natgillin/translations-raw huggingface dataset:
Markedly abnormal (> 3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with normal values prior to treatment, following treatment with both medicinal products.
Znatno nenormalne (> 3* ULN) vrednosti jetrnih transaminaz (ALT, AST in GGT) so našli po zdravljenju z obema zdraviloma pri 2- 6% bolnikov, ki so imeli pred zdravljenjem normalne vrednosti.
Marked decrease in haematological values, hematocrit (≤ 0.37) and hemoglobin (≤ 115 g/ l) were seen in 40% and 13-15%, respectively, of patients with normal values prior to treatment, following treatment with both medicinal products.
Znatno zmanjšanje hematoloških vrednosti, hematokrita (≤0, 37) pri 40% bolnikov in hemoglobina (≤115 g/ l) pri 13- 15% bolnikov, so ugotovili po zdravljenju z obema zdraviloma pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti.
It is unknown to what extent this decrease in haematological values was caused by the underlying prostate cancer and to what extent it was a consequence of androgen deprivation therapy.
Ni znano, do kakšne mere je to zmanjšanje hematoloških vrednosti povzročila osnovna bolezen, t. j. rak prostate, do kakšne mere pa je bilo zmanjšanje posledica zdravljenja z deprivacijo androgenov.
5 normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Znatno nenormalne vrednosti kalija (≥5, 8 mmol/ l), kreatinina (≥177 μmol/ l) oziroma dušika iz plazemske sečnine (≥10, 7 mmol/ l) pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti, so ugotovili pri 6%, 2% oziroma 15% bolnikov, zdravljenih z degareliksom, in pri 3%, 2% oziroma 14% bolnikov, zdravljenih z levprorelinom.
Changes in ECG measurements Changes in ECG measurements seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
Elektrokardiografske spremembe Elektrokardiografske spremembe, ki so jih ugotovili med enim letom zdravljenja, so bile za degareliks in agonist GnRH (levprorelin), ki so ga uporabili kot primerjalno zdravilo, v istih mejah.
Three (< 1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec.
Trije (< 1%) od 409 bolnikov v skupini z degareliksom in štirje (2%) od 201 bolnikov v skupini, zdravljeni z levprorelinom v odmerku 7, 5 mg, so imeli QTcF ≥ 500 msek.
From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec.
Od izhodišča do konca študije je bila mediana sprememba QTcF pri degareliksu 12, 0 msek in pri levprorelinu 16, 7 msek.
Other hormone antagonists and related agents, ATC code:
Drugi hormonski antagonisti in sorodne učinkovine, oznaka ATC:
L02BX02
L02BX02.
Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/ tumour stimulation and potential symptomatic flare after the initiation of treatment.
Za razliko od agonistov GnRH antagonisti GnRH ne sprožijo porasta LH s poznejšim porastom testosterona/ stimulacijo tumorja in možnim izbruhom simptomov po uvedbi zdravljenja.
A single dose of 240 mg degarelix, followed by a monthly maintenance dose of 80 mg, rapidly causes a decrease in the concentrations of LH, FSH and subsequently testosterone.
En sam 240- miligramski odmerek degareliksa, ki mu sledi mesečni 80- miligramski vzdrževalni odmerek, hitro povzroči znižanje koncentracij LH, FSH in nato testosterona.
The plasma concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Plazemska koncentracija dihidrotestosterona (DHT) se zniža na podoben način kot koncentracija testosterona.
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ ml.
Degareliks je učinkovit za dosego in vzdrževanje supresije testosterona precej pod ravnijo medicinske kastracije, ki je 0, 5 ng/ ml.
Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Mesečni vzdrževalni odmerek 80 mg je povzročil dolgotrajno supresijo testosterona pri 97% bolnikov, ki je trajala vsaj eno leto.
Median testosterone levels after one year of treatment were 0.087 ng/ ml (interquartile range 0.06-0.15) N=167.
