natgillin/translations-raw huggingface dataset:
Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Bikalutamid je racemat, katerega antiandrogeno delovanje je skoraj izključno omejeno na (R) - enantiomer.
Bicalutamide 150 mg was studied as a treatment for patients with localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).
Bikalutamid je bil uporabljen kot takojšnja hormonska terapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije (v prvi vrsti z zunanjim obsevanjem).
At 7.4 years median follow-up, 27.4% of all bicalutamide-treated patients and 30.7% of all placebo-treated patients had experienced objective disease progression.
Po mediano 7, 4 leta spremljanja se je objektivno napredovanje bolezni pojavilo pri 27, 4% vseh bolnikov, ki so prejemali bikalutamid, in pri 30, 7% vseh bolnikov, ki so prejemali placebo.
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Zato se lahko zdravniki odločijo, da je optimalna medicinska strategija pri bolniku z majhnim tveganjem za napredovanje bolezni, zlasti v adjuvantnih okoliščinah po radikalni prostatektomiji, odložitev hormonskega zdravljenja, dokler se ne pojavijo znaki napredovanja bolezni.
No overall survival difference was seen at 7.4 years median follow-up with 22.9% mortality (HR = 0.99; 95% confidence interval 0.91 to 1.09).
Po mediano 7, 4 leta spremljanja ni bilo razlik v preživetju; umrljivost je bila 22, 9%, (koeficient tveganja[ J1] = 0, 99; 95% interval zaupanja 0, 91 do 1, 09).
Table 1 Progression-free survival in locally advanced disease by therapy sub-group
Preglednica 1 Preživetje brez napredovanja pri lokalno napredovali bolezni po terapevtskih podskupinah
Events (%) in Bicalutamide patients
Dogodki (%) pri bolnikih, ki so prejemali bikalutamid
Watchful waiting Radiotherapy Radical prostatectomy
Radioterapija Radikalna prostatektomija
0.60 (0.49 to 0.73) 0.56 (0.40 to 0.78) 0.75 (0.61 to 0.91)
0, 56 (0. 40 do 0, 78) 0, 75 (0, 61 do 0, 91)
10 Table 2 Overall survival in locally advanced disease by therapy sub-group
10
Deaths (%) in Deaths (%) in Bicalutamide patients placebo patients
Smrti (%) pri bolnikih, ki so prejemali placebo
164/ 335 (49.0) 183/ 322 (56.8) 49/ 161 (30.4) 61/ 144 (42.4) 137/ 870 (15.7) 122/ 849 (14.4)
49/ 161 (30, 4) 137/ 870 (15, 7)
0.81 (0.66 to 1.01) 0.65 (0.44 to 0.95) 1.09 (0.85 to 1.39)
61/ 144 (42, 4) 122/ 849 (14, 4)
In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16, 95% CI 0.99 to 1.37).
Pri teh bolnikih je bil opazen tudi trend zmanjšanega preživetja v primerjavi z bolniki, ki so dobivali placebo (koeficient tveganja=1, 16, 95% IZ 0, 99 do 1, 37).
There was no significant difference in survival (HR=1.05 (CI=0.81-1.36), p=0.669) or in the interval until progression (HR=1.20 (CI 0.96-1.51), p=0.107) between the group treated with bicalutamide 150 mg and the group treated with castration.
Med skupino, ki je bila zdravljena s 150 mg biklautamidom, in skupino, ki je bila zdravljena s kastracijo, v preživetju (koeficient tveganja=1, 05, (IZ=0, 81- 1, 36), p=0, 669) ali v obdobju do napredovanja (koeficient tveganja=1, 20, (IZ=0, 96- 1, 51), p=0, 107) ni bilo bistvenih razlik.
A general trend with respect to quality of life in favour of bicalutamide 150 mg in comparison with castration was observed; the subgroups that provided these data showed significantly higher sexual appetence (p=0.029) and fitness (p=0.046).
Podskupine, na katerih so bili podatki pridobljeni, so pokazale značilno večje spolno poželenje (p=0, 029) in boljše zdravstveno stanje (p=0, 046).
The estimated difference is 42 days while the mean survival time is 2 years.
