FrancophonIA/ELRC3.0 huggingface dataset:
English: The steady-state is established after approximately two weeks of thrice daily dosing.
Croatian: Stanje dinamičke ravnoteže utvrđeno je nakon otprilike dva tjedna doziranja tri puta dnevno.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Croatian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co.
English: A post-hoc analysis of time to persistent 10% worsening in 6MWD showed that 26% of patients in the ataluren 40 mg/kg/day arm had progressed at Week 48 compared to 44% in the placebo group (p=0.0652) (Figure 2).
Croatian: Post-hoc analiza vremena do perzistentnog 10%-tnog pogoršanja u udaljenosti prijeđenoj u 6 minuta pokazala je da je u 26% bolesnika u skupini koja je primala ataluren 40 mg/kg/dan došlo do progresije u 48. tjednu u usporedbi sa 44% u skupini koja je primala placebo (p=0,0652) (Slika 2).
English: Each prepared dose is best administered immediately after preparation.
Croatian: Najbolje je primijeniti svaku pripremljenu dozu odmah nakon pripreme.
English: Following multiple dosing, the increase in ataluren and ataluren metabolite is anticipated to be higher in patients with severe renal impairment and end-stage renal disease when compared with patients with normal renal function at steady state.
Croatian: Nakon višekratnog doziranja, predviđa se da će povećanje atalurena i metabolita atalurena biti više u bolesnika s teškim oštećenjem funkcije bubrega i završnim stadijem bubrežne bolesti u usporedbi sa stanjem dinamičke ravnoteže u bolesnika s normalnom funkcijom bubrega.
English: Translarna is available in sachets of 125 mg, 250 mg or 1000 mg.
Croatian: Lijek Translarna dostupan je u vrećicama od 125 mg, 250 mg ili 1000 mg.
English: Placental transfer was shown of radiolabelled ataluren in rats.
Croatian: Transplacentalni prijenos dokazan je pomoću radiološki označenog atalurena u štakora.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ataluren in two subsets of the paediatric population from birth to less than 28 days and infants from 28 days to less than 6 months in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja atalurena u dvije podskupine pedijatrijske populacije, od rođenja do manje od 28 dana i u dojenčadi od 28 dana do manje od 6 mjeseci s DMD-om s besmislenom mutacijom, sukladno uvjetima zadanim u planu pedijatrijskog ispitivanja (PIP-u), u odobrenoj indikaciji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Other endpoints included in both trials were time to persistent 10% worsening in 6MWD, change in time to run/walk 10 meters at Week 48, change in time to climb 4 stairs at Week 48, and change in time to descend 4 stairs at Week 48.
Croatian: Ostale mjere ishoda uključene u oba ispitivanja bile su vrijeme do perzistentnog 10%-tnog pogoršanja rezultata 6-minutnog testa hoda, promjena u trajanju trčanja/hoda na 10 metara u 48. tjednu, promjena u trajanju uspona po 4 stube u 48. tjednu te promjena u trajanju silaska niz 4 stube u 48. tjednu.
English: Mean Change in Timed Function Tests (Study 1)
Croatian: Slika 3. Srednja promjena u rezultatima vremenski mjerenih testova funkcije (Ispitivanje 1)
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (eg rifampicin).
Croatian: Potreban je oprez kada se ataluren primjenjuje istovremeno s lijekovima koji su induktori UGT1A9 (primjerice rifampicin).
English: Adverse reactions were generally mild or moderate in severity, and no treatment-related serious adverse events were reported among ataluren-treated patients in these 2 studies.
Croatian: Nuspojave su bile općenito blagog ili umjerenog intenziteta te u ta 2 ispitivanja za bolesnike liječene atalurenom nisu prijavljene ozbiljne nuspojave povezane s liječenjem.
English: In order to confirm the efficacy and safety of ataluren in the treatment of ambulant patients with nmDMD aged 5 years or older, the MAH should conduct and submit the results of a multicentre, randomised, double-blind, 18-month, placebocontrolled study, followed by a 18-month open label extension, according to an agreed protocol.
Croatian: Kako bi se potvrdila djelotvornost i sigurnost atalurena u liječenju pokretnih bolesnika s Duchenneovom mišićnom distrofijom uzrokovanom besmislenom mutacijom u dobi od 5 godina ili starijih, nositelj odobrenja treba provesti i dostaviti rezultate multicentričnog, randomiziranog, dvostruko slijepog, 18mjesečnog, placebom kontroliranog ispitivanja, nakon kojeg slijedi 18-mjesečni otvoreni nastavak ispitivanja, u skladu s dogovorenim planom ispitivanja.
