natgillin/translations-raw huggingface dataset:
In vitro studies indicate that alogliptin does not induce CYP1A2, CYP2B6 and CYP2C9 and does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations achieved with the recommended dose of 25 mg alogliptin. 
In vitro ispitivanja pokazuju da u koncentracijama koje se postižu preporučenom dozom od 25 mg, alogliptin ne inducira CYP1A2, CYP2B6 i CYP2C9 niti inhibira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4.
In vitro studies have shown no inhibition of any subtype of cytochrome P450. 
In vitro ispitivanja pokazala su da nema inhibicije bilo kojeg podtipa citokroma P450.
In these studies, 312 alogliptin/pioglitazone-treated patients were ≥ 65 years old. 
U tim je ispitivanjima 312 bolesnika liječenih alogliptinom/pioglitazonom bilo u dobi
Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Lactose monohydrate 
Jezgra tablete manitol celuloza, mikrokristalična hidroksipropilceluloza karmelozanatrij, umrežena magnezijev stearat laktoza hidrat
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 12.5 mg alogliptin, active-control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively). 
U analizi objedinjenih podataka iz 12 ispitivanja, ukupna incidencija epizoda hipoglikemije bila je niža u bolesnika liječenih s 25 mg alogliptina nego u bolesnika liječenih s 12,5 mg alogliptina, aktivnom kontrolom ili placebom (3,6%, 4,6%, 12,9% i 6,2%, istim redoslijedom).
Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects. 
U bolesnika s umjerenim oštećenjem jetre ukupna izloženost alogliptinu bila je približno 10% niža, a vršna izloženost bila je približno 8% niža u usporedbi s kontrolnim ispitanicima.
The co-administration of alogliptin and pioglitazone has been studied as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea) and as add-on therapy to metformin. 
Istodobna primjena alogliptina i pioglitazona ispitana je kao dvojna terapija u bolesnika koji su inicijalno liječeni samo pioglitazonom (s ili bez metformina ili sulfonilureje), te kao dodatak terapiji metforminom.
A total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety. 
Ukupno 3504 bolesnika sa šećernom bolešću tipa 2, uključujući 1908 bolesnika liječenih alogliptinom i pioglitazonom, sudjelovalo je u 4 dvostruko slijepih ispitivanja faze 3 kontroliranih placebom ili aktivnom kontrolom u kojima su procijenjeni učinci istodobno primijenjenih alogliptina i pioglitazona na kontrolu glikemije i njihova sigurnost.
Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate). 
Pomoćna(e) tvar(i) s poznatim učinkom: Jedna tableta sadrži 121 mg laktoze (u obliku hidrata)
These studies evaluated the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea), and as add-on therapy to metformin. 
U tim ispitivanjima procijenjeni su učinci istodobno primijenjenih alogliptina i pioglitazona na kontrolu glikemije, te njihova sigurnost kao inicijalne kombinirane terapije, kao dvojne terapije u bolesnika koji su inicijalno liječeni samo pioglitazonom (s ili bez metformina ili sulfonilureje), te kao dodatak terapiji metforminom.
Alogliptin as add-on therapy to pioglitazone with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3). 
Alogliptin kao dodatak terapiji pioglitazonu s metforminom Dodavanje 25 mg alogliptina jedanput na dan terapiji s 30 mg pioglitazona u kombinaciji s terapijom metforminkloridom (srednja vrijednost doze = 1867,9 mg) dovelo je u 52. tjednu do poboljšanja HbA1c koje se pokazalo neinferiornim i statistički superiornim onome postignutom terapijom s 45 mg pioglitazona u kombinaciji s metforminkloridom (srednja vrijednost doze = 1847,6 mg, tablica 6).
There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8). 
Nakon stavljanja pioglitazona u promet prijavljeni su rijetki slučajevi hepatocelularne disfunkcije (vidjeti dio 4.8).
A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator-controlled, double-blind clinical studies in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration. 
Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
Alogliptin as add-on therapy to pioglitazone 
Alogliptin kao dodatak terapiji pioglitazonom
There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months. 
Hiperplazija mokraćnog mjehura nije opažena u pasa i majmuna liječenih pioglitazonom u trajanju do 12 mjeseci.
In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively. 
U analizi objedinjenih podataka iz 13 ispitivanja, ukupne stope prijavljenih pankreatitisa u bolesnika liječenih s 25 mg alogliptina, 12,5 mg alogliptina, aktivnom kontrolom ili placebom bila je 2, 1, 1 odnosno 0 događaja na 1000 bolesnik godina.
Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone. 
U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi novonastalog ili pogoršanje postojećeg dijabetičkog makularnog edema sa smanjenjem oštrine vida kod uzimanja tiazolidindiona, uključujući pioglitazon.
The pharmacokinetics of pioglitazone in children and adolescents < 18 years old has not been established. 
Farmakokinetika alogliptina u djece i adolescenata < 18 godina starosti nije ispitana.
For patients with moderate renal impairment, Incresync 12.5 mg/30 mg or 12.5 mg/45 mg should be administered once daily. 
Bolesnicima s umjerenim oštećenjem bubrega treba primijeniti Incresync 12,5 mg/30 mg ili 12,5 mg/45 mg jedanput na dan.
The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies. 
Podaci se temelje na iskustvu na ukupno 3504 bolesnika sa šećernom bolešću tipa 2, uključujući 1908 bolesnika liječenih alogliptinom i pioglitazonom, koji su sudjelovali u 4 dvostruko-slijepa, klinička ispitivanja faze 3 kontrolirana placebom ili aktivnom kontrolom.
Iron oxide black (E172) 
željezov oksid, crni (E172)
SN: 
Česte:
Excipient(s) with known effect Each tablet contains 105 mg of lactose (as monohydrate). 
Pomoćna(e) tvar(i) s poznatim učinkom: Jedna tableta sadrži 105 mg laktoze (u obliku hidrata)
The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint. 
Simptomi mogu uključivati: osip, koprivnjaču, teškoće pri gutanju ili disanju, oticanje usnica, lica, grla ili jezika, te osjećaj nesvjestice.
Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets. 
Klinička ispitivanja provedena za potvrdu djelotvornosti i sigurnosti Incresynca uključivala su istodobnu primjenu alogliptina i pioglitazona kao zasebnih tableta.
Iron oxide yellow (E172) 
željezov oksid, žuti (E172)
Risk related to alogliptin 
Rizik vezan uz alogliptin
The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). 
Dodavanje 25 mg alogliptina jedanput na dan terapiji pioglitazonom (srednja vrijednost doze = 35,0 mg, s ili bez metformina ili sulfonilureje) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 5).
In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo. 
Dodatno, 25 mg alogliptina, samog ili u kombinaciji s 30 mg pioglitazona, dovelo je u 16. tjednu u usporedbi s placebom do statistički značajnih (p<0,001) sniženja ukupnih triglicerida izmjerenih kao postprandijalna inkrementalna promjena AUC(0-8) od početne vrijednosti.
Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing. 
Proporcionalno povišenje koncentracije u serumu bilo je primijećeno kod doza od 2-60 mg.
Incresync should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). 
Incresync treba primjenjivati s oprezom tijekom istodobne primjene inhibitora (npr. gemfibrozil) ili induktora (npr. rifampicin) citokroma P450 2C8.
The following section outlines the interactions observed with the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics. 
Sljedeći dio navodi interakcije opažene za pojedinačne tvari u Incresyncu (alogliptin/pioglitazon) kako su navedene u Sažetku opisa svojstava lijeka svakog od njih.
In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin. 
In vitro podaci pokazuju da ograničenom metabolizmu alogliptina pridonose CYP2D6 i CYP3A4.
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks. 
U mladih štakora nakon ponovljene primjene tijekom 4 i 8 tjedana nisu opaženi učinci povezani s alogliptinom.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone. 
Prijavljeno je da istodobna primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira smanjenjem AUC-a pioglitazona za 54%.
Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session. 
Temeljem srednjih vrijednosti koncentracija dijalizata, u 3-satnoj hemodijalizi ukloni se približno 7% lijeka.
This indicates no time-dependency in the kinetics of alogliptin after multiple dosing. 
To ukazuje da kinetika alogliptina ne ovisi o vremenu ni nakon višekratnog doziranja.
The following section outlines the pharmacokinetic properties of the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics. 
U sljedećem dijelu navedene se farmakokinetička svojstva pojedinačnih sastojaka Incresynca (alogliptin/pioglitazon) kako su navedene u Sažetku opisa svojstava lijeka svakog od njih.
NAME OF THE MARKETING AUTHORISATION HOLDER Takeda 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda
Clinical studies conducted to support the efficacy of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets. 
Klinička ispitivanja provedena za potvrdu djelotvornosti Incresynca uključivala su istodobnu primjenu alogliptina i pioglitazona kao zasebnih tableta.
In toxicology studies, plasma volume expansion with haemodilution, anaemia and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs and monkeys. 
U toksikološkim ispitivanjima nakon ponovljenog doziranja u miševa, štakora, pasa i majmuna dosljedno su primijećeni povećanje volumena plazme s hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca.
The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points). 
Značajna sniženja HbA1c opažena s 25 mg alogliptina s 30 mg pioglitazona i metforminom u usporedbi s 45 mg pioglitazona s metforminom bio je dosljedno tijekom čitavog 52-tjednog razdoblja liječenja (p<0,001 u svim vremenskim točkama).
Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose. 
Iako plodnost nije bila oštećena, u mužjaka pri izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi opaženo je blago, statističko povećanje broja abnormalnih spermija.
Therefore, one tablet of 12.5 mg/30 mg or 12.5 mg/45 mg once daily, depending on the dose of pioglitazone already being taken, is recommended in patients with moderate renal impairment (see section 5.2). 
Stoga se bolesnicima s umjerenim oštećenjem bubrega preporučuje jedna tableta od 12,5/30 mg ili 12,5/45 mg jedanput na dan, ovisno o dozi pioglitazona koju bolesnik već uzima (vidjeti dio 5.2).
How to store Incresync 
Kako čuvati Incresync
For the different dose regimens Incresync is available in strengths of 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/30 mg and 12.5 mg/45 mg film-coated tablets. 
Za različite režime doziranja Incresync je dostupan kao filmom obložene tablete u jačinama od 25 mg/30mg, 25 mg/45 mg, 12,5 mg/30 mg i 12,5 mg/45 mg.
In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001). 
Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća s 25 mg alogliptina i 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2). 
Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (vidjeti dio 4.2)
Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common 
Infekcije i infestacije Infekcije gornjeg respiratornog trakta
- Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, 
• problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože i bjeloočnica.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the serum concentration of pioglitazone (see section 4.5). 
Opaženo je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u serumu (vidjeti dio 4.5).
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2). 
Kako bi se održala sistemska izloženost alogliptinu slična onoj opaženom u bolesnika s normalnom funkcijom bubrega, u bolesnika s umjerenim i teškim oštećenjem bubrega, te završnim stadijem bolesti bubrega na dijalizi, potrebno je primijeniti nižu dozu alogliptina (vidjeti dio
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). 
Viša stopa prijeloma bila je primijećena u žena koje su uzimale pioglitazon (2,6%) naspram usporednog lijeka (1,7%).
It is unknown whether alogliptin and pioglitazone are excreted in human milk. 
Nije poznato izlučuju li se alogliptin i pioglitazon u majčino mlijeko kod ljudi.
Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S
Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis. 
Incresync se ne preporučuje bolesnicima s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega koji zahtijeva dijalizu.
Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known 
Poremećaji kože i potkožnog tkiva Eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom Erythema multiforme
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone. 
Prijavljeno je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) rezultira 3 puta povećanjem AUC-a pioglitazona.
The results of bioequivalence studies in healthy subjects demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets. 
Rezultati ispitivanja bioekvivalencije u zdravih ispitanika pokazuju da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona primijenjenim istodobno kao zasebne tablete.
Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004). 
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (49,2%) nego oni koji su primali placebo (34,0%) (p<0,004).
Add-on combination therapy studies Alogliptin 25 mg once daily with pioglitazone + metformin vs titrating pioglitazone + metformin 
Alogliptin 25 mg jedanput na dan s pioglitazonom + metformin ili sulfonilurejom
MACE Reported in cardiovascular outcomes study Number of Patients (%) 
MACE prijavljeni u ispitivanju kardiovaskularnih ishoda
Takeda UAB Tel: +370 521 09 070 lt-info@takeda.com 
Lietuva ”Takeda” UAB Tel: +370 521 09 070 info@nycomed.lt
Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets 
Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete
There are no data from the use of alogliptin in pregnant women. 
Nema podataka o primjeni alogliptina u trudnica.
Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05). 
U 16. tjednu primjene 25 mg alogliptina, samog i u kombinaciji s 30 mg pioglitazona, postiže se u usporedbi s placebom značajno smanjenje postprandijalne glukoze i postprandijalnog glukagona uz značajni porast postprandijalnih razina aktivnog GLP-1 (p<0,05).
Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with pioglitazone ± metformin or a sulphonylurea (n=195) FAS = full analysis set LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment 
FAS = analiza svih uključenih bolesnika (engl. full analysis set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) †Srednja vrijednost metodom najmanjih kvadrata prilagođena prvobitnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima * p<0,001 u usporedbi s placebom ili liječenjem placebom+kombinacijom
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets. 
Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona istodobno primijenjenim kao zasebne tablete.
Risk related to pioglitazone 
Rizik vezan uz pioglitazon
Date of latest renewal: 
ROK VALJANOSTI Rok valjanosti:
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively. 
U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2, odnosno 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi odmah nakon doziranja alogliptina.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience. 
Nakon stavljanja lijeka u promet bilo je rijetkih slučajeva povišenih jetrenih enzima i hepatocelularne disfunkcije.
INFORMATION IN BRAILLE Incresync 25 mg/45 mg 
16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/45 mg
Table 1: Adverse reactions System organ class Adverse reaction 
Tablica 1: Nuspojave opažene objedinjenim pivotalnim kontroliranim ispitivanjima faze 3 Organski sustav
Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001). 
U 52. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su uzimali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego oni koji su uzimali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. 
U bolesnika, posebno u žena koje su uzimale pioglitazon primijećen je povećan broj prijeloma kostiju.
The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone. 
U ispitivanja je alogliptinom/pioglitazonom liječeno 1269 bolesnika s blagim oštećenjem bubrega i 161 bolesnik s umjerenim oštećenjem bubrega.
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9). 
Stoga u bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh indeks 5 do 9) nije potrebna prilagodba doze.