Kombinirana analiza dveh kliničnih študij, ki sta zajeli 805 predhodno nezdravljenih bolnikov s karcinomom prostate z zasevki, s pričakovano smrtnostjo 43%, je pokazala, da je zdravljenje s 150 mg bikalutamidom glede preživetja manj učinkovito kot kastracija (koeficient tveganja = 1, 30 [interval zaupanja 1, 04- 1, 65]). Ocenjena razlika je 42 dni, medtem ko je srednji čas preživetja 2 leti.
11 LABELLING
11 OZNAČEVANJE
12 The valid labelling text is the final version achieved during the Coordination group procedure.
12 Veljavno označevanje je zadnja različica, ki je bila pripravljena v postopku koordinacijske skupine.
13 PACKAGE LEAFLET
13 NAVODILO ZA UPORABO
14 The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
14 Veljavno navodilo za uporabo je zadnja različica, ki je bila pripravljena v postopku koordinacijske skupine z naslednjimi dopolnili.
WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BIKALUTAMID IN ZAKAJ GA UPORABLJAMO
Bicalutamide belongs to the group of anti-androgens.
Bikalutamid spada v skupino zdravil, imenovani antiandrogeni.
15 ANNEX IV
15 DODATEK IV
16 CONDITIONS OF THE MARKETING AUTHORISATION
16 POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
- In addition to routine pharmacovigilance activities, identified and potential risks highlighted for
- Poleg rutinskih farmakovigilančnih aktivnosti je treba med ugotovljena in potencialna tveganja,
hepatic failure, interstitial lung disease, breast cancer, and reports concerning pregnancy in partners of patients taking bicalutamide.
izbrana za podroben nadzor in spremljanje, vključiti odpoved srca, odpoved jeter, intersticijsko pljučno bolezen, rak dojke ter poročila, ki obravnavajo nosečnost pri partnerjih bolnikov, ki jemljejo bikalutamid.
International Non-Proprietary Name (INN): bicalutamide
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Bicaluplex in z njim povezana imena Mednarodno nelastniško ime (INN): bikalutamid
Ingers Industrials Solutions s. r. o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005.
Podjetje Ingers Industrials Solutions s. r. o je predložilo vloge za medsebojno priznavanje zdravila Bicaluplex in z njim povezanih imen, 150 mg, filmsko obložene tablete na osnovi dovoljenja za promet z zdravilom, ki ga je odobrila Češka republika dne 30. novembra 2005.
Significant differences have been identified with regard to the benefit/ risk ratio of the product.
V zvezi z razmerjem med koristmi in tveganji zdravila so bile ugotovljene znatne razlike.
This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.
Te se nanašajo na dve indikaciji (zdravljenje lokalno napredovalega karcinoma prostate brez metastaz, pri katerem kirurška kastracija ali druga vrsta zdravstvenega posega ni indicirana ali sprejemljiva, ter kot monoterapija pri zgodnjem zdravljenju ali kot dopolnilo k zdravljenju z obsevanjem ali radikalno prostatektomijo pri bolnikih s karcinomom prostate (T3- T4, katerikoli stadij N, M0)) in predstavljajo resen zadržek glede javnega zdravja.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Poročevalec je bil dr.
During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem septembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med koristmi in tveganji za zdravilo Bicaluplex in z njim povezana imena ugodno, ter da ugovori, ki jih je podala Nemčija, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo referenčne države članice dopolniti.
A positive opinion was adopted by consensus on 20 September 2007.
Pozitivno mnenje je bilo soglasno sprejeto dne 20. septembra 2007.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, Povzetek glavnih značilnosti zdravila pa v Dodatku III.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Člen 29( 4) of Direktive 2001/ 83/ ES, kakor je bila spremenjena.
London, 16 August 2007 EMEA/ 378451/ 2007
London, 16. avgust 2007 EMEA/ 378451/ 2007
SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/ 83/ EC, AS AMENDED, FOR
POVZETEK MNENJA, SPREJETEGA V OKVIRU POSTOPKA NAPOTITVE V SKLADU S ČLENOM 31 DIREKTIVE SVETA 2001/ 83/ ES, KAKOR JE BILA SPREMENJENA, ZA
On 27 July 2006, Belgium presented a referral to the EMEA under Article 31 of Directive 2001/ 83, as amended.
Belgija je 27. julija 2006 EMEA posredovala napotitev v skladu s členom 31 Direktive 2001/ 83/ ES, kakor je bila spremenjena.
