natgillin/translations-raw huggingface dataset:
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Približno 33% bolnikov v skupini z irbesartanom je doseglo primarno povezan ledvični izid v primerjavi s 39% pri placebu in 41% v skupini z amlodipinom [20% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0, 024) in 23% relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0, 006)].
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
8 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
8 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30- 300 mg/ dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤1, 5 mg/ dl, pri ženskah < 1, 1 mg/ dl).
The study examined the long-term effects (2 years) of Aprovel on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Aprovel na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom - “ urinary albumin excretion rate ” - UAER > 300 mg/ dan in povečanje UAER- a najmanj za 30% začetne vrednosti).
The predefined blood pressure goal was ≤ 135/ 85 mmHg.
Ciljni krvni tlak je bil ≤135/ 85 mmHg.
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Medtem ko so dosegli v vseh skupinah podoben krvni tlak, je manj oseb v skupini z irbesartanom 300 mg (5, 2%) doseglo izid izražene proteinurije, kot v placebo skupini (14, 9%) ali v skupini z irbesartanom 150 mg (9, 7%) in s tem pokazalo 70% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0, 0004) pri višjem odmerku.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
5. 2 Farmakokinetične lastnosti
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Irbesartan se po peroralni uporabi dobro absorbira: študije absolutne biološke razpoložljivosti so dale vrednosti približno 60- 80%.
The volume of distribution is 53-93 litres.
Volumen porazdelitve je 53- 93 litrov.
Following oral or intravenous administration 14 of C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Po peroralni ali intravenski uporabi 14C irbesartana, prispeva 80- 85% radioaktivnosti v plazemskem obtoku nespremenjeni irbesartan.
Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Največje plazemske koncentracije so dosežene 1, 5- 2 uri po peroralni uporabi.
The total body and renal clearance are 157-176 and 3-3.5 ml/ min, respectively.
Celokupni telesni in ledvični očistek je 157- 176 oziroma 3- 3, 5 ml/ min.
The terminal elimination half-life of irbesartan is 11-15 hours.
Končni razpolovni eliminacijski čas irbesartana je 11- 15 ur.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Ravnotežne koncentracije v plazmi so dosežene v 3 dneh po začetku enkrat- dnevnega režima odmerjanja.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Omejeno kopičenje irbesartana (< 20%) v plazmi so opazili ob ponovitvah enkrat - dnevnega odmerjanja.
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18- 40 let).
After either oral or IV 14 administration of C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Po peroralnem ali i. v. dajanju 14C irbesartana, se približno 20% radioaktivnosti izloči z urinom in preostanek z blatom.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Farmakokinetiko irbesartana so ocenili pri 23 hipertenzivnih otrocih po uporabi posamičnega in večkratnih dnevnih odmerkov irbesartana (2 mg/ kg) do največjega dnevnega odmerka 150 mg štiri
Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Od teh 23 otrok je bilo pri 21- ih farmakokinetiko možno primerjati s farmakokinetiko pri odraslih (dvanajst otrok starejših od 12 let, devet otrok starih od 6 do 12 let).
9 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/ kg/ day in rats and ≥ 100 mg/ kg/ day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
V nekliničnih raziskavah o varnosti so visoki odmerki irbesartana (≥250 mg/ kg/ dan pri podganah in ≥100 mg/ kg/ dan pri makako opicah) povzročili zmanjšanje parametrov rdečih krvnih celic (eritrociti, hemoglobin, hematokrit).
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Zelo visoki odmerki irbesartana (≥500 mg/ kg/ dan) so pri podganah in makako opicah sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
Furthermore, irbesartan induced hyperplasia/ hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/ kg/ day, in macaques at ≥ 10 mg/ kg/ day).
Poleg tega je irbesartan sprožil hiperplazijo/ hipertrofijo jukstaglomerulnih celic (pri podganah pri ≥90 mg/ kg/ dan, pri makako opicah pri ≥10 mg/ kg/ dan).
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Za terapevtske odmerke pri človeku kaže, da je hiperplazija/ hipertrofija ledvičnih jukstaglomerulnih celic brez pomena.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Poskusi na živalih z irbesartanom kažejo pri podganjih zarodkih prehodne toksične učinke (povečanje ledvično- medenične votline, razširjen sečevod ali podkožne edeme), ki izginejo po rojstvu.
6.4 Special precautions for storage
10 6. 4 Posebna navodila za shranjevanje
Cartons of 14 tablets:
Škatle s 14 tabletami:
1 blister card of 14 tablets in PVC/ PVDC/ Aluminium blisters.
1 pretisni omot iz PVC/ PVDC/ aluminija s 14 tabletami.
10 Cartons of 28 tablets:
Škatle z 28 tabletami:
2 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
2 pretisna omota iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 56 tablets:
Škatle z 56 tabletami:
4 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
4 pretisni omoti iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 98 tablets:
Škatle z 98 tabletami:
7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
7 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 tabletami.
Cartons of 56 x 1 tablet; 7 blister cards of 8 x 1 tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
7 perforiranih pretisnih omotov iz PVC/ PVDC/ aluminija za enkratni odmerek z 8 x 1 tableto.
SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC 174 avenue de France F-75013 Paris - France
SANOFI PHARMA BRISTOL- MYERS SQUIBB SNC 174 avenue de France F- 75013 Paris - Francija
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET
27 August 1997 Date of latest renewal:
27. avgust 1997 Datum zadnjega podaljšanja dovoljenja za promet:
27 August 2007
27. avgust 2007
30.75 mg of lactose monohydrate per tablet.
30, 75 mg laktoze monohidrata na tableto.
12 4.3 Contraindications
12 Pediatrični bolniki:
13 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
14 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
14 Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
15 je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan, in pri 26, 3% bolnikov v placebo skupini.
15 Common:
Pogosti:
16 Metabolism and nutrition disorders:
16 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
17 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
18 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
18 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
19 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
6.4 Special precautions for storage
20 6. 4 Posebna navodila za shranjevanje
20 Cartons of 28 tablets:
Škatle z 28 tabletami:
61.50 mg of lactose monohydrate per tablet.
61, 50 mg laktoze monohidrata na tableto.
22 4.3 Contraindications
22 Pediatrični bolniki:
23 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
24 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
24 Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
25 je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan, in pri 26, 3% bolnikov v placebo skupini.
25 Common:
Pogosti:
26 Metabolism and nutrition disorders:
26 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
27 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
28 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.
28 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana odloži napredovanje do izražene proteinurije.
29 Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
6.4 Special precautions for storage
30 6. 4 Posebna navodila za shranjevanje
30 Cartons of 28 tablets:
Škatle z 28 tabletami:
25.50 mg of lactose monohydrate per film-coated tablet.
25, 50 mg laktoze monohidrata na filmsko obloženo tableto.
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Zdravljenje ledvične bolezni pri bolnikih s hipertenzijo in diabetesom tipa 2, kot del antihipertenzivnega režima zdravljenja z zdravili (glejte poglavje 5. 1).
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Aprovel (see section 4.5).
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Aprovel (glejte poglavje 4. 5).
32 4.3 Contraindications
32 Pediatrični bolniki:
In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
In sicer, so bili videti manj ugodni pri ženskah in pri ne- belcih (glejte poglavje 5. 1).
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Primarni aldosteronizem: bolniki s primarnim aldosteronizmom se na splošno ne odzivajo na antihipertenzive, ki delujejo preko inhibicije sistema renin- angiotenzin.
33 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Pediatrični bolniki: irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4. 8, 5. 1 in 5. 2).
34 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
34 Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
Aprovel is contraindicated (see section 4.3) during breast-feeding. It is not known whether irbesartan is excreted in human milk.
Dojenje: med dojenjem je zdravilo Aprovel kontraindicirano (glejte poglavje 4. 3).
Irbesartan is excreted in the milk of lactating rats.
Ni znano ali se irbesartan izloča z materinim mlekom.
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%).
Prekinitev zaradi kateregakoli kliničnega ali laboratorijskega neželenega dogodka je bila pri bolnikih z irbesartanom manj pogosta (3, 3%) kot pri bolnikih s placebom (4,%).
In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalnim delovanjem ledvic, so poročali o ortostatski omotici in ortostatski hipotenziji pri 0, 5% bolnikov (to je občasno), a več kot pri placebu.
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Hiperkaliemija * se je pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom pogosteje kot pri bolnikih, ki so dobivali placebo.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalno ledvično funkcijo, se je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 29, 4% bolnikov, ki so prejemali 300 mg irbesartana in pri 22% bolnikov v skupini s placebom.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
35 hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan in pri 26, 3% bolnikov v placebo skupini
35 Common:
Pogosti:
Uncommon: sexual dysfunction
Občasni:
Headache
Glavobol.
Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Oslabljeno delovanje ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4. 4).
36 Metabolism and nutrition disorders:
36 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Hypersensitivity reactions such as angioedema, rash, urticaria
Bolezni imunskega sistema: preobčutljivostne reakcije, kot so angioedem, izpuščaj, koprivnica
37 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Učinki irbesartana in tiazidnih diuretikov na zniževanje krvnega tlaka se seštevajo.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/ 3-6 mm Hg (systolic/ diastolic).
Pri bolnikih, ki niso zadostno kontrolirani s samim irbesartanom, se z dodatno uvedbo nizkega odmerka hidroklorotiazida (12, 5 mg) enkrat dnevno, poleg enkrat dnevnega odmerka irbesartana, doseže nadaljnje s placebom- uravnano znižanje krvnega tlaka v celoti za 7- 10/ 3- 6 mmHg (sistolični / diastolični).
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT )” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Hipertenzija in sladkorna bolezen tipa 2 z ledvično boleznijo Preskušanje irbesartana pri diabetični nefropatiji “ Irbesartan Diabetic Nephropathy Trial "(IDNT) kaže, da irbesartan pri bolnikih s kronično ledvično insuficienco in izraženo proteinurijo zmanjša napredovanje ledvične bolezni.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
Pri 1. 715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥ 900 mg/ dan in serumskim kreatininom 1, 0- 3, 0 mg/ dl, so raziskovali dolgotrajne učinke zdravila Aprovel (povprečje 2, 6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
38 V sekundarnem izidu fatalnih in nefatalnih srčnožilnih dogodkov med tremi skupinami celotne populacije ni bilo razlik, čeprav je bilo opaziti povečano pogostost nefatalnih MI (miokardni infarkt) pri ženskah in zmanjšano pogostost nefatalnih MI pri moških v skupini z irbesartanom, v primerjavi s placebo skupino.