natgillin/translations-raw huggingface dataset:
What Jardiance is and what it is used for 2.
Što se nalazi u ovoj uputi: 1. Što je Jardiance i za što se koristi
Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.4 and 5.2).
Empagliflozin se ne smije koristiti u bolesnika u završnom stadiju bolesti bubrega ili u bolesnika na dijalizi, budući da se ne očekuje da empagliflozin bude učinkovit u tih bolesnika (vidjeti dijelove 4.4 i
At 78 weeks, empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared to placebo.
U 78. tjednu empagliflozin je postigao statistički značajno sniženje vrijednosti HbA1c i uštedu inzulina u usporedbi s placebom.
The efficacy and safety of empagliflozin as monotherapy was evaluated in a double-blind, placebo- and active-controlled study of 24 weeks duration in treatment-naïve patients.
Djelotvornost i sigurnost monoterapije empagliflozinom ocijenjena je u dvostruko slijepom, placebom i aktivno kontroliranom ispitivanju u trajanju od 24 tjedna u prethodno neliječenih bolesnika.
The frequency of patients with minor hypoglycaemia was similar for empagliflozin and placebo as monotherapy, add-on to metformin, and add-on to pioglitazone with or without metformin.
Učestalost blage hipoglikemije kod bolesnika bila je slična u skupinama koje su primale empagliflozin i placebo u obliku monoterapije, te kao dodatak metforminu odnosno pioglitazonu sa ili bez metformina.
Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:
Znakovi dehidracije nisu specifični, ali mogu uključivati:
Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Ispitivanja interakcija provedenih u zdravih dobrovoljaca sugeriraju da istodobna primjena s metforminom, glimepiridom, pioglitazonom, sitagliptinom, linagliptinom, varfarinom, verapamilom, ramiprilom, simvastatinom, torasemidom i hidroklorotiazidom nije utjecala na farmakokinetiku empagliflozina.
No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Nije potrebno prilagođavanje doze u bolesnika s eGFR ≥60 ml/min/1,73 m2 ili klirensom kreatinina ≥60 ml/min.
Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex.
Jardiance 25 mg filmom obložene tablete su ovalne, blijedožute i bikonveksne.
NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim
Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Terapija empagliflozinom mora se prekinuti kada je eGFR perzistentno ispod 45 ml/min/1,73 m2 ili klirens kreatinina perzistentno ispod 45 ml/min.
Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Empagliflozin nije povećao incidenciju tumora u ženki miša u dozama do 1000 mg/kg/dan, što približno odgovara 62-strukom iznosu maksimalne kliničke izloženosti empagliflozinu.
The most frequently reported adverse reaction was hypoglycaemia when used with sulphonylurea or insulin (see description of selected adverse reactions).
Kada se empagliflozin primjenjivao sa sulfonilurejom ili inzulinom, najčešće prijavljena nuspojava je bila hipoglikemija (vidjeti opis odabranih nuspojava).
Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Homeostasis Model Assessment-β).
• burning sensation when passing urine
• osjećaj pečenja pri mokrenju
Empagliflozin induced renal tumours in male mice at 1000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Empagliflozin je inducirao tumore bubrega u mužjaka miša pri dozi od 1000 mg/kg/dan, ali ne pri 300 mg/kg/dan, što približno odgovara 11-strukom iznosu maksimalne izloženosti empagliflozinu.
a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 Mean adjusted for baseline value
Last observation carried forward, LOCF) prije pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) 1 srednja vrijednost prilagođena za početnu vrijednost
• thrush or genital yeast infection
• kandidijaza ili gljivična infekcija spolnih organa
Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
rezultirala je 26%-tnim povećanjem vršne koncentracije empagliflozina u plazmi (Cmax) i 53%-tnim povećanjem površine ispod krivulje koncentracija-vrijeme (AUC).
• urine that appears cloudy
• mokraća zamućenog izgleda
Iron oxide yellow (E172)
Ovojnica tablete hipromeloza titanijev dioksid (E171) talk makrogol 400 željezov oksid, žuti (E172)
Major hypoglycaemia (hypoglycaemia requiring assistance) No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, and add-on to pioglitazone with or without metformin.
Nije opaženo povećanje epizoda teške hipoglikemije u skupinama koje su primale empagliflozin u odnosu na placebo u obliku monoterapije, kao dodatak uz metformin, kao dodatak uz metformin i sulfonilureju te kao dodatak uz pioglitazon sa ili bez metformina.
Table 8 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea
Rezultati djelotvornosti u 12. tjednu u placebom kontroliranom ispitivanju empagliflozina u bolesnika sa šećernom bolešću tipa2 i nereguliranim krvnim tlakoma
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Tijekom kliničkih ispitivanja i nakon stavljanja lijeka u promet, u bolesnika liječenih SGLT2 inhibitorima, uključujući empagliflozin, prijavljeni su rijetki slučajevi dijabetičke ketoacidoze (DKA), uključujući i slučajeve opasne po život.
The apparent steady-state volume of distribution was estimated to be 73.8 l based on the population pharmacokinetic analysis.
Na temelju farmakokinetičke analize populacije procijenjeno je da je prividni volumen distribucije u stanju dinamičke ravnoteže iznosio 73,8 l.
In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
U bolesnika koji podnose empagliflozin i čiji je eGFR perzistentno ispod 60 ml/min/1,73 m2 ili klirens kreatinina <60 ml/min, potrebno je prilagoditi ili zadržati dozu empagliflozina na 10 mg jedanput dnevno.
There is no experience with doses above 800 mg in humans.
Ne postoje iskustva s dozama višim od
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
iznenadnog smanjenja doze inzulina ili povećane potrebe za inzulinom zbog velikog kirurškog zahvata ili ozbiljne bolesti.
The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) and placebo (0.3%).
Deplecija volumena Sveukupna učestalost deplecije volumena (uključujući prethodno definirane pojmove sniženi krvni tlak (izmjeren ambulantno ), sniženi sistolički krvni tlak, dehidraciju, hipotenziju, hipovolemiju, ortostatsku hipotenziju i sinkopu) bila je slična u bolesnika liječenih empagliflozinom (empagliflozin
Each tablet contains 25 mg empagliflozin.
TVARI Svaka tableta sadrži 25 mg empagliflozina.
A total of 11,250 patients with type 2 diabetes were treated in 10 double-blind, placebo- and active-controlled clinical studies, of which 7,015 received empagliflozin (empagliflozin 10 mg: 3021 patients; empagliflozin 25 mg: 3994 patients).
placebom i aktivno kontroliranih kliničkih ispitivanja od kojih je 7015 primalo empagliflozin (empagliflozin 10 mg: 3021 bolesnik; empagliflozin 25 mg: 3994 bolesnika).
HbA1c ≥7%2
HbA1c ≥7% u 52. tjednu
In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
(hemangiomi) mezenterijalnih limfnih čvorova koje su povezane s liječenjem, bile su opažene pri najvišoj dozi, ali ne pri dozi od 300 mg/kg/dan, što približno odgovara 26-strukom iznosu maksimalne kliničke izloženosti empagliflozinu.
• passing more urine than usual or needing to pass urine more often
• pojačano mokrenje ili češća potreba za mokrenjem
Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Ispitivanja interakcija provedena na zdravim dobrovoljcima sugeriraju da empagliflozin nije imao klinički značajan učinak na farmakokinetiku metformina, glimepiridina, pioglitazona, sitagliptina,
However, temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Međutim, u bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid terapije empagliflozinom.
2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure
Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde
Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin.
Tumori intersticijskih stanica testisa opaženi su s višom incidencijom u štakora pri 300 mg/kg/dan i više, ali ne pri 100 mg/kg/dan što odgovara približno
HbA1c (%) at week 522
HbA1c (%) u 52. tjednu2
Empagliflozin should not be used in patients with ESRD or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.2 and 5.2).
Empagliflozin se ne smije koristiti u bolesnika u završnom stadiju bolesti bubrega ili u bolesnika na dijalizi budući da se ne očekuje da empagliflozin bude učinkovit u tih bolesnika (vidjeti dijelove 4.2 i
Add-on combination therapy
Dodatak kombiniranoj terapiji
Add-on to insulin therapy
Dodatak terapiji inzulinom
N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5% CI) N Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7%2
No dose adjustment is required for patients with hepatic impairment.
Oštećenje jetrene funkcijeNije potrebno prilagođavanje doze u bolesnika s oštećenjem jetre.
Other side effects while taking Jardiance:
• nesvjesticu ili gubitak svijesti Druge nuspojave tijekom uzimanja lijeka Jardiance:
During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Tijekom početnih 18 tjedana i posljednjih 12 tjedana doza inzulina je bila stalna, ali se između 19. i 40. tjedna prilagođavala u cilju postizanja razine glukoze <100 mg/dl
How to store Jardiance 6.
Moguće nuspojave 5. Kako čuvati Jardiance
Empagliflozin does not inhibit P-gp at therapeutic doses.
P-gp pri terapijskim dozama.
Jardiance 10 mg film-coated tablets
Jardiance 10 mg filmom obložene tablete
Table 7 Results at 24 week in a placebo-controlled study of empagliflozin in renally impaired type 2 diabetes patientsa
Rezultati u 24. tjednu u placebom kontroliranom ispitivanju empagliflozina u bolesnika s oštećenjem bubrežne funkcije i šećernom bolešću tipa 2a
What Jardiance looks like and contents of the pack Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex and bevel-edged.
Jardiance 10 mg filmom obložene tablete su okrugle, blijedožute, bikonveksne i ukošenih rubova.
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
- bol u trbuhu - prekomjerna žeđ - ubrzano i duboko disanje - smetenost - neuobičajena pospanost ili umor - zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
Jardiance 25 mg film-coated tablets
Jardiance 25 mg filmom obložene tablete
It is unknown if Jardiance is harmful to the unborn child. Do not use Jardiance if you are breast-feeding.
Nije poznato je li Jardiance štetan za nerođeno dijete.
Film coating Hypromellose
Empagliflozin ne inhibira
SBP (mmHg)4
Sistolički krvni tlak (mmHg)4
Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m or
Terapija empagliflozinom ne smije se započeti u bolesnika s eGFR<60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
(add-on to metformin: placebo +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl, add-on to metformin and a sulphonylurea: placebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Liječenje empagliflozinom kao dodatnom terapijom uz metformin ili metformin i sulfonilureju rezultiralo je klinički značajnim smanjenjem vrijednosti glukoze 2 sata nakon obroka (test tolerancije nakon obroka) u 24. tjednu (dodatak uz metformin: placebo +5,9 mg/dl, empagliflozin 10 mg: -46,0 mg/dl, empagliflozin 25 mg: -44,6 mg/dl, dodatak uz metformin i sulfonilureju: placebo -2,3 mg/dl, empagliflozin 10 mg: -35,7 mg/dl, empagliflozin 25 mg: -36,6 mg/dl).
1 Mean adjusted for baseline value
1 Srednja vrijednost prilagođena za početnu vrijednost
Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or
Terapija lijekom Jardiance ne smije se započeti u bolesnika s eGFR ispod 60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
Boehringer Ingelheim International GmbH Binger Str. 173
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim International GmbH Binger Str. 173
Increased urinationa
Pojačano mokrenjea
SBP (mmHg)2
Sistolički krvni tlak (mmHg)2
The efficacy and safety of empagliflozin as add-on to multiple daily insulin with or without concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Empagliflozin kao dodatak inzulinu koji se primjenjuje više puta dnevno Djelotvornost i sigurnost empagliflozina kao dodatka inzulinu koji se primjenjuje više puta dnevno sa ili bez istodobne terapije metforminom ocijenjena je u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna.
The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3%) or empagliflozin 25 mg (4.4%) compared to placebo (2.1%).
(2,3%) ili empagliflozinom od 25 mg (4,4%) u usporedbi s placebom (2,1%).
Boehringer Ingelheim International GmbH Binger Strasse 173
Nositelj odobrenja za stavljanje lijeka u promet Boehringer Ingelheim International GmbH Binger Strasse 173
In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg) and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg) at week 24 that were maintained up to week 52.
empagliflozin 25 mg: -4,3 mmHg) u usporedbi s placebom (-0,5 mmHg) i dijastoličkog krvnog tlaka (empagliflozin 10 mg: -1,8 mmHg; empagliflozin 25 mg: -2,0 mmHg) u usporedbi s placebom (-0,5 mmHg) u 24. tjednu koje se održalo do 52. tjedna.
Empagliflozin improves both fasting and post-prandial plasma glucose levels.
Empagliflozin snižava razinu glukoze natašte i nakon jela.
NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets
Jardiance 10 mg filmom obložene tablete Jardiance 25 mg filmom obložene tablete
Table 3: Efficacy results of 24 week placebo-controlled studiesa Add-on to metformin therapy Placebo
Tablica 3: Rezultati djelotvornosti 24-tjednih placebom kontroliranih ispitivanjaa
1 LOCF, values after taking antidiabetic rescue therapy censored
4 LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka
Patients with renal impairment, 52 week placebo controlled data The efficacy and safety of empagliflozin as add on to antidiabetic therapy was evaluated in patients with renal impairment in a double-blind, placebo-controlled study for 52 weeks.
Djelotvornost i sigurnost empagliflozina kao dodatka antidijabetičkoj terapiji ocijenjeni su u bolesnika s oštećenjem bubrežne funkcije u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna.
Therapy
Terapija
<7% with baseline
<7% s početnom vrijednošću HbA1c
An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following coadministration.
Ispitivanje interakcija s gemfibrozilom, in vitro inhibitorom prijenosnika OAT3 i OATP1B1/1B3,
Baseline (mean) Change from baseline1 Difference from placebo1
Promjena od početne vrijednosti1 Razlika od placeba1
Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1
An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), and as add-on to insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 27.1%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, placebo 35.3% over the 78-week trial).
Povećana učestalost je zabilježena kada je lijek primjenjivan kao dodatak uz metformin i sulfonilureju (empagliflozin 10 mg: 16,1%, empagliflozin 25 mg: 11,5%, placebo: 8,4%) i kao dodatak uz inzulin sa ili bez metformina te sa ili bez sulfonilureje (empagliflozin 10 mg: 19,5%,
Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
* p-value <0.0001
* p-vrijednost<0,0001 ** p-vrijednost <0,001
Urinary tract infection
Infekcija mokraćnog sustavaa
At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in FPG and body weight.
HbA1c i uštedom inzulina u usporedbi s placebom te sniženjem vrijednosti FPG i tjelesne težine.
In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
60 ml/min/1,73 m2 ili klirens kreatinina ispod 60 ml/min, potrebno je prilagoditi ili zadržati dozu empagliflozina na 10 mg jedanput dnevno.
QUALITATIVE AND QUANTITATIVE COMPOSITION Jardiance 10 mg film-coated tablets
KVALITATIVNI I KVANTITATIVNI SASTAV Jardiance 10 mg filmom obložene tablete Svaka tableta sadrži 10 mg empagliflozina.
NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg film-coated tablets Empagliflozin
Jardiance 25 mg filmom obložene tablete empagliflozin
N HbA1c (%) at week 18 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N HbA1c (%) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Basal insulin dose (IU/day) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) a Full analysis set (FAS) - Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value * p-value <0.0001 ** p-value <0.025
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5% CI) N Doza bazalnog inzulina (IU/dan) u 78. Tjednu
At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Pri izloženostima koje su bile dostatno više od izloženosti u ljudi nakon terapijskih doza,
NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Empagliflozin
Jardiance 10 mg filmom obložene tablete empagliflozin
Treatment with empagliflozin provided reductions in seated SBP and DBP.
Liječenje empagliflozinom dovelo je do sniženja sistoličkog (SKT) i dijastoličkog (DKT) krvnog tlaka mjerenog u sjedećem položaju.
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FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]).
U četiri placebom kontroliranih ispitivanja, liječenje empagliflozinom u obliku monoterapije ili kao dodatna terapija uz metformin, pioglitazon ili metformin plus sulfonilureja rezultiralo je srednjom promjenom početne vrijednosti FPG-a u iznosu -20,5 mg/dl [-1,14 mmol/l] za empagliflozin od 10 mg i -23,2 mg/dl [-1,29 mmol/l] za empagliflozin od 25 mg u usporedbi s placebom (7,4 mg/dl [0,41 mmol/l]).
1 Mean adjusted for baseline value 2 LOCF, values after antihypertensive rescue censored
Razlika od placeba CI) a Potpuni skup za analizu (Full analysis set, FAS) 1 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy)
Hepatic injury
Oštećenje jetre
Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Na osnovi farmakokinetičke analize populacije, indeks tjelesne mase (BMI) nije imao klinički značajan učinak na farmakokinetiku empagliflozina.
2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
1 Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde
5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Srednja vrijednost prilagođena za početnu vrijednost dijastoličkog krvnog tlaka (DKT), početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova