Pa December 23, 2014, US Food and Drug Administration (FDA) inavomereza liraglutide ngati njira yothetsera vuto lolemera kwambiri. Liraglutide ikugulitsidwa ndi Novo Nordisk, Inc., pansi pa dzina lakuti Saxenda®. Ichi ndichinayi mankhwala olemera omwe avomerezedwa ndi FDA kuyambira 2012.
Kodi Saxenda (Liraglutide) ndi chiyani?
Saxenda® ndi jekeseni yomwe imapezeka kale mu mlingo wapang'ono monga mankhwala ena, Victoza®, omwe amagwiritsidwa ntchito pochiza mtundu wa shuga .
Zili m'gulu la mankhwala omwe amadziwika kuti biochemically monga glucagon-ngati peptide-1 (GLP-1) agonist receptor. Mankhwala ena m'kalasiyi akuphatikizapo kuwonjezera (Byetta®). Ngakhale kuti onse amagwiritsidwa ntchito pa shuga, liraglutide (mu mlingo wake wapamwamba monga Saxenda®) ndiyo woyamba kulandira chivomerezo cha FDA makamaka pa kayendedwe ka kulemera.
Kodi Saxenda Amafuna Ndani?
Saxenda® yavomerezedwa kuti igwiritsidwe ntchito kwa anthu achikulire omwe ali ndi chiwerengero cha thupi la 30 kapena kuposa, kapena achikulire omwe ali ndi BMI ya 27 kapena akuluakulu omwe ali ndi matenda ena olemera, monga shuga, kuthamanga kwa magazi , kapena cholesterol.
Kuonjezerapo, Saxenda ® imagwiritsidwa ntchito kuti ikhale yogwirizana ndi zakudya komanso masewera olimbitsa thupi kuti azitha kulemera kwa akuluakulu. Sichiyenera kutengera zakudya ndi zolimbitsa thupi.
Kodi Zimathandiza Bwanji?
Mayesero atatu am'chipatala adayesa kufufuza ndi kupambana kwa Saxenda®. Mayeserowa analembetsa pafupifupi 4,800 odwala onse oposa oposa onse.
Chiyeso chimodzi chachipatala chomwe chinayang'ana odwala omwe alibe shuga, chinapeza kulemera kwake kwa 4.5% mwa odwala omwe anatenga Saxenda®. Chiyesochi chinapezanso kuti 62% mwa iwo amene anachiritsidwa ndi Saxenda® ataya pafupifupi 5% ya kulemera kwa thupi lawo.
Mu mayesero ena omwe adayang'ana odwala omwe ali ndi matenda a shuga 2, zotsatira zake zimasonyeza kuti anthu omwe anachiritsidwa ndi Saxenda® adataya 3.7% palemera kwake poyerekeza ndi mankhwala a placebo, ndipo 49 peresenti ya iwo omwe amatenga Saxenda® adataya osachepera 5% (poyerekeza ndi 16 peresenti yokha ya omwe amatenga placebo).
Choncho, zikuwoneka kuti Saxenda® ikhoza kukhala yothandiza kwambiri kulemera kwa odwala omwe alibe mtundu wa shuga wa 2, ngakhale kuti zinkakhalabe ndi zotsatirapo-ngakhale kuchepetsa kulemera kwa odwala matenda a shuga.
Kodi Zotsatira Zilipo?
A FDA apereka machenjezo a mabulosi wakuda pa Saxenda®, kunena kuti zotupa za chithokomiro zakhala zikuwonetsedwa mu maphunziro pa makoswe, koma kuti sizidziwika ngati Saxenda ® kapena izi sizingayambitse zotupa mwa anthu.
Zotsatira zoyipa zomwe zafotokozedwa pa odwala omwe akutenga Saxenda ® zikuphatikizapo kuperewera kwa matenda (kutupa kwa kapangidwe, komwe kumayambitsa moyo), matenda a ndulu, matenda a impso, ndi malingaliro odzipha. Kuwonjezera apo, Saxenda ® imatha kukweza mtima, ndipo FDA imalangiza kuti imachotsedwa mwa wodwala aliyense amene akukumana ndi kuwonjezeka kwowonjezereka mu kupuma kwa mtima.
Zotsatira zofala kwambiri za Saxenda® zomwe zinawoneka m'mayesero a zachipatala zinali zonyansa, kudzimbidwa, kusanza, kutsekula m'mimba, kuchepa kwa chilakolako, ndi shuga ya magazi (hypoglycemia).
Kodi Sitiyenera Kutenga Saxenda?
Chifukwa cha ziwalo za chithokomiro, Saxenda® sayenera kutengedwa ndi odwala omwe ali ndi vuto lochepa la endocrine lotchedwa multiple endocrine neoplasia matenda 2 (AMEN-2), kapena odwala omwe ali ndi mbiri yaumwini kapena banja lawo wa khansa ya chithokomiro yotchedwa medullary thyroid carcinoma (MTC).
Ena omwe sayenera kutenga Saxenda® ndi awa: ana (a FDA akufunikira mayesero a kachipatala kuti awonetsetse kuti ana ndi otetezeka komanso ogwira ntchito), amayi omwe ali ndi mimba kapena akuyamwitsa, ndi aliyense yemwe wakhala akudwala kwambiri matenda a liraglutide kapena za zida za Saxenda®.
Zovuta zina
Malinga ndi nkhani ya FDA yonena za kuvomerezedwa kwa Saxenda®, bungweli likufuna zotsatirazi zotsatsa malonda kwa mankhwalawa:
- Mayesero a zachipatala kuti aone ngati ali ndi chitetezo, athawi, komanso kuti awononge ana;
- Kulembetsa kafukufuku wa kansa ya chithokomiro yomwe imakhala ndi zaka khumi ndi zisanu (15);
- Kafukufuku kuti aone zotsatira zowonjezera, kukula kwa kayendedwe ka mitsempha ndi kugwiritsira ntchito zokhudzana ndi kugonana ndi makoswe; ndi
- Kuwunika kuopsa kwa khansara ya m'mawere kwa odwala omwe amatenga Saxenda® m'mayesero omwe akuchitika.
Zotsatira:
Nkhani ya FDA. FDA imavomereza mankhwala osokoneza bongo Saxenda. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
Saxenda akufotokoza zambiri. Novo Nordisk. www.saxenda.com.