Ngo-Disemba 23, 2014, i-liraglutide evunyelwe i-US Food and Drug Administration (FDA) njengendlela yokwelapha yokuphathwa kwesisindo esingapheli. I-Liraglutide ithengiswa nguNovo Nordisk, Inc., ngaphansi kwegama legama elithi Saxenda®. Lesi yisidakamizwa sesine sokulahlekelwa kwesisindo esivunywe yi-FDA kusukela ngo-2012.
Kuyini iSaxenda (i-Liraglutide)?
I-Saxenda® ingumjovo osevele usutholakale kumthamo ophansi njengomunye umuthi, u-Victoza®, obuye usetshenziselwe ukwelashwa ngohlobo lwesifo sikashukela sohlobo lwe-2 .
Kungenxa yeklasi yezidakamizwa ezaziwa njenge-biochemically njenge-goncagon-like peptide-1 (GLP-1) i-receptor agonists. Esinye isidakamizwa kuleli klasi kufaka ukuphakama (Byetta®). Nakuba zonke zisetshenziselwa isifo sikashukela, i-liraglutide (esilinganisweni sayo esiphezulu njenge-Saxenda®) iyona yokuqala yokuthola imvume ye-FDA ngokukhethekile ekulawuleni isisindo.
I-Saxenda Inhloso Yani?
I-Saxenda® ivunyelwe ukusetshenziswa kubantu abadala nge-index mass mass (BMI) engama-30 noma ngaphezulu, noma kubantu abadala abane-BMI abaneminyaka engu-27 noma ngaphezulu abanesifo esisodwa esisodwa esinezifo, njengesifo sikashukela, ukucindezelwa kwegazi eliphezulu , noma i-cholesterol ephezulu.
Ngaphezu kwalokho, i-Saxenda® isetshenziselwa ukusetshenziselwa ukuhambisana nokudla nokuzivocavoca ekulawuleni isisindo esingapheli kubantu abadala. Akuhlosiwe ukufaka esikhundleni sokudla nokuzivocavoca.
Iphumelela Kangakanani?
Izivivinyo ezintathu zokwelapha ziye zahlola ukuphepha nokusebenza kwe-Saxenda®. Lezi zivivinyo zabhalisa cishe iziguli ezingaphezu kuka-4,800 nezikhulu ngokweqile.
Isivivinyo esisodwa somtholampilo esihlolisisa iziguli ezingenaso isifo sikashukela sathola ukulahlekelwa kwesisindo esijwayelekile esingu-4.5% kwiziguli ezithatha iSaxenda®. Leli cwaningo lithole ukuthi u-62% walabo abaphathwa nge-Saxenda® balahlwe okungenani u-5% wesisindo somzimba wabo.
Kwesinye isilingo somtholampilo esibheke iziguli ezine-type 2 yesifo sikashukela, imiphumela yabonisa ukuthi labo abaphathwa nge-Saxenda® balahlekelwa ngu-3.7% wesisindo sabo uma kuqhathaniswa nokwelashwa nge-placebo, kanti abangu-49% kulabo abathatha i-Saxenda® balahlekelwa okungenani u-5% wesisindo somzimba wabo (kuqhathaniswa namaphesenti angu-16 kuphela alabo abathatha indawo ye-placebo).
Ngakho-ke, kubonakala sengathi i-Saxenda® ingase iphumelele kangcono ekulahlekeni kwesisindo ezigulini ezingenaso isifo sikashukela sohlobo lwezinhlobo ezimbili, nakuba sisenomthelela-nakuba ukuphathwa kwesisindo esincinci kulabo abanesifo sikashukela.
Yiziphi Imiphumela Ezingezansi?
I-FDA ikhishwe isixwayiso sebhokisi elimnyama ku-Saxenda®, esho ukuthi izicubu zegciwane le-thyroid ziye zaphawulwa ekucwaningweni kwamagundane, kodwa ukuthi aziwa noma ngabe iSaxenda® ingabangela lezi zicubu kubantu noma cha.
Imiphumela emibi kakhulu ebikwe ezigulini ezithatha i-Saxenda® zifaka ukuphazamiseka (ukuvuvukala ama-pancreas, okungasongela ukuphila), isifