natgillin/translations-raw huggingface dataset:
Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Pričakovani obseg sprememb v koncentracijah aliskirena v prisotnosti ketokonazola se giblje v okviru, ki bi ga dosegli s podvojenim odmerjanjem aliskirena.
Yet, P-gp inhibitors are expected to increase tissue concentrations more than plasma concentrations.
Vendar pa je od zaviralcev P - gp mogoče pričakovati, da bodo zvišali koncentracije v tkivih bolj kot koncentracije v plazmi.
Therefore, caution should be exercised when aliskiren is administered with ketoconazole or other moderate pgp inhibitors (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
Zato je potrebna previdnost pri sočasni uporabi aliskirena s ketokonazolom ali z drugimi zmernimi zaviralci P- gp (itrakonazolom, klaritomicinom, telitromicinom, eritromicinom, amiodaronom).
P-gp potent inhibitors A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Močni zaviralci P- gp V študiji medsebojnega delovanja zdravil z enkratnim odmerjanjem pri zdravih osebah se je pokazalo, da ciklosporin (200 in 600 mg) zviša Cmax aliskirena (75 mg) približno 2, 5- krat, AUC pa približno 5 - krat.
Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Zato je sočasna uporaba aliskirena in močnih zaviralcev P- gp kontraindicirana (glejte poglavje 4. 3).
Furosemide When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49% respectively.
Furosemid Pri sočasni uporabi aliskirena s furosemidom se je AUC furosemida znižala za 28%, Cmax furosemida pa za 49%.
It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of volume overload.
Zato je pri uvedbi in prilagajanju zdravljenja s furosemidom pripročljivo spremljanje
4 potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
4 učinkov, da ne bi uporabljali premajhnih odmerkov v stanjih volumske preobremenitve.
Grapefruit juice Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Grenivkin sok Zaradi pomanjkanja podatkov medsebojnega delovanja med grenivkinim sokom in aliskirenom ni mogoče izključiti.
Pregnancy There are no data on the use of aliskiren in pregnant women.
Nosečnost Ni podatkov o uporabi aliskirena pri nosečnicah.
Enviage was not teratogenic in rats or rabbits (see section 5.3).
Zdravilo Enviage ni bilo teratogeno pri podganah ali kuncih (glejte poglavje 5. 3).
Other substances that act directly on the RAS have been associated with serious foetal malformations and neonatal death.
Druge snovi, ki delujejo neposredno na sistem renin- angiotenzin, so povezane s hudimi okvarami ploda in smrtjo novorojenčka.
As for any medicine that acts directly on the RAS, Enviage should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin- angiotenzin, tudi zdravila Enviage ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4. 3).
Healthcare professionals prescribing any agents acting on the RAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Zdravstveni delavci, ki predpisujejo katerokoli učinkovino, ki deluje na sistem renin- angiotenzin, morajo ženskam v rodni dobi razložiti možna tveganja uporabe teh učinkovin med nosečnostjo.
Lactation It is not known whether aliskiren is excreted in human milk.
Dojenje Ni znano, ali se aliskiren izloča v materino mleko pri človeku.
Enviage has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Varnost zdravila Enviage so ocenjevali pri več kot 7. 800 bolnikih, med drugim pri več kot 2. 300 bolnikih, ki so bili zdravljeni več kot 6 mesecev, in pri več kot 1. 200 bolnikih, ki so bili zdravljeni več kot 1 leto.
The most common adverse drug reaction is diarrhoea.
Zaradi neželenih učinkov je bilo zdravljenje le redko potrebno prekiniti.
The incidence of cough was similar in placebo (0.6%) and Enviage treated (0.9%) patients.
Incidenca kašlja je bila podobna pri bolnikih, ki so prejemali placebo (0, 6%), in pri bolnikih, ki so bili zdravljeni z zdravilom Enviage (0, 9%).
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, 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), including isolated reports.
Neželeni učinki (preglednica 1) so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, po naslednjem dogovoru: zelo pogosti (≥1/ 10); pogosti (≥1/ 100, < 1/ 10); občasni (≥1/ 1. 000, < 1/ 100);
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
5 redki (≥1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
5 Table 1
Preglednica 1
Diarrhoea
driska
In the event of any signs suggesting an allergic reaction (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/ or tongue) patients should discontinue treatment and contact the physician.
V primeru znakov, ki bi nakazovali alergično reakcijo (še posebno, če gre za težave z dihanjem ali pri požiranju, otekanje obraza, okončin, oči, ustnic in/ ali jezika), mora bolnik prekiniti zdravljenje in se obrniti na zdravnika.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Enviage.
Laboratorijski izvidi V kontroliranih kliničnih študijah je bila uporaba zdravila Enviage občasno povezana s klinično pomembnimi spremembami standardnih laboratorijskih parametrov.
Haemoglobin and haematocrit:
Hemoglobin in hematokrit:
Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/ l and 0.16 volume percent, respectively) were observed.
Opažali so majhno znižanje vrednosti hemoglobina in hematokrita (povprečno znižanje koncentracije hemoglobina za približno 0, 05 mmol/ l in hematokrita za 0, 16 volumskega odstotka).
This effect is also seen with other agents acting on the renin- angiotensin system, such as angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers.
Ta učinek so opažali tudi pri drugih učinkovinah, ki delujejo na sistem renin- angiotenzin, kot so zaviralci angiotenzinske konvertaze (zaviralci ACE) in zaviralci angiotenzinskih receptorjev.
Serum potassium:
Kalij v serumu:
Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Enviage alone (0.9% compared to 0.6% with placebo).
Pri bolnikih z esencialno hipertenzijo, zdravljenih samo z zdravilom Enviage, je redko in v majhni meri prišlo do zvišanja vrednosti kalija v serumu (0, 9% v primerjavi z 0, 6% pri placebu).
However, in one study where Enviage was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Vendar pa je v eni študiji, v kateri so zdravilo Enviage uporabljali v kombinaciji z zaviralci angiotenzinske konvertaze pri sladkornih bolnikih, pogosteje prihajalo do zvišanja vrednosti kalija v serumu (5, 5%).
Therefore as with any agent acting on the RAS system, routine monitoring of electrolytes and renal function is indicated in patients with diabetes mellitus, kidney disease, or heart failure.
Zato je pri bolnikih s sladkorno boleznijo, z ledvično boleznijo ali s popuščanjem srca indicirano rutinsko spremljanje vrednosti elektrolitov in delovanja ledvic, tako kot pri vsaki učinkovini, ki deluje na sistem renin- angiotenzin.
Renin inhibitor, ATC code:
Farmakoterapevtska skupina: zaviralec renina, oznaka ATC:
By inhibiting the enzyme renin, aliskiren inhibits the RAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Z zaviranjem encima renina aliskiren zavre delovanje sistema renin- angiotenzin na točki aktivacije, saj zavre pretvorbo angiotenzinogena v angiotenzin I in tako zniža ravni angiotenzina I in angiotenzina II.
Whereas other agents that inhibit the RAS (ACEI and angiotension II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
V nasprotju z drugimi učinkovinami, ki zavirajo sistem renin- angiotenzin (zaviralci angiotenzinske konvertaze in antagonisti angiotenzina II) in povzročajo kompenzacijsko zvišanje delovanja renina v
Similar reductions were found when aliskiren was combined with other antihypertensive agents.
6 plazmi, pa zdravljenje z aliskirenom zniža delovanje renina v plazmi pri hipertenzivnih bolnikih za približno 50 do 80%.
Elevated PRA has been independently associated with increased cardiovascular risk in hypertensive and normotensive patients.
Do podobnega znižanja pride tudi pri uporabi aliskirena v kombinaciji z drugimi antihipertenzivnimi zdravili.
6 Hypertension In hypertensive patients, once-daily administration of Enviage at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Znižanje krvnega tlaka je bilo odvisno od velikosti odmerka in se je ohranilo skozi celoten 24- urni interval odmerjanja (ohranjena koristnost učinka v zgodnjih jutranjih urah).
85 to 90% of the maximal blood- pressure-lowering effect was observed after 2 weeks.
Po dveh tednih so opažali izraženost 85 do 90% največjega učinka zniževanja krvnega tlaka.
Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Zdravilo Enviage so proučevali pri 1. 864 bolnikih, starih 65 let ali več, in pri 426 bolnikih, starih 75 let ali več.
Compared to a diuretic (hydrochlorothiazide - HCTZ), Enviage 300 mg lowered systolic/ diastolic blood pressure by 17.0/ 12.3 mmHg, compared to 14.4/ 10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
V primerjavi z diuretikom hidroklorotiazidom je Enviage po 12 tednih zdravljenja v odmerku 300 mg znižal sistolični/ diastolični krvni tlak za 17, 0/ 12, 3 mmHg, hidroklorotiazid v odmerku 25 mg pa za 14, 4/ 10, 5 mmHg.
In diabetic hypertensive patients, Enviage provided additive blood pressure reductions when added to ramipril, while the combination of Enviage and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
Pri sladkornih bolnikih s hipertenzijo je dodatek zdravila Enviage k zdravljenju z ramiprilom povzročil dodatno znižanje krvnega tlaka, incidenca kašlja pa je bila ob kombinaciji zdravila Enviage in ramiprila nižja (1, 8%) kot pri zdravljenju samo z ramiprilom (4, 7%).
Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Enviage alone.
Pri bolnikih s hipertenzijo brez zapletov, ki so se zdravili samo z zdravilom Enviage, so občasno (pri 0, 1%) opažali pretirano hipotenzijo.
Hypotension was also uncommon (< 1%) during combination therapy with other antihypertensive agents.
Hipotenzijo so občasno (pri manj kot 1%) opažali tudi med zdravljenjem v kombinaciji z drugimi antihipertenzivnimi zdravili.
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Enviage 150 mg was well tolerated.
V 3- mesečni študiji, ki je vključevala 302 bolnika z blagim, stabilnim srčnim popuščanjem, od katerih so vsi prejemali standardno terapijo pri stabilnem srčnem popuščanju, so bolniki dodajanje zdravila Enviage v odmerku 150 mg dobro prenašali.
However the clinical significance of this reduction is unknown.
Koncentracije možganskega natriuretičnega peptida (BNP - B- type natriuretic peptide) so bile v skupini z zdravilom Enviage nižje za 25% v primerjavi s skupino s placebom, vendar klinični pomen tega znižanja ni znan.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Enviage 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
7 V 6- mesečni študiji, ki je vključevala 599 bolnikov s hipertenzijo, sladkorno boleznijo tipa 2 in nefropatijo, so vsi bolniki prejemali 100 mg losartana in optimizirano antihipertenzivno osnovno zdravljenje.
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Enviage and placebo, respectively.
Dodajanje zdravila Enviage v odmerku 300 mg je v primerjavi s placebom povzročilo 20- odstotno zmanjšanje razmerja med koncentracijo albumina in kreatinina v urinu (UACR - urinary albumin: creatinine ratio), to je od 58 mg/ mmol na 46 mg/ mmol.
The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Delež bolnikov, ki so imeli UACR zmanjšano za vsaj 50% od izhodiščne vrednosti, je bil pri zdravilu Enviage 24, 7%, pri placebu pa 12, 5%.
Enviage did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Kliničnega pomena zmanjšanja UACR niso ugotovili glede na to, da ne vpliva na krvni tlak.
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
Zdravilo Enviage ni vplivalo na koncentracijo kreatinina v serumu, povezano pa je bilo z večjo pogostnostjo (4, 2% v primerjavi z 1, 9% pri placebo) koncentracije kalija v serumu (≥ 6, 0 mmol/ l), čeprav razlika ni bila statistično značilna.
7 Beneficial effects of Enviage on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Ugodni vplivi zdravila Enviage na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
Cardiac electrophysiology No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Elektrofiziologija srca V randomizirani, dvojno slepi, s placebom in aktivno kontrolirani študiji, v kateri so uporabljali standardno in Holter elektrokardiografijo, niso opažali učinka na QT interval.
Absorption Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Absorpcija Po peroralni absorpciji doseže aliskiren največje koncentracije v plazmi po 1 - 3 urah.
The absolute bioavailability of aliskiren is approximately 2-3%.
Absolutna biološka uporabnost aliskirena je približno 2 - 3%.
Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Obroki z veliko vsebnostjo maščob zmanjšajo Cmax za 85% in AUC za 70%.
Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than with the initial dose.
Koncentracije v stanju dinamičnega ravnovesja so približno 2- krat višje kot po začetnem odmerku.
Distribution Following intravenous administration, the mean volume of distribution at steady state is approximately 135 litres, indicating that aliskiren distributes extensively into the extravascular space.
Porazdelitev Po intravenski aplikaciji je povprečen volumen porazdelitve v stanju dinamičnega ravnovesja približno 135 litrov, kar nakazuje, da se aliskiren v veliki meri porazdeli po ekstravaskularnem prostoru.
Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Aliskiren se zmerno veže na proteine v plazmi (47 - 51%) in sicer neodvisno od koncentracije.
Metabolism and elimination The mean half-life is about 40 hours (range 34-41 hours).
Presnova in izločanje Povprečen razpolovni čas je približno 40 ur (v okviru 34 - 41 ur).
Aliskiren is mainly eliminated as unchanged compound in the faeces (78%).
Aliskiren se večinoma izloča z blatom v nespremenjeni obliki (78%).
Approximately 1.4% of the total oral dose is metabolised.
Približno 1, 4% celotnega peroralnega odmerka se presnovi.
Approximately 0.6% of the dose is recovered in urine following oral administration.
Po peroralni aplikaciji je približno 0, 6% odmerka možno zaslediti v urinu.
Following intravenous administration, the mean plasma clearance is approximately 9 l/ h.
Po intravenski aplikaciji je povprečni plazemski očistek približno 9 l/ h.
Linearity/ non-linearity Exposure to aliskiren increased more than in proportion to the increase in dose.
Linearnost/ nelinearnost Izpostavljenost aliskirenu ni naraščala sorazmerno z višanjem odmerka, ampak hitreje.
After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6- fold increase in AUC and Cmax, respectively.
Pri aplikaciji enkratnih odmerkov v obsegu od 75 do 600 mg dvakratno zvišanje odmerka povzroči 2, 3- kratno povečanje AUC in 2, 6- kratno zvišanje Cmax.
Characteristics in patients Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Posebne skupine bolnikov Aliskiren predstavlja učinkovito antihipertenzivno zdravljenje za enkrat dnevno odmerjanje pri odraslih bolnikih ne glede na spol, starost, indeks telesne mase in etnično pripadnost.
The AUC is 50% higher in elderly (> 65 years) than in young subjects.
AUC je pri starejših (> 65 let) 50% večja kot pri mladih osebah.
The pharmacokinetics of aliskiren were evaluated in patients with varying degrees of renal insufficiency.
Farmakokinetične lastnosti aliskirena so ocenjevali pri bolnikih z različnimi stopnjami ledvične
8 5.3 Preclinical safety data
8 insuficience.
Carcinogenic potential was assessed in a 2-year rat study and a 6-month transgenic mouse study.
Zato pri bolnikih z blago do hudo okvaro jeter ni treba prilagajati začetnega odmerka aliskirena.
No carcinogenic potential was detected.
Karcinogeni potencial so ocenjevali v 2- letni študiji na podganah in v 6- mesečni študiji na transgenskih miših: karcinogenega potenciala niso zasledili.
One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/ kg/ day were not statistically significant.
Pri podganah je pri odmerku 1. 500 mg/ kg/ dan prišlo do enega adenoma debelega črevesa in enega adenokarcinoma slepega črevesa, kar pa ni bilo statistično značilno.
Although aliskiren has known irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/ kg/ day in the rat carcinogenicity study.
Čeprav je znano, da aliskiren lahko povzroča draženje, so v študiji z zdravimi prostovoljci, ki so prejemali odmerke 300 mg, ugotovili, da obsega okvir še varnih odmerkov 9 do 11- kratne vrednosti glede na koncentracije v blatu oziroma 6- kratne vrednosti glede na koncentracije v sluznici v primerjavi z odmerkom 250 mg/ kg/ dan v študiji karcinogenosti na podganah.
Reproductive toxicity studies with aliskiren did not reveal any evidence of embryofoetal toxicity or teratogenicity at doses up to 600 mg/ kg/ day in rats or 100 mg/ kg/ day in rabbits.
V študijah vpliva na sposobnost razmnoževanja z aliskirenom niso zasledili znakov toksičnosti za zarodek oziroma plod ali teratogenosti pri odmerkih do 600 mg/ kg/ dan pri podganah oziroma 100 mg/ kg/ dan pri kuncih.
Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/ kg/ day.
Odmerki do 250 mg/ kg/ dan pri podganah niso vplivali na plodnost ter na razvoj ploda pred skotitvijo in po njej.
The doses in rats and rabbits provided systemic exposures of 1 to 4 and 5 times higher, respectively, than the maximum recommended human dose (300 mg).
Odmerjanje pri podganah in kuncih je povzročilo sistemsko izpostavljenost zdravilu, ki je bila pri podganah 1 do 4- krat večja, pri kuncih pa 5- krat večja kot pri najvišjem priporočenem odmerku za človeka (300 mg).
Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone Silica, colloidal anhydrous Hypromellose Macrogol Talc Iron oxide, black (E 172) Iron oxide, red (E 172) Titanium dioxide (E 171)
krospovidon magnezijev stearat mikrokristalna celuloza povidon brezvodni koloidni silicijev dioksid hipromeloza makrogol smukec črni železov oksid (E 172) rdeči železov oksid (E 172) titanov dioksid (E 171)
PA/ Alu/ PVC blisters
PA/ Alu/ PVC pretisni omoti
Light-red, biconvex, ovaloid tablet, imprinted “ IU ” on one side and “ NVR” on the other side.
Bikonveksna ovalna tableta svetlo rdeče barve, z vtisnjeno oznako ‘ IU ’ na eni strani in ‘ NVR ’ na drugi.
11 4.3 Contraindications
11 4. 3 Kontraindikacije
Second and third trimesters of pregnancy (see section 4.6).
Drugo in tretje trimesečje nosečnosti (glejte poglavje 4. 6).
When administered with atorvastatin, steady-state Enviage AUC and Cmax increased by 50%.
12 sočasne uporabe z atorvastatinom sta se AUC in Cmax zdravila Enviage v stanju dinamičnega ravnovesja zvišala za 50%.
Co- administration of Enviage had no significant impact on atorvastatin, valsartan, metformin or
Sočasna uporaba zdravila Enviage ni pomembno vplivala na farmakokinetične lastnosti atorvastatina, valsartana, metformina in amlodipina.
13 Potassium and potassium-sparing diuretics Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
13 učinkov, da ne bi uporabljali premajhnih odmerkov v stanjih volumske preobremenitve.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
14 redki (≥1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
14 Table 1
Preglednica 1
Similar reductions were found when aliskiren was combined with other antihypertensive agents.
15 plazmi, pa zdravljenje z aliskirenom zniža delovanje renina v plazmi pri hipertenzivnih bolnikih za približno 50 do 80%.
15 Hypertension In hypertensive patients, once-daily administration of Enviage at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Znižanje krvnega tlaka je bilo odvisno od velikosti odmerka in se je ohranilo skozi celoten 24- urni interval odmerjanja (ohranjena koristnost učinka v zgodnjih jutranjih urah).
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Enviage 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
16 V 6- mesečni študiji, ki je vključevala 599 bolnikov s hipertenzijo, sladkorno boleznijo tipa 2 in nefropatijo, so vsi bolniki prejemali 100 mg losartana in optimizirano antihipertenzivno osnovno zdravljenje.