natgillin/translations-raw huggingface dataset:
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Zdravilo EVISTA je indicirano za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
When determining the choice of EVISTA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Ko se zdravnik pri posamezni ženski po menopavzi odloča med zdravilom EVISTA ali drugimi oblikami zdravljenja, vključno z estrogeni, mora pri tem upoštevati simptome menopavze pri njej in učinke zdravila na tkivo maternice in dojke ter pretehtati koristi in tveganja za srčnožilna obolenja (glejte poglavje 5. 1).
Due to the nature of this disease process, EVISTA is intended for long term use.
Zaradi narave tega bolezenskega procesa je zdravilo EVISTA namenjeno dolgotrajni uporabi.
Use in renal impairment:
Uporaba pri ledvični okvari:
EVISTA should not be used in patients with severe renal impairment (see section 4.3).
Zdravila EVISTA ne smemo uporabljati pri bolnikih s hudo ledvično okvaro (glejte poglavje 4. 3).
In patients with moderate and mild renal impairment, EVISTA should be used with caution.
Zdravilo EVISTA moramo uporabljati previdno pri bolnikih z zmerno in blago ledvično okvaro.
Use in hepatic impairment:
Uporaba pri jetrni okvari:
EVISTA should not be used in patients with hepatic impairment (see section 4.3).
Zdravila EVISTA ne smemo uporabljati pri bolnikih z jetrno okvaro (glejte poglavje 4. 3).
2 Hepatic impairment including cholestasis.
2 Aktivni venski tromboembolični zapleti ali venski tromboembolični zapleti v anamnezi, vključno s trombozo globokih ven, pljučno embolijo in trombozo retinalnih ven.
EVISTA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Zdravila EVISTA ne bi smeli uporabljati pri bolnicah, ki kažejo znake ali imajo simptome raka endometrija, saj varnost zdravila pri tej skupini bolnic še ni bila zadosti raziskana.
EVISTA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Zdravilo EVISTA je treba prenehati jemati pri katerikoli bolezni ali motnji, ki vodi do daljše imobilizacije bolnice.
Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
3 dni pred začetkom obdobja imobilizacije.
The incidence of stroke mortality was 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene.
Incidenca smrtnosti zaradi kapi je bila 1, 5 na 1000 žensk na leto za placebo proti 2, 2 na 1000 žensk na leto za raloksifen.
Any uterine bleeding during EVISTA therapy is unexpected and should be fully investigated by a specialist.
Vsakršna krvavitev iz maternice med terapijo z zdravilom EVISTA je nepričakovana in jo mora v celoti raziskati specialist.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Pri ženskah po menopavzi, ki so bile 4 leta zdravljene z raloksifenom, so poročali o benignih polipih endometrija v 0, 9% primerov v primerjavi z 0, 3% primerov pri ženskah, ki so prejemale le placebo.
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Ko so bolnicam s cirozo in blago jetrno okvaro (razred A po Child- Pughu) dali en odmerek raloksifena, so izmerili plazemske koncentracije raloksifena, ki so bile približno 2, 5- krat višje od tistih, ki so jih ugotovili pri preiskovankah iz kontrolne skupine.
Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of EVISTA is not recommended in this patient population.
Dokler varnost in učinkovitost zdravila pri bolnicah z jetrno insuficienco ne bosta bolje raziskani, ne priporočamo uporabe zdravila EVISTA pri tej vrsti bolnic.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Med zdravljenjem je treba skrbno spremljati vrednosti serumskih koncentracij celokupnega bilirubina, gama- glutamil transferaze, alkalne fosfataze, ALT in AST, če pri bolnici ugotovimo povišane vrednosti.
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/ l), raloxifene may be associated with a marked increase in serum triglycerides.
Omejeno število kliničnih podatkov kaže, da je pri bolnicah, ki so že imele s peroralnimi estrogeni povzročeno hipertrigliceridemijo (> 5, 6 mmol/ l), raloksifen lahko povezan z znatno povečanimi serumskimi trigliceridi.
The safety of EVISTA in patients with breast cancer has not been adequately studied.
Tako ni podatkov o sočasnem zdravljenju z zdravilom EVISTA in drugimi zdravili, ki se uporabljajo za zdravljenje zgodnjega ali napredovalega raka dojke.
No data are available on the concomitant use of EVISTA and agents used in the treatment of early or advanced breast cancer.
Zdravilo EVISTA se za zdravljenje in preprečevanje
Therefore, EVISTA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
3 osteoporoze lahko uporablja le po zaključenem zdravljenju raka dojke, vključno z vso spremljajočo terapijo.
3 EVISTA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
EVISTA ni učinkovito zdravilo za zmanjševanje vazodilatacije (navalov vročine) ali drugih simptomov menopavze, ki so povezani s pomanjkanjem estrogena.
EVISTA contains lactose.
Zdravilo EVISTA vsebuje laktozo.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Tega zdravila ne smejo uporabljati pacientke z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorbcijo glukoze- galaktoze.
Effects on prothrombin time may develop over several weeks if EVISTA treatment is started in patients who are already on coumarin anticoagulant therapy.
Vplivi na protrombinski čas se lahko pokažejo šele čez nekaj tednov, če zdravljenje z zdravilom EVISTA uvedemo pri bolnicah, ki so že na kumarinski antikoagulantni terapiji.
The Cmax of digoxin increased by less than 5%.
Cmax digoksina se je povečala za manj kot 5%.
Compared to placebo there was no increased use in EVISTA treated patients.
V primerjavi s placebom ni bila opažena povečana uporaba pri bolnicah, zdravljenih z zdravilom EVISTA.
EVISTA is only for use in postmenopausal women.
4 Zdravilo EVISTA je namenjeno le za zdravljenje žensk po menopavzi.
EVISTA must not be taken by women of child bearing potential.
Zdravila EVISTA ne smejo jemati ženske v rodni dobi.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Če ženska to zdravilo pomotoma vzame med nosečnostjo ali če bolnica zanosi med jemanjem tega zdravila, jo je treba obvestiti o možni nevarnosti za plod (glejte poglavje 5. 3).
Its clinical use, therefore, cannot be recommended in breast-feeding women.
Ni znano, ali se raloksifen izloča v materino mleko, zato njegove klinične uporabe pri doječih materah ne priporočamo.
EVISTA may affect the development of the baby.
Zdravilo EVISTA lahko vpliva na dojenčkov razvoj.
4 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Raloxifene has no known influence on the ability to drive and use machines.
Raloksifen nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactions were recorded.
V raziskavah zdravljenja in preprečevanja osteoporoze, v katerih je sodelovalo več kot 13. 000 postemnopavzalnih žensk, so beležili vse neželene učinke.
The duration of treatment in these studies ranged from 6 to 60 months.
Zdravljenje v teh raziskavah je trajalo od 6 do 60 mesecev.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 EVISTA treated patients and 11.1% of 584 placebo-treated patients.
V populaciji, pri kateri so raloksifen uporabljali za preventivo, so zdravljenje zaradi katerekoli od neželenih učinkov prekinili pri 10, 7% od 581 bolnic, zdravljenih z zdravilom EVISTA, in pri 11, 1% od 584 bolnic, ki so prejemale placebo.
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8% of 2,557 EVISTA treated patients and 11.1% of 2,576 placebo treated patients.
V populaciji, pri kateri so raloksifen uporabljali za zdravljenje, so zdravljenje zaradi kateregakoli od kliničnih neželenih dogodkov prekinili pri 12, 8% od 2. 557 bolnic, zdravljenih z zdravilom EVISTA, in pri 11, 1% od 2. 576 bolnic, ki so prejemale placebo.
The adverse reactions associated with the use of raloxifene in osteoporosis clinical trials are summarised in the table below.
Neželeni učinki, povezani z uporabo raloksifena v kliničnih preskušanjih osteoporoze, so povzeti v tabeli spodaj.
The following convention has been used for the classification of the adverse reactions: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Za klasifikacijo neželenih učinkov smo uporabili naslednji dogovor: zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100 do < 1/ 10), občasno (≥ 1/ 1. 000 do < 1/ 100), redko (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redko (< 1/ 10. 000), neznano (ocena ni možna iz danih podatkov).
Peripheral oedema
Žilne bolezni Zelo pogosto: vazodilatacija (navali vročine) Manj pogosto: venski tromboembolični zapleti, vključno z globoko vensko trombozo, pljučnimi embolijami, trombozo mrežničnih ven tromboflebitis povrhnjih ven Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosto: krči v nogah Splošne težave in spremembe na mestu aplikacije Zelo pogosto: sindrom gripe Pogosto: periferni edem
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in EVISTA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% EVISTA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for EVISTA and 7.1% placebo).
V primerjavi z bolnicami, ki so prejemale placebo, je bila pogostnost pojavov vazodilatacije (navali vročine) zmerno povečana pri bolnicah, zdravljenih z zdravilom EVISTA (pri kliničnih preskušanjih za preventivo osteoporoze, trajanje menopavze 2 do 8 let – 24, 3% pri zdravilu EVISTA in 18, 2% pri placebu; pri kliničnih raziskavah za zdravljenje osteoporoze, povprečna starost 66 let – 10, 6% pri zdravilu EVISTA in 7, 1% pri placebu).
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
V študiji 10101 postmenopavzalnih žensk z dokazano koronarno srčno boleznijo ali s povečanim tveganjem za koronarne dogodke (RUTH), je bila pojavnost vazodilatacije (navalov vročine) pri bolnicah zdravljenih z raloksifenom 7, 8% in 4, 7% pri bolnicah, ki so jemale placebo.
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
V vseh kliničnih preskušanjih raloksifena pri osteoporozi, nadzorovanih s placebom, so se venski tromboembolični zapleti, vključno s trombozo globokih ven, pljučnimi embolijami in trombozo retinalnih ven, pojavljali v približno 0, 8% ali 3, 22 primerih na 1. 000 bolniških let.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in EVISTA treated patients compared to placebo.
Pri bolnicah, zdravljenih z zdravilom EVISTA, je bilo v primerjavi s tistimi, ki so prejemale placebo, ugotovljeno 5 relativno tveganje 1, 60 (CI 0, 95, 2, 71).
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
Tromboflebitis povrhnjih ven se je pojavljal s pogostnostjo, manjšo od 1%.
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
V študiji RUTH so se venski tromboembolični zapleti pojavljali v približno 2, 0% ali 3, 88 primerih na 1. 000 bolnških let v skupini raloksifena in 1, 4% ali 2, 70 primerih na 1. 000 bolnških let v skupini placeba.
The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 – 1.95).
Razmerje tveganja za vse venske tromboembolične zaplete v študiji RUTH je bilo HR = 1, 44, (1, 66 – 1, 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
Pojavnost površinskega venskega tromboflebitisa je bila 1% v skupini raloksifena in 0, 6% v skupini placeba.
5 Another adverse reaction observed was leg cramps (5.5% for EVISTA, 1.9% for placebo in the prevention population and 9.2% for EVISTA, 6.0% for placebo in the treatment population).
Naslednji opaženi neželeni učinek so bili krči v nogah (5, 5% pri zdravilu EVISTA in 1, 9% pri placebu v skupini, v kateri so raloksifen uporabljali za preventivo, ter 9, 2% pri zdravilu EVISTA in 6, 0% pri placebu v skupini, v kateri so raloksifen uporabljali za zdravljenje).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
V študiji RUTH so opažali krče v nogah pri 12, 1% bolnic zdravljenih z raloksifenom in 8, 3% bolnic, ki so jemale placebo.
Flu syndrome was reported by 16.2% of EVISTA treated patients and 14.0% of placebo treated patients.
O sindromu gripe so poročali pri 16, 2% bolnic, zdravljenih z zdravilom EVISTA, in pri 14, 0% bolnic, ki so jemale placebo.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Opažena je bila še ena sprememba, katere pojavnost ni bila statistično značilna (p > 0, 05), bila pa je v precejšnji meri odvisna od odmerka zdravila.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for EVISTA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for EVISTA and 6.1% for placebo.
To je bil periferni edem, ki se je v skupini, pri kateri so raloksifen uporabljali za preventivo, pojavljal z incidenco 3, 1% za zdravilo EVISTA in 1, 9% za placebo ter v skupini, pri kateri so raloksifen uporabljali za zdravljenje, z incidenco 7, 1% za zdravilo EVISTA in 6, 1% za placebo.
In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.
V študiji RUTH se je periferni edem pojavljal pri 14, 1% bolnic zdravljenih z raloksifenom in 11, 7% bolnic, ki so jemale placebo, kar je bilo statistično značilno.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
Med zdravljenjem z raloksifenom v s placebom nadzorovanih kliničnih študijah raloksifena pri osteoporozi so opažali tudi rahlo znižanje (6- 10%) števila trombocitov.
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Poročali so tudi o redkih primerih zmernega zvišanja AST in/ ali ALT, v katerih ni bilo mogoče izključiti vzročne povezave z raloksifenom.
In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.
V študiji (RUTH) postmenopavzalnih žensk z dokazano koronarno srčno boleznijo ali s povečanim tveganjem za koronarne dogodke se je pojavil dodatni neželeni učinek, holelitiaza pri 3, 3% bolnic zdravljenih z raloksifenom in 2, 6% bolnic, ki so jemale placebo.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Stopnje holecistomije za raloksifen (2, 3%) niso bile statistično značilno drugačne od placeba (2, 0%).
EVISTA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Zdravilo EVISTA (n = 317) so v nekaterih kliničnih preskušanjih primerjali s kontinuirano kombinirano (n = 110) hormonsko nadomestno terapijo (HRT – hormone replacement therapy) ali s ciklično HRT (n = 205).
The adverse reactions reported in post-marketing experience and are presented in the table below.
Med postmarketinškimi izkušnjami so poročali o dogodkih, ki so prikazani v tabeli spodaj.
Rash Reproductive system and breast disorders Very rare:
Bolezni krvi in limfatičnega sistema Zelo redko: trombocitopenija Bolezni prebavil Zelo redko: gastrointestinalni simptomi, kot so slabost, bruhanje, bolečine v trebuhu, dispepsija Splošne težave in spremembe na mestu aplikacije Redko: periferni edem Preiskave Zelo redko: povišan krvni tlak Bolezni živčevja Zelo redko: glavobol, vključno z migreno Bolezni kože in podkožja
6 4.9 Overdose
6 Zelo redko: izpuščaj Motnje reprodukcije in dojk Zelo redko: blagi simptomi v dojkah, kot so bolečina, povečanje in občutljivost za dotik Žilne bolezni Redko: venska tromboembolična reakcija Zelo redko: arterijska tromboembolična reakcija
The highest overdose has been approximately 1.5 grams.
Največji preveliki odmerek je bil približno 1, 5 grama.
Selective Oestrogen Receptor Modulator, ATC code:
Farmakoterapevtska skupina: selektivni modulatorji estrogenskega receptorja, oznaka ATC:
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
Novejši podatki kažejo, da lahko estrogenski receptor regulira gensko ekspresijo po vsaj dveh različnih poteh, ki sta specifični za ligand, tkivo in/ ali gen.
In postmenopausal women with osteoporosis, EVISTA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Pri ženskah po menopavzi, ki imajo osteoporozo, zdravilo EVISTA zmanjša incidenco zlomov vretenc, ohrani kostno maso in poveča mineralno kostno gostoto (BMD – bone mineral density).
Based on these risk factors, prevention of osteoporosis with EVISTA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Glede na naštete dejavnike tveganja je preventiva osteoporoze z zdravilom EVISTA indicirana v obdobju desetih let po nastopu menopavze pri tistih ženskah, ki imajo vrednosti BMD za hrbtenico za 7 1, 0 do 2, 5 SD nižje od srednje vrednosti zdrave mlade populacije, upoštevajoč, da obstaja pri teh ženskah veliko tveganje za zlome kosti zaradi osteoporoze skozi vso nadaljnjo življenjsko dobo.
Likewise, EVISTA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
Podobno velja, da je zdravilo EVISTA indicirano za zdravljenje osteoporoze ali ugotovljene osteoporoze pri ženskah, ki imajo vrednosti BMD za hrbtenico za 2, 5 SD nižje od srednje vrednosti zdrave mlade populacije in/ ali imajo zlome vretenc, ne glede na vrednosti BMD.
i) Incidence of fractures.
i) Incidenca zlomov:
Forty five women with osteoporosis or 15 women with
V raziskavi pri 7. 705 ženskah po menopavzi s srednjo starostjo 66 let in z osteoporozo je 3- letno zdravljenje z zdravilom EVISTA zmanjšalo incidenco zlomov vretenc za 47% (relativno tveganje (RR) 0, 53 pri 95% intervalu zaupanja (CI) 0, 35– 0, 79; p < 0, 001), pri ženskah z osteoporozo in obstoječim zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31% (RR 0, 69 pri 95% CI 0, 56– 0, 86; p < 0, 001).
7 osteoporosis with an existing fracture would need to be treated with EVISTA for 3 years to prevent one or more vertebral fractures.
Da bi preprečili enega ali več zlomov vretenc, bi bilo treba z zdravilom EVISTA zdraviti petinštirideset žensk z osteoporozo ali 15 žensk z osteoporozo in obstoječim zlomom 3 leta.
EVISTA treatment for 4 years reduced the incidence of vertebral fractures by 46% (RR 0.54, CI 0.38, 0.75) and 32% (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Štiriletno zdravljenje z zdravilom EVISTA je pri bolnicah z osteoporozo zmanjšalo incidenco zlomov vretenc za 46% (RR 0, 54 pri 95% CI 0, 38– 0, 75), pri bolnicah z osteporozo in obstoječim zlomom pa je incidenca zmanjšana za 32% (RR 0, 68 pri 95% CI 0, 56 – 0, 83).
In the 4th year alone, EVISTA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Samo v četrtem letu zdravljenja je prejemanje zdravila EVISTA znižalo tveganje za nov zlom vretenca za 39% (RR 0, 61 pri 95% CI 0, 43– 0, 88).
EVISTA reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
Evista je zmanjšala incidenco kliničnih zlomov vretenc za 35% v primerjavi s placebom (HR 0, 65, CI 0, 47– 0, 89).
ii) Bone Mineral Density (BMD):
ii) Mineralna kostna gostota (BMD):
The efficacy of EVISTA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Učinkovitost zdravljenja z zdravilom EVISTA enkrat dnevno so ugotavljali pri ženskah po menopavzi, starih do 60 let, z maternico ali brez nje, in sicer med 2- letnim zdravljenjem s tem zdravilom.
Three trials included 1,764 postmenopausal women who were treated with EVISTA and calcium or calcium supplemented placebo.
V treh kliničnih preskušanjih je sodelovalo 1. 764 žensk po menopavzi, ki so bile zdravljene z zdravilom EVISTA in dodatki kalcija ali s placebom in dodatki kalcija.
EVISTA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
Zdravilo EVISTA je povzročilo značilno povečanje kostne gostote v kolku in hrbtenici, pa tudi značilno povečanje celotne kostne mineralne mase v telesu v primerjavi s placebom.
This increase was generally a 2% increase in BMD compared to placebo.
Na splošno je šlo za 2- odstotno povečanje BMD v primerjavi s placebom.
A similar increase in BMD was seen in the treatment population who received EVISTA for up to 7 years.
Podobno povečanje BMD so ugotovili pri zdravljeni populaciji, ki je prejemala zdravilo EVISTA do 7 let.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
V preskušanjih preventive osteoporoze z zdravilom EVISTA so bili odstotki preiskovank, pri katerih so ugotovili povečanje ali zmanjšanje BMD med terapijo z raloksifenom, naslednji: za hrbtenico so pri 37% preiskovank ugotovili zmanjšanje in pri 63% povečanje BMD; za celoten kolk so pri 29% ugotovili zmanjšanje in pri 71% povečanje BMD.
iii) Calcium kinetics.
iii) Kinetika kalcija:
EVISTA and oestrogen affect bone remodelling and calcium metabolism similarly.
Zdravilo EVISTA in estrogen imata podoben vpliv na prestrukturiranje kostnega tkiva in presnovo kalcija.