Oleh Admin Kalbe Medical pada January 10, 2017 07:30

Efektivitas Sotagliflozin untuk Pasien DM tipe 1

Sotagliflozin merupakan obat pertama yang menghambat pada kedua jenis sodium glucose cotransporter 1 dan 2 (SGLT1 dan SGLT2). Seperti diketahui bahwa SGLT1 bekerja dalam penyerapan glukosa di saluran pencernaan, sedangkan SGLT2 bekerja dalam proses reabsorpsi glukosa oleh ginjal. Mekanisme kerja obat ini bersifat independen/ tidak tergantung dari insulin. Jika nantinya mendapatkan persetujuan pemasaran, maka obat ini merupakan obat hipoglikemik oral pertama yang dapat diberikan bagi pasien DM tipe 1 sebagai tambahan terhadap pengobatan insulin pasien tersebut.
   
Hal tersebut berdasarkan studi klinik acak kedua yang menunjukkan bahwa obat baru sotagloflozin ini dapat menjadi tambahan terapi yang efektif bersama dengan terapi insulin bagi pasien diabetes melitus tipe 1. Studi tersebut diberikan judul studi InTandem1, studi pertama dari tiga studi acak pivotal fase 3 dengan desain tersamar ganda, dengan kontrol plasebo. InTandem1 dilakukan di Amerika Utara; studi kedua, InTandem2 dengan desain yang sama, dilakukan di Eropa dan Israel.

   
Dalam studi InTandem2, melibatkan 782 subjek pasien DM tipe 1 yang sebelumnya telah menggunakan insulin pump atau injeksi insulin multipel, dengan rerata kadar HbA1c basal yaitu 7,0% sampai 11%. Sebelum dilakukan randomisasi, dilakukan suatu periode optimalisasi dosis insulin selama 6 minggu, dengan tujuan untuk memperbaiki kadar glukosa darah hanya dengan insulin saja. Setelah dilakukan optimalisasi, subjek kemudian dibagi menjadi 3 kelompok, yaitu pemberian sotagliflozin 200 mg, 400 mg, atau plasebo. Saat randomisasi dilakukan, rerata HbA1c adalah 7,8% pada kelompok plasebo dan 7,7% pada kedua kelompok dosis sotagliflozin.


Hasil studi ini sama sepert studi InTandem1 yaitu berhasil mencapai keluaran/outcome primer. Rerata penurunan HbA1c dari basal setelah 24 minggu terapi adalah sebesar 0,39% dengan pemberian 200 mg sotagliflozin dan 0,37% dengan 400 mg sotagliflozin (kedua p< 0,01) versus 0,03% dengan plasebo.


Kejadian tidak diinginkan yang bersifat gawat akibat pemberian plasebo, 200 mg sotagliflozin ataupun 400 mg sotagliflozin adalah 51,4%, 55,9%, dan 54,4%. Insidens kejadian tidak diinginkan serius adalah 3,5%, 4,2% dan 4,2%. Insidens dari kejadian tidak diinginkan serius adalah 3,5%, 4,2% dan 4,2% untuk masing-masing dari ketiga kelompok tersebut. Persentase pasien yang berhenti melanjutkan studi karena kejadian tidak diinginkan adalah masing-masing 1,6%, 1,9%, dan 3,0%. Dua kematian terjadi pada kelompok plasebo selama studi berlangsung. Kejadian hipoglikemia terjadi pada 2,7%, 3,8% ,dan 2,3% pada kelompok plasebo, 200 mg, dan 400 mg sotagliflozin. Tidak ditemukan laporan kejadian ketoasidosis diabetikum pada kelompok plasebo, namun ada 1 kejadian (0,4%) yang terjadi pada kelompok 200 mg dan 3 kejadian (1,1%) pada kelompok 400 mg sotagliflozin.


Saat ini sedang dilakukan uji klinik fase 3 studi InTandem3, yang melibatkan kurang lebih 1400 pasien DM tipe 1, diberikan 400 mg sotagliflozin dan insulin, tanpa dilakukan periode optimalisasi. Kita tetap menunggu bagaimana hasil dari studi ini dapat menguatkan ataupun mendukung dari proses persetujuan pemasaran dari produk ini di masa yang akan datang. (PMD)


Image : Ilustrasi
Referensi:
1.Tucker ME. Sotagliflozin meets end point in second type 1 diabetes trial [Internet]. 2016 [cited 2016 Dec 27]. Available from: http://www.medscape.com/viewarticle/873697.
2.Tucker ME. Novel SGLT inhibitor adds benefit to insulin in type 1 diabetes [Internet]. 2016 [cited 2016 Dec 26]. Available from: http://www.medscape.com/viewarticle/868717.

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