Ranar 23 ga watan Disamban shekarar 2014, Cibiyar Abinci da Drugura ta Amirka (FDA) ta amince da liraglutide a matsayin wani zaɓi don magance kullun kula. Luraglutide ana sayar da shi ne daga Novo Nordisk, Inc., karkashin sunan saxin Saxenda®. Wannan shi ne karo na hudu na asarar asarar da FDA ta amince tun shekarar 2012.
Menene Saxenda (Liraglutide)?
Saxenda® wani allura ne wanda ya riga ya samuwa a cikin ƙananan kashi kamar wani magani, Victoza®, wanda ake amfani da ita don maganin ciwon sukari na iri 2 .
Yana da wani nau'i na magungunan da aka sani kamar yadda glucagon-like peptide-1 (GLP-1) agonists. Wani miyagun ƙwayoyi a wannan aji ya haɗa da exenatide (Byetta®). Duk da yake an yi amfani da su duka don ciwon sukari, liraglutide (a matsayin mafi girma a matsayin Saxenda®) shine na farko da zai karbi takardar izinin FDA musamman don gudanarwa.
Wanene Ana Bukatar Saxenda?
An amince da Saxenda® don amfani dashi a cikin manya tare da lakabi na jiki (BMI) na 30 ko mafi girma, ko kuma tsofaffi tare da BMI na 27 ko mafi girma waɗanda ke da akalla nauyin wasu nauyin nau'i, irin su ciwon sukari, hawan jini , ko high cholesterol.
Bugu da ƙari, Saxenda® yana nufin a yi amfani da shi a matsayin mai haɗaka ga abinci da kuma motsa jiki don ci gaba da kulawa da manya a cikin manya. Ba a nufin maye gurbin abinci da motsa jiki ba.
Yaya Yayi Amfani?
Gwajin gwaje-gwaje uku sun gwada tsaro da tasiri na Saxenda®. Wadannan gwaji sun sanya kimanin kimanin mutane 4,800 marasa lafiya da yawa.
Ɗaya daga cikin gwajin da aka gwada marasa lafiya ba tare da ciwon sukari ya sami asarar nauyi na 4.5% a cikin marasa lafiya da suka dauki Saxenda® ba. Wannan fitina ta kuma gano cewa kashi 62 cikin 100 na waɗanda aka bi da su tare da Saxenda® sun rasa akalla 5% na nauyin jikin su.
A wani gwaji na gwaji wanda yake kula da marasa lafiya da ciwon sukari 2, sakamakon ya nuna cewa waɗanda aka bi da Saxenda® sun rasa 3.7% nauyin su idan aka kwatanta da magani tare da placebo, 49% na wadanda ke dauke da Saxenda® sun rasa akalla 5% na nauyin jikin su (idan aka kwatanta da kawai kashi 16 cikin dari na wadanda ke zaune).
Sabili da haka, yana bayyana cewa Saxenda® na iya zama dan kadan kaɗan ga asarar nauyi a marasa lafiya waɗanda basu da ciwon sukari na iri 2, kodayake har yanzu yana da tasiri mai sauƙi ga masu fama da ciwon sukari.
Mene Ne Hanyoyin Hanya?
FDA ta ba da sanarwar gargaɗin fata a kan Saxenda®, yana nuna cewa ciwon sukari na glandon thyroid sun kasance a cikin binciken akan rodents, amma ba a san ko Saxenda® ba zai iya haifar da ciwon sukari a cikin mutane.
Abubuwa masu tsanani wadanda suka kamu da cutar a cikin marasa lafiya da ke shan Saxenda® sun hada da pancreatitis (kumburi na pancreas, wanda zai iya zama barazanar rayuwa), cututtuka da cutar, koda da kuma tunanin suicidal. Bugu da ƙari, Saxenda® na iya tayar da zuciya, kuma FDA ta ba da shawarar cewa za a dakatar da shi a cikin wani mai haƙuri da ke samun ci gaba da ƙimar zuciya.
Sakamakon saxenda® mafi yawancin da aka gani a cikin gwajin gwaji sune tashin hankali, ƙyama, vomiting, diarrhea, rage yawan ci, da kuma jini mai zurfin jini (hypoglycemia).
Wanda ba za a dauki Saxenda ba?
Saboda rashin lafiyar ƙwayar cutar ciwon karoid, Saxenda® bazai karɓa da marasa lafiya wanda ke fama da cututtukan cututtuka da aka sani da ƙananan endocrine neoplasia irin na 2 (MEN-2), ko kuma marasa lafiya wanda ke da sirri ko tarihin iyali na wani nau'i na ciwon daji na thyroid wanda aka sani da suna thyroid carcinoma (MTC).
Sauran wadanda ba za su dauki Saxenda® sun haɗa da: yara (FDA na buƙatar aikin jarrabawa don gwada lafiyar da inganci a cikin yara), mata masu ciki ko nono, da kuma wanda ya taɓa yin mummunan aiki ga liraglutide ko kuma ga wani na samfurin samfurin Saxenda®.
Wasu damuwa
A cewar sanarwar FDA game da amincewar Saxenda®, hukumar ta buƙaci karatun bayanan sayar da wannan magani:
- Gwajen gwaje-gwaje don gwada lafiyar, inganci, da kuma maganin yara;
- A rajista na likitancin ciwon maganin thyroid na akalla shekaru 15;
- Binciken da za a gwada tasirin da ake samu a kan ci gaba, ci gaba da ci gaba da ci gaba da jima'i a cikin ratsi marasa kyau; da kuma
- Binciken yiwuwar cutar ciwon nono a cikin marasa lafiya ɗauke da Saxenda® a cikin gwaji na asibiti.
Sources:
FDA ta saki labarai. FDA ta amince da maganin Saxenda mai kula da ma'auni. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
Saxenda mai bayanin bayanin. Novo Nordisk. www.saxenda.com.