Oleh Admin Kalbe Medical pada January 02, 2017 07:30

Perluasan Indikasi Insulin Degludec

FDA Amerika Serikat telah memberikan lampu hijau agar insulin degludec dapat diberikan bagi pasien diabetes melitus yang berusia dari 1 tahun sampai dewasa. Insulin degludec ini memiliki waktu paruh 25 jam dan tersedia dalam sediaan pen dengan kekuatan 100-U/mL atau 200-U/mL. Insulin degludec pertama kalinya disetujui FDA pada September 2015, dan kini diindikasikan bagi DM tipe 1 dan 2 dari usia 1 tahun hingga dewasa.
   
Indikasi baru ini dikeluarkan berdasarkan hasil dari studi fase 3b yang berjudul BEGIN™ Young 1 di mana hasil studi itu menunjukkan bahwa pemberian insulin degludec sekali sehari yang dikombinasikan dengan insulin aspart, dapat memperbaiki kontrol glikemik pada anak dan dewasa diabetes tipe 1, yang berusia 1 hingga 17 tahun, jika dibandingkan dengan insulin detemir yang sebaiknya diberikan sekali atau dua kali sehari, juga dengan kombinasinya dengan insulin aspart.


Kejadian tidak diinginkan yang paling sering dilaporkan adalah infeksi, hipoglikemia dan hiperglikemia. Studi ini merupakan studi fase 3b, multinasional, berdurasi 26 minggu, terkontrol, open-label, paralel, non-inferior, di mana dilakukan suatu periode ekstensi selama 26 minggu berikutnya. Penggunaan insulin degludec pada pasien berusia 1 tahun atau lebih yang mengidap DM tipe 2 juga didukung oleh adanya studi klinik yang baik pada pasien dewasa DM tipe 2.

   
Insulin degludec ini tidak direkomendasikan sebagai terapi ketoasidosis diabetikum atau untuk pasien anak yang memerlukan dosis insulin degludec di bawah 5 unit. (PMD)


Image : Ilustrasi
Referensi:
1.Wendling P. FDA expands Tresiba indication to children and adolescents with diabetes [Internet]. 2016 [cited 2016 Desember 21]. Available from: http://www.medscape.com/viewarticle/873519.
2.Anonim. Novo Nordisk receives FDA approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes [Internet]. 2016 [cited 2016 Dec 23]. Available from: http://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-approval-of-tresiba-insulin-degludec-injection-100-uml-200-uml-for-use-in-children-and-adolescents-with-diabetes-300381285.html.

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