Oleh Admin Kalbe Medical pada October 06, 2017 07:30

Insulin Glargine U-300 DM Tipe 1 dan 2

Hiperglikemia yang persisten dan tidak terkontrol baik dapat terkait dengan komplikasi jangka panjang. Insulin telah menjadi terapi penurun glukosa darah yang paling efektif, dan diperlukan bagi pasien DM tipe 1 untuk mengontrol kadar glukosa darah mereka. Banyak juga pasien DM tipe 2 yang pada akhirnya memerlukan terapi insulin, karena progresivitas perjalanan penyakit ini. Dalam rangka memenuhi kebutuhan akan hal ini, panduan internasional dan nasional untuk tatalaksana diabetes merekomendasikan bahwa terapi insulin dapat diinisiasi pada pasien DM tipe 2 yang tidak terkontrol dengan obat diabetes oral. Namun, sampai saat ini ada saja barrier terhadap penggunaan insulin seperti pasien khawatir efek samping hipoglikemia, takut sakit karena suntikan, peningkatan berat badan, dampak gaya hidup yang berubah, serta biaya finansial untuk pengobatan.
   
Bagi pasien DM tipe 2 yang tidak terkontrol hanya dengan OHO, terapi dapat dikombinasikan ataupun diganti dengan insulin basal. Agar menyerupai suatu pola sekresi insulin yang menyerupai insulin fisiologis, maka insulin basal yang “ideal” haruslah memiliki durasi kerja yang panjang, memberikan kontrol glukosa darah puasa yang mencukupi dengan injeksi insulin sekali sehari. Diharapkan pula risiko hipoglikemia yang ditimbulkan rendah. Formulasi insulin glargine 300 unit/mL (Gla-300) telah dikembangkan, dan mengirimkan jumlah insulin yang sama dengan Gla-100 namun dengan hanya sepertiga volume injeksi Gla-100, sehingga akan membentuk depot subkutan yang lebih kecil, menghasilkan pelepasan insulin yang lebih panjang dan konstan lalu masuk ke sirkulasi.


Studi glucose clamp yang dilakukan pada DM tipe 1 menunjukkan bahwa kadar mantap tercapai dalam 3-4 hari setelah pemberian sekali sehari Gla-300 pada dosis klinis yang relevan. Waktu paruh pada kadar mantap berkisar setelah 19 jam. Di bawah kondisi kadar mantap, Gla-300 menunjukkan profil yang lebih mendatar dan durasi kerja yang lebih panjang dibandingkan Gla-100. Gla-100 sendiri mencapai kadar mantap setelah 2-4 hari setelah pemberian sekali sehari, dengan waktu paruh setelah 12 jam.


Studi fase III, non-inferioritas, membandingkan Gla-300 vs Gla-100 dalam penurunan HbA1c pasien DM tipe 1 dan 2. Selama periode follow up 6-12 bulan, Gla-300 secara konsisten memberikan efikasi kontrol glikemik yang sebanding dengan Gla-100, namun dengan hipoglikemia yang lebih rendah bahkan pada 8 minggu pertama terapi. Terjadi peningkatan dosis insulin 11-17% lebih tinggi pada Gla-300 vs Gla-100, namun peningkatan berat badan sebanding antar kelompok ataupun cenderung lebih kecil pada Gla-300.
   
Gla-300 diberikan melalui injeksi dengan pen prefilled (sepertiga dari volume yang diberikan melalui Gla-100). Pen dapat mengirimkan dosis maksimum sampai 80 unit per injeksi. Jika pasien mengganti dari Gla-100 ke Gla-300 maka akan terjadi penyesuaian dosis karena kedua formulasi ini tidak ekuivalen. Dosis yang lebih tinggi mungkin diakibatkan karena rendahnya bioavailabilitas Gla-300 akibat peningkatan residence time pada lokasi depot subkutan. Karena adanya durasi kerja yang lebih panjang, maka pemberian Gla-300 lebih fleksibel dibandingkan Gla-100 (sampai 3 jam). (PMD)


Image : Ilustrasi
Referensi:
Lau IT, Lee KF, So WY, Tan K, Yeung VTF. Insulin glargine 300 U/mL for basal insulin therapy in type 1 and type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2017;10:273-84. doi: 10.2147/DMSO.S131358.

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