Mediana koncentracija testosterona po enem letu zdravljenja je bila 0, 087 ng/ ml (interkvartilni razpon 0, 06- 0, 15) N=167.
Results of the confirmatory Phase III study The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Rezultati potrditvene študije faze III Učinkovitost in varnost degareliksa so ovrednotili v odprti, multicentrični, randomizirani študiji s paralelnimi skupinami, kontrolirani z aktivnim primerjalnim zdravilom.
The study investigated the efficacy and safety of two different degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ ml) followed by monthly doses subcutaneous administration of 160 mg (40 mg/ ml) or 80 mg (20 mg/ ml), in comparison to monthly intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen deprivation therapy.
6 240 mg (40 mg/ ml), ki so mu sledili subkutano dani vsakomesečni odmerki po 160 mg (40 mg/ ml) ali 80 mg (20 mg/ ml), v primerjavi z vsakomesečnim intramuskularnim dajanjem levprorelina v odmerku 7, 5 mg pri bolnikih z rakom prostate, zaradi katerega je bilo potrebno zdravljenje z deprivacijo androgenov.
In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
Vsega skupaj 620 bolnikov so randomizirali v eno od treh zdravljenih skupin, od katerih je 504 (81%) bolnikov dokončalo študijo.
In the degarelix 240/ 80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
V skupini, zdravljeni z degareliksom 240/ 80 mg, je 41 (20%) bolnikov prekinilo sodelovanje v študiji, v skupini z levprorelinom pa 32 (16%) bolnikov.
Of the 610 patients treated • 31% had localised prostate cancer • 29% had locally advanced prostate cancer • 20% had metastatic prostate cancer • 7% had an unknown metastatic status • 13% had previous curative intent surgery or radiation and a rising PSA
Od 610 zdravljenih bolnikov jih je imelo • 31% lokaliziranega raka prostate, • 29% lokalno napredovalega raka prostate, • 20% raka prostate z metastazami, • 7% neznano stanje glede metastaz, • 13% predhodno operacijo z namenom zdravljenja ali obsevanje in naraščajoč PSA.
6 Baseline demographics were similar between the arms.
Izhodiščni demografski podatki so bili pri obeh krakih podobni.
The primary objective was to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to below 0.5 ng/ ml, during 12 months of treatment.
Primarni namen je bil dokazati, da je degareliks med enoletnim zdravljenjem učinkovit za doseganje in vzdrževanje supresije testosterona pod 0, 5 ng/ ml.
Attainment of serum testosterone (T) ≤ 0.5 ng/ ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Doseganje koncentracije serumskega testosterona (T) ≤0, 5 ng/ ml Zdravilo FIRMAGON je učinkovito za doseganje hitre supresije testosterona, glejte preglednico 2.
Percentage of patients attaining T≤ 0.5 ng/ ml after start of treatment.
Odstotek bolnikov, ki so po začetku zdravljenja dosegli T≤0, 5 ng/ ml.
Time Day 1 Day 3 Day 7 Day 14 Day 28
Čas 1. dan 3. dan 7. dan 14. dan 28. dan
Leuprorelin 7.5 mg 0% 0% 1% 18% 100%
Levprorelin 7, 5 mg 0% 0% 1% 18% 100%
Avoidance of testosterone surge Surge was defined as testosterone exceeding baseline by ≥ 15% within the first 2 weeks.
Izogibanje porastu testosterona Porast je bil definiran kot koncentracija testosterona, ki v prvih 2 tednih zdravljenja preseže izhodiščno vrednost za ≥15%.
None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Nobeden od bolnikov, zdravljenih z degareliksom, ni imel porasta testosterona; 3. dne se je testosteron znižal povprečno za 94%.
Most of the leuprorelin-treated patients experienced testosterone surge; there was an average increase of 65% in testosterone at day 3.
Večina bolnikov, zdravljenih z levprorelinom, je dobila porast testosterona; 3. dne se je testosteron povprečno zvišal za 65%.
This difference was statistically significant (p < 0.001).
Ta razlika je bila statistično signifikantna (p < 0, 001).
Figure 1:
7 Slika 1:
Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Odstotna sprememba testosterona od izhodišča po zdravljenih skupinah do 28. dne (mediana z interkvartilnimi razponi).
7 Long-term effect Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ ml.
Dolgoročni učinek Uspešen odziv je bil v študiji opredeljen kot dosežena medicinska kastracija 28. dne in njeno vzdrževanje do 364. dne, če v tem obdobju nobena izmerjena koncentracija testosterona ni bila višja od 0, 5 ng/ ml.
Cumulative probability of testosterone ≤ 0.5 ng/ ml from Day 28 to Day 364.
Kumulativna verjetnost, da bo koncentracija testosterona od 28. do 364. dne ≤0, 5 ng/ ml.
Leuprorelin 7.5 mg N=201
Levprorelin 7, 5 mg N=201
Response Rate (confidence intervals)* * Kaplan Meier estimates within group
* Kaplan- Meierjeve ocene znotraj skupine
Attainment of prostate specific antigen (PSA) reduction Tumour size was not measured directly during the clinical trial programme, but there was an indirect beneficial tumour response as shown by a 95% reduction after 12 months in median PSA for degarelix.
Zniževanje za prostato specifičnega antigena (PSA) Med programom kliničnega preskušanja velikosti tumorja niso merili neposredno, pač pa se je posreden koristni odziv tumorja pri degareliksu po 12 mesecih pokazal s 95- odstotnim znižanjem medianega PSA.
The median PSA in the study at baseline was: • for the degarelix 240/ 80 mg treatment group 19.8 ng/ ml (interquartile range:
Mediani PSA v študiji ob izhodišču je bil: • pri skupini, zdravljeni z degareliksom v odmerkih 240/ 80 mg, 19, 8 ng/ ml (interkvartilni razpon:
P25 9.4 ng/ ml, P75 46.4 ng/ ml) • for the leuprorelin 7.5 mg treatment group 17.4 ng/ ml (interquartile range:
P25 9, 4 ng/ ml, P75 46, 4 ng/ ml); • pri skupini, zdravljeni z levprorelinom v odmerku 7, 5 mg, 17, 4 ng/ ml (interkvartilni razpon:
Figure 2:
8 Slika 2:
Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Odstotna sprememba PSA od izhodišča po zdravljenih skupinah do 56. dne (mediana z interkvartilnimi razponi).
This difference was statistically significant (p < 0.001) for the pre-specified analysis at day 14 and day 28.
Ta razlika je bila za vnaprej določeno analizo 14. dne in 28. dne statistično signifikantna (p < 0, 001).
8 Prostate specific antigen (PSA) levels are lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed (approximately 97%) throughout the one year of treatment.
Koncentracije za prostato specifičnega antigena (PSA) se znižajo za 64% dva tedna po aplikaciji degareliksa, za 85% po enem mesecu, za 95% po treh mesecih, nato pa ostanejo suprimirane (za približno 97%) ves čas do konca prvega leta zdravljenja.
Both therapies showed QT/ QTc intervals exceeding 450 msec in approximately 20% of the patients.
Pri obeh zdravilih so intervali QT/ QTc pri približno 20% bolnikov presegali 450 msek.
From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Od izhodišča do konca študije je bila mediana sprememba pri zdravilu FIRMAGON 12, 0 msek, pri levprorelinu pa 16, 7 msek.
Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year.
Razvoj protiteles proti degareliksu so ugotovili pri 10% bolnikov po enoletnem zdravljenju z zdravilom FIRMAGON.
There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after one year of treatment.
Nič ne kaže, da bi nastajanje protiteles vplivalo na učinkovitost ali varnost zdravljenja z zdravilom FIRMAGON po enem letu zdravljenja.
Efficacy and safety data in relation to antibody development beyond one year is not available.
