Avgust 2021: Birinchi og'iz orqali yuboriladigan gonadotropin chiqaradigan gormon (GnRH) retseptorlari antagonisti relugolix (ORGOVYX, Myovant Sciences, Inc.) 18-yil 2020-dekabrda oziq-ovqat va farmatsevtika idorasi tomonidan metastatik prostata saratoni bilan og'rigan kattalar uchun tasdiqlangan.
HERO (NCT03085095), a randomised, open label trial in males requiring at least one year of androgen deprivation therapy for prostate cancer recurrence after radiotherapy or surgery or newly diagnosed castration-sensitive advanced prostate cancer, was used to assess efficacy. Relugolix 360 mg oral loading dosage on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg injection subcutaneously every 3 months for 48 weeks were given to patients (N=934).
Samaradorlikning yakuniy o'lchovi tibbiy kastratsiya darajasi bo'lib, u davolashning 50-kunigacha sarum testosteron darajasini (29 ng/dL) bostirishga erishish va uni keyingi 48 hafta davomida saqlab turish sifatida belgilangan. Relugolix qo'lida tibbiy kastratsiya darajasi 96.7 foizni tashkil etdi (95 foiz CI: 94.9 foiz, 97.9 foiz).
HEROda relugoliksni qabul qilgan bemorlarda qizdirish, mushak-skelet tizimining og'rig'i, charchoq, diareya va ich qotishi eng ko'p uchraydigan nojo'ya ta'sirlar (o'n foiz) edi. Glyukoza, triglitseridlar, alanin aminotransferaza va aspartat aminotransferaza kontsentratsiyasining ortishi eng keng tarqalgan laboratoriya anormalliklari (15%) edi. Gemoglobin darajasi ham pastroq ekanligi aniqlandi.
Birinchi kunida 360 mg yuklanish dozasi ko'rsatiladi, so'ngra har kuni taxminan bir vaqtning o'zida ovqat bilan yoki ovqatlanmasdan 120 mg og'iz orqali qabul qilinadi.
Malumot: https://www.fda.gov/
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