qanastek/EMEA-V3 huggingface dataset:
The studies measured the level in the blood of a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood glucose is controlled.
F' kura trippla, l- effikaċja ta 'Actos ġiet studjata f' aktar minn 1, 400 pazjent li kienu qegħdin jirċievu kombinazzjoni ta' metformin u sulphonylurea, ma 'liema ġie miżjud jew Actos jew plaċebo għal mhux aktar minn 3 snin u nofs L- istudji kejlu l- livell fid- demm ta' sustanza (glycosylated haemoglobin, HbA1c), li tagħti indikazzjoni ta ’ kemm il- glucosju fid- demm huwa kkontrollat.
What benefit has Actos shown during the studies?
X’ benefiċċju wera Actos matul l- istudji?
Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15 mg, 30 mg and 45 mg.
Actos wassal għal tnaqqis fil- livell ta ’ HbA1c, u dan jindika li l- livelli tal- glucosju fid- demm tnaqqsu f’ dożi ta ’ 15 mg, 30 mg u 45 mg.
Doses below 15 mg were not effective, and doses above 45 mg (once daily) did not show additional benefit.
Dożi taħt il- 15 mg ma kienux effettivi, u dożi ogħla minn 45 mg (darba kuljum) ma wrew ebda benefiċċju addizzjonali.
Actos on its own was shown to be as effective as metformin and gliclazide.
Actos waħdu intwera li huwa effettiv daqs metformin u gliclazide.
In combination, Actos showed that it improves the control obtained in type 2 diabetes when added to existing treatment.
F’ kombinazzjoni, Actos wera li jtejjeb il- kontroll miksub f’ dijabete ta ’ tip 2 meta miżjud mat- trattament eżistenti.
At the end of the triple therapy study, the effect of adding Actos to the existing treatment with metformin and a sulphonylurea was a 0.94% reduction in HbA1c levels, while adding placebo led to a 0.35% reduction.
Fi tmiem ta 'l- istudju ta' kura trippla, l- effett ta ’ Actos mal- kura eżistenti b' metformin u sulphonylurea kien tnaqqis ta '0. 94% fil- livelli ta' HbA1c, filwaqt li ż- żieda ta 'plaċebo wasslet għal tnaqqis ta' 0. 35%.
In a small study examining the combination of Actos and insulin in 289 patients, patients adding Actos to insulin had a 0.69% reduction in HbA1c levels after 6 months, compared to 0.14% in those adding placebo.
Fi studju żgħir li jeżamina l- kombinazzjoni ta 'Actos u insulina f' 289 pazjent, il- pazjenti li żiedu Actos ma' l- insulina kellhom tnaqqis ta '0. 69% fil- livelli ta' HbA1c wara 6 xhur, meta mqabbla ma '0. 14% f' dawk li jżidu plaċebo.
What is the risk associated with Actos?
X’ inhu r- riskju assoċjat ma ’ Actos?
The most common side effects with Actos are visual disturbance, upper respiratory tract infection (colds), weight increase, and hypoaesthesia (decreased sensitivity to a stimulus).
L- aktar effetti sekondarji komuni Actos huma disturbi fil- vista, infezzjoni fil- parti ta ’ fuq ta ’ l- apparat respiratorju (irjiħat), żjieda fil- piż, u hypoaesthesia (tnaqqis fis- sensittività għal stimulu).
For the full list of all side effects reported with Actos, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b' Actos, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
Actos should not be used in people who may be hypersensitive (allergic) to pioglitazone or any of the other ingredients, or in patients with liver problems, heart failure or diabetic ketoacidosis (high levels of ketones [acids] in the blood).
Actos ma għandux jintuża fuq persuni li jista 'jkollhom sensittività eċċessiva (allerġiċi) għal pioglitazone jew għal xi sustanza oħra, jew f’ pazjenti bi problemi fil- fwied, problemi fil- qalb jew b' ketoaċidożi dijabetika (livelli għoljin ta' ketoni [aċidi] fid- demm).
Why has Actos been approved?
Għaliex ġie approvat Actos?
The Committee for Medicinal products for Human Use (CHMP) decided that Actos’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Actos jisbqu r- riskji tiegħu għall- kura ta 'dijabete tat- tip 2.
The committee recommended that Actos be given marketing authorisation.
Il- kumitat jirrikmanda li Actos jingħata awtorizzazzjoni għat- tqegħid fis- suq.
In monotherapy (used on its own), the committee decided that Actos should be an alternative to the standard treatment, metformin, to be used when patients cannot take metformin.
F’ monoterapija (użat waħdu), il- kumitat iddeċieda li Actos għandu jkun alternattiva għat- trattament standard, metformin, li għandu jintuża meta pazjenti ma jkunux jistgħu jieħdu metformin.
Other information about Actos:
Tagħrif ieħor dwar Actos:
The European Commission granted a marketing authorisation valid throughout the European Union, for Actos to Takeda Europe R & D Centre Limited on 13 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Actos lil Takeda Europe R & D Centre Limited nhar it- 13 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 13 October 2005.
L - awtorizzazzjoni ġiet imġedda fit- 13 ta ’ Ottubru 2005.
The full EPAR for Actos is available here
EPAR sħiħ għal Actos huwa disponibbli minn hawnhekk. http: // www. emea. eu. int/ humandocs/ Humans/ EPAR/ actos/ actos. htm Dan is- sommarju ġie aġġornat l- aħħar fi 01- 2007.
Actos 15 mg tablets.
Pilloli Actos 15 mg.
Each tablet contains 15 mg of pioglitazone as hydrochloride.
Kull pillola fiha 15 mg ta ’ pioglitazone bħala hydrochloride.
For a full list of excipients, see 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Tablet.
Pillola.
The tablets are white to off-white, round, convex and marked ‘ 15’ on one face and ‘ ACTOS’ on the other face.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, bbużżati miż- żewġ naħat u mmarkati b ’ ‘ 15 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
Pioglitazone huwa ndikat fil- kura ta ’ dijabete mellitus tat- tip 2:
as monotherapy
bħala monoterapija
- in patients (particularly overweight patients) inadequately controlled by diet and exercise
- F’ pazjenti (speċjalment pażjenti b’ piż żejjed) li mhumiex ikkontrollati sew minn dieta
for whom metformin is inappropriate because of contraindications or intolerance
u eżerċizzju li għalihom metformin mhux adattat minħabbla kontra- indikazzjonijiet jew intolleranza
as dual oral therapy in combination with
bħala terapija doppja mill- ħalq f’ taħlita ma ’
- metformin, in patients (particularly overweight patients) with insufficient glycaemic
- metformin, f’ pazjenti (speċjalment pażjenti b’ piż żejjed) b’ kontroll gliċemiku
control despite maximal tolerated dose of monotherapy with metformin
insuffiċjenti minkejja monoterpija b’ metformin fl- għola doża ttollerata
- a sulphonylurea, only in patients who show intolerance to metformin or for whom
- mediċina tat- tip sulphonylurea, f’ pazjenti li wrew intolleranza għal metformin jew li
metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
għalihom metformin huwa kontra- indikat, b’ kontroll gliċemiku insuffiċjenti minkejja monoterpija b’ mediċina tat- tip sulphonylurea fl- għola doża ttollerata
as triple oral therapy in combination with
bħala terapija trippla mill- ħalq f’ taħlita ma ’
- metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient
- metformin u mediċina tat- tip sulphonylurea, f’ pazjenti (speċjalment pażjenti b’ piż
glycaemic control despite dual oral therapy.
żejjed) b’ kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill- ħalq.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Pioglitazone huwa indikat ukoll għall- użu flimkien ma ’ insulina f’ pazjenti b’ dijabete mellitus tat- tip 2 b’ kontroll gliċemiku insuffiċjenti bl- insulina u li għalihom metformin mhux adattat minħabba kontra - indikazzjonijiet jew intolleranza (ara sezzjoni 4. 4).
Pioglitazone tablets are taken orally once daily with or without food.
Pilloli pioglitazone jittieħdu mill- ħalq darba kuljum ma ’ l- ikel jew mingħajr ikel.
Pioglitazone may be initiated at 15mg or 30mg once daily.
Pioglitazone jista ’ jinbeda b’ 15mg jew 30mg darba kuljum.
The dose may be increased in increments up to 45mg once daily.
Id- doża tista ’ tiġi miżjuda bil- mod sa 45mg darba kuljum.
2 In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
2 Anzjani
No dosage adjustment is necessary for elderly patients (see section 5.2).
L- ebda aġġustament fid- doża ma huwa neċessarju għall- pazjenti anzjani (ara sezzjoni 5. 2).
Patients with renal impairment:
Pazjenti b’ indeboliment renali
No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/ min) (see section 5.2).
L- ebda aġġustament fid- doża ma huwa neċessarju f’ pazjenti b’ indeboliment renali (tneħħijja ta ’ creatinine > 4 ml/ min) (ara sezzjoni 5. 2).
No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
M’ hemmx tagħrif disponibbli minn pazjenti b’ dijalisi u għalhekk pioglitazone m’ għandux jintuża f’ dawn il- pazjenti.
Patients with hepatic impairment:
Pazjenti b’ indeboliment epatiku
Pioglitazone should not be used in patients with hepatic impairment (see section 4.4).
Pioglitazone m’ għandux jintuża f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 4. 4).
Children and adolescents:
Tfal u adolexxenti
There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.
M’ hemmx dejta disponibbli dwar l- użu ta ’ pioglitazone f’ pazjenti taħt l- eta ’ ta ’ 18- il sena, u għalhekk l- użu tiegħu mhux rakkomandat f’ dan il- grupp ta ’ eta ’.
Pioglitazone is contraindicated in patients with:
Pioglitazone huwa kontra- indikat f’ pazjenti b ’:
- hypersensitivity to the active substance or to any of the excipients
- sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi
- cardiac failure or history of cardiac failure (NYHA stages I to IV)
- insuffiċjenza kardijaka jew passat ta ’ insuffiċjenza kardijaka (NYHA stadju I sa IV)
- hepatic impairment
- indeboliment epatiku
- diabetic ketoacidosis.
- ketoaċidożi dijabetika.
Fluid retention and cardiac failure:
Żamma ta ’ fluwidu u insuffiċjenza kardijaka
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Pioglitazone jista ’ jikkawża żamma ta ’ fluwidu, li tista ’ tirkada jew twassal għall- insuffiċjenza tal - qalb.
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually.
Meta jiġu kkurati pazjenti li għandhom ta ’ l- inqas fattur ta ’ riskju wieħed għall- iżvilupp ta ’ nsuffiċjenza tal- qalb konġestiva (e. ż. infart mijokardijaku minn qabel jew mard fl- arterji koronarji bis - sintomi), it- tobba għandhom jibdew bl- inqas doża disponibbli u jżidu d- doża bil- mod.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema particularly those with reduced cardiac reserve.
Il- pazjenti għandhom jiġu osservati għal sinjali u sintomi ta ’ insuffiċjenza tal- qalb, żieda fil- piż jew edima, speċjalment dawk b’ riserva kardijaka mnaqqsa.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulinor in patients with a history of cardiac failure; patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Kien hemm każijiet ta ’ insuffiċjenza kardijaku rrappurtati mis- suq meta pioglitazone intuża flimkien ma ’ insulina jew f’ pazjenti b’ insuffiċjenza tal - qalb; pazjenti għandhom jiġu osservati għal sinjali u sintomi ta ’ insuffiċjenza tal- qalb, żieda fil- piż jew edima meta pioglitazone jingħata flimkien ma ’ insulina.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Minħabba li insulina u pioglitazone huma assoċjati ma ’ żamma ta ’ fluwidu, l- għotja flimkien tista ’ żżid ir- riskju ta ’ edima.
Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Pioglitazone għandu jitwaqqaf jekk iseħħ xi deterjorament fl- istat kardijaku.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Sar studju dwar ir- riżultat kardjovaskulari b’ pioglitazone f’ pazjenti taħt il- 75 sena b’ dijabete mellitus tat- tip 2 u b’ mard makrovaskulari maġġuri eżistenti minn qabel.
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Pioglitazone jew plaċebo kienu miżjuda mat- terapija anti- dijabetika u kardjovaskulari eżistenti sa 3. 5 snin.
This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
Dan l- istudju wera żieda fir- rapporti ta ’ insuffiċjenza tal- qalb, iżda dan ma wassalx għal żieda fil- mortalià f’ dan l- istudju.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Irid ikun hemm kawtela f’ pazjenti l- fuq minn 75 sena minħabba l- esperjenza limitata f’ dan il- grupp ta ’ pazjenti.
3 Monitoring of liver function:
Sorveljanza tal- funzjoni tal- fwied
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Kien hemm rapporti rari ta ’ disfunzjoni epatoċellolari waqt l- esperjenza ta ’ wara t- tqegħid fis- suq (ara sezzjoni 4. 8).
It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes.
Għalhekk, huwa rakkomandat li, pazjenti kkurati b’ pioglitazone jagħmlu sorveljanza perjodika ta ’ l- emżimi tal- fwied.
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients.
L- enżimi tal- fwied għandhom jiġu ċċekkjati qabel ma tinbeda
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Terapija b’ pioglitazone m’ għandiex tinbeda f’ pazjenti b’ livelli miżjuda ta ’ l- enżimi tal- fwied fil- linja bażika (ALT > 2. 5 X l- għola limitu tan- normal) jew b’ xi evidenza oħra ta ’ mard tal- fwied.
Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Wara l- bidu tat- terapija b’ pioglitazone, huwa rakkomandat li l- enżimi tal- fwied ikunu sorveljati perjodikament ibbażat fuq ġudizzju kliniku.
If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Jekk il- livelli ta ’ ALT jiżdiedu sa 3 X l- għola limitu tan - normal waqt it- terapija b’ pioglitazone, il- livelli ta ’ l- enżimi tal- fwied għandhom jerġu jiġu ċċekkjati mill- aktar fis possibli.
If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Jekk il- livelli ta ’ ALT jibqgħu > 3 X l- għola limitu tan- normal, it- terapija għandha titwaqqaf.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Jekk xi pazjent jiżviluppa sintomi li jissuġġerixxu disfunzjoni epatika, li jistgħu jinkludu tqallih mhux spjegat, rimettar, uġigħ addominali, għejja, anoressija u/ jew awrina skura, l - enżimi tal- fwied iridu jiġu ċċekkjati.
The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni dwar jekk il- pazjent għandux jitkompla bit- terapija b’ pioglitazone għandha tiġi ggwidata minn ġudiżżju kliniku sakemm isiru l- valutazzjonijiet tal - laboratorju.
If jaundice is observed, drug therapy should be discontinued.
Jekk tkun osservata s- suffejra, it- terapija bil- mediċina għandha titwaqqaf.
Weight gain:
Żieda fil- piż
In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Fi provi kliniċi b’ pioglitazone kien hemm evidenza ta ’ żieda fil- piż relatata mad- doża, li setgħet kienet minħabba akkumulazzjoni ta ’ xaħam u f’ xi każijiet assoċjata ma ’ żamma ta ’ fluwidu.
In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
F’ xi każijiet żieda fil- piż tista ’ tkun sintomu ta ’ insuffiċjenza kardijaka, għalhekk il- piż għandu jiġi sorveljat mill - viċin.
Part of the treatment of diabetes is dietary control.
Parti mill- kura ta ’ dijabete hija kontroll tad- dieta.
Patients should be advised to adhere strictly to a calorie-controlled diet.
Il- pazjenti għandhom jiġu rakkomandati biex isegwu b’ reqqa dieta li tikkontrolla l- ammont ta ’ kaloriji.
Haematology:
Ematoloġija
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Kien hemm tnaqqis żgħir fil- medja ta ’ emoglobina (tnaqqis relattiv ta ’ 4%) u ematokrita (tnaqqis relattiv ta ’ 4. 1%) waqt terapija b’ pioglitazone, konsistenti ma ’ emodiluzzjoni.
Similar changes were seen in metformin (haemoglobin 3 - 4% and haematocrit 3.6 – 4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2% and haematocrit 1 – 3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Tibdiliet simili dehru fi provi kkontrollati komparattivi b’ pioglitazone f’ pazjenti kkurati b’ metformin (tnaqqis relattiv fl - emoglobina 3 - 4% u fl- ematokrita 3. 6 – 4. 1%) u fi kwantità inqas b’ sulphonylurea u bl- insulina (tnaqqis relattiv fl- emoglobina 1 – 2% u fl- ematokrita 1 – 3. 2%).
Hypoglycaemia
Ipogliċemija
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Bħala konsegwenza ta ’ żieda fis- sensittività għall- insulina, pazjenti li qed jirċievu pioglitazone f’ terapija mill- ħalq doppja jew trippla ma ’ mediċina tat- tip sulphonylurea jew f’ terapija doppja mal - insulina jistgħu jkunu f’ riskju ta ’ ipogliċemija relatat mad- doża, u tista ’ tkun neċessarja tnaqqis fid - doża tal- mediċina tat- tip sulphonylurea jew tal- insulina.
Eye disorders:
Mard fl- għajnejn
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Rapporti ta ’ wara t- tqegħid fis- suq ta ’ żvilupp jew irkadar ta ’ edima makulari dijabetika bi tnaqqis fl - akutezza viżiva ġew irrappurtati b ’ thiazolidinediones, inkluż pioglitazone.
Many of these patients reported concurrent peripheral oedema.
Ħafna minn dawn il - pazjenti rrappurtaw edima perifirika fl- istess ħin.
It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Mhux ċar jekk hemmx assoċjazzjoni diretta bejn pioglitazone u l- edima makulari iżda it- tobba għandhom joqgħodu attenti għall- possibilità ta ’ edima makulari jekk il- pazjenti jirrappurtaw disturbi fl- akutezza viżiva; għandha tiġi kkunsidrata referenza oftalmoloġika xieraq.
Others:
Oħrajn
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Kienet osservata żieda fl- inċidenza ta ’ fratturi fl- għadam fin- nisa f’ analiżi globali ta ’ rapporti ta ’ avvennimenti avversi ta ’ fratturi fl- għadam miksuba minn provi kliniċi randomised, ikkontrollati u double blind b’ aktar minn 8100 pazjent ikkurat b’ pioglitazone u 7400 pazjent ikkurat bi prodott paragun, fuq kura sa 3. 5 snin.
Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Fratturi kienu osservati f’ 2. 6% ta ’ nisa li kienu qed jieħdu pioglitazone meta mqabbel ma ’ 1. 7% tan - nisa kkurati bi prodott paragun.
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Ma kienux osservati żidiet fir- rati ta ’ fratturi fl- irġiel kkurati b’ pioglitazone (1. 3%) meta mqabbel mal- prodott ta ’ paragun (1. 5%).
4 The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
4 L- inċidenza ta ’ fratturi kkalkulata kienet ta ’ 1. 9 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati b’ pioglitazone u 1. 1 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati bi prodott ta ’ paragun.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Iż- żieda osservata fir- riskju ta ’ fratturi għan- nisa f’ dan id- dataset fuq pioglitazone għalhekk huwa ta ’ 0. 8 fratturi kull 100 sena ta ’ pazjent ta ’ użu.
In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Fl- istudju PROactive dwar ir- riskju kardjovaskulari li dam 3. 5 snin, 44/ 870 (5. 1%; 1. 0 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati b’ pioglitazone kellhom esperjenza ta ’ fratturi meta mqabbel ma ’ 23/ 905 (2. 5%; 0. 5 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati bi prodott paragun.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Ma kinietx osservata żieda fir- rata ta ’ fratturi f’ irġiel ikkurati b’ pioglitazone (1. 7%) meta mqabbla ma ’ prodott paragun (2. 1%).
The risk of fractures should be considered in the long term care of women treated with pioglitazone.
Ir- riskju ta ’ fratturi għandu jiġi kkunsidrat fil- kura fit- tul ta ’ nisa kkurati b’ pioglitazone.
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Bħala konsegwenza ta ’ azzjoni msaħħa ta ’ l- insluina, kura b’ pioglitazone f’ pazjenti bis- sindromu ta ’ ovarji poliċistiċi jista ’ jwassal għal bidu mill- ġdid tal- ovulazzjoni.
These patients may be at risk of pregnancy.
Dawn il- pazjenti jistgħu jkunu f’ riskju ta ’ tqala.
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Il- pazjenti għandhom ikunu konxji tar- riskju ta ’ tqala u jekk il- pazjenta tixtieq tinqabad tqila jew jekk it- tqala sseħħ, il- kura għandha titwaqqaf (ara sezzjoni 4. 6).
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
Pioglitazone għandu jintuża b’ attenzjoni waqt l- għotja fl- istess ħin ta ’ inibituri (e. ż. gemfibrozil) jew indutturi (e. ż. rifampicin) taċ- ċitokromju P450 2C8.
Glycaemic control should be monitored closely.
Il- kontroll gliċemiku għandu jiġi sorveljat mill - viċin.
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Għandhom jiġu kkunsidrati aġġustament fid- doża ta ’ pioglitazone fil- firxa ta ’ dożaġġ rakkomandat jew bidliet fil- kura dijabetika (ara sezzjoni 4. 5).
Actos tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Il- pilloli Actos fihom lactose monohydrate u għalhekk m’ għandhomx jingħataw lill- pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose.
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott urew li pioglitazone m’ għandu l- ebda effett rilevanti fuq il- farmakokinetika u l- anqas fuq il- farmakodinamika ta ’ digoxin, warfarin, phenprocoumon u metformin.
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
L- għotja ta ’ pioglitazone flimkien ma ’ mediċini tat- tip sulphonylureas ma tidhirx li taffettwa il- farmakokinetika tal- mediċini tat- tip sulphonylurea.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/ 9 and 3A4.
Studji fil- bniedem jissuġġerixxu li m’ hemm l- ebda induzzjoni taċ- ċitokromju prinċipali induċibbli P450, 1A, 2C8/ 9 u 3A4.
In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Studji in vitro wrew li m’ hemm l- ebda induzzjoni ta ’ kull sottotip ta ’ ċitokromju P450.
Interactions with substances metabolised by these enzymes, e. g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Mhumiex mistennija interazzjonijiet ma ’ sustanzi metabolizzati minn dawn l- enżimi, e. ż. kontraċettivi mill- ħalq, cyclosporin, imblokkaturi tal- kanali tal- kalċju, u inibituri ta ’ HMGCoA reductase.
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Huwa rrappurtat li l- għotja ta ’ pioglitazone flimkien ma ’ gemfibrozil (inibitur taċ- ċitokromju P450 2C8) twassal għall- żieda ta ’ 3- darbiet fl- AUC ta ’ pioglitazone.
Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Minħabba li hemm potenzjal ta ’ żieda fl- effetti avversi relatati mad- doża ta ’ pioglitazone, jista ’ jkun hemm bżonn ta ’ tnaqqis fid- doża ta ’ pioglitazone meta gemfibrozil jingħata fl- sitess ħin.
Close monitoring of glycaemic control should be considered (see section 4.4).
Sorveljanza mill- viċin tal- kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4. 4).
Co- administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Ħija rrappurtata li l- għotja ta ’ piogltazone flimkien ma ’ rifampicin (induttur taċ- ċitokromju P450 2C8) twassal għal tnaqqis ta ’ 54% fl- AUC ta ’ pioglitazone.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Jista ’ jkun hemm bżonn li d- doża ta ’ pioglitazone tiżdied meta rifampicin jingħata fl- istess ħin.
Use in pregnancy:
Użu fit- tqala
There are no adequate human data to determine the safety of pioglitazone during pregnancy.
M’ hemmx dejta biżżejjed fil- bniedem sabiex tiġi determinata is- sigurtà ta ’ pioglitazone waqt it- tqala.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Dan kien
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
5 attribwit għall- azzjoni ta ’ pioglitazone li jnaqqas l- iperinsulinemija fl- omm u jżid ir- reżistenza għall - insulina li jseħħu waqt it- tqala u b’ hekk inaqqas id- disponibilità tas- substrati metaboliċi għat- tkabbir tal- fetu.
The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy.
Ir- rilevanza ta ’ dan il- mekkaniżmu fil- bnedmin mhix ċara u pioglitazone m’ għandux jintuża fit- tqala.
5 Use in breast-feeding:
Użu fit- treddigħ
Pioglitazone has been shown to be present in the milk of lactating rats.
Intwera li pioglitazone jinstab fil- ħalib ta ’ firien li qed ireddgħu.
It is not known whether pioglitazone is secreted in human milk.
Mhux magħruf jekk pioglitazone jitneħħiex fil- ħalib tal- bniedem.
Therefore, pioglitazone should not be administered to breast-feeding women.
Għalhekk, pioglitazone m’ għandux jingħata lill- nisa li qed ireddgħu.
No effects on ability to drive and use machines have been observed.
M’ għandu l- ebda effett fuq il- ħila ta 'sewqan u l- użu ta ’ magni.
Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Reazzjonijiet avversi rrappurtati aktar (> 0. 5%) milli fil- plaċebo u f’ aktar minn każ iżolat f’ pazjenti li qed jirċievu pioglitazone fi studji double- blind huma mniżżla hawn taħt bis- sistema ta ’ terminu ppreferut MedDRA permeżż tas- sistema tal- klassifika tal- organi u frekwenza assoluta.
Frequencies are defined as: very common > 1/ 10; common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100; rare > 1/ 10000 ,< 1/1000; very rare < 1/10000; not known (cannot be estimated from the available data).
Il- frekwenzi huma definiti bħala: komuni ħafna > 1/ 10; komuni > 1/ 100, < 1/ 10; mhux komuni > 1/ 1000, < 1/ 100; rari > 1/ 10000, < 1/ 1000; rari ħafna < 1/ 10000; mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
PIOGLITAZONE MONOTHERAPY Eye disorders
MONOTERAPIJA B’ PIOGLITAZONE
Common:
Disturbi fl- għajnejn Komuni:
visual disturbance
disturbi viżwali
Common:
Infeżżjonijiet u Komuni:
upper respiratory tract infection
infestazzjonijiet infezzjoni fil- passaġġ respiratorju ta ’ fuq
Uncommon: sinusitis
Mhux komuni: sinusite
Common:
Investigazzjonijiet Komuni:
weight increased
żieda fil- piż
Common:
Disturbi fis- sistema nervuża Komuni:
hypoaesthesia
ipoesteżija
Uncommon: insomnia
Mhux komuni: insonnja
PIOGLITAZONE IN COMBINATION THERAPY WITH METFORMIN Blood and lymphatic system disorders
PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ METFORMIN
Common:
Disturbi tad- demm u tas- sistema limfatika Komuni:
Eye disorders
Disturbi fl- għajnejn Komuni:
Uncommon: flatulence
Disturbi gastro- intestinali Mhux komuni: gass
6 Musculoskeletal system and connective tissue disorders
6 Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
arthralgia
artralġja
Renal and urinary disorders
uġigħ ta ’ ras
Common:
Disturbi fil- kliewi u fis- sistema urinarja Komuni:
haematuria
ematurja
Common:
Disturbi fis- sistema riproduttiva u fis- sider Komuni:
erectile dysfunction
disfunzjoni erettili
PIOGLITAZONE IN COMBINATION THERAPY WITH SULPHONYLUREA Ear and labyrinth disorders
PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ SULPHONYLUREA
Uncommon: vertigo
Disturbi fil- widnejn u fis- sistema labirintika Mhux komuni: vertigo
Eye disorders
Disturbi fl- għajnejn
Uncommon: visual disturbance
Mhux komuni: disturbi viżwali
Common:
Disturbi gastro- intestinali Komuni:
flatulence
gass
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni: għejja
Uncommon: fatigue
Investigazzjonijiet Komuni:
Uncommon: increased lactic dehydrogenase
Mhux komuni: żieda ta ’ lactic dehydrogenase
Uncommon: appetite increased, hypoglycaemia
Disturbi fil- metaboliżmu u n- nutrizzjoni Mhux komuni: żieda fl- aptit, ipogliċemija
dizziness
sturdament
Renal and urinary disorders
Mhux komuni: uġigħ ta ’ ras
Uncommon: glycosuria, proteinuria
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni: glikosurja, proteina fl- awrina
7 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: għaraq
PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
PIOGLITAZONE F’ TERAPIJA TRIPPLA KOMBINATA MA ’ METFORMIN U SULPHONYLUREA MIL- ĦALQ
weight increased, blood creatine phosphokinase increased
żieda fil- piż, żieda fil- creatine phosphokinase fid- demm
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna: iopogliċemija
connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
Common:
artralġja
arthralgia
7
PIOGLITAZONE IN COMBINATION THERAPY WITH INSULIN Metabolism and nutrition disorders
PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ INSULINA
Common:
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni:
hypoglycaemia
ipogliċemija
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna: edima
Very common: oedema
Infeżżjonijiet u infestazzjonijiet Komuni:
Common:
bronkite
weight increase
żieda fil- piż
Musculoskeletal system and connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
Common:
uġigħ fid- dahar, artralġja
back pain, arthralgia
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Respiratory, thoracic and mediastinal disorders
qtugħ ta ’ nifs
Common:
Disturbi fil- qalb Komuni:
dyspnoea
insuffiċjenza tal- qalb
Cardiac disorders
TAGĦRIF TA ’ WARA T- TQEGĦID FIS- SUQ
Common:
Disturbi fl- għajnejn Edima makulari:
heart failure
mhux magħruf
POST-MARKETING DATA
Edima kienet irrappurtata
8 Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
f’ 6 – 9% tal- pazjenti kkurati b’ pioglitazone fuq medda ta ’ sena fi provi
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
Ir- rati ta ’ edima għall- gruppi ta ’ paragun (sulphonylurea, metformin) kienu ta ’ 2 – 5%.
The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Ir- rapporti ta ’ edima ġeneralment kienu ħfief għal moderati u normalment ma kienux jinħtieġu t - twaqqif tal- kura.
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
Fi provi attivi kkontrollati ta ’ paragun, iż- żieda medja fil- piż bi pioglitazone mogħti bħala monoterapija kienet ta ’ 2 – 3 kg fuq medda ta ’ sena.
This is similar to that seen in a sulphonylurea active comparator group.
Dan huwa simili għal dak sservat fi grupp attiv ta ’ paragun b’ sulphonylurea.
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
Fi provi ta ’ taħlita, pioglitazone miżjud ma ’ metformin wassal għall- żieda medja fil- piż fuq medda ta ’ sena ta ’ 1. 5 kg u miżjud ma ’ sulphonylurea ta ’ 2. 8 kg.
In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Fi gruppi ta ’ paragun, iż- żieda ta ’ sulphonylurea ma ’ metformin wasslet għall- żieda medja fil- piż ta ’ 1. 3 kg u ż - żieda ta ’ metformin ma ’ sulphonylurea għall- tnaqqis medju fil- piż ta ’ 1. 0 kg.
Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic agents.
Disturbi viżwali ġew irrappurtati l- aktar fil- bidu tal- kura u huma relatati ma ’ tibdil fil- glucose fid- demm minħabba alterazzjoni temporanja fit- turġidità u fl- indiċi refrattiv tal- lenti kif osservat b’ aġenti ipogliċemiċi oħra.
In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Fi provi klinċi b’ pioglitazone l- inċidenża ta ’ elevazzjonijiet ta ’ ALT aktar minn tlett darbiet l- għola limitu tan- normal kienet daqs il- plaċebo iżda inqas minn dik li deheret fil- grupp ta ’ paragun b’ metformin jew b’ sulphonylurea.
Mean levels of liver enzymes decreased with treatment with pioglitazone.
Livelli medji tal- enżimi tal- fwied naqsu b’ kura bi pioglitazone.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Każijiet rari ta ’ żieda fl- enżimi tal- fwied u disfunzjoni epatoċellolari seħħew fl- esperjenza ta ’ wara t - tqegħid fis- suq.
Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Minkejja li f’ każijiet rari ħafna kien irrappurtat riżultat fatali, relazzjoni kawżali ma ġietx stabbilita.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Fi provi kliniċi kkontrollati, l- inċidenza ta ’ rapporti ta ’ insuffiċjenza tal- qalb b’ kura b’ pioglitazone kienet l- istess bħall- gruppi ta ’ kura bil- plaċebo, metformin u sulphonylurea, iżda żdiedet meta ntuża f’ terapija kombinata ma ’ insulina.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
Fi studju dwar ir- riżultat f’ pazjenti b’ mard makrovaskulari maġġuri minn qabel, l- inċidenza ta ’ insuffiċjenza serja tal- qalb kienet 1. 6% għola b’ pioglitazone milli bil - plaċebo, meta miżjud ma ’ terapija li tinkludi insulina.
However, this did not lead to an increase in mortality in this study.
Madankollu dan ma wassalx għall- żieda fil -
Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Insuffiċjenza tal- qalb kienet irrappurtata b’ mod rari bl- użu ta ’ pioglitazone wara t- tqegħid fis- suq, iżda aktar ta ’ spiss meta pioglitazone intuża flimkien ma ’ insulina jew f’ pazjenti b’ passat ta ’ insuffiċjenza kardijaka.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Twettqet analiżi ta ’ tagħrif miġbur ta ’ rapporti ta ’ avvennimenti avversi ta ’ fratturi fl- għadam minn provi kliniċi randomised, ikkontrollati b’ paragun, u double blind b’ aktar minn 8100 pazjent fil- gruppi kkurati b’ pioglitazone u 7400 pazjent fil- gruppi kkurrati bi prodott paragun li damu sa 3. 5 snin.
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Kienet osservata rata akbar ta ’ fratturi fl- għadam f’ nisa li kienu qed jieħdu pioglitazone (2. 6%) meta mqabbla mal- paragun (1. 7%).
In the 3.5 year PROactive study, 44/ 870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%) of female patients treated with comparator.
Fl- istudju PROactive ta ’ 3. 5 snin, 44/ 870 (5. 1%) tal- pazjenti nisa kkurati b’ pioglitazone kellhom esperjenza ta ’ fratturi meta mqabbel ma ’ 23/ 905 (2. 5%) tal- pazjenti nisa kkurati bi prodott paragun.
Patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Pazjenti ħadu pioglitazone f’ doża aktar mill- għola doża rakkomandata ta ’ 45 mg kuljum.
The maximum reported dose of 120 mg/ day for four days, then 180 mg/ day for seven days was not associated with any symptoms.
Id- doża massima rrappurtata ta ’ 120 mg/ kuljum għal erbat ijiem, u wara 180 mg/ kuljum għal sebat ijiem ma kienet assoċjat ma ’ l- ebda sintomi.
Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Ipogliċemija tista ’ sseħħ f’ għotja flimkien ma ’ sulphonylureas jew insulina.
Symptomatic and general supportive measures should be taken in case of overdose.
Miżuri ta ’ sapport sintomatiku u ġenerali għandhom jittieħdu f’ każ ta ’ doża eċċesiva.
Pharmacotherapeutic group: oral blood glucose lowering drugs; Thiazolidinediones; ATC code:
Kategorija farmakoterapewtika: mediċini mill- ħalq li jbaxxu l- glucose fid- demm; Thiazolidinediones; kodiċi ATC:
9 Pioglitazone effects may be mediated by a reduction of insulin resistance.
L- effetti ta ’ pioglitazone jistgħu jkunu medjati minn tnaqqis fir- reżistenza għall- insulina.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Pioglitazone jidher li jaħdem permezz ta ’ attivazzjoni ta ’ riċetturi nuklejari speċifiċi (peroxisome proliferator activated receptor gamma) li jwassal għal żieda fis- sensittività għall- insulina tal- fwied, xaħam u ċelloli tal- muskoli skeletrali fl- annimali.
Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Kura b’ pioglitazone intweriet li tnaqqas il- ħruġ ta ’ glucose mill - fwied u żżid it- tneħħijja periferali ta ’ glucose f’ każ ta ’ reżistenza għall- insulina.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Kontroll gliċemiku waqt is- sawm jew wara l- ikel jitjieb f’ pazjenti b’ dijabete mellitus tat- tip 2.
The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Il - kontroll gliċemiku mtejjeb huwa assoċjat ma ’ tnaqqis fil- konċentrazzjonijiet fil- plażma tal- insulina kemm waqt is- sawm kif ukoll wara l- ikel.
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Prova klinika ta ’ pioglitazone vs. gliclazide bħala monterapija ġiet estiża għal sentejn sabiex jiġi studjat il- ħin sal- falliment tal- kura (definit bħala d - dehra ta ’ HbA1c ≥ 8. 0% wara l- ewwel sitt xhur ta ’ terapija).
Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Analiżi Kaplan- Meier wriet ħin iqsar għall- falliment tal- kura f’ pazjenti kkurati b’ gliclazide, meta mqabbla ma ’ pioglitazone.
At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Wara sentejn, il- kontroll gliċemiku (iddefinit bħala HbA1c < 8. 0%) inżamm f’ 69% tal- pazjenti kkurati b’ pioglitazone, meta mqabbla ma ’ 50% tal- pazjenti fuq gliclazide.
In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Fi studju ta ’ sentejn b’ terapija kombinata li qabbel pioglitazone ma ’ gliclazide meta miżjuda ma ’ metformin, il- kontroll gliċemiku mkejjel bħala it- tibdil medju mill- linja bażika ta ’ HbA1c kien simili bejn il- gruppi ta ’ kura wara l - ewwel sena.
The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Ir- rata ta ’ deterjorazzjoni ta ’ HbA1c waqt it- tieni sena kienet inqas b’ pioglitazone milli b’ gliclazide.
In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Fi prova kkontrollata bil- plaċebo, pazjenti b’ kontroll gliċemiku inadegwat minkejja perjodu ta ’ ottimizzazzjoni b’ insulina ta ’ 3 xhur, kienu randomised għal pioglitazone jew plaċebo għal 12- il xahar.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
9 dawk li komplew fuq l- insulina biss, u fil- grupp ikkurat b’ pioglitazone kien hemm tnaqqis fid- doża tal- insulina.
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Analiżi HOMA juri li pioglitazone itejjeb il- funzjoni taċ- ċellola beta kif ukoll iżid is- sensittività għall - insulina.
Two-year clinical studies have shown maintenance of this effect.
Studji klinċi ta ’ sentejn urew żamma ta ’ dan l- effett.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
Fi provi kliniċi ta ’ sena, pioglitazone b’ mod konsistenti wassal għal tnaqqis statistikament sinifikanti fil- proporzjon ta ’ albumin/ creatinine meta mqabbel mal- linja bażika.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
L- effett ta ’ pioglitazone (45 mg monoterapija vs. plaċebo) kien studjat fi prova żgħira ta ’ 18- il ġimgħa f’ pazjenti bid- dijabete tat- tip 2.
Pioglitazone was associated with significant weight gain.
Pioglitazone kien assoċjat ma ’ żieda sinifikanti fil- piż.
Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Xaħam fil - vixxri naqas b’ mod sinifikanti, filwaqt li kien hemm żieda fil- massa ta ’ xaħam ekstra- addominali.
Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Tibdiliet simili fid- distribuzzjoni tax- xaħam fil- ġisem b’ pioglitazone saru flimkien ma ’ titjib fis - sensittività għall- insulina.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Fil- biċċa l- kbira tal- provi kliniċi, kienu osservati tnaqqis fit- triġliċeridi totali fil- plażma u fil- fatty acids ħielsa, u żieda fil- livelli ta ’ HDL- kolesterol meta mqabbel mal- plaċebo, b’ żiediet żgħar, iżda klinikament rilevanti fil- livelli ta ’ LDL- kolesterol.
In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
Fi provi kliniċi li damu sa sentejn, pioglitazone naqqas it- triġliċeridi totali fil- plażma u l- fatty acids ħielsa, u żied l- livelli ta ’ HDL kolesterol, meta mqabbel mal- plaċebo, metformin jew gliclazide.
Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazone ma wassalx għall - żieda statistikament sinifikanti fil- livell ta ’ LDL cholesterol meta mqabbel mal- plaċebo, filwaqt li tnaqqis kien osservat b’ metformin u gliclazide.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Fi studju ta ’ 20 ġimgħa, minbarra li naqqas it - triġliċeridi waqt is- sawm, pioglitazone naqqas l- ipertrigliċeridemija wara l- ikel permezz ta ’ effett kemm fuq it- trigliċeridi assorbiti kif ukoll fuq dawk prodotti mill- fwied.
These effects were independent of pioglitazone’ s effects on glycaemia and were statistically significant different to glibenclamide.
Dawn l- effetti kienu indipendenti mill- effetti ta ’ pioglitazone fuq il- gliċemija u kienu differenti b’ mod statistikament sinifikanti minn dawk ta ’ glibenclamide.