natgillin/translations-raw huggingface dataset:
2 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
2 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Mimpare.
PTH should be monitored approximately every 1-3 months during maintenance.
Med vzdrževalnim zdravljenjem je treba PTH kontrolirati približno na 1 do 3 mesece.
Either the intact PTH (iPTH) or bio- intact PTH (biPTH) may be used to measure PTH levels; treatment with Mimpara does not alter the relationship between iPTH and biPTH.
Za merjenje koncentracije PTH je mogoče uporabimo intaktni PTH (iPTH) ali biointaktni PTH (biPTH); zdravljenje z Mimparo ne spremeni razmerja med iPTH in biPTH.
Information regarding the pharmacokinetic/ pharmacodynamic (PK/ PD) profile of cinacalcet is given in section 5.1
Informacije o farmakokinetičnih in farmakodinamičnih značilnostih cinakalceta vsebuje poglavje 5. 1.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara.
Med titriranjem odmerka pogosto kontrolirajte koncentracijo kalcija v serumu; prav tako jo kontrolirajte v 1 tednu po začetku zdravljenja oz. po prilagoditvi odmerka Mimpare.
If serum calcium levels decrease below the normal range, appropriate steps should be taken (see section 4.4).
Če se koncentracija kalcija v serumu zmanjša pod normalno območje, ustrezno ukrepajte (glejte poglavje 4. 4).
Concomitant therapy with phosphate binders and/ or vitamin D sterols should be adjusted as appropriate.
Sočasno terapijo z vezalci fosfatov in/ ali steroli vitamina D je treba prilagoditi, kot je primerno.
Safety and efficacy have not been established in patients below the age of 18 years.
Varnost in učinkovitost nista ugotovljeni pri bolnikih, mlajših od 18 let.
Parathyroid Carcinoma and Primary Hyperparathyroidism
Paratiroidni karcinom in primarni hiperparatiroidizem
The recommended starting dose of Mimpara for adults is 30 mg twice per day.
Priporočeni začetni odmerek Mimpare za odrasle je 30 mg dvakrat na dan.
The dosage of Mimpara should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Odmerjanje Mimpare je treba titrirati na 2 do 4 tedne z zaporednimi odmerki 30 mg dvakrat na dan, 60 mg dvakrat na dan, 90 mg dvakrat na dan in 90 mg trikrat ali štirikrat na dan, kot je potrebno za znižanje koncentracije kalcija v serumu na zgornjo mejo normalnega območja ali pod njo.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Kalcij v serumu je treba izmeriti v 1 tednu po začetku zdravljenja oz. prilagoditvi odmerka Mimpare.
Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months.
Ko je vzdrževalni odmerek določen, je treba kalcij v serumu meritina 2 do 3 mesece.
After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
(glejte poglavje 5. 1).
Safety and efficacy have not been established in patients below the age of 18 years.
Varnost in učinkovitost nista ugotovljeni pri bolnikih, mlajših od 18 let..
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Mimpara and placebo groups reported a history of seizure disorder at baseline.
V treh kliničnih študijah bolnikov s kronično boleznijo ledvic na dializi je anamnezo konvulzivne motnje izhodiščno navedlo 5% bolnikov, tako v skupini z Mimparo kot v skupini s placebom.
In these studies, seizures were observed in 1.4% of Mimpara treated patients and 0.4% of placebo-treated patients.
V teh študijah so konvulzije opažali pri 1, 4% bolnikov, zdravljenih z Mimparo, in 0, 4% bolnikov, ki so dobivali placebo.
While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.
Zakaj ta razlika v pojavljanju konvulzij, ni jasno; res pa je, da bistveno znižanje koncentracije kalcija v serumu zniža prag za konvulzije.
3 Hypotension and/ or worsening heart failure
3 znižanih koncentracij kalcija v serumu.
Serum Calcium
Kalcij v serumu
Mimpara treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Zdravljenja z Mimparo ne smete začeti pri bolnikih, ki imajo kalcij v serumu (korigiran za albumin) pod spodnjo mejo normalnega območja.
Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of hypocalcaemia (see section 4.2).
Ker cinakalcet znižuje kalcij v serumu, je treba bolnike natančno nadzirati glede hipokalciemije (glejte poglavje 4. 2).
In CKD patients receiving dialysis who were administered Mimpara, 4% of serum calcium values were less than 7.5 mg/ dl (1.875 mmol/ l).
Pri bolnikih s kronično boleznijo ledvic, ki so se zdravili z dializo in so dobivali zdravilo Mimpara, so bile serumske koncentracije kalcija nižje od 7, 5 mg/ dl (1, 875 mmol/ l) pri 4% bolnikov.
In the event of hypocalcaemia, calcium-containing phosphate binders, vitamin D sterols and/ or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium.
V primeru hipokalciemije je za zvišanje kalcija v serumu mogoče uporabiti vezalce fosfatov, ki vsebujejo kalcij, sterole vitamina D in/ ali prilagoditev koncentracije kalcija v dializni tekočini.
If hypocalcaemia persists, reduce the dose or discontinue administration of Mimpara.
Če hipokalciemija traja, zmanjšajte odmerek Mimpare ali njeno uporabo prekinite.
Potential manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Med možnimi znaki hipokalciemije so lahko parestezije, mialgije, krči, tetanija in konvulzije.
Cinacalcet is not indicated for CKD patients not on dialysis.
Cinakalcet ni indiciran za bolnike s kronično ledvično odpovedjo, ki se ne zdravijo z dializo.
Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/ dl [2.1 mmol/ l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/ or the presence of residual kidney function.
V raziskovalnih študijah se je pokazalo, da je pri bolnikih s kronično ledvično odpovedjo, ki se ne zdravijo z dializo, prejemajo pa cinakalcet, tveganje za hipokalciemijo (koncentracije kalcija v serumu < 8, 4 mg/ dl [2, 1 mmol/ l]) večje v primerjavi z bolniki s kronično ledvično odpovedjo, ki se zdravijo z dializo in prejemajo cinakalcet.
Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 1.5 times the upper limit of normal with the iPTH assay.
Adinamična bolezen kosti se lahko pojavi, če je koncentracija PTH kronično zavrta pod približno 1, 5- kratno zgornjo mejo normalnega območja (merjeno s testom iPTH).
If PTH levels decrease below the recommended target range in patients treated with Mimpara, the dose of Mimpara and/ or vitamin D sterols should be reduced or therapy discontinued.
Če se pri bolnikih, zdravljenih z Mimparo, koncentracija PTH zniža pod priporočeno ciljno območje, odmerek Mimpare in/ ali sterolov vitamina D zmanjšajte ali terapijo prekinite.
Testosterone Levels
Koncentracija testosterona
In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
V klinični študiji bolnikov s končno odpovedjo ledvic na dializi se je koncentracija prostega testosterona po 6 mesecih zdravljenja z Mimparo znižala za mediano 31, 3%, po 6 mesecih uporabe placeba pa za mediano 16, 3%.
An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Odprto podaljšanje te študije med 3- letnim obdobjem ni pokazalo dodatnega znižanja koncentracije prostega in celotnega testosterona pri bolnikih, ki so dobivali Mimparo.
The clinical significance of these reductions in serum testosterone is unknown.
Klinični pomen tega znižanja testosterona v serumu ni znan.
Hepatic Insufficiency
Insuficienca jeter
Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment (Child-Pugh classification), Mimpara should be used with caution in these patients and treatment should be closely monitored (see sections 4.2 and 5.2).
Zato je treba Mimparo pri teh bolnikih uporabljati previdno, zdravljenje pa natančno nadzirati (glejte poglavji 4. 2 in 5. 2).
Caution should be exercised when administering Mimpara concomitantly with strong inhibitors or inducers of CYP3A4 and/ or CYP1A2.
Med sočasno uporabo Mimpare in močnih zaviralcev ali induktorjev CYP3A4 in/ ali CYP1A2 je potrebna previdnost.
Dose adjustment of Mimpara may be necessary (see section 4.5).
Potrebna utegne biti prilagoditev odmerka Mimpare (glejte poglavje 4. 5).
Caution should be exercised when Mimpara is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
Previdnost je potrebna, če je Mimpara uporabljena z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6.
Dose adjustments of concomitant medications may be necessary (see section 4.5).
Potrebne utegnejo biti prilagoditve odmerkov sočasno uporabljenih zdravil (glejte poglavje 4. 5).
4 Plasma levels of cinacalcet may be lower in smokers due to induction of CYP1A2-mediated metabolism.
Koncentracija cinakalceta v plazmi je pri kadilcih zaradi indukcije presnove s CYP1A2 lahko nižja.
Dose adjustments may be necessary if a patient starts or stops smoking during cinacalcet treatment (see section 4.5).
Če bolnik med zdravljenjem s cinakalcetom začne kaditi ali opusti kajenje, utegnejo biti potrebne prilagoditve odmerka (glejte poglavje 4. 5).
Co-administration of 200 mg bid ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
Sočasna uporaba 200 mg ketokonazola (močnega zaviralca CYP3A4) dvakrat na dan je povzročilo približno 2- kraten porast koncentracije cinakalceta.
Dose adjustment of Mimpara may be required if a patient receiving Mimpara initiates or discontinues therapy with a strong inhibitor (e. g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Če bolnik, ki dobiva Mimparo, začne ali preneha uporabljati terapijo z močnim zaviralcem tega encima (npr. ketokonazolom, itrakonazolom, telitromicinom, vorikonazolom, ritonavirjem) ali njegovim induktorjem (npr. rifampicinom), utegne biti potrebna prilagoditev dmerka Mimpare (glejte poglavje 4. 4).
Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Kajenje inducira CYP1A2; očistek cinakalceta pri kadilcih je za 36 do 38% večji kot pri nekadilcih.
The effect of CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
Učinek zaviralcev CYP1A2 (npr. fluvoksamina, ciprofloksacina) na koncentracijo cinakalceta v plazmi ni raziskan.
Dose adjustment may be necessary if a patient starts or stops smoking or when concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.
Prilagoditve doze so lahko potrebne, Če bolnik začne kaditi ali opusti kajenje, utegne biti potrebna prilagoditev odmerka; enako velja po uvedbi ali prekinitvi sočasnega zdravljenja z močnimi zaviralci CYP1A2.
Co-administration of calcium carbonate (single 1500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Sočasna uporaba kalcijevega karbonata (posamičen 1500- mg odmerek) ni spremenila farmakokinetike cinakalceta.
Co-administration of sevelamer (2400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Sočasna uporaba sevelamera (2400 mg trikrat na dan) ni vplivala na farmakokinetiko cinakalceta.
Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Sočasna uporaba pantoprazola (80 mg na dan) ni spremenila farmakokinetike cinakalceta.
Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6):
Zdravila, ki se presnavljajo z encimom 2D6 (CYP2D6) P450:
Cinacalcet is a strong inhibitor of CYP2D6.
Cinakalcet je močan zaviralec CYP2D6.
Dose adjustments of concomitant medicinal products may be required when Mimpara is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e. g., flecainide, propafenone, metoprolol given in heart failure, desipramine, nortriptyline, clomipramine) (see section 4.4).
Če bolnik dobiva Mimparo hkrati z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol pri srčnem popuščanju, dezipramin, nortriptilin, klomipramin), utegne biti potrebna prilagoditev odmerka sočasno rabljenih zdravil (glejte poglavje 4. 4).
Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
3, 0, 4, 4).
Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Večkratni peroralni odmerki cinakalceta niso vplivali na farmakokinetiko ali farmakodinamiko varfarina (merjeno s protrombinskim časom in faktorjem strjevanja VII).
The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto- induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Dejstvo, da cinakalcet ne vpliva na farmakokinetiko R - in S- varfarina in da večkratno odmerjanje pri bolnikih ne povzroči avtoindukcije, kaže, da cinakalcet pri človeku ne inducira CYP3A4, CYP1A2 ali CYP2C9.
Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam.
Sočasna uporaba cinakalceta (90 mg) s peroralnim midazolamom (2 mg), ki je substrat CYP3A4 in CYP3A5, ni spremenila farmakokinetike midazolama.
These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of drugs that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
To nakazuje, da cinakalcet ne bi vplival na farmakokinetiko tistih skupin zdravil, ki se presnavljajo s CYP3A4 in CYP3A5, npr. nekaterih imunosupresivov, vključno s ciklosporinom in takrolimusom.
Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development.
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, porod ali postnatalni razvoj.
No embryonal/ foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3).
V študijah na brejih podganah in kunkah niso opazili embrionalnih ali fetalnih toksičnih učinkov, razen zmanjšane telesne mase plodov pri podganah ob odmerkih, ki so jih spremljali toksični učinki pri samicah -
Mimpara should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Mimparo naj bi med nosečnostjo uporabljati le, če možne koristi upravičujejo potencialno tveganje za plod.
It is not known whether cinacalcet is excreted in human milk.
Ni znano, ali se cinakalcet pri človeku izloča v mleko.
Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
V mleku doječih podgan se cinakalcet izloča z velikim razmerjem med mlekom in plazmo.
Following careful benefit/ risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Po natančni oceni koristi in tveganj se je treba odločiti bodisi za prenehanje dojenja bodisi prenehanje zdravljenja z Mimparo.
Data presented from controlled studies include 656 patients who received Mimpara and 470 patients who received placebo for up to 6 months.
Prikazani podatki iz kontroliranih kliničnih študij zajemajo 656 bolnikov, ki so dobivali Mimparo, in 470 bolnikov, ki so dobivali placebo, in sicer do 6 mesecev.
The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Mimpara and 19% placebo treated patients, and 27% Mimpara and 15% placebo treated patients, respectively.
Najpogosteje opisana neželena učinka sta bila navzeja (pojavila se je pri 31% prejemnikov Mimpare in 19% prejemnikov placeba) in bruhanje (pojavilo se je pri 27% prejemnikov Mimpare in 15% prejemnikov placeba).
Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Navzeja in bruhanje sta bila pri večini bolnikov blaga do zmerna ter prehodna.
Discontinuation of therapy as a result of undesirable effects was mainly due to nausea (1% placebo; 5% cinacalcet) and vomiting (< 1% placebo; 4% cinacalcet).
Prekinitev zdravljenja zaradi neželenih učinkov sta v glavnem povzročila navzeja (1% placebo, 5% cinakalcet) in bruhanje (< 1% placebo, 4% cinakalcet).
Adverse reactions, defined as adverse events considered at least possibly attributable to cinacalcet treatment based on best-evidence assessment of causality and reported in excess of placebo in double- blind clinical studies are listed below 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).
Pri navedbi je upoštevana naslednja konvencija: zelo pogoste (> 1/ 10), pogoste (> 1/ 100, < 1/ 10), občasne (> 1/ 1. 000, < 1/ 100), redke (> 1/ 10. 000, < 1/ 1. 000), zelo redke (< 1/ 10. 000).
Immune system disorders Uncommon: hypersensitivity reactions
Bolezni imunskega sistema občasne: preobčutljivostna reakcija
Metabolism and nutrition disorders Common: anorexia
Presnovne in prehranske motnje Pogoste: anoreksija
Nervous system disorders Common: dizziness, paraesthesia Uncommon: seizures
Bolezni živčevja Pogoste: omotica, parestezije Občasne: konvulzije
Gastrointestinal disorders Very common:
Bolezni prebavil Zelo pogoste: navzeja, bruhanje Občasne: dispepsija, diareja
Uncommon: dyspepsia, diarrhoea
Bolezni kože in podkožja Pogoste: osip
Skin and subcutaneous tissue disorders Common: rash
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogoste: mialgija
Musculoskeletal, connective tissue and bone disorders Common: myalgia
Splošne težave in spremembe na mestu aplikacije Pogoste: astenija
6 Investigations Common: hypocalcaemia (see section 4.4), reduced testosterone levels (see section 4.4)
Preiskave Pogoste: hipokalciemija (glejte poglavje 4. 4), znižana koncentracija testosterona (glejte poglavje 4. 4)
Parathyroid Carcinoma and Primary Hyperparathyroidism
6 Paratiroidni karcinom in primarni hiperparatiroidizem
The safety profile of Mimpara in these patient populations is generally consistent with that seen in patients with Chronic Kidney Disease.
Varnostne značilnosti Mimpare v teh populacijah bolnikov se v glavnem skladajo z značilnostmi pri bolnikih s kronično boleznijo ledvic.
The most frequent ADRs in these patient populations were nausea and vomiting.
Najpogostejši neželeni reakciji na zdravilo sta bili tudi v teh populacijah navzeja in bruhanje.
Post-marketing Experience
Postmarketinške izkušnje
There have been reports of isolated, idiosyncratic cases of hypotension and/ or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post marketing safety surveillance.
V postmarketinških raziskavah varnosti so poročali o posameznih idiosinkratičnih primerih hipotenzije in/ ali poslabšanja srčnega popuščanja pri bolnikih z okvarjenim delovanjem srca, zdravljenih s cinakalcetom.
Overdosage of Mimpara may lead to hypocalcaemia.
Preveliko odmerjanje Mimpare lahko povzroči hipokalciemijo.
In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and supportive.
V primeru prevelikega odmerjanja je treba bolnike spremljati glede znakov in simptomov hipokalciemije, zdravljenje pa mora biti simptomatsko in podporno.
Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdosage.
Cinakalcet je močno vezan na beljakovine, zato hemodializa za zdravljenje prevelikega odmerjanja ni učinkovita.
Pharmacotherapeutic group: anti-parathyroid agents.
Farmakoterapevtska skupina: paratiroideo zavirajoča zdravila.
Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Cinakalcet je kalcimimetično sredstvo, ki neposredno zniža koncentracijo PTH tako, da poveča občutljivost teh receptorjev na zunajcelični kalcij.
Soon after dosing, PTH begins to decrease until a nadir at approximately 2 to 6 hours postdose, corresponding with cinacalcet Cmax.
Kmalu po uporabi zdravila začne koncentracija PTH upadati in doseže najnižjo točko približno 2 do 6 ur po odmerku, kar ustreza Cmax cinakalceta.
Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once-daily dosing interval.
Ko začne koncentracija cinakalceta upadati, se koncentracija PTH zvišuje do 12 ur po uporabi zdravila, nato ostane supresija PTH do konca odmernega intervala enkrat na dan približno stalna.
PTH levels in Mimpara clinical trials were measured at the end of the dosing interval.
Koncentracijo PTH so v kliničnih preskušanjih Mimpare merili na koncu odmernega intervala.
Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1136).
Pri dializiranih bolnikih s končno odpovedjo ledvic in neobvladanim sekundarnim hiperparatiroidizmom (n = 1136) so opravili tri 6- mesečne, dvojno slepe, s placebom kontrolirane klinične študije.
Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ ml (77.8 and 72.4 pmol/ l) for the cinacalcet and placebo groups, respectively.
Povprečna izhodiščna koncentracija iPTH za vse 3 študije je bila v skupinah s cinakalcetom 733 pg/ ml (77, 8 pmol/ l) in v skupinah s placebom 683 pg/ ml (72, 4 pmol/ l).
Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet treated patients compared with placebo-treated patients receiving standard of care, and the results were
Pri prejemnikih cinakalceta so v primerjavi z bolniki, ki so prejemali placebo in standardno oskrbo, ugotovili značilno znižanje iPTH, zmnožka kalcija in fosforja v serumu (Ca x P) ter kalcija in fosforja.
7 consistent across the 3 studies.
Rezultati vseh 3 študij so se skladali.
In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/ ml (≤ 26.5 pmol/ l)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
6% bolnikov, ki so prejemali placebo.
Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
7 Približno 60% s cinakalcetom zdravljenih bolnikov je doseglo ≥ 30% znižanje vrednosti iPTH; tak učinek je bil dosleden prek spektra različnih izhodiščnih koncentracij iPTH.