FDA ta amince da sabon magani don nau'in ciwon sukari na 2
FDA ta amince da sabon magani don nau'in ciwon sukari na 2
Anonim

Hukumar Abinci da Magunguna ta Amurka a yau ta amince da allunan Tradjenta (linagliptin), waɗanda aka yi amfani da su tare da abinci da motsa jiki, don haɓaka sarrafa glucose na jini a cikin manya masu fama da ciwon sukari na 2.

Mutanen da ke da nau'in ciwon sukari na 2 ba sa samarwa ko amsa ga al'ada ga insulin, hormone wanda ke daidaita adadin glucose a cikin jini. A tsawon lokaci, yawan matakan glucose na jini na iya ƙara haɗarin haɗari mai tsanani, ciki har da cututtukan zuciya, makanta, da lalacewar jijiya da koda.

"Wannan amincewar ta ba da wani zaɓi na magani ga miliyoyin Amirkawa masu fama da ciwon sukari na 2," in ji Mary Parks, MD, darektan Sashen Metabolism da Endocrinology Products a Cibiyar Nazarin Magunguna da Magunguna ta FDA. "Yana da tasiri idan aka yi amfani da shi kadai ko kuma idan aka ƙara zuwa tsarin jiyya na yanzu."

Nau'in ciwon sukari na 2 shine nau'in cutar da aka fi sani, wanda ke shafar tsakanin kashi 90 zuwa kashi 95 na mutane miliyan 24 a Amurka masu ciwon sukari. Tradjenta yana haɓaka matakin hormones waɗanda ke motsa sakin insulin bayan cin abinci ta hanyar toshe enzyme dipeptidyl peptidase-4 ko DPP-4, wanda ke haifar da ingantaccen sarrafa glucose na jini.

An nuna Tradjenta ya kasance mai aminci da tasiri a cikin makafi guda takwas, nazarin asibiti mai sarrafa wuribo wanda ya shafi kusan marasa lafiya 3, 800 masu fama da ciwon sukari na 2. Nazarin ya nuna haɓakar sarrafa glucose na jini idan aka kwatanta da placebo.

An yi nazarin Tradjenta a matsayin magani mai zaman kansa kuma a hade tare da wasu hanyoyin kwantar da hankali na nau'in ciwon sukari na 2 da suka hada da metformin, glimepiride, da pioglitazone. Ba a yi nazarin Tradjenta tare da insulin ba, kuma bai kamata a yi amfani da shi don kula da masu fama da ciwon sukari na Nau'i na 1 ba ko a cikin waɗanda suka ƙara yawan ketone a cikin jini ko fitsari (mai ciwon sukari ketoacidosis).

Za a ba da Tradjenta tare da Fakitin Fakitin Mara lafiya da FDA ta amince da shi wanda ke bayyana amfanin da miyagun ƙwayoyi da kasada. Mafi yawan illolin Tradjenta sune kamuwa da cuta ta sama, kumburin hanci ko hanci, ciwon makogwaro, ciwon tsoka, da ciwon kai.

Tradjenta yana kasuwa ta hanyar Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., da Eli Lilly Co na tushen Indianapolis.

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