FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4 Efficacy parameters in clinical studies comparing Glyxambi 10 mg/5 mg to empagliflozin 10 mg as well as Glyxambi 25 mg/5 mg to empagliflozin 25 mg as add-on therapy in patients inadequately controlled on empagliflozin 10 mg/25 mg and metformin
Maltese: Tabella 4 Il-parametri tal-effikaċja fi studji kliniċi li qabblu Glyxambi 10 mg / 5 mg ma' empagliflozin 10 mg kif ukoll Glyxambi 25 mg / 5 mg ma' empagliflozin 25 mg bħala terapija aġġuntiva f'pazjenti li ma għandhomx kontroll adegwat fuq empagliflozin 10 mg/25 mg u metformin.
English: INFORMATION IN BRAILLE Glyxambi 25 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glyxambi 25 mg/5 mg
English: Number of patients analysed
Maltese: Għadd ta' pazjenti analizzati
English: In clinical trials, nineteen patients 75 years or older were treated with Glyxambi.
Maltese: Fi provi kliniċi, dsatax-il pazjent li għandhom 75 sena u iktar kienu ttratati b'Glyxambi.
English: Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Mixed-effects models for repeated measurements (MMRM) on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit treatment,and treatment by visit interaction.
Maltese: Il-mudelli ta' effetti mħallta għal kejl ripetut (MMRM, mixed-effects models for repeated measurements) fuq FAS (OC) jinkludu HbA1c.tal-linja bażi, eGFR (MDRD) tal-linja bażi, ir-reġjun ġeografiku, it-trattament fiż-żjara, u l-interazzjoni tat-trattament fiż-żjara.
English: The most frequent adverse reaction was urinary tract infection (7.5 % with Glyxambi 10 mg empagliflozin / 5 mg linagliptin and 8.5 % with Glyxambi 25 mg empagliflozin / 5 mg linagliptin) (see Description of selected adverse reactions).
Maltese: Ir-reazzjoni avversa l-aktar frekwenti kienet infezzjoni tal-passaġġ urinarju) (7.5% b'Glyxambi 10 mg empagliflozin / 5 mg linagliptin u 8.5% b'Glyxambi 25 mg empagliflozin / 5 mg linagliptin) (ara Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: In empagliflozin trials, the overall frequency of urinary tract infection was similar in patients treated with empagliflozin 25 mg and placebo (7.0 % and 7.2 %), and higher in patients treated with empagliflozin 10 mg (8.8 %).
Maltese: Fil-provi b'empagliflozin, il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata kienet simili f'pazjenti ttrattati b'empagliflozin 25 mg u plaċebo (7.0 % u 7.2 %) u ogħla f'pazjenti ttrattati b'empagliflozin 10 mg (8.8 %).
English: A minor fraction is metabolised via uridine 5'diphosphoglucuronosyltransferases (UGT); therefore, a clinically relevant effect of UGT inhibitors on empagliflozin is not expected (see section 5.2).
Maltese: Frazzjoni żgħira hija metabolizzata permezz ta' uridine 5'-diphosphoglucuronosyltransferases (UGT); għalhekk, mhu mistenni l-ebda effett klinikament sinifikanti ta' impedituri ta' UGT fuq empagliflozin (ara sezzjoni 5.2).
English: Linagliptin cardiovascular safety (CAROLINA) study
Maltese: Studju b'linagliptin dwar is-sigurtà kardjovaskulari (CAROLINA)
English: In a factorial design study patients inadequately controlled on metformin were treated for 24-weeks with Glyxambi 10 mg/5 mg, Glyxambi 25 mg/5 mg, empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg.
Maltese: Fi studju b'disinn fattoriku, pazjenti li ma għandhomx kontroll adegwat fuq metformin kienu ttrattati għal 24 ġimgħa b'Glyxambi 10 mg/5 mg, Glyxambi 25 mg/5 mg, empagliflozin 10 mg, empagliflozin 25 mg jew linagliptin 5 mg.
English: One patient administered Glyxambi experienced a confirmed (investigator-defined), major hypoglycaemic event (defined as an event requiring assistance) in the active- or placebo-controlled trials (overall frequency 0,1 %).
Maltese: Pazjent wieħed mogħti Glyxambi kellu avveniment ipogliċemiku kbir (definit bħala avveniment li jeħtieġ għajnuna) ikkonfermat (definit minn investigatur) fil-provi attivi jew ikkontrollati bi plaċebo (frekwenza ġenerali 0,1%).
English: In patients with mild, moderate or severe renal impairment (eGFR <30 to <90 mL/min/1.73 m2) and patients with kidney failure or 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: F'pazjenti b'indeboliment tal-kliewi ħafif, moderat jew sever (eGFR < 30 sa < 90 mL/min/1.73 m2) u pazjenti b'falliment tal-kliewi jew mard tal-kliewi tal-aħħar stadju (ESRD), l-AUC ta' empagliflozin żdiedet b'madwar 18%, 20%, 66% u 48%, rispettivament meta mqabbla ma' individwi b'funzjoni tal-kliewi normali.
English: Hypersensitivity to the active substances, to any other Sodium-Glucose-Co-Transporter-2 (SGLT2) inhibitor, to any other Dipeptidyl-Peptidase-4 (DPP-4) inhibitor, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi, jew għal kwalunkwe impeditur ieħor ta' Kotrasportatur-2 ta' Sodium-Glucose (SGLT2), jew għal kwalunkwe impeditur ta' Dipeptidyl-Peptidase-4 (DPP-4), jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: The intensity of urinary tract infections was similar to placebo for mild, moderate and severe intensity reports.
Maltese: L-intensità tal-infezzjonijiet tal-passaġġ urinarju kienet simili għal plaċebo għal rapporti ta' intensità ħafifa, moderata u severa.
English: Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Maltese: Kull pillola fiha 10 mg empagliflozin u 5 mg linagliptin.
English: Hypoglycaemia (when used with sulphonylurea or insulin) Thirst
Maltese: Ipogliċemija (meta ntuża ma' sulfonylurea jew mal-insulina)
English: Table 2 Efficacy parameters in clinical study comparing Glyxambi to individual active substances as add-on therapy in patients inadequately controlled on metformin
Maltese: Tabella 2 Il-parametri tal-effikaċja fi studju kliniku li qabbel Glyxambi mas-sustanzi attivi individwali bħala terapija aġġuntiva f'pazjenti li ma għandhomx kontroll adegwat fuq metformin.
English: The frequency of patients with major hypoglycaemic events was increased in patients treated with empagliflozin compared to placebo when given as add-on to basal insulin +/- metformin and +/sulphonylurea (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo: 0 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo 0 % over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, placebo: 1.6 % during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
Maltese: Il-frekwenza ta' pazjenti b'avvenimenti ipogliċemiċi maġġuri żdiedet f'pazjenti ttratati b'empagliflozin mqabbla ma' plaċebo meta mogħti bħala terapija aġġuntiva ma' insulina bażali +/metformin u +/- sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, plaċebo: 0% waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, plaċebo 0% fuq prova ta' 78 ġimgħa), u terapija aġġuntiva għal insulina MDI flimkien ma' jew mingħajr metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, plaċebo:
English: Patients ( %) achieving HbA1c <7 % 25.9 Comparison vs. placebo (odds ratio) (95 % CI)
Maltese: Pazjenti (%) li jiksbu HbA1c < 7% Mqabbel ma' plaċebo (proporzjon tal-probabilita) (95% CI)
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 mL/min), moderate (30 to <50 mL/min), and severe (<30 mL/min), as well as patients with ESRD on haemodialysis.
Maltese: L-istudju kien jinkludi pazjenti b'insuffiċjenza tal-kliewi kklassifikati fuq il-bażi tar-rata ta' tneħħija ta' kreatinina bħala ħafifa (50 sa < 80 mL/min), moderata (30 sa < 50 mL/min), u severa (< 30 mL/min), kif ukoll pazjenti b'ESRD fuq l-emodijalisi.
English: In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 % the reduction from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg was -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg) and with empagliflozin 10 mg/ linagliptin 5 mg -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg).
Maltese: Fis-sottogrupp ta' pazjenti speċifikat minn qabel li għandhom HbA1c tal-linja bażi ikbar jew ugwali għal 8.5%, it-tnaqqis mil-linja bażi fl-HbA1c b'empagliflozin 25 mg/linagliptin 5 mg kien -1.3% f'ġimgħa 24 (p< 0.0001 kontra plaċebo u linagliptin 5 mg) u b'empagliflozin 10 mg/ linagliptin 5 mg -1.3% f'ġimgħa 24 (p< 0.0001 kontra plaċebo u linagliptin 5 mg).
English: Initiation of therapy with Glyxambi in this population is not recommended (see section 4.2).
Maltese: Mhux irrakkomandat li tinbeda terapija b'Glyxambi f'din il-popolazzjoni (ara sezzjoni 4.2).
English: A multiple-dose, open-label study was conducted to evaluate the pharmacokinetics of linagliptin (5 mg dose) in patients with varying degrees of chronic renal insufficiency compared to subjects with normal renal function.
Maltese: Studju dwar dożi multipli, open label, sar biex jevalwa l-farmakokinetika ta' linagliptin (doża ta' 5 mg) f'pazjenti bi gradi varji ta' insuffiċjenza kronika tal-kliewi meta mqabbla ma' persuni b'saħħithom b'funzjoni tal-kliewi normalil.
English: How to store Glyxambi
Maltese: Kif taħżen Glyxambi
English: A statistically significant greater number of patients with a baseline HbA1c ≥7.0 % and treated with linagliptin achieved a target HbA1c of <7 % compared to placebo (see Table 4).
Maltese: Numru ikbar statistikament sinifikanti ta' pazjenti b'HbA1c tal-linja bażi ≥ 7.0% u ttrattati b'linagliptin kisbu HbA1c fil-mira ta' < 7% mqabbla mal-plaċebo (ara Tabella 4).
English: - 95.0 % CI - p-value vs. 25 mg vs. 10 mg
Maltese: Mqabbel ma' empagliflozin medja aġġustata2 (SE) 95.0% CI valur p kontra 25 mg kontra 10 mg
English: • increased blood enzyme amylase
Maltese: Żieda fl-amylase
English: 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: CV = kardjovaskulari, MI = infart mijokardijaku Sett trattat (TS - Treated set), jiġifieri pazjenti li rċevew 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: Seen commonly
Maltese: Mhux komuni
English: Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Maltese: Kull pillola fiha 25 mg empagliflozin u 5 mg linagliptin.
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Maltese: Il-maġġoranza tat-tossiċita kienet marbuta ma' farmakoloġija sekondarja relatata ma' telf ta' glukożju urinarju u żbilanċi fl-elettroliti li jinkludu tnaqqis fil-piż tal-ġisem u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidrazzjoni, tnaqqis ta' glukożju fis-serum u żidiet f'parametri oħra fis-serum li jirriflettu żieda fil-metaboliżmu ta' proteini u glukoneoġenesi, bidliet urinarji bħal polijurja u glukosurja, u bidliet mikroskopiċi li jinkludu mineralizzazzjoni fil-kliewi u xi tessuti rotob u vaskulari.
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Maltese: Data dwar is-sigurtà minn dan l-istudju kienet konformi mal-profil tas-sigurtà preċedenti magħruf ta' linagliptin.
English: Glyxambi added to metformin
Maltese: Glyxambi bħal terapija aġġuntiva mal-metformin
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD19
Maltese: Mediċini użati fid-dijabete, kombinazzjonijiet ta' mediċini orali li jbaxxu l-glukożju fid-demm, Kodiċi ATC:
English: No patient was older than 85 years.
Maltese: L-ebda pazjent ma kellu iktar minn 85 sena.
English: After 24 weeks, rescue therapy was used in 4 (3.6 %) patients treated with empagliflozin 25 mg and in 2 (1.8 %) patients treated with empagliflozin 10 mg, compared to 13 (12.0 %) patients treated with placebo (all patients on background metformin + linagliptin 5 mg).
Maltese: Wara 24 ġimgħa, ntużat terapija ta' salvataġġ f'4 (3.6%) pazjenti ttrattati b'empagliflozin 25 mg u f'2 (1.8%) pazjenti ttrattati b'empagliflozin 10 mg, mqabbla ma' 13-il (12.0%) pazjent ttrattati bi plaċebo (il-pazjenti kollha kienu fuq trattament fl-isfond ta' metformin + linagliptin 5 mg).
English: Glyxambi combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: empagliflozin, a sodium-glucose co-transporter (SGLT2) inhibitor, and linagliptin, DPP-4 inhibitor.
Maltese: Glyxambi jikkombina żewġ prodotti mediċinali kontra l-ipergliċemija b'mekkaniżmi t'azzjoni kumplimentari biex itejjeb il-kontroll gliċemiku f'pazjenti li għandhom dijabete ta' tip 2: empagliflozin, impeditur tal-kotrasportatur-2 ta' Sodium-Glucose (SGLT2), u linagliptin, impeditur ta' DPP-4.
English: The frequencies have been comparable to those reported from the empagliflozin clinical trials (see also section 4.4).
Maltese: Il-frekwenzi kienu komparabbli ma' dawk irrapportati mill-provi kliniċi b'empagliflozin (ara wkoll sezzjoni 4.4).
English: The double-blind, placebo-controlled CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo as adjunct to standard care therapy in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease.
Maltese: L-istudju double-blind, ikkontrollat bil-plaċebo CARMELINA evalwa s-sigurtà kardjovaskulari u renali ta' linagliptin kontra l-plaċebo bħala żieda ma' terapija ta' kura standard f'pazjenti bid-dijabete tat-tip 2 u b'riskju CV miżjud muri permezz ta' storja ta' mard makrovaskulari jew renali stabbilit.
English: • if you have serious kidney problems.
Maltese: • jekk għandek problemi serji bil-kliewi.
English: - 95.0 % CI - p-value Last observation (prior to glycaemic rescue ) carried forward (LOCF) Mean adjusted for baseline value and stratification
Maltese: L-aħħar osservazzjoni li ġiet imexxija 'l quddiem (LOCF, last observation carried forward) (qabel l-għoti ta' terapija għal salvataġġ gliċemiku)
English: In clinical trials with empagliflozin, 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: 0.6 %, empagliflozin 25 mg: 0.4 %) and placebo (0.3 %).
Maltese: Fi provi kliniċi b'empagliflozin, il-frekwenza globali ta' żvojtjar tal-volum (li jinkludi termini mfissra minn qabel ta' pressjoni tad-demm (ambulatorja) mnaqqsa, pressjoni tad-demm sistolika mnaqqsa, deidrazzjoni, pressjoni baxxa, ipovolemja, pressjoni baxxa meta tqum minn pożizzjoni ta' serħan u sinkope) kienet simili f'pazjenti ttrattati b'empagliflozin (empagliflozin 10 mg: 0.6 %, empagliflozin 25 mg: 0.4 %) u plaċebo (0.3%).
English: In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 %, the reduction from baseline in HbA1c at 24 weeks with Glyxambi 25 mg/5 mg was -1.8 % (p<0.0001 versus linagliptin 5 mg, p<0.001 versus empagliflozin 25 mg) and with Glyxambi 10 mg/ 5 mg -1.6 % (p<0.01 versus linagliptin 5 mg, n.s. versus empagliflozin 10 mg).
Maltese: Fis-sottogrupp ta' pazjenti speċifikat minn qabel li għandhom HbA1c tal-linja bażi ikbar jew ugwali għal 8.5%, it-tnaqqis mil-linja bażi fl-HbA1c b'Glyxambi 25 mg/5 mg kien -1.8% f'ġimgħa 24 (p< 0.0001 kontra linagliptin 5 mg, p< 0.001 kontra empagliflozin 25 mg) u b'Glyxambi 10 mg/
English: • if you develop symptoms of acute pancreatitis, like persistent, severe abdominal pain.
Maltese: • jekk tiżviluppa sintomi ta' pankreatite akuta, bħal uġigħ ta' żaqq sever u persistenti.
English: 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.
Maltese: Inċidenza ogħla ta' tumuri fiċ-ċelluli interstizjali fit-testikoli kienet osservata fil-firien f'doża ta' 300 mg/kg/jum u iżjed, iżda mhux f'doża ta' 100 mg/kg/jum li tikkorrispondi għal madwar 18-il darba l-esponiment kliniku massimu ta' empagliflozin.
English: Rare cases of DKA, including life-threatening cases, have been reported in clinical trials and postmarketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi 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'impedituri ta' SGLT2, inkluż empagliflozin.
English: Therefore the effect was attenuated at week 94, with an adjusted mean (SE) improvement in HbA1c of 0.08 % (0.02) in the placebo group, 0.50 % (0.02) and 0.55 % (0.02) in the empagliflozin 10 and 25 mg groups.
Maltese: Għalhekk, l-effett naqas f'Ġimgħa 94, b'titjib fil-medja aġġustata (SE) fl-HbA1c ta' 0.08 % (0.02) fil-grupp tal-plaċebo, u 0.50 % (0.02) u 0.55 % (0.02) fil-gruppi ta' empagliflozin 10 u 25 mg.
English: The most frequently reported adverse event in clinical trials with linagliptin was hypoglycaemia observed under the triple combination, linagliptin plus metformin plus sulphonylurea (22.9 % vs 14.8 % in placebo).
Maltese: L-iktar każ avvers irrappurtat b'mod frekwenti fi provi kliniċi b'linagliptin kienet ipogliċemija osservata bil-kombinazzjoni tripla, linagliptin flimkien ma' metformin flimkien ma' sulfonylurea 1(22.9% kontra 14.
English: Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin (see sections 4.4 and 5.1).
Maltese: Minħabba l-mekkaniżmu ta' azzjoni, tnaqqis fil-funzjoni tal-kliewi jirriżulta fi tnaqqis fl-effikaċja gliċemika ta' empagliflozin (ara sezzjonijiet 4.4 u 5.1).
English: Body mass index
Maltese: Sistema tal-klassifika tal-organi
English: Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Maltese: Glyxambi 25 mg/5 mg pilloli miksija b'rita (pilloli) huma roża ċari, ark trijangolari, b'wiċċ ċatt u bit-truf imċanfrin.
English: Comparison vs. placebo (adjusted mean) (95 % CI)
Maltese: Mqabbel ma' plaċebo (medja aġġustata) (95% CI)
English: Table 3 Efficacy parameters in the clinical study comparing empagliflozin to placebo as add-on therapy in patients inadequately controlled on metformin and linagliptin 5 mg
Maltese: Tabella 3 Il-parametri tal-effikaċja fi studju kliniku li qabbel empagliflozin ma' plaċebo bħala terapija aġġuntiva f'pazjenti li ma għandhomx kontroll adegwat fuq metformin u linagliptin 5 mg.
English: Hazard ratio vs. placebo (95% CI) p-value
Maltese: Proporzjon ta' periklu vs. plaċebo (CI ta' 95%) valur−p
English: Empagliflozin in patients inadequately controlled on metformin and linagliptin
Maltese: Empagliflozin f'pazjenti mingħajr kontroll adegwat fuq metformin u linagliptin
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99 % at 1 nmol/L to 75-89 % at ≥30 nmol/L, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Maltese: It-twaħħil mal-proteini fil-plażma ta' linagliptin jiddependi mill-konċentrazzjoni, u jonqos minn madwar 99% f'1 nmol/L għal 75-89% f'≥ 30 nmol/L, li jirrifletti saturazzjoni tat-twaħħil ma' DPP-4 maż-żieda fil-konċentrazzjoni ta' linagliptin.
English: In clinical trials with Glyxambi, there was no notable difference of the frequency of urinary tract infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 8.5 %; Glyxambi 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin.
Maltese: Fi provi kliniċi b'Glyxambi, ma kien hemm l-ebda differenza notevoli fil-frekwenza ta' infezzjonijiet tal-passaġġ urinarju f'pazjenti ttrattati b'Glyxambi (Glyxambi 25 mg/5 mg: 8.5%; Glyxambi 10 mg/5 mg: 7.5%) mqabbla ma' pazjenti ttrattati b'empagliflozin u linagliptin.
English: • skin rash
Maltese: • għatx
English: Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita Glyxambi 25 mg/5 mg pilloli miksija b'rita empagliflozin/linagliptin
English: Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value
Maltese: Puplesija mhux fatali N (%) Proporzjon ta' periklu vs. plaċebo (CI ta' 95%) valur−p
English: Co-administration with other potent inducers of P-gp and CYP3A4, such as carbamazepine, phenobarbital and phenytoin, has not been studied.
Maltese: L-għoti flimkien ma' indutturi qawwija oħrajn ta' P-gp u CYP3A4, bħal carbamazepine, phenobarbital u phenytoin, ma ġiex studjat.
English: Patients randomized to the linagliptin 5 mg group were receiving either fixed dose combination tablets Glyxambi 10 mg/5 mg plus metformin or fixed dose combination tablets Glyxambi 25 mg/5 mg plus metformin; patients randomized to the placebo group were receiving placebo plus empagliflozin 10 mg plus metformin or placebo plus empagliflozin 25 mg plus metformin MMRM model on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Maltese: Pazjenti magħżula b'mod każwali għall-grupp ta' linagliptin 5 mg kienu qed jirċievu jew pilloli kombinati b'doża fissa ta' Glyxambi 10 mg/5 mg u metformin jew pilloli kombinati b'doża fissa ta' Glyxambi 25 mg/5 mg u metformin; pazjenti magħżula b'mod każwali għall-grupp tal-plaċebo kienu qed jirċievu plaċebo u empagliflozin 10 mg u metformin jew plaċebo u empagliflozin 25 mg u metformin
English: A statistically significant greater number of patients with a baseline HbA1c ≥7.0 % treated with both doses of empagliflozin achieved a target HbA1c of <7 % compared to placebo (see Table 3).
Maltese: Numru ikbar statistikament sinifikanti ta' pazjenti b'HbA1c tal-linja bażi ≥ 7.0% ttrattati biż-żewġ dożi ta' empagliflozin kisbu HbA1c fil-mira ta' < 7% mqabbla mal-plaċebo (ara Tabella 3).
English: Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints Logistic regression on FAS (NCF) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, and treatment; based on patients with HbA1c of 7 % and above at baseline
Maltese: Ir-rigressjoni loġistika fuq FAS (NCF) tinkludi HbA1c tal-linja bażi, eGFR (MDRD) tal-linja bażi, ir-reġjun ġeografiku u t-trattament; ibbażat fuq pazjenti b'HbA1c ta' 7% u iktar fil-linja bażi
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Maltese: GLP-1 u GIP iżidu l-bijosintesi tal-insulina u t-tnixxija miċ-ċelluli beta pankreatiċi fil-preżenza ta' livelli normali u għolja ta' glukożju fid-demm.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg and confirmed by an improved overall survival (see Table 5).
Maltese: It-tnaqqis ta' mwiet kardjovaskulari kien komparabbli għal empagliflozin 10 mg u 25 mg u kkonfermat b'sopravivenza ġenerali mtejba (ara Tabella 5).