The reasons for referral concerned a review of the benefit/ risk profile of medicinal products containing bicalutamide 150 mg.
Razlog za napotitev je bila preverba razmerja med tveganji in koristmi za zdravila, ki vsebujejo bikalutamid 150 mg.
- the lack of an overall survival benefit versus adverse events in ‘ locally advanced prostate cancer’;
napredovalem raku prostate;
- statistical concerns regarding multiplicity;
- statistični pomisleki v zvezi z multipliciteto;
- the standard of care for the placebo group in the relevant studies;
- standardno zdravljenje v skupini s placebom v zadevnih raziskavah;
- the number of deaths due to cardiac failure.
- število smrti zaradi srčne odpovedi.
Based on evaluation of the available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.
Na podlagi ovrednotenja razpoložljivih podatkov in poročil o oceni, ki so jih podali poročevalci, je CHMP menil, da ostaja razmerje med koristmi in tveganji za zdravila, ki vsebujejo 150 mg bikalutamida, pozitivno ter je zato 24. maja 2007 sprejel mnenje, s katerim priporoča ohranitev ali podelitev, kot ustreza, dovoljenj za promet z zdravilom z dopolnitvami ustreznih poglavij Povzetka glavnih značilnosti zdravila, za zdravila, ki vsebujejo 150 mg bikalutamida.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©. EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged * Note:
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©. EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Seznam zadevnih imen zdravil je naveden v Dodatku I.
The information given in this document and Annexes reflect only the CHMP Opinion dated 24 May 2007.
Informacije, podane v tem dokumentu in dodatkih, odražajo le mnenje CHMP z dne 24. maja 2007.
16 August, 2007
26 August, 2007
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
1 Marketing Authorisation Holders
1 Imetniki dovoljenja za promet z zdravilom
Ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer Gasse 3 1140 Wien
Ratiopharm Arzneimittel Vertriebs- GmbH Albert- Schweitzer Gasse 3 1140 Wien
617 00 Brno CY - Cyprus
CY - Ciper
Bicalutamid Alternova 150 mg
Bicalutamid 150 mg Alternova
20 Queen Frederiks Street, Office 301 1066 Nicosia, Cyprus FI - Finland
FI - Finska
Tad Pharma GmbH Heinz-Lohmann-Strasse 5 27472 Cuxhaven, Germany
Tad Pharma GmbH
150 mg
Bicatad 150 mg
film-coated tablet
filmsko obložena
20097 Hamburg, Germany FI - Finland
FI - Finska
FR - France
1066 Nicosia, Cyprus FR - Francija
Pharmaconsult Kft.:
HU - Madžarska Pharmaconsult Kft.:
AstraZeneca KFt.
HU - Madžarska AstraZeneca KFt.
AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
IS - Islandija AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
Astrazeneca S. P. A.
IT - Italija Astrazeneca S. P. A.
AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
LT - Litva AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
LU - Luxembourg
LU - Luksemburg NV AstraZeneca SA rue E.
NV AstraZeneca SA 110 rue E.
110
AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
LV - Latvija AstraZeneca UK Limited Silk Road Business Park Macclesfield
PL - Poland AstraZeneca UK Limited
PL - Poljska
Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom PT - Portugal
PT - Portugalska
RO-Romania
RO - Romunija
AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
AstraZeneca UK Ltd 600 Capability Green Luton, Bedfordshire LU1 3LU, United Kingdom
SK – Slovakia
SK - Slovaška
SL - Slovenia
SL - Slovenija
8 Member State
8 Država članica
AstraZeneca AB Västra Mälarehamnen 9 SE-151 85 Södertälje
AstraZeneca AB Västra Mälarehamnen 9 SE- 151 85 Södertälje
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
10 SCIENTIFIC CONCLUSIONS
10 ZNANSTVENI ZAKLJUČKI
At that time, the RMS concluded that Casodex (bicalutamide) 150 mg should not be used in the treatment of ‘ localised’ prostate cancer, however, it was concluded that the benefit/ risk balance remained positive for selected patients in ‘ locally advanced’ prostate cancer, as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Takrat je referenčna država članica zaključila, da zdravila Casodex (bikalutamid) 150 mg ne bi smeli uporabljati za zdravljenje „ lokaliziranega “ raka prostate, vendar pa je zaključila tudi, da je razmerje med koristmi in tveganji ostalo pozitivno za izbrane bolnike z „ lokalno napredovalim “ rakom prostate in pri uporabi za takojšnje zdravljenje bodisi samostojno ali kot adjuvans k zdravljenju z radikalno prostatektomijo ali radioterapijo.
Section 5.1 of the SPC was amended to note that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, might be to defer hormonal therapy until signs that the disease is progressing.
Poglavje 5. 1 Povzetka glavnih značilnosti zdravila je bilo dopolnjeno z opozorilom, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja bolnikov z majhnim tveganjem za napredovanje bolezni, še posebej če se ga namerava uporabiti kot adjuvans po radikalni prostatektomiji.
Following their own review of these data carried out in 2004 and due to their resulting concerns over the benefit/ risk balance of bicalutamide 150 mg in locally advanced prostate cancer, the Belgian Regulatory Authority suspended their national Marketing Authorisation for Casodex (bicalutamide) 150 mg in August 2005.
Na podlagi lastnega pregleda teh podatkov, opravljenega leta 2004, in zaradi posledičnih zadržkov glede razmerja med koristmi in tveganji bikalutamida 150 mg pri lokalno napredovalem raku prostate, je belgijski regulativni organ avgusta leta 2005 začasno razveljavil dovoljenje za promet z zdravilom Casodex (bikalutamid) 150 mg.
In view of the concerns related to safety and efficacy for bicalutamide 150 mg the National Competent Authority (NCA) in Belgium considered it to be in the interest of public health to perform a new benefit/ risk assessment.
Zaradi zadržkov glede varnosti in učinkovitosti bikalutamida 150 mg je pristojni nacionalni organ (NCA) v Belgiji zaključil, da bi bila izvedba nove ocene tveganj in koristi v interesu javnega zdravja.
Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/ 83/ EC, as amended.
Zaradi tega je Belgija dne 27. julija 2006 odboru CHMP predložila sporno vprašanje na napotitveni postopek po členu 31 Direktive 2001/ 83/ ES z vsemi spremembami.
The 4 issues raised in the referral concern the analyses of the Early Prostate Cancer Programme (EPC):
Štiri sporna vprašanja v napotitvenem postopku so bila:
- the lack of an overall survival benefit versus adverse events in ‘ locally advanced prostate cancer’;
- pomanjkanje koristnega učinka za celotno preživetje napram neželenim učinkom pri „ lokalno
- statistical concerns regarding multiplicity;
- statistični zadržki glede multiplikativnosti;
- the standard of care for the placebo group in the relevant studies;
- standard oskrbe za skupino, ki je prejemala placebo, v zadevnih študijah;
- the number of deaths due to cardiac failure.
- število smrti zaradi odpovedi srca.
Based on the concerns raised, the following questions were posed to the Applicants/ MAHs as part of the consolidated CHMP List of Questions, the responses to which were the basis of the CHMP reassessment of the benefit/ risk balance:
Na temelju spornih vprašanj so predlagateljem/ imetnikom dovoljenj za promet z zdravilom zastavili naslednja vprašanja, ki so bila del konsolidiranega seznama vprašanj CHMP, odgovori nanje pa so bili osnova za ponovno oceno razmerja med koristmi in tveganji:
1/ How does the company justify the indication of bicalutamide 150 mg for locally advanced prostate cancer knowing the absence of statistically significant overall survival and the important side effects?
1 / Kako družba utemeljuje indikacijo bikalutamida 150 mg za lokalno napredovali rak prostate, če ve, da so statistično značilno celotno preživetje in pomembni neželeni učinki odsotni?
2/ How does the company justify the absence of adjustment for tests of multiplicity in the analysis of the EPC results?
2 / Kako družba utemeljuje odsotnost prilagajanj za teste multiplikativnosti pri analizi rezultatov za zgodnji rak prostate?
4/ How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial?
Kako lahko družba izključi kakršnokoli vlogo bikalutamida 150 mg v povišani smrtnosti zaradi odpovedi srca v skupini, ki je v preizkušanju za zgodnji rak prostate prejemala zdravilo Casodex?
Further, the referral concerned only
Napotitveni postopek se je nanašal na vse vloge za izdajo dovoljenja za promet, ki so bile v postopku odobritve, kot tudi na dovoljenja za promet za zdravila, ki vsebujejo 150 mg bikalutamida.
11 the locally advanced prostate cancer indication based on the Early Prostate Cancer study programme, and the directly related wording in sections 4.1 and 5.1 of the SPC.
Poleg tega se je nanašal samo na indikacijo v zvezi z lokalno napredovalim rakom prostate, ki temelji na programu preučevanja zgodnjega raka prostate, in na besedilo, neposredno povezano s tem, ki se nahaja v poglavju 4. 1 in 5. 1 Povzetka glavnih značilnosti zdravila.
As regards the multiplicity issue raised, it is considered appropriate to look at subgroups from a statistical viewpoint, as they have helped to narrow the indication to patients with a more favourable benefit/ risk balance for bicalutamide 150 mg.
Kar se tiče vprašanja multiplikativnosti, se zdi primerno pregledati podskupine iz statističnega stališča, saj so pri bikalutamidu 150 mg pomagale zožiti indikacijo na bolnike z bolj ugodnim razmerjem med koristmi in tveganji.
Progression-free survival in locally advanced disease by therapy sub-group
Preživetje brez napredovanja bolezni pri lokalno napredovalem raku po zdravljenih podskupinah
Events (%) in Casodex patients
Dogodki (%) pri bolnikih,
Events (%) in placebo patients
Razmerje tveganja
Watchful waiting Radiotherapy Radical prostatectomy
Oprezno čakanje Radioterapija Radikalna prostatektomija
0.60 (0.49 to 0.73) 0.56 (0.40 to 0.78) 0.75 (0.61 to 0.91)
0, 60 (0, 49 do 0, 73) 0, 56 (0, 40 do 0, 78) 0, 75 (0, 61 do 0, 91)
In particular, there is a statistically significant and clinically meaningful improvement in progression-free survival in the patients with locally advanced prostate cancer who received Casodex (bicalutamide) as compared to placebo (58% versus 69% progressors in patients who were not receiving adjuvant surgery or radiotherapy).
12 Opaziti je statistično značilno in klinično pomembno izboljšanje preživetja brez napredovanja bolezni pri bolnikih z lokalno napredovalim rakom prostate, ki so prejemali zdravilo Casodex (bikalutamid), glede na tiste, ki so prejemali placebo (58% napram 69% bolnikov z napredovanjem bolezni in ki niso prejemali adjuvantne kirurgije ali radioterapije).
With reference to the adequacy of treatment in the placebo group in the EPC studies, given that at the time of initiation of these studies there was no widely agreed standard of care in locally advanced prostate cancer (something which remains the case), the empirical design of the studies, which compared Casodex (bicalutamide) 150mg or placebo when given as an adjunct to “ standard care” is considered reasonable.
Z ozirom na primernost zdravljenja v placebo skupini v študijah EPC in glede na dejstvo, da v času uvajanja teh študij ni bilo široko sprejetega standarda nege lokalno napredovalega raka prostate (to še vedno velja), velja empirična zasnova študij, v katerih so primerjali dajanje zdravila Casodex (bikalutamid) 150 mg ali placeba kot dodatek „ standardni negi “, za sprejemljivo.
12 None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.
V nobenem od preizkušanj EPC niso zahtevali, da bi bolnikom v placebo skupini odrekli zdravljenje do kliničnega napredovanja bolezni.
In the clinical studies this was severe in around 5% of patients.
V kliničnih študijah sta bila ta neželena učinka posebej resna pri približno 5% bolnikov.
The majority of patients with heart failure had confounding factors at study entry, and the causality assessment of investigators for all deaths ascribed to heart failure was “ not related”.
Večina bolnikov z odpovedjo srca je imela pri vstopu v študijo zmedene faktorje, tako da je bila ocena preiskovalcev o vzročnosti pri vseh primerih smrti zaradi domnevne odpovedi srca „ ni povezave “.
However, it is not possible to entirely “ rule out” thromboembolic events as contributory explanation of increased cardiovascular mortality.
Kljub temu pa ni mogoče povsem izključiti vpliva tromboemboličnih dogodkov, kot razlage za povečano kardiovaskularno smrtnost.
The need to further study cardiovascular morbidity and mortality remains.
13 Potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.