Podatkov o učinkovitosti in varnosti v povezavi z razvojem protiteles od enega leta naprej ni na voljo.
Absorption Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ ml to prostate cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ ml, Cmax was 66.0 (61.0-71.0) ng/ ml and occurred at tmax at 40 (37-42) hours.
Absorpcija Po subkutani aplikaciji 240 mg degareliksa v koncentraciji 40 mg/ ml bolnikom z rakom prostate v ključni študiji CS21 je bila AUC0- 28 dni 635 (602- 668) dan* ng/ ml, Cmax je bila 66, 0 (61, 0- 71, 0) ng/ ml, nastopila pa je ob tmax 40 (37- 42) ur.
Mean trough values were approximately 11-12 ng/ ml after the starting dose and 11-16 ng/ ml after maintenance dosing of 80 mg at a concentration of 20 mg/ ml.
Srednje najnižje vrednosti so bile približno 11- 12 ng/ ml po začetnem odmerku in 11- 16 ng/ ml po vzdrževalnem odmerjanju 80 mg v koncentraciji 20 mg/ ml.
Degarelix is eliminated in a biphasic fashion, with a median terminal half- life (t½) of approximately 43 days for the starting dose or 28 days for the maintenance dose, as estimated based on population pharmacokinetics modelling.
Degareliks se odstranjuje iz telesa na bifazičen način, z medianim terminalnim razpolovnim časom (t½) približno 43 dni za začetni odmerek in 28 dni za vzdrževalni odmerek, kot je bilo ocenjeno na podlagi modeliranja populacijske farmakokinetike.
The long half-life after subcutaneous administration is a consequence of a very slow release of degarelix from the depot formed at the injection site(s).
Dolgi razpolovni čas po subkutanem dajanju zdravila je posledica zelo počasnega sproščanja degareliksa iz depoja, ki nastane na mestu / - ih
Distribution The distribution volume in healthy elderly men is approximately 1 l/ kg.
Porazdelitev Porazdelitveni prostor pri zdravih starejših moških je približno 1 l/ kg.
Plasma protein binding is estimated to be approximately 90%.
Ocenjujejo, da je vezava na plazemske beljakovine približno 90- odstotna.
Metabolism Degarelix is subject to common peptidic degradation during the passage of the hepato-biliary system and is mainly excreted as peptide fragments in the faeces.
Presnova Degareliks se pri prehodu skozi hepatobiliarni sistem razgradi kot vsak peptid in se v blatu izloča večinoma v obliki peptidnih fragmentov.
Excretion In healthy men, approximately 20-30% of a single intravenously administered dose is excreted in the urine, suggesting that 70-80% is excreted via the hepato-biliary system.
Izločanje Pri zdravih moških se približno 20- 30% posameznega intravensko danega odmerka izloči v urinu, kar kaže, da se 70- 80% zdravila izloča skozi hepatobiliarni sistem.
The clearance of degarelix when administered as single intravenous doses (0.864-49.4 µg/ kg) in healthy elderly men was found to be 35-50 ml/ h/ kg.
Ugotovili so, da je očistek degareliksa, danega zdravim starejšim moškim v obliki posameznih intravenskih odmerkov (0, 864- 49, 4 µg/ kg), 35- 50 ml/ h/ kg.
Patients with renal impairment No pharmacokinetic studies in renally impaired patients have been conducted.
Bolniki z okvaro ledvic Pri bolnikih z okvaro ledvic farmakokinetičnih študij niso opravili.
Only about 20-30% of a given dose of degarelix is excreted unchanged by the kidneys.
Ledvici izločita v nespremenjeni obliki le okrog 20- 30% danega odmerka degareliksa.
A population pharmacokinetics analysis of the data from the confirmatory Phase III study has demonstrated that the clearance of degarelix in patients with mild to moderate renal impairment is reduced by approximately 23%; therefore, dose adjustment in patients with mild or moderate renal impairment is not recommended.
