natgillin/translations-raw huggingface dataset:
Lactation (see section 4.6).
Dojenje (glejte poglavje 4. 6).
Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Zmanjšan intravaskularni volumen: pri bolnikih, ki imajo zmanjšan volumen krvi in/ ali pomanjkanje natrija zaradi intenzivnega zdravljenja z diuretiki, omejevanja vnosa soli s hrano, driske ali bruhanja, se lahko pojavi simptomatska hipotenzija, zlasti po prvem odmerku.
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renovaskularna hipertenzija: pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice, je pri uporabi zdravil z vplivom na sistem renin- angiotenzin - aldosteron, povečano tveganje za hudo hipotenzijo in ledvično insuficienco.
In particular, they appeared less favourable in women and non-white subjects (see section 5.1).
(glejte poglavje 5. 1).
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin- angiotenzin- aldosteron, se lahko tudi med zdravljenjem z zdravilom Aprovel pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ ali odpovedi srca.
Close monitoring of serum potassium in patients at risk is recommended (see section 4.5).
Pri ogroženih bolnikih se priporoča stalno spremljanje kalija v serumu (glejte poglavje 4. 5).
Lithium: the combination of lithium and Aprovel is not recommended (see section 4.5).
Litij: sočasna uporaba zdravila Aprovel in litija ni priporočljiva (glejte poglavje 4. 5).
Therefore, the use of Aprovel is not recommended.
Primarni aldosteronizem: bolniki s primarnim aldosteronizmom se na splošno ne odzivajo na antihipertenzive, ki delujejo preko inhibicije sistema renin- angiotenzin, zato uporaba zdravila Aprovel ni priporočljiva.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Splošno: pri bolnikih, pri katerih sta žilni tonus in ledvična funkcija pretežno odvisna od delovanja sistema renin- angiotenzin- aldosteron (npr. bolniki s hudim kongestivnim srčnim odpovedovanjem ali primarnimi ledvičnimi boleznimi, vključno s stenozo ledvične arterije), je zdravljenje z zaviralci angiotenzinske konvertaze (ACE) ali antagonisti angiotenzina II, ki vplivajo na ta sistem, povezano z akutno hipotenzijo, azotemijo, oligurijo ali v redkih primerih z akutno odpovedjo ledvic.
As with any anti- hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Kot pri vseh antihipertenzivih, ima lahko izrazito zmanjšanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično srčnožilno boleznijo za posledico miokardni infarkt ali kap.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Kot so že opazili pri zaviralcih ACE, so irbesartan in drugi antagonisti angiotenzina izrazito manj učinkoviti pri zniževanju krvnega tlaka pri temnopoltih ljudeh kot pri drugih ne- temnopoltih, verjetno
3 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.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4. 3 in 4. 6).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
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).
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).
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Aprovel (glejte poglavje 4. 4).
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Dodatki kalija in diuretiki, ki varčujejo s kalijem: na podlagi izkušenj z drugimi zdravili, ki vplivajo na sistem renin- angiotenzin, lahko sočasna uporaba diuretikov, ki varčujejo s kalijem, dodatkov kalija, nadomestkov soli, ki vsebujejo kalij, ali drugih zdravil, ki lahko povečajo koncentracijo kalija v serumu (npr. heparin), zviša kalij v serumu in zato ni priporočljiva (glejte poglavje 4. 4).
Therefore, this combination is not recommended (see section 4.4).
Zato se takšne kombinacije ne priporoča (glejte poglavje 4. 4).
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroidna protivnetna zdravila: kadar sočasno jemljemo antagoniste angiotenzina II in nesteroidna protivnetna zdravila (NSAID) (npr. selektivne COX- 2 zaviralce, acetilsalicilno kislino (> 3 g dnevno) in neselektivne NSAID) lahko oslabi antihipertenzivni učinek.
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Uporaba antagonistov angiotenzina II v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4. 4).
The use of AIIRAs is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4. 3 in 4. 4).
4 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.
4 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.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5. 3).
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
Aprovel is contraindicated (see section 4.3) during breast-feeding.
Dojenje: med dojenjem je zdravilo Aprovel kontraindicirano (glejte poglavje 4. 3).
It is not known whether irbesartan is excreted in human milk.
Ni znano ali se irbesartan izloča z materinim mlekom.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan se izloča v mleku doječih podgan.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
V s placebom kontroliranih preskušanjih z bolniki s hipertenzijo, se celotna pogostost neželenih dogodkov med skupinama z irbesartanom (56, 2%) in placebom (56, 5%) ni razlikovala.
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, 5%).
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), kar je več kot pri placebu.
The following table presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Sledeča tabela predstavlja neželene učinke zdravila o katerih so poročali v s placebom kontroliranih preskušanjih, v katerih je sodelovalo 1. 965 bolnikov z visokim krvnim tlakom, ki so prejemali irbesartan.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/ 10); pogosti (≥1/ 100, < 1/ 10); občasni (≥1/ 1. 000, < 1/ 100); redki (≥1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Hiperkaliemija * se je pogosteje pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom 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.
5 je hiperkaliemija (≥ 5, 5 mEq/ l) pojavila pri 46, 3% bolnikov, ki so dobivali irbesartan, in pri 26, 3% bolnikov v placebo skupini.
5 Common:
Pogosti:
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
pri bolnikih zdravljenih z irbesartanom so pogosto (1, 7%) opazili pomembno povečanje plazemske kreatinin kinaze.
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Pri 1, 7% bolnikov z visokim krvnim tlakom z napredovalo diabetično ledvično boleznijo, ki so jih zdravili z irbesartanom, so opazili znižanje hemoglobina *, ki ni bilo klinično pomembno.
Nervous system Common:
Bolezni živčevja:
disorders: dizziness, orthostatic dizziness*
omotica, ortostatska omotica *
nausea/ vomiting diarrhoea, dyspepsia/ heartburn
slabost/ bruhanje. driska, dispepsija / zgaga
and connective tissue disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
musculoskeletal pain*
mišičnoskeletna bolečina *
orthostatic hypotension* flushing
ortostatska hipotenzija * rdečica
fatigue chest pain
utrujenost. bolečina v prsih
sexual dysfunction
motnje na področju spolnosti
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Po pridobitvi dovoljenja za promet so poročali o naslednjih dodatnih neželenih učinkih, ki izhajajo iz spontanih poročil, zato je pogostnost teh neželenih učinkov neznana:
Dysgeusia
Paragevzija
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)
Musculoskeletal and connective tissue disorders:
6 Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Artralgija, mialgija (v nekaterih primerih sta bili povezani z zvišanjem ravni kreatin- kinaze v plazmi), mišični krči
6 Metabolism and nutrition disorders:
Presnovne in prehranske motnje:
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Med randomiziranim preskušanjem pri 318 hipertenzivnih otrocih in mladostnikih, starih od 6 do 16 let, so se med 3- tedensko dvojno slepo fazo pojavili naslednji neželeni dogodki: glavobol (7, 9%), hipotenzija (2, 2%), omotica (1, 9%), kašelj (0, 9%).
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Med 26- tedenskim odprtim obdobjem tega preskušanja so bila najpogostejša laboratorijska odstopanja zvišanje kreatinina (6, 5%) in zvišanje vrednosti kreatinin- kinaze (CK) pri 2% otrok.
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Izkušnje pri odraslih, ki so bili 8 tednov izpostavljeni odmerkom do 900 mg/ dan, niso odkrile toksičnosti.
Suggested measures include induction of emesis and/ or gastric lavage.
Priporočeni ukrepi vključujejo sprožitev bruhanja in/ ali izpiranje želodca.
ATC code:
Antagonisti angiotenzina II, enokomponentna zdravila oznaka ATC:
C09C A04.
C09CA04.
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Pričakovani učinek je blokada vseh učinkov angiotenzina II, ki se prenašajo preko receptorja AT1, ne glede na izvor ali sintezno pot angiotenzina- II.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ne zavira ACE (kininaze- II), to je encima, ki tvori angiotenzin II in tudi razgrajuje bradikinin v neučinkovite metabolite.
Hypertension Irbesartan lowers blood pressure with minimal change in heart rate.
Hipertenzija Irbesartan znižuje krvni tlak z minimalno spremembo srčnega utripa.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg.
Enkratni dnevni odmerki 150- 300 mg v povprečju vseskozi (npr.
Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i. e.
24 ur po odmerku) znižajo krvni tlak v ležečem ali sedečem položaju za 8- 13/ 5- 8 mmHg (sistolični/ diastolični) več, kot se zniža s placebom.
24 hours after dosing) by an average of 8-13/ 5-8 mm Hg (systolic/ diastolic) greater than those associated with placebo.
Največje znižanje krvnega tlaka je doseženo v 3- 6 urah po jemanju zdravila.
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
Antihipertenzivni učinek traja najmanj 24 ur.
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Po 24 urah je bilo zmanjšanje krvnega tlaka 60- 70% ustreznega največjega diastoličnega in sistoličnega odziva na priporočeni odmerek.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Enkratno dnevno odmerjanje 150 mg
The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Učinek zdravila Aprovel na znižanje krvnega tlaka je viden po 1- 2 tednih, največji učinek pa nastopi 4- 6 tednov po začetku zdravljenja.
7 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).
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Podobno kot pri drugih zdravilih, ki delujejo na sistem renin- angiotenzin, se temnopolti bolniki z visokim krvnim tlakom izrazito slabše odzivajo na monoterapijo z irbesartanom.
When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e. g.
Kadar se irbesartan uporablja sočasno z nizkim odmerkom hidroklorotiazida (npr.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
12, 5 mg dnevno), se antihipertenzivni odziv temnopoltih bolnikov z visokim krvnim tlakom približa odzivu belcev.
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Znižanje krvnega tlaka s ciljnimi titracijskimi odmerki irbesartana 0, 5 mg/ kg (nizki odmerek), 1, 5 mg/ kg (srednji odmerek) in 4, 5 mg/ kg (visoki odmerek) so v 3- tedenskem obdobju ocenili pri 318 ogroženih (diabetes, družinska anamneza hipertenzije) otrocih in mladostnikih, starih od 6 do 16 let.
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Po koncu 3- tedenskega obdobja se je primarna spremenljivka učinkovitosti, najnižji sistolični krvni tlak sede (SeSBP – seated systolic blood pressure), v primerjavi z izhodiščem znižala za povprečno 11, 7 mmHg (nizki odmerek), 9, 3 mmHg (srednji odmerek) oz.
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows:
Korigirana povprečna sprememba najnižjega diastoličnega krvnega tlaka sede (SeDBP – seated diastolic blood pressure) je bila 3, 8 mmHg (nizki odmerek), 3, 2 mmHg (srednji odmerek) oz.
3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
5, 6 mmHg (visoki odmerek).
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
V naslednjih dveh tednih so bolnike ponovno randomizirali bodisi na zdravilno učinkovino bodisi na placebo; tistim, ki so dobivali placebo, se je SeSBP zvišal za 2, 4 mmHg in SeDBP za 2, 0 mmHg, medtem ko se je bolnikom na vseh odmerkih irbesartana SeSBP spremenil za +0, 1 mmHg in SeDBP za – 0, 3 mmHg (glejte poglavje 4. 2).
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.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Bolnikom so postopoma povečevali odmerek zdravila Aprovel od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2, 5 do 10 mg, oziroma placeba, kot so ga prenesli.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
V vseh zdravljenih skupinah so bolniki običajno prejemali 2 do 4 antihipertenzive (diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce adrenergičnih receptorjev alfa), da so dosegli ciljni krvni tlak, ki je bil ≤135/ 85 mmHg, ali znižanje krvnega tlaka za najmanj 10 mmHg, če je bil začetni krvni tlak > 160 mmHg.