English: These findings were seen in dogs at systemic exposure equivalent to 0.8 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 40 mg/kg/day and higher.
Croatian: Ovi su nalazi uočeni u pasa kod sistemske izloženosti ekvivalentne 0,8 puta AUC u stanju dinamičke ravnoteže u bolesnika koji primaju lijek Translarna u jutarnjim, podnevnim i večernjim dozama od 40 mg/kg/dan i više.
English: In timed function tests (TFTs), tests of time to run/walk 10 meters, time to climb 4 stairs, and time to descend 4 stairs, ataluren-treated patients demonstrated smaller increases in the time it takes to run/walk 10 meters, climb 4 stairs, and descend 4 steps, indicating slowing of nmDMD progression relative to placebo.
Croatian: U vremenski mjerenim testovima funkcije, testovima vremena trčanja/hodanja na 10 metara, vremena potrebnog za uspinjanje uz 4 stepenice i vremena za silaženje niz 4 stepenice, bolesnici liječeni atalurenom pokazali su manje povećanje vremena koje je potrebno za trčanje/hodanje na 10 metara, uspinjanje uz 4 stepenice i silazak niz 4 stepenice, ukazujući na usporavanje progresije DMD-a s besmislenom mutacijom u odnosu na placebo.
English: Caution should also be exercised when ataluren is co-administered with OAT3 substrates (eg, ciprofloxacin), especially those OAT3 substrates with a narrow therapeutic window.
Croatian: Prilikom primjene atalurena sa supstratima OAT3 (npr. ciprofloksacinom) potreban je oprez, naročito ako se primjenjuje s onim supstratima OAT3 koji imaju usku terapijsku širinu.
English: There should be 6 hours between morning and midday doses, 6 hours between midday and evening doses, and 12 hours between the evening dose and the first dose on the next day.
Croatian: Razmak između jutarnje i podnevne doze treba biti 6 sati, između podnevne i večernje doze 6 sati, a između večernje i prve doze sljedećeg dana 12 sati.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ataluren in one subset of the paediatric population aged 6 months to less than 5 years old in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja atalurena u jednoj podskupini pedijatrijske populacije u dobi od 6 mjeseci do manje od 5 godina starosti s DMD-om s besmislenom mutacijom, sukladno uvjetima zadanim u planu pedijatrijskog ispitivanja (PIP-u), u odobrenoj indikaciji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: As the primary endpoint (change in 6MWD from baseline to Week 48) did not reach statistical significance (p≤0.05),
Croatian: Budući da mjera primarnog ishoda (promjena rezultata 6-minutnog testa hoda od početka do 48. tjedna) nije dostigla statistički značajnu vrijednost (p≤0,05), sve druge p-vrijednosti treba smatrati nominalnima.
English: Renal toxicity (nephrosis in the distal nephron) occurred in repeat oral dose studies in mice at systemic exposure equivalent to 0.3 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 10-, 10-, 20-mg/kg and higher.
Croatian: Renalna toksičnost (nefroza u distalnom nefronu) nastupila je u ispitivanjima ponovljene peroralne doze u miševa pri ekvivalentu sistemske izloženosti od 0,3 puta AUC u stanju dinamičke ravnoteže u bolesnika koji su primili lijek Translarna u jutarnjim, podnevnim i večernjim dozama od 10, 10, 20 mg/kg/dan i više.
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Croatian: Prijavljeno je povećanje izloženosti atalurenu i metabolitima atalurena u bolesnika s teškim oštećenjem funkcije bubrega (eGFR <30 ml/min).
English: The co-administration of these medicinal products with ataluren should be avoided (see section 4.3).
Croatian: Potrebno je izbjegavati istovremenu primjenu ovih lijekova s atalurenom (vidjeti dio 4.3).
English: Adverse reactions reported in >1 ataluren-treated patients with nmDMD at a frequency greater than placebo in the 2 placebo-controlled studies (pooled analysis)
Croatian: Nuspojave prijavljene kod > 1 bolesnika s DMD-om s besmislenom mutacijom liječenog atalurenom s učestalošću većom od one u skupini s placebom u 2 placebom kontrolirana ispitivanja (združena analiza)
English: Mean Change in Timed Function Tests (Study 2)
Croatian: Slika 5. Srednja promjena u rezultatima vremenski mjerenih testova funkcije (Ispitivanje 2)
English: Translarna is white to off-white granules for oral suspension in sachets.
Croatian: Kako Translarna izgleda i sadržaj pakiranja Translarna su bijele do gotovo bijele granule za oralnu suspenziju u vrećicama.
English: Because changes in lipid profile (increased triglycerides and cholesterol) were reported for some patients in clinical trials, it is recommended that total cholesterol, LDL, HDL, and triglycerides be monitored on an annual basis in nonsense mutation Duchenne muscular dystrophy (nmDMD) patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Croatian: Budući da su promjene u lipidogramu (povećanje triglicerida i kolesterola) prijavljene za pojedine bolesnike u kliničkim ispitivanjima, preporučeno je praćenje vrijednosti ukupnog kolesterola, LDL, HDL i triglicerida na godišnjoj osnovi u bolesnika s Duchenneovom mišićnom distrofijom (DMD) s besmislenom mutacijom koji primaju ataluren ili češće prema potrebi na temelju kliničkog statusa bolesnika.
English: Mean Change in 6-Minute Walk Distance (Study 1)
Croatian: Srednja promjena u udaljenosti prijeđenoj u 6 minuta (Ispitivanje 1)
English: 125 mg sachets
Croatian: 125 mg vrećice
English: Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3).
Croatian: Ataluren se ne smije primjenjivati istovremeno s intravenskim aminoglikozidima zbog slučajeva smanjenja funkcije bubrega uočenih u kliničkom ispitivanju u bolesnika oboljelih od cistične fibroze (CF) s besmislenom mutacijom (vidjeti dio 4.3).
English: The effect of co-administration of ataluren with other nephrotoxic medicinal products is unknown.
Croatian: Nije poznat učinak istovremene primjene atalurena s drugim nefrotoksičnim lijekovima.
English: The elimination of ataluren is likely dependent on hepatic and renal glucuronidation of ataluren followed by renal and hepatic excretion of the resulting glucuronide metabolite.
Croatian: Eliminacija atalurena vjerojatno ovisi o glukuronidaciji atalurena u jetri i bubrezima nakon čega slijedi izlučivanje rezultirajućih metabolita glukuronida putem bubrega i jetre.
English: Nausea, upper abdominal pain, flatulence, abdominal discomfort, constipation
Croatian: Poremećaji probavnog sustava povraćanje mučnina, bol u gornjem dijelu abdomena, flatulencija, nelagoda u abdomenu, konstipacija
English: Over 48 weeks, ataluren-treated patients showed less decline in muscle function, as evidenced by smaller increases in the time to run/walk 10 meters, climb 4 steps, and descend 4 steps in the atalurentreated group relative to placebo.
Croatian: Tijekom 48 tjedana, bolesnici liječeni atalurenom pokazali su manje pogoršanje mišićne funkcije prema pokazanom manjem povećanju trajanja trčanja/hoda na 10 metara, uspona po 4 stube i silaska niz 4 stube u skupini liječenoj atalurenom u odnosu na placebo.
English: Translarna is available in 3 strengths, each containing 125 mg, 250 mg and 1000 mg of the active substance, called ataluren.
Croatian: Lijek Translarna dostupan je u 3 jačine, svaka sadrži 125 mg, 250 mg i 1000 mg djelatne tvari naziva ataluren.
English: Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (coloring and polyester/foil bond), aluminum foil (moisture barrier), adhesive (polyurethane class), copolymer of ethylene and methacrylic acid (sealant resin for packaging integrity).
Croatian: Toplinski zalijepljena vrećica od laminirane aluminijske folije: polietilen tereftalat (onemogućava djeci jednostavno otvaranje), polietilen (obojenje i vezivo poliestera i folije), aluminijska folija (zaštita od vlage), ljepilo (poliuretansko), kopolimer etilena i metakrilne kiseline (ljepljiva smola za cjelovitost pakiranja).
English: The prepared dose should be mixed well before administration.
Croatian: Pripremljenu dozu treba dobro promiješati prije primjene.
English: Translarna 1000 mg granules for oral suspension EU/1/13/902/003
Croatian: Translarna 1000 mg granule za oralnu suspenziju EU/1/13/902/003
English: No apparent differences of the total ataluren exposure in the control, mild, and severe hepatic impairment groups were observed.
Croatian: Nisu opažene vidljive razlike u ukupnoj izloženosti atalurenu između kontrolne skupine i skupina s blagim i teškim oštećenjem funkcije jetre.
English: In a rat distribution study a high adrenal concentration of ataluren was observed.
Croatian: U ispitivanju distribucije u štakora uočene su visoke koncentracije atalurena u nadbubrežnoj žlijezdi.
English: Adverse reactions reported in >1 patient in the 40 mg/kg/day group at a frequency greater than that of the placebo group are presented by MedDRA System Organ Class, Preferred Term, and frequency.
Croatian: Nuspojave prijavljene kod > 1 bolesnika u skupini koja je primala 40/mg/kg/dan s većom učestalošću od skupine koja je primala placebo, prikazane su prema MedDRA klasifikaciji organskih sustava, preporučenih pojmova i učestalosti.
English: Translarna 125 mg granules for oral suspension EU/1/13/902/001
Croatian: Translarna 125 mg granule za oralnu suspenziju EU/1/13/902/001
English: Treatment should not be initiated in previously untreated patients with eGFR <30 ml/min (see sections 4.2 and 5.2).
Croatian: Liječenje ne treba započinjati u prethodno neliječenih bolesnika s vrijednošću eGFR-a <30 ml/min
English: Because hypertension with use of concomitant systemic corticosteroids was reported for some patients in clinical trials, it is recommended that resting systolic and diastolic blood pressure be monitored every 6 months in nmDMD patients receiving ataluren concomitantly with corticosteroids, or more frequently as needed based on the patient's clinical status.
Croatian: Budući da je za pojedine bolesnike u kliničkim ispitivanjima prijavljena hipertenzija kod istovremene primjene sistemskih kortikosteroida, preporuča se da se sistolički i dijastolički krvni tlak u mirovanju prate svakih 6 mjeseci u bolesnika s Duchenneovom mišićnom distrofijom s besmislenom mutacijom koji primaju ataluren zajedno s kortikosteroidima ili češće prema potrebi na temelju kliničkog statusa bolesnika.
English: If there is a delay of more than 3 hours after the morning or midday doses or more than 6 hours after the evening dose, the dose should not be taken, and patients should resume their usual dosing schedule.
Croatian: Ako je odgoda dulja od 3 sata nakon jutarnje ili podnevne doze ili dulja od 6 sati nakon večernje doze, doza se ne smije uzeti, a bolesnik treba nastaviti svoj uobičajeni raspored doziranja.
English: In the urine, unchanged ataluren and the acyl glucuronide metabolite account for <1% and 49%, respectively, of the administered dose.
Croatian: U urinu, neizmijenjeni ataluren čini < 1%, a metabolit acil glukuronid 49% primijenjene doze.
English: If you are late in taking Translarna by less than 3 hours after the morning or midday doses, or by less than 6 hours after the evening dose, take the dose.
Croatian: Ako kasnite s primjenom lijeka Translarna manje od 3 sata nakon jutarnje ili podnevne doze ili manje od 6 sati nakon večernje doze, uzmite dozu.
English: The efficacy and safety of Translarna were assessed in 2 randomised, double-blind, placebo-controlled, trials in nmDMD.
Croatian: Djelotvornost i sigurnost lijeka Translarna procijenjeni su u 2 randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja Duchenneove mišićne distrofije s besmislenom mutacijom.
English: 6MWD Results in Patients with a Baseline 6MWD < 350 meters.
Croatian: Rezultati udaljenosti prijeđene u 6 minuta u bolesnika s početnom vrijednosti < 350 metara.
English: Translarna 250 mg granules for oral suspension EU/1/13/902/002
Croatian: Translarna 250 mg granule za oralnu suspenziju EU/1/13/902/002
English: If you are late by more than 3 hours after the morning or midday doses, or by more than 6 hours after the evening dose, do not take the dose.
Croatian: Ako kasnite više od 3 sata nakon jutarnje ili podnevne doze ili više od 6 sati nakon večernje doze, nemojte uzeti dozu.
English: Translarna 1000 mg granules for oral suspension Each sachet contains 1000 mg ataluren.
Croatian: Translarna 1000 mg granule za oralnu suspenziju Jedna vrećica sadrži 1000 mg atalurena.
English: Mean Change in 6-Minute Walk Distance (Study 2)
Croatian: Slika 4. Srednja promjena u udaljenosti prijeđenoj u 6 minuta (Ispitivanje 2)
English: Translarna is available in the following sachet strengths: 125 mg, 250 mg and 1000 mg of ataluren per sachet.
Croatian: Translarna je dostupna u sljedećim jačinama vrećice: 125 mg, 250 mg i 1000 mg atalurena po vrećici.
English: Because small increases in mean serum creatinine, blood urea nitrogen (BUN), and cystatin C were observed in the controlled studies of nmDMD, it is recommended that serum creatinine, BUN, and cystatin C be monitored every 6 to 12 months in nmDMD patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Croatian: Budući da je malo povećanje u srednjim vrijednostima kreatinina u serumu, ureje u krvi (BUN) i cistatina C uočeno u kontroliranim ispitivanjima DMD-a s besmislenom mutacijom, preporuča se da se vrijednosti kreatinina u serumu, BUN-a i cistatina C prate svakih 6 do 12 mjeseci u bolesnika s Duchenneovom mišićnom distrofijom (DMD) s besmislenom mutacijom koji primaju ataluren ili češće prema potrebi na temelju kliničkog statusa bolesnika.
English: The adverse reactions reported in patients with nmDMD treated with the recommended daily dose of 40 mg/kg/day ataluren in the 2 placebo-controlled studies are presented in Table 1.
Croatian: Nuspojave prijavljene u bolesnika oboljelih od Duchenneove mišićne distrofije (DMD) s besmislenom mutacijom, liječenih preporučenom dnevnom dozom od 40 mg/kg/dan atalurena u 2 placebom kontrolirana ispitivanja prikazane su u Tablici 1.
English: 250 mg sachets mg sachets
Croatian: 250 mg vrećice mg vrećice
English: No dosage adjustment is required for patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavanje doze za bolesnike s blagim ili umjerenim oštećenjem funkcije bubrega.
English: Translarna 250 mg granules for oral suspension Each sachet contains 250 mg ataluren.
Croatian: Translarna 250 mg granule za oralnu suspenziju Jedna vrećica sadrži 250 mg atalurena.
English: How to store Translarna
Croatian: Kako čuvati lijek Translarna
English: ≥75 meters without the need for assistive devices during a screening 6-Minute Walk Test (6MWT).
Croatian: Svi bolesnici morali su imati sposobnost hodanja ≥ 75 metara bez potrebe pomagala tijekom 6-minutnog testa hoda na probiru.
English: How to take Translarna
Croatian: Kako uzimati lijek Translarna
English: If you have severe kidney problems (eGFR <30 ml/min) or if you are receiving dialisys because your kidneys do not work (end-stage renal disease) your doctor will established if treatment with Translarna is suitable for you.
Croatian: Ako imate teške bubrežne probleme (eGFR <30 ml/min) ili ako primate dijalizu jer
English: Mix the prepared dose well before taking it.
Croatian: Pripremljenu dozu dobro pomiješajte prije primjene.
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in observed time to run/walk 10 meters (better by 1.2 seconds, p=0.117), time to climb 4 stairs (better by 1.8 seconds, p=0.058), and time to descend 4 stairs (better by 1.8 seconds, p=0.012), Figure 5.
Croatian: Srednja promjena rezultata vremenski mjerenih testova funkcije od početne vrijednosti do 48. tjedna bila je veća u skupini s atalurenom u dozi od 40 mg/kg/dan nego kod placeba u zabilježenom trajanju trčanja/hoda na 10 metara (bolje za 1,2 sekunde, p=0,117), trajanju uspona po 4 stube (bolje za 1,8 sekundi, p=0,058) i trajanja silaska niz 4 stube (bolje za 1,8 sekundi, p=0,012), Slika 5.
English: Translarna 1000 mg granules for oral suspension ataluren
Croatian: Translarna 1000 mg granule za oralnu suspenziju ataluren
English: Patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk (see sections 4.2 and 4.4).
Croatian: Bolesnike s teškim oštećenjem funkcije bubrega (eGFR <30 ml/min) ili završnim stadijem bubrežne bolesti treba liječiti atalurenom samo ako predviđena klinička korist nadmašuje potencijalni rizik
English: Age-adjusted dosing is not required.
Croatian: Nije potrebno doziranje prilagoditi dobi.
English: Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension
Croatian: Translarna 125 mg granule za oralnu suspenziju Translarna 250 mg granule za oralnu suspenziju Translarna 1000 mg granule za oralnu suspenziju
English: Pain in extremity, musculoskeletal chest pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u ekstremitetu, mišićno-koštana bol u prsnom košu
English: Number of sachets
Croatian: Broj vrećica
English: These results indicate that ataluren 40 mg/kg/day slows the loss of walking ability in nmDMD patients.
Croatian: Ovi rezultati ukazuju da ataluren u dozi od 40 mg/kg/dan usporava gubitak sposobnosti hodanja u bolesnika s Duchenneovom mišićnom distrofijom s besmislenom mutacijom.
English: Posology table
Croatian: Tablica doziranja
English: In the ITT population, the difference between the ataluren and placebo arms in mean change in observed 6MWD from baseline to Week 48 was 15.4 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm.
Croatian: Kod ITT (engl. intent-to-treat) populacije, razlika između skupina s atalurenom i placebom u srednjoj promjeni zabilježenoj 6-minutnim testom hoda od početne vrijednosti do 48. tjedna bila je 15,4 metara bolja u skupini s atalurenom u dozi od 40 mg/kg/dan nego u skupini s placebom.