Populacijska farmakokinetična analiza podatkov iz potrditvene študije faze III je pokazala, da se očistek degareliksa pri bolnikih z blago do zmerno okvaro ledvic zmanjša za približno 23%; zato prilagajanja odmerka pri bolnikih z blago do zmerno okvaro ledvic ne priporočajo.
9 Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Bolniki z okvaro jeter Degareliks so raziskovali v farmakokinetični študiji pri bolnikih z blago do zmerno okvaro jeter.
It caused a dosage dependent prolongation of the time to mating and to pregnancy, a reduced number of corpora lutea, and an increase in the number of pre- and post-implantation losses, abortions, early embryo/ foetal deaths, premature deliveries and in the duration of parturition.
Degareliks je povzročil od odmerka odvisno podaljšanje časa do parjenja in brejosti, zmanjšano število rumenih telesc (corpora lutea) in zvečano število pred - in postimplantacijskih izgub, splavov, zgodnjih smrti zarodkov/ plodov, prezgodnjih kotitev in trajanja poroda.
After reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Po rekonstituciji Kemijsko in fizikalno stabilnost v času uporabe so dokazali za 2 uri pri 25 ºC.
10 Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal.
Viale iz stekla tipa I z zamaškom iz bromometilne gume in aluminijasto zaporko (tipa "flip- off").
1 vial containing 80 mg powder for solution for injection 1 vial containing 6 ml solvent 1 syringe (5 ml) 1 reconstitution needle (21G 0.8 x 50 mm) 1 injection needle (27G 0.4 x 25 mm)
1 viala z 80 mg praška za raztopino za injiciranje 1 viala s 6 ml vehikla 1 brizga (5 ml) 1 igla za rekonstitucijo (21G 0, 8 x 50 mm) 1 injekcijska igla (27G 0, 4 x 25 mm)
NOTE: • THE VIALS SHOULD BE KEPT VERTICAL AT ALL TIMES • THE VIALS SHOULD NOT BE SHAKEN
11 OPOZORILO: • PAZITE, DA BODO VIALE VES ČAS V NAVPIČNEM POLOŽAJU • VIAL NE SMETE STRESATI
The pack contains 1 set of powder and solvent that must be prepared for subcutaneous injection.
Zloženka vsebuje 1 komplet praška in vehikla, ki ga je treba pripraviti za subkutano injekcijo.
Draw up 4.2 ml solvent for injection with the reconstitution needle (green needle, 21G / 0.8 x 50 mm).
Povlecite 4, 2 ml vehikla za injiciranje z iglo za rekonstitucijo (zelena igla, 21G / 0, 8 x 50 mm).
Discard the vial with the remaining solvent.
Vialo s preostankom vehikla zavrzite.
Inject the solvent slowly into the vial with powder.
Počasi vbrizgajte vehikel v vialo s praškom.
DO NOT REMOVE THE SYRINGE AND THE NEEDLE, to keep the medicinal product and syringe sterile.
NE ODSTRANITE BRIZGE IN IGLE, da bosta zdravilo in brizga ostala sterilna.
KEEP THE VIAL IN AN UPRIGHT POSITION.
PAZITE, DA BO VIALA VES ČAS V POKONČNEM POLOŽAJU.
Swirl very gently until the liquid looks clear and without undissolved powder or particles.
Zelo previdno sukajte vialo, dokler ne bo tekočina na pogled bistra in brez neraztopljenega praška ali delcev.
In case the powder adheres to the vial over the liquid surface, the vial can be tilted slightly.
Če se prašek drži notranje stene viale nad površino tekočine, lahko vialo rahlo nagnete.
AVOID SHAKING TO PREVENT FOAM FORMATION.
VIALE NE STRESAJTE, DA NE BO NASTALA PENA.
The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes.
Postopek rekonstitucije lahko včasih traja do 15 minut, navadno pa nekaj minut.
Tilt the vial slightly and keep the needle in the lowest part of the vial.
Vialo rahlo nagnite in pazite, da bo igla v najnižjem delu viale.
Withdraw 4.0 ml of the solution without turning the vial upside down.
Potegnite v brizgo 4, 0 ml raztopine, ne da bi vialo zasukali s spodnjim delom navzgor.
5. Exchange the green needle with the white needle for deep subcutaneous injection (27G / 0.4 x 25 mm).
5. Zamenjajte zeleno iglo z belo iglo za globoko subkutano injiciranje (27G / 0, 4 x 25 mm).
Remove any air bubbles.
Odstranite morebitne zračne mehurčke.
Grasp the skin of the abdomen, elevate the subcutaneous tissue.
S palcem in kazalcem primite kožo na trebuhu, dvignite podkožno tkivo.
Perform a profound subcutaneous injection.
Vsebino brizge vbrizgajte globoko subkutano.
To do so, insert the needle deeply at an angle of not less than 45 degrees.
To storite tako, da iglo globoko zabodete pod kotom vsaj 45 stopinj.
Please be aware:
12 Upoštevajte tole, prosim:
• No injections should be given in areas where the patient will be exposed to pressure, e. g. around the belt or waistband or close to the ribs.
• Injekcij ne smete dajati v predele, ki so izpostavljeni pritisku, na primer v bližini pasu ali reber.
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK-2300 Copenhagen S Denmark Tel: +45 88 33 88 34
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK- 2300 Copenhagen S Danska Tel: +45 88 33 88 34
{DD/ MM/ YYYY}
{DD/ MM/ LLLL}
Subcutaneous use ONLY, not to be administered intravenously.
14 SAMO za subkutano uporabo, zdravilo ni namenjeno za intravensko uporabo.
13 Intramuscular administration is not recommended as it has not been studied.
Intramuskularna uporaba ni priporočljiva, ker je niso raziskovali.
14 A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
15 Toleranca za glukozo Pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH, so opazili zmanjšano toleranco za glukozo.
Table 1:
16 Preglednica 1:
Changes in laboratory parameters Changes in laboratory values seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
17 Spremembe laboratorijskih parametrov Spremembe laboratorijskih vrednosti, ki so jih ugotovili med enoletnim zdravljenjem, so bile za degareliks in agonist GnRH (levprorelin), ki so ga uporabili kot primerjalno zdravilo, v istih mejah.
16 normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Znatno nenormalne vrednosti kalija (≥5, 8 mmol/ l), kreatinina (≥177 μmol/ l) oziroma dušika iz plazemske sečnine (≥10, 7 mmol/ l) pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti, so ugotovili pri 6%, 2% oziroma 15% bolnikov, zdravljenih z degareliksom, in pri 3%, 2% oziroma 14% bolnikov, zdravljenih z levprorelinom.
The study investigated the efficacy and safety of two different degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ ml) followed by monthly doses subcutaneous administration of 160 mg (40 mg/ ml) or 80 mg (20 mg/ ml), in comparison to monthly intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen deprivation therapy.
18 240 mg (40 mg/ ml), ki so mu sledili subkutano dani vsakomesečni odmerki po 160 mg (40 mg/ ml) ali 80 mg (20 mg/ ml), v primerjavi z vsakomesečnim intramuskularnim dajanjem levprorelina v odmerku 7, 5 mg pri bolnikih z rakom prostate, zaradi katerega je bilo potrebno zdravljenje z deprivacijo androgenov.
17 Baseline demographics were similar between the arms.
Izhodiščni demografski podatki so bili pri obeh krakih podobni.
18 Long-term effect Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ ml.
Dolgoročni učinek Uspešen odziv je bil v študiji opredeljen kot dosežena medicinska kastracija 28. dne in njeno vzdrževanje do 364. dne, če v tem obdobju nobena izmerjena koncentracija testosterona ni bila višja od 0, 5 ng/ ml.
Figure 2:
20 Slika 2: