natgillin/translations-raw huggingface dataset:
Clearance af lasofoxifen kan være øget hos patienter i kronisk behandling med inducere af CYP3A4 og UGT- enzymer (f. eks. phenytoin, carbamazepin, barbiturater og perikum), hvilket vil resultere i lavere steady state- koncentrationer og potentielt nedsat effekt.
Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John’ s Wort) resulting in reduced steady-state concentrations and may result in reduced efficacy.
4 Ketoconazol – Den stærke CYP3A4/ 5- inhibitor ketoconazol øger den systemiske eksponering for lasofoxifen med 20%, hvilket ikke vurderes at være klinisk relevant.
4 Ketoconazole - The strong CYP3A4/ 5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
Paroxetin – Den stærke CYP2D6- inhibitor paroxetin øger den systemiske eksponering for lasofoxifen med 35%, hvilket ikke vurderes at være klinisk relevant.
Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful.
Der bør derfor udvises forsigtighed ved samtidig brug af lasofoxifen og disse stoffer.
Proton pump inhibitors – Data on the effect of concomitant administration of proton pump inhibitors (PPIs) with lasofoxifene is not available; thus, use of these agents with lasofoxifene should be considered with caution.
I kliniske studier ændrede lasofoxifen ikke metaboliseringen af dextromethorphan (CYP2D6- substrat) og chlorzoxazon (CYP2E1- substrat) eller farmakokinetikken af warfarin (CYP2C9- substrat), methylprednisolon (CYP3A4- substrat) eller digoxin (MDR1 P- glycoproteinsubstrat).
In clinical studies, lasofoxifene did not alter the metabolism of dextromethorphan (CYP2D6 substrate) and chlorzoxazone (CYP2E1 substrate) or the pharmacokinetics of warfarin (CYP2C9 substrate), methylprednisolone (CYP3A4 substrate) or digoxin (MDR1 P-glycoprotein substrate).
Det er derfor usandsynligt, at Fablyn ændrer farmakokinetikken af lægemidler, der metaboliseres via disse CYP- isoformer eller transporteres af MDR1 P- glycoprotein.
Therefore FABLYN is unlikely to alter the pharmacokinetics of medicinal products that are cleared by metabolism via these CYP isoforms, or are transported by MDR1 P-glycoprotein.
Warfarin - Lasofoxifen havde ingen virkning på farmakokinetikken af R - og S- warfarin.
Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin.
8% og 16% lavere end efter warfarin alene.
Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone.
4. 3).
FABLYN must not be taken by women of child-bearing potential (see section 4.3).
4. 3).
FABLYN must not be taken during lactation (see section 4.3).
Sikkerheden af Fablyn ved osteoporosebehandling blev vurderet i et stort (8556 patienter) dobbeltblindt, randomiseret, placebokontrolleret multinationalt fase 3- fraktur- studie (PEARL- studiet).
The safety of FABLYN in the treatment of osteoporosis was assessed in a large (8,556 patients) double-blind, randomized, placebo-controlled multinational Phase 3 fracture trial (the PEARL study).
Behandlingen blev seponeret som følge af bivirkninger hos 12, 9% af de Fablyn- behandlede kvinder og 12, 3% af de placebobehandlede kvinder.
Within this study, 12.9% of FABLYN-treated women and 12.3% of placebo-treated women discontinued therapy due to adverse events.
5 Venøse Tromboemboliske hændelser (VTE):
5 Venous Thromboembolic Events:
Den alvorligste bivirkning relateret til Fablyn var VTE (dyb venetrombose, lungeemboli og retinal venetrombose).
The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
1000 patientår) og hazard ratio var 2, 06 (95% CI:
Through 5 years of follow-up, 37 FABLYN-treated women (1.3%, or 2.90 per 1,000 patients years) had a VTE compared to 18 placebo-treated women (0.6%, or 1.41 per 1,000 patients years) and the hazard ratio was 2.06 (95% CI:
4%) i trombocyttal hos lasofoxifenbehandlede patienter i PEARL- studiet.
As observed with other Selective Estrogen Receptor Modulators (SERMs), slightly decreased (approximately 4%) platelet counts were observed in lasofoxifene-treated patients in PEARL.
Muskelsitren sås hos 1 ud af 9 patienter.
Muscle spasms occurred in about one in 9 patients.
Fablyns sikkerhed ved osteoporosebehandling blev også vurderet i et fase- 2 placebokontrolleret studie med japanske, koreanske og taiwanesiske kvinder.
The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebo-controlled trial in Japanese, Korean and Taiwanese women.
Behandlingen blev seponeret som følge af bivirkninger hos 3, 2% af de Fablyn- behandlede og 8, 0% af de placebobehandlede kvinder.
Within this study, 3.2% of FABLYN-treated women and 8.0% of placebo-treated women discontinued therapy due to adverse events.
Tabel 1 indeholder de bivirkninger, der blev set i de to osteoporose- studier med en højere hyppighed blandt Fablyn- behandlede personer end blandt placebo- behandlede personer.
Table 1 lists adverse reactions occurring in the two osteoporosis treatment clinical trials that occurred at an incidence greater than placebo.
Bivirkninger er anført efter organklasse og hyppighed (meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100) og sjælden (≥1/ 10. 000 til < 1/ 1. 000)).
Adverse reactions are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1,000)).
Bivirkninger set i placebokontrollerede osteoporose- studier med en højere hyppighed hos Fablyn- behandlede end hos placebobehandlede kvinder
Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Vaginal candidiasis, vaginal infektion, vulvovaginitis, urinvejsinfektion, Bronkitis, cellulitis, cervicitis, diverticulit, furunculus, genital candidiasis, herpes simplex, impetigo, infektiøs artrit, labyrintit, ophthalmicus, pyelonefrit, pyometra, svampeinfektion
Urinary tract infection, vaginal candidiasis, vaginal infection, vulvovaginitis Arthritis infective, bronchitis, cellulitis, cervicitis, diverticulitis, fungal infection, furuncle, genital candidiasis, herpes simplex ophthalmic, impetigo, labyrinthitis, pyelonephritis, pyometra
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Ikke almindelig:
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon:
Fibrom, uterint leiomyom Benignt neoplasme i bryst, benign parathyroideatumor, fibrom i bryst, hepatisk neoplasme, hæmangiom, kronisk lymfatisk leukæmi, malignt leiomyom, melanocytisk nævus, multipelt myelom, neoplasme, neoplasme i endometrie, neoplasme i kvindelige reproduktionsorganer
Fibroma, uterine leiomyoma Benign breast neoplasm, breast fibroma, chronic lymphocytic leukaemia, endometrial neoplasm, female reproductive neoplasm, haemangioma, hepatic neoplasm malignant, leiomyoma, melanocytic naevus, multiple myeloma, neoplasm, parathyroid tumour benign
Blod og lymfesystem Ikke almindelig:
Blood and lymphatic Uncommon:
Anæmi, makrocytose, trombocytopeni Hypokromasi, megaloblastær anæmi
system disorders Anaemia, macrocytosis, thrombocytopenia Anaemia megaloblastic, hypochromasia
Sjælden:
Immune system disorders Rare:
Det endokrine system Sjælden:
Seasonal allergy Endocrine disorders Rare:
6 Metabolisme og ernæring Ikke almindelig:
6 Metabolism and nutrition disorders Uncommon:
Diabetes mellitus Anoreksi, hypertriglyceridæmi, hypoalbuminæmi, hypofosfatæmi, nedsat appetit, tetani, type 2 diabetes mellitus, øget appetit
Diabetes mellitus Anorexia, decreased appetite, hypertriglyceridaemia, hypoalbuminaemia, hypophosphataemia, increased appetite, tetany, type 2 diabetes mellitus
Psykiske forstyrrelser Sjælden:
Psychiatric disorders Rare:
Cyklotymi, drømmeforstyrrelser
Abnormal dreams, cyclothymic disorder Nervous system disorders Uncommon:
Brændende fornemmelse, cerebralt infarkt, hovedpine, uro i benene Alzheimers demens, amnesi, dysgeusi, epilepsi, hukommelsessvækkelse, hydrocephalus, hypogeusi, ischias, migræne, migræne med aura, motorneuronsygdom, nervekompression, parese, postural svimmelhed, præsynkope, vaskulær hovedpine
Burning sensation, cerebral infarction, headache, restless legs syndrome Amnesia, dementia Alzheimer’ s type, dizziness postural, dysgeusia, epilepsy, hydrocephalus, hypogeusia, memory impairment, migraine, migraine with aura, motor neurone disease, nerve compression, paresis, presyncope, sciatica, vascular headache
Tørre øjne Afaki, chorioretinopati, keratoconjunctivitis sicca, konjunktival blødning, konjunktival hyperæmi, maculadegeneration, nethindeløsning, okulær hyperæmi, retinopati, reduceret synsskarphed, synsforstyrrelse, uensartede pupiller, vaskulær sygdom i retina, øjenblødning, øjenkløe, øjenlågsødem
Dry eye Aphakia, chorioretinopathy, conjunctival haemorrhage, conjunctival hyperaemia, eye haemorrhage, eye pruritus, eyelid oedema, keratoconjunctivitis sicca, macular degeneration, ocular hyperaemia, pupils unequal, retinal detachment, retinal vascular disorder, retinopathy, visual acuity reduced, visual disturbance
Hjerte
Ear and labyrinth disorders Rare:
Positionel vertigo, sygdom i det indre øre, ubehag i øret
Ear discomfort, inner ear disorder, vertigo positional Cardiac disorders Uncommon:
Palpitationer, takykardi Cor pulmonale, hjerteinsufficiens, kardiomegali, sinusarrest, supraventrikulære ekstrasystoler, trikuspidalklap- insufficiens
Palpitations, tachycardia Cardiac failure, cardiomegaly, cor pulmonale, sinus arrest, supraventricular extrasystoles, tricuspid valve incompetence
Almindelig Ikke almindelig:
Uncommon:
Hedeture Dyb venetrombose, flebit, overfladisk tromboflebit, rødmen, tromboflebit, venestase
Hot flush Deep vein thrombosis, flushing, phlebitis, thrombophlebitis, thrombophlebitis superficial, venous stasis
Allergisk rinit, hoste, lungeemboli, Kronisk obstruktiv lungesygdom, lungegranulom, vasomotorisk rinit
Cough, pulmonary embolism, rhinitis allergic Chronic obstructive pulmonary disease, pulmonary granuloma, vasomotor rhinitis
Obstipation Abdominalsmerter, flatulens, gastritis, irritabel tyktarm, nedre abdominalsmerter, mundtørhed, øvre abdominalsmerter
Constipation Abdominal pain, abdominal pain lower, abdominal pain upper, dry mouth, flatulence, gastritis, irritable bowel syndrome
Ikke almindelig:
Hepatobiliary disorders Uncommon:
Galdesten, leversteatose Galdegangssten, gulsot, hepatitis, kolecystitis, leversygdom
Cholelithiasis, hepatic steatosis Bile duct stone, cholecystitis, hepatitis, jaundice, liver disorder
Hud og subkutane væv Almindelig Ikke almindelig:
Skin and subcutaneous tissue disorders Common Uncommon:
Hyperhidrose Alopeci, erytem, nattesved, pruritus Abnorm hårstruktur, angioødem, fotosensitivitet, generaliseret pruritus, hudirritation, hudlæsion, hudødem, hyperpigmentering af huden, knækkede
Hyperhidrosis Alopecia, erythema, night sweats, pruritus Angioedema, dry skin, hair texture abnormal, nail disorder, onychoclasis, photosensitivity reaction, pruritus generalized, rash maculo-papular, rash pruritic,
7 negle, kløende udslæt, maculopapuløst, neglesygdom, nældefeber, rosacea, tør hud, udslæt Knogler, led, muskler og bindevæv Meget almindelig Muskeltrækning Ikke almindelig:
Uncommon:
Nakkesmerter, rygsmerter, smerter i ekstremiteter Artropati, bursitis, coccygodyni, costochondritis, dactylitis, exostose, hæmartrose, kontraktur af ekstremitet, ledstivhed, muskelkontraktur, muskeltrækninger, muskuloskeletale gener, periartrit, rheumatoid artrit, rotator cuff- syndrom, smerter i kæbe, tendosynovitis, trommestikfingre
Muscle spasms Back pain, neck pain, pain in extremity Arthropathy, bursitis, clubbing, coccydynia, costochondritis, dactylitis, exostosis, extremity contracture, haemarthrosis, joint stiffness, muscle contracture, muscle twitching, musculoskeletal discomfort, pain in jaw, periarthritis, rheumatoid arthritis, rotator cuff syndrome, tenosynovitis
Ikke almindelig:
Renal and urinary disorders Uncommon:
Hyperkalciuri, hyperton blære, nefrosklerose, polyp i urinblæren, sten i blæren, uretralblødning, urinvejssygdom
Micturition urgency, nocturia, pollakiuria, urethral disorder, urinary incontinence Calculus bladder, hypercalciuria, hypertonic bladder, nephrosclerosis, urethral haemorrhage, urinary bladder polyp, urinary tract disorder
Der reproduktive system og mammae Almindelig
Reproductive system and breast disorders Common:
Cystocele, endometrielidelse, endometriehypertrofi * (ultralydsbestemt endometrietykkelse), uteruspolyp, vaginalt udflåd, vaginal sygdom
Cystocele, endometrial disorder, endometrial hypertrophy* (sonographic endometrial thickness), uterine polyp, vaginal discharge, vaginal disorder
Cervikal polyp, cervixsygdom, cervixdysplasi, endometriehyperplasi ** (baseret på indrapportering fra investigator), erosion af cervix uteri, genitalt udflåd, genitalblødning, hydrometra, metroragi, mammasygdom, mammainduration, postmenopausal blødning, rectocele, smerter i mamma, uterusprolaps, vaginalblødning, vaginalprolaps, vaginalt hernie, vulvovaginal kløe
Breast disorder female, breast induration, breast pain, cervix disorder, cervical dysplasia, cervical polyp, colpocele, endometrial hyperplasia** (based on investigator reporting), genital discharge, genital haemorrhage, hydrometra, metrorrhagia, postmenopausal haemorrhage, rectocele, uterine cervical erosion, uterine prolapse, vaginal haemorrhage, vaginal prolapse, vulvovaginal pruritus
Blodophobning i vaginalvæg, brystvortesygdom, cyste i adnexa uteri, cyste i tuba uterina, endometriosis interna, fibrose i bryst, flåd fra bryst, forstørrelse af mamma, forstørrelse af klitoris, genital kløe, laceration af perineum, pladeepitelmetaplasi i cervix uteri, smerter i brystvorte, udfyldning i adnexa uteri, uterin blødning, uterusudfyldning, vaginal erosion, vaginal inflammation, vaginalsmerte, varicer i vulva, vulvasygdom
Adenomyosis, adnexa uteri cyst, adnexa uteri mass, breast discharge, breast engorgement, breast fibrosis, enlarged clitoris, fallopian tube cyst, nipple disorder, nipple pain, perineal laceration, pruritus genital, uterine cervical squamous metaplasia, uterine haemorrhage, uterine mass, vaginal erosion, vaginal inflammation, vaginal pain, vaginal wall congestion, varicose veins vulval, vulvar disorder
Medfødte, familiære og genetiske sygdomme Sjælden:
Congenital, familial and genetic disorders Rare:
Almene symptomer og reaktioner på administrationsstedet Almindelig Ikke almindelig:
Uncommon:
Uventet terapeutisk respons Fornemmelse af varme, perifert ødem, thoraxsmerter, træthed Følelse af beruselse, hypertermi, inflammation, polyp, thorakalt ubehag, udfyldning, ødem
Therapeutic response unexpected Chest pain, fatigue, feeling hot, oedema peripheral Chest discomfort, feeling drunk, hyperthermia, inflammation, mass, oedema, polyp
Forhøjet aspartat- aminotransferase Abnormt cervix- smear, forhøjet alanin- aminotransferase, forhøjet blodsukker, forhøjede transaminaser, vægtøgning
Aspartate aminotransferase increased Alanine aminotransferase increased, blood glucose increased, smear cervix abnormal, transaminases increased, weight increased
Abnorm EKG T- bølge, abnormt fund ved røntgen af thorax, abnorm serumkreatinin, abnorm ultralydsundersøgelse af bryst, abnorm ultralydsundersøgelse af ovarier blod i urinen, forhøjet 5 ′ - nukleotidase, forhøjet gamma- glutamyltransferase, forhøjet low density lipoprotein, forhøjede serumtriglycerider, nedsat fodpuls, nedsat high density lipoprotein, nedsat knogletæthed, nedsat serumalbumin, nedsat trombocyttal, positiv test for hepatitis B- overfladeantigen,
5′ nucleotidase increased, blood albumin decreased, blood creatinine abnormal, blood triglycerides increased, blood urine present, bone density decreased, chest X-ray abnormal, electrocardiogram T wave abnormal, gamma-glutamyltransferase increased, hepatitis B surface antigen positive, high density lipoprotein decreased, low density lipoprotein increased, pedal pulse decreased, platelet count decreased, ultrasound breast abnormal, ultrasound ovary abnormal
Traumer, forgiftninger og behandlingskomplikationer Sjælden:
Injury and poisoning Rare:
* Endometriehypertrofi er en MedDRA- term, som betegner endometrietykkelse påvist ved ultralyd.
* Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
8 ** Endometriehyperplasi- hændelser baseret på indrapporteringer fra investigatorer uden histopatologi og uden histologisk verifikation.
8 ** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation.
Lasofoxifen er administreret til postmenopausale kvinder i enkeltdoser så høje som 100 mg (200 gange den anbefalede enkeltdosis) og i flere doser så høje som 10 mg dagligt (20 gange den anbefalede dosis) i op til et år uden alvorlige dosis- relaterede bivirkninger.
Lasofoxifene has been administered to postmenopausal women at single doses as high as 100 mg (200 times the recommended unit dose) and multiple doses as high as 10 mg/ day (20 times the recommended dose) for up to one year without dose-related serious adverse reactions.
I tilfælde af overdosering skal der initieres generelt understøttende behandling afhængigt af patientens symptomer.
In the event of overdose, general supportive measures should be initiated based on the patient’ s signs and symptoms.
Selektiv østrogenreceptormodulator (SERM), ATC- kode:
Selective Estrogen Receptor Modulator (SERM), ATC code:
Denne binding resulterer i aktivering af nogle østrogen- pathways og blokering af andre.
This binding results in the activation of some estrogenic pathways and a blockade of others.
Lasofoxifen har vævs - og cellespecifikke virkninger i østrogen- responsivt væv.
Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues.
Fablyns virkning på knoglevæv viser sig ved reduktion af serum - og urinindholdet af knogleomsætningsmarkører, forøgelse af knoglemineraldensiteten (BMD) samt nedsat forekomst af frakturer.
The effects of FABLYN on bone are manifested as reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures.
C- telopeptid og knogledannelsesmarkører: osteocalcin, procollagen type 1 N- terminal propeptid og knoglespecifik alkalisk fosfatase).
In the osteoporosis treatment trials, FABLYN therapy resulted in consistent, statistically significant suppression of bone resorption and bone formation, as reflected by changes in serum and urine markers of bone turnover (e. g., C-telopeptide and markers of bone formation: osteocalcin, procollagen type 1 N-terminal propeptide, and bone-specific alkaline phosphatase).
Hæmningen af knogleomsætningsmarkørerne kunne påvises efter 3 måneder og blev fastholdt gennem en observationsperiode på 36 måneder i et substudie under PEARL- studiet.
The suppression of bone turnover markers was evident by 3 months and persisted throughout the 36-month observation period in a sub-study of the PEARL study.
9 5- årsresultater fra stort, multinationalt frakturstudie (PEARL)
9 5-year results from large, multinational fracture trial (PEARL)
BMD og knoglebiomarkører hos postmenopausale kvinder med osteoporose blev undersøgt gennem 3 år i PEARL- studiet.
The effects of FABLYN on fracture incidence (table 2) were examined through 5 years; and BMD and bone biomarkers in postmenopausal women with osteoporosis were examined through 3 years in the PEARL study.
Studiepopulationen bestod af 8556 postmenopausale kvinder med osteoporose, defineret ved lav BMD (rygsøjle - eller hofte- BMD mindst 2, 5 SD under den gennemsnitlige værdi for raske unge kvinder).
The study population consisted of 8,556 postmenopausal women with osteoporosis as defined by low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women).
Alle kvinder i studiet fik calcium (1000 mg dagligt) og vitamin D (400- 800 IU dagligt).
All women in the study received calcium (1,000 mg/ day) and Vitamin D (400-800 IU/ day).
Forekomsten af frakturer hos postmenopausale kvinder gennem 5 år
Fracture incidence in postmenopausal women over 5 years
Fablyn
FABLYN
Relativ
Relative risk
risikoreduk tion (95% CI) vs. placebo Nye radiografisk verificerede rygsøjlefrakturer
reduction (95% CI) vs. placebo New radiographic vertebral fractures
Procentdel af patienter med nye frakturer Nye radiografisk verificerede rygsøjlefrakturer hos
Percentage of patients with new fracture New radiographic vertebral fracture in patients with ≥ 1
(28%; 52%)
(28%, 52%)
patienter med ≥ 1 baseline- fraktur
baseline fracture
Procentdel af patienter med nye frakturer Nye radiografisk verificerede rygsøjlefrakturer hos
Percentage of patients with new fracture New radiographic vertebral fracture in patients without any
(21%; 57%)
(21%, 57%)
patienter uden prævalent fraktur ved baseline Procentdel af patienter med nye frakturer Non- vertebrale frakturer Procentdel af patienter med non- vertebrale frakturer Alle kliniske frakturer Procentdel af patienter med kliniske frakturer Forkortelser: n= antallet af patienter; CI = Konfidensinterval a
prevalent fracture at baseline Percentage of patients with new fracture Non-vertebral fractures Percentage of patients with non-vertebral fracture
n=1970 4, 4% n=2852 8, 1% n=2852 9, 3%
n=1,970 4.4% n=2,852 8.1%
n=1970 7, 4% n=2852 10, 4% n=2852 12, 1%
n=1,970 7.4% n=2,852 10.4%
41% c (23%; 55%) 24% d (9%; 36%) 25% e (12%; 36%)
41%c (23%, 55%) 24%d (9%, 36%)
R adiografisk verificerede rygsøjlefrakturer
-Radiographic vertebral fractures
Fablyn nedsatte signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer (undtagen forværring af tidligere frakturer) fra 9, 3% for placebo til 5, 6% for Fablyn (relativ reduktion af risiko = 41%, p < 0, 0001).
FABLYN significantly decreased the incidence of new radiographic vertebral fractures (excluding worsening of previous fractures) from 9.3% for placebo to 5.6% for FABLYN (relative risk reduction = 41%, p < 0.0001).
Hos kvinder med en prævalent rygsøjlefraktur ved baseline reducerede Fablyn signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer fra 14, 2% for placebo til 8, 7% for Fablyn (relativ reduktion af risiko = 42%, p = 0, 0004).
In women with a prevalent vertebral fracture at baseline, FABLYN significantly reduced the incidence of new vertebral radiographic fractures from 14.2% for placebo to 8.7% for FABLYN (relative risk reduction = 42%, p = 0.0004).
Hos kvinder uden prævalent rygsøjlefraktur ved baseline var forekomsten af nye radiografisk verificerede rygsøjlefrakturer signifikant reduceret fra 7, 4% for placebo til 4, 4% for Fablyn (relativ reduktion af risiko = 41%, p = 0, 0002).
In women without any prevalent vertebral fractures at baseline, the incidence of new radiographic vertebral fractures was significantly reduced from 7.4% for placebo to 4.4% for FABLYN (relative risk reduction = 41%, p = 0.0002).
I Fablyn gruppen fik signifikant færre kvinder multiple radiografisk verificerede rygsøjlefrakturer sammenlignet med placebogruppen gennem 5 års behandling (p < 0, 0001).
Significantly fewer women experienced multiple radiographic vertebral fractures in the FABLYN treatment group versus the placebo group throughout 5 years of dosing (p < 0.0001).
Signifikant færre Fablyn- behandlede kvinder fik moderate eller alvorlige rygsøjlefrakturer (bestemt ved Genant- skala) sammenlignet med placebobehandlede kvinder (5, 2% placebobehandlede kvinder versus 3, 3% Fablyn- behandlede kvinder; p = 0, 0006).
Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006).
10 - Non- vertebrale frakturer
10 -Non-vertebral fractures