogol (400), rumeni železov oksid (E172)
English: Table 1: Tabulated list of adverse reactions (MedDRA) from reported placebo-controlled studies and from post-marketing experience System organ class
Slovenian: Preglednica 1: Tabelarični pregled neželenih učinkov (MedDRA), o katerih so poročali pri s placebom nadzorovanih študijah in na osnovi izkušenj v obdobju trženja
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Slovenian: Ena tableta vsebuje manj kot 1 mmol (23 mg) natrija, kar v bistvu pomeni ‘brez natrija'.
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters
Slovenian: • izpuščaj ali pordela koža - lahko sta srbeča in vključujeta izbokline, izcedek ali mehurje
English: Co administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and14% increase in Cmax of digoxin.
Slovenian: Sočasno dajanje digoksina, substrata P-gp, z empagliflozinom je povzročila 6-odstotno povečanje AUC in 14-odstotno povečanje Cmax digoksina.
English: Jardiance is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.
Slovenian: Zdravilo Jardiance spada v skupino zdravil, imenovanih zaviralci natrijevega glukoznega prenašalca 2 (SGLT2, sodium-glucose co-transporter 2).
English: What Jardiance is Jardiance contains the active substance empagliflozin.
Slovenian: Kaj je zdravilo Jardiance Zdravilo Jardiance vsebuje zdravilno učinkovino empagliflozin.
English: • unusual sleepiness or tiredness
Slovenian: neobičajna utrujenost ali zaspanost.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Slovenian: Zdravilo Jardiance vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
English: How Jardiance works
Slovenian: Kako deluje zdravilo Jardiance
English: Other side effects while taking Jardiance:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med jemanjem zdravila Jardiance: Pogosti
English: In the EMPA-REG OUTCOME study, for time to first nephropathy event, the HR was 0.61 (95 % CI 0.53, 0.70) for empagliflozin (12.7 %) vs placebo (18.8 %).
Slovenian: V študiji EMPA-REG-OUTCOME je bilo v obdobju do prvega pojava nefropatije razmerje ogroženosti 0,61 (95-% IZ 0,53; 0,70) za empagliflozin (12,7 %) v primerjavi s placebom (18,8 %).
English: Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Slovenian: Empagliflozin kot dodatno zdravljenje k metforminu, sulfonilsečnini, pioglitazonu Empagliflozin kot dodatno zdravljenje k metforminu, metforminu s sulfonilsečnino ali pioglitazonu z metforminom ali brez njega je povzročilo statistično značilno (p < 0,0001) zmanjšanje vrednosti HbA1c in telesne mase v primerjavi s placebom (preglednica 3).