FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Mejju 2014
English: eGFR ≥30 to <60 ml/min/1.73 m²
Maltese: eGFR ≥30 sa <60 ml/min/1.73 m²
English: Comparison vs. met (95% CI)
Maltese: Tqabbil kontra met (95% CI)
English: Add-on to pioglitazone +/- metformin therapy Placebo
Maltese: Terapija aġġuntiva għal pioglitazone +/- metformin Plaċebo
English: Treatment with empagliflozin in combination with metformin (5 mg and 500 mg; 5 mg and 1000 mg; 12.5 mg and 500 mg, and 12.5 mg and 1000 mg given twice daily) provided statistically significant improvements in HbA1c (Table 4) and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Maltese: It-trattament b'empagliflozin mogħti flimkien ma' metformin (5 mg u 500 mg; 5 mg u 1000 mg; 12.5 mg u 500 mg, u 12.5 mg u 1000 mg mogħtija darbtejn kuljum) wassal għal titjib ta' rilevanza statistika fl-HbA1c (Tabella 4) u għal tnaqqis ikbar fl-FPG (mqabbla mal-komponenti individwali) u l-piż tal-ġisem (mqabbla ma' metformin).
English: 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.
Maltese: Studji ta' interazzjoni li saru fuq voluntieri b'saħħithom jissuġġerixxu li empagliflozin ma kellux effett klinikament rilevanti fuq il-farmakokinetika ta' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, dijuretiċi u kontraċettivi orali.
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Maltese: Studji ta' interazzjoni jissuġġerixxu li l-farmakokinetiċi ta' empagliflozin ma kinux influwenzati blgħoti konġunt ta' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide u hydrochlorothiazide.
English: Haematocrit increased a see subsections below for additional information b derived from postmarketing experience Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 4.9% and 5.7% versus 3.5%; HDL-cholesterol 3.3% and 3.6% versus 0.4%; LDL-cholesterol 9.5% and 10.0% versus 7.5%; triglycerides 9.2% and 9.9% versus 10.5%.
Maltese: Żidiet perċentwali medji mil-linja bażi għal empagliflozin 10 mg u 25 mg meta mqabbla ma' plaċebo, rispettivament, kienu l-kolesterol totali 4.9% u 5.7% meta mqabbla ma' 3.5%; HDLkolesterol 3.3% u 3.6% meta mqabbla ma' 0.4%; LDL-kolesterol 9.5% u 10.0% meta mqabbla ma' 7.5%; trigliċeridi 9.2% u 9.9% meta mqabbla ma' 10.
English: Insulin dose (IU/day) at week 52
Maltese: Doża tal-insulina (IU/jum) f'Ġimgħa 52
English: Jardiance tablets are available in PVC/aluminium perforated unit dose blisters.
Maltese: Il-pilloli Jardiance jiġu f'folji tal-PVC/aluminju perforati u f'doża waħda.
English: Pruritus (generalised)
Maltese: Ħakk (ġeneralizzat)
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo (7.0% and 7.2%) and higher in empagliflozin 10 mg (8.8%).
Maltese: Il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala avveniment avvers kienet simili f'pazjenti trattati b'empagliflozin 25 mg u plaċebo (7.0% u 7.2%) u ogħla f'pazjenti trattati b'empagliflozin 10 mg (.8.8%).
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Maltese: Kien innotat titjib fil-markaturi sostituti tal-funzjoni taċ-ċelluli beta li jinkludu l-Mudell Omeostatiku ta' Assessjar  (HOMA-βHomeostasis Model Assessment-B).
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Maltese: L-impediment ta t-trasportaturi OATPB1/1B3 bl-għoti konġunt ma' rifampicin irriżulta f'żieda ta' 75% fis-Cmax u żieda ta' 35% fl-AUC ta' empagliflozin.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Maltese: Il-plażma fl-istat fiss medju AUC u Cmax kienu ta' 1870 nmol/l u 259 nmol/l b'empagliflozin 10 mg u 4740 nmol.h u 687 nmol/l b'empagliflozin 25 mg li jingħata darba kuljum.
English: Treatment with empagliflozin resulted in a statistically significant (p<0.0001) reduction in HbA1c compared to placebo (Table 2) and a clinically meaningful decrease in FPG.
Maltese: It-trattament b'empagliflozin irriżulta fi tnaqqis statistikament sinifikanti (p<0.0001) f'HbA1c meta mqabbel ma' plaċebo (tabella 2) u tnaqqis klinikament validu fil-FBG.
English: In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9.
Maltese: Dejta in vitro tissuġerixxi li r-rotta prinċipali ta' metaboliżmu ta' empagliflozin fil-bniedem hi l-glukuronidazzjoni permezz ta' uridine 5'-diphosphoglucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, u UGT1A9.
English: Combination therapy
Maltese: Terapija ta' kombinazzjoni
English: Blood creatinine increased/Glomerular filtration rate decreased
Maltese: Żieda fil-krejatinina fid-demm/Tnaqqis fir-rata ta' filtrazzjoni glomerulari
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke) N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Maltese: Żmien sa l-ewwel avveniment ta' mewta CV, MI mhux fatali, jew puplesija mhux fatali) N (%) Proporzjon ta' periklu vs. plaċebo (95.02% CI) valur−p għal superjorità Mewta CV N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p MI mhux fatali N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p Puplesija mhux fatali N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p Mortalita b'kull kawża N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p Mortalita mhux CV N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) CV = kardjovaskulari, MI = infart mijokardijaku Sett trattat (TS), jiġifieri pazjenti li rċievew għallinqas doża waħda tal-mediċina tal-istudju Dożi miġburin ta' empagliflozin 10 mg u 25 mg Minħabba li d-data mill-prova ġiet inkluża f'analiżi interim, applika intervall ta' fiduċja ta' 95.
English: How to store Jardiance 6.
Maltese: Kif taħżen Jardiance 6.
English: Table 8: Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add-on to basal insulin with or without metformin or a sulphonylurea Placebo
Maltese: Tabella 8: Riżultati ta' effikaċja fit-18 u 78 ġimgħa fi studju kkontrollat bi plaċebo ta' empagliflozin bħala terapija aġġuntiva għal insulina bażali bi jew mingħajr metformin jew sulphonylurea Plaċebo
English: Treatment with empagliflozin as add-on to metformin or metformin and a sulphonylurea resulted in a clinically meaningful reduction of 2-hour post-prandial glucose (meal tolerance test) at 24 weeks (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).
Maltese: It-trattament b'empaglifloin bħala terapija addizzjonali għal metformin jew metformin u sulphonylurea rriżulta fi tnaqqis klinikament validu fil-livell ta' glukosju sagħtejn wara ikla (test ta' tolleranza ta' ikla) wara 24 ġimgħa (terapija addizzjonali għal metformin: plaċebo +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg mg/dl, terapija addizzjonali għal metformin u sulphonylurea: plaċebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Maltese: F'individwi b'indeboliment tal-kliewi ħafif, moderat u sever skont il-klassifikazzjoni ta' Child Pugh, lAUC ta' empagliflozin żdied b'madwar 23%, 47% u 75% u Cmax b'madwar 4%, 23% u 48%, rispettivament, meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: MMRM model included baseline SBP and baseline HbA1c as linear covariate(s), and baseline eGFR, geographical region, treatment, visit, and visit by treatment interaction as fixed effects.
Maltese: Il-mudell MMRM inkluda SBP tal-linja bażi u HbA1c tal-linja bażi bħala kovarjat(i) lineari, u eGFR tal-linja bażi, reġjun ġeografiku, trattament, żjara, u żjara skont l-interazzjoni tat-trattament bħala effetti fissi.
English: 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.
Maltese: OAT3 u OATP1B1/1B3, wera li Cmax ta' empagliflozin żded bi 15% u l-AUC żdied b'59% wara l-għoti konġunt.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra Infezzjonijiet talpassaġġ urinarju
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg (Figure 1) and confirmed by an improved overall survival (Table 10).
Maltese: It-tnaqqis ta' mwiet kardjovaskulari kien komparabbli għal empagliflozin 10 mg u 25 mg (Figura 1) u kkonfermat b'sopravivenza ġenerali mtejba (Tabella 10).
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Maltese: Empagliflozin kuljum irriżulta fi tnaqqis statistikament sinifikanti fil-piż talġisem, fil-pressjoni sistolika u dijastolika tad-demm u proporzjon statistikament sinifikanti aktar baxx f'pazjenti b'każijiet ipogliċemiċi meta mqabbla ma' glimepiride (2,5% għal empagliflozin, 24,2% għal glimepiride, p<0.0001).
English: Hypoglycaemia (when used with sulphonylurea or insulin)
Maltese: Ipogliċemija (meta ntuża ma' sulphonylurea jew mal-insulina)
English: Blood creatinine increased/Glomerular filtration rate decreased The overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo (blood creatinine increased: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, placebo 0.5%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.3%).
Maltese: Il-frekwenza globali ta' pazjenti b'żieda fil-krejatinina fid-demm u tnaqqis fir-rata ta' filtrazzjoni glomerulari kienet simili bejn empagliflozin u plaċebo (żieda fil-krejatinina fid-demm: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, plaċebo 0.5%; tnaqqis fir-rata ta' filtrazzjoni glomerulari: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, plaċebo 0.3%).
English: 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.
Maltese: Każijiet rari ta' ketoaċidosi dijabetika (DKA, diabetic ketoacidosis) inklużi każijiet ta' periklu għall-ħajja, ġew irrapportati fi provi kliniċi u wara t-tqegħid fis-suq f'pazjenti ttrattati b'inibituri ta' SGLT2, inkluż empagliflozin.
English: Body Weight (kg) at week 52 Baseline (mean) Change from baseline Difference from placebo (97.5% CI) Mean adjusted for baseline value Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value <0.0001 ** p-value = 0.0003 *** p-value = 0.0005 # p-value = 0.0040
Maltese: Piż tal-Ġisem (kg) f'Ġimgħa 52 Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI) Medja aġġustata għall-valur ta' linja bażi Ġimgħa 19-40: programm ta' trattament biex jiġu stabbiliti miri għall-aġġustament tad-doża ta' insulina sabiex jintlaħqu livelli definiti minn qabel ta' livelli ta' glukosju fil-mira (qabel ikla <100 mg/dl (5.5 mmol/l), wara l-ikla <140 mg/dl (7.8 mmol/l) * valur p <0.0001 ** valur p = 0.0003 *** valur p =0.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 8).
Maltese: F'ġimgħa 18, empagliflozin ġab titjib statistikament sinifikanti f'HbA1c (Tabella 8).
English: Treatment with empagliflozin led to a statistically significant reduction of HbA1c (Table 9) and clinically meaningful improvement in FPG compared to placebo at Week 24.
Maltese: It-trattament b'empagliflozin wassal għal tnaqqis statistikament sinifikanti ta' HbA1c (Tabella 9) u titjib klinikament validu fil-FBG meta mqabbel ma' plaċebo f'Ġimgħa 24.
English: In 6 placebo-controlled trials of 18 to 24 weeks duration, 3,534 patients were included of which 1,183 were treated with placebo and 2,351 with empagliflozin.
Maltese: F'6 provi li damu sejrin għal bejn 18-il ġimgħa sa 24 ġimgħat bil-plaċebo bħala kontroll, 3,534 pazjent kienu inklużi li minnhom 1,183 kienu trattati bi plaċebo u 2,351 b'empagliflozin.
English: Renal impairment In patients with mild, moderate or severe renal impairment (eGFR <30 - <90 ml/min/1.73 m2) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Maltese: Indeboliment tal-kliewi F'pazjenti b'indeboliment tal-kliewi ħafif, moderat jew sever (eGFR <30 - <90 ml/min/1.73 m2) u pazjenti b'falliment tal-kliewi/mard tal-kliewi tal-aħħar stadju (ESRD - End Stage Renal Disease), lAUC ta' empagliflozin żdied b'madwar 18%, 20%, 66% u 48%, rispettivament meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with empagliflozin (empagliflozin 10 mg: 4.0%, empagliflozin 25 mg: 3.9%) compared to placebo (1.0%).
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra Monolijasi vaġinali, vulvovaġinite, balanite u infezzjonijiet ġenitali oħra kienu rapportati bi frekwenza akbar f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 4.0%, empagliflozin 25 mg 3.9%) meta mqabbel ma' plaċebo (1.0%).
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets Empagliflozin
Maltese: Jardiance 25 mg pilloli Empagliflozin
English: Glycaemic efficacy and cardiovascular outcomes have been assessed in a total of 14,663 patients with type 2 diabetes who were treated in 12 double-blind, placebo- and active-controlled clinical studies, of which 9,295 received empagliflozin (empagliflozin 10 mg: 4,165 patients; empagliflozin 25 mg: 5,130 patients).
Maltese: L-effikaċja gliċemika u r-riżultati kardjovaskulari ġew evalwati f'total ta' 14,663 pazjent b'dijabete ta' tip 2 li kienu trattati fi 12-il studju kliniku double-blind, ikkontrollati bi plaċebo u b'mod attiv, li minnhom 9,295 ħadu empagliflozin (empagliflozin 10 mg: 4,165 pazjent; empagliflozin 25 mg: 5,130 pazjent).
English: In a pool of placebo-controlled double-blind trials of 18 to 24 weeks duration, the overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg (see section 4.8).
Maltese: F'ġabra ta' provi double-blind ikkontrollati bi plaċebo ta' 18 sa 24 ġimgħa, il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala każ avvers kienet simili f'pazjenti trattati b'empagliflozin 25 mg u plaċebo u ogħla f'pazjenti trattati b'empagliflozin 10 mg (ara sezzjoni 4.8).
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy Placebo
Maltese: Tabella 3: Riżultati ta' effikaċja fi studju ta' 24 ġimgħa kkontrollat bi plaċebo Terapija aġġuntiva għal metformin Plaċebo
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (<1/10,000), mhux magħrufa (ma tistax tittieħed stima middata disponibbli).
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Maltese: Għalhekk is-CHMP jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fissuq għal Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance u Synjardy.
English: Complicated urinary tract infections (including serious urinary tract infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Maltese: Infezzjonijiet ikkumplikati tal-passaġġ urinarju (inkluż infezzjonijiet serji tal-passaġġ urinarju, pijelonefrite jew urosepsis) ġiet osservata bi frekwenza simili f'pazjenti trattati b'empagliflozin meta mqabbla ma' plaċebo.
English: A total of 7020 patients were treated (empagliflozin 10 mg: 2345, empagliflozin 25 mg: 2342, placebo: 2333) and followed for a median of 3.1 years.
Maltese: B'kollox ġew ittrattati 7,020 pazjent (empagliflozin 10 mg: 2,345, empagliflozin 25 mg: 2,342, plaċebo: 2,333) u ġew segwiti għal medjan ta' 3.1 snin.
English: Jardiance contains the active substance empagliflozin which works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: Jardiance fih is-sustanza attiva empagliflozin li taħdem billi timblokka proteina fil-kliewi li tissejjaħ kotrasportatur 2 tas-sodju-glukożju (SGLT2).
English: Treatment with empagliflozin as monotherapy and in combination with metformin, pioglitazone, a sulphonylurea, DPP-4 inhibitors, and insulin lead to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure.
Maltese: It-trattament ta' empagliflozin bħala monoterapija u f'limkien ma' metformin. pioglitazone, sulphonylurea, impedituri DPP-4, u insulina wasslu għal titjib klinikament rilevanti fl-HbA1c, ilglukosju fil-plażma waqt sawm (FPG -Fasting Plasma Glucose), il-piż tal-ġisem u l-pressjoni taddemm sistolika u dijastolika.
English: Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components Empagliflozin 10 mg
Maltese: Tabella 4: Ir-riżultati tal-effikaċja f'ġimgħa 24 li jqabblu empagliflozin mogħti flimkien ma' metformin mal-komponenti individwali Empagliflozin 10 mg
English: A total of 15,582 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin, of which 10,004 patients received empagliflozin, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.
Maltese: Total ta' 15,582 pazjent b'dijabete ta' tip 2 kienu inklużi fl-istudji kliniċi sabiex tiġi evalwata s-sigurtà ta' empagliflozin li minnhom, 10,004 pazjenti rċevew, empagliflozin waħdu jew flimkien ma' metformin, sulphonylurea, pioglitazone, impedituri ta' DPP-4, jew insulina.
English: HbA1c (%) Baseline (mean) Change from baseline Comparison vs. empa (95% CI)
Maltese: HbA1c (%) Tal-linja bażi (medja) Bidla millinja bażi Tqabbil kontra empa (95% CI)
English: Mean changes from baseline in haematocrit were 3.4% and 3.6% for empagliflozin 10 mg and 25 mg, respectively, compared to 0.1% for placebo.
Maltese: Bidliet medji mil-linja bażi fl-ematokrit kienu 3.4% u 3.6% għal empagliflozin 10 mg u 25 mg, rispettivament, meta mqabbla ma' 0.1% għal plaċebo.
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m
Maltese: 4% u 17.3% inqas f'individwi b'BMI ta' 30, 35 u 45 kg/m2, rispettivament, meta mqabbla ma' individwi b'indiċi tal-piz tal-ġisem ta' 25 kg/m
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI) Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 95% CI LOCF, values after antihypertensive rescue censored *p-value <0.0001
Maltese: SBP (mmHg) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI) Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet imexxija 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: 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.
Maltese: F'analiżi speċifikata minn qabel fejn inġabru r-riżultati ta' 4 studji bi plaċebo bħala kontroll, ittrattament b'empagliflozin irriżulta fi tnaqqis fil-pressjoni sistolika tad-demm (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) meta mqabbel ma' plaċebo (-0.5 mmHg) u filpressjoni dijastolika tad-demm (empagloflozin 10 mg: -1.8 mmHg; empagliflozin 25 mmHg: -2.0 mmHg) meta mqabbel ma' plaċebo (-0.5 mmHg) f'ġimgħa 24 li kienu matenuti sa ġimgħa 52.
English: In four placebo-controlled studies, treatment with empagliflozin as monotherapy or add-on therapy to metformin, pioglitazone, or metformin plus a sulfonylurea resulted in mean changes from baseline in 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]).
Maltese: F'erba' studji bil-plaċebo bħala kontroll, it-trattament b'empagliflozin bħala monoterapija jew terapija addizzjonali għal ma' metformin, pioglitazone, jew metformin flimkien ma' sulfonylurea irriżulta f'bidliet medji mil-linja bażi fl-FPG ta' -20.5 mg/dl [-1.14 mmol/L] għal empagliflozin 10 mg u23.2 mg/dl [-1.29 mmol/L] għal empagliflozin 25 mg meta mqabbla mal-plaċebo (7.4 mg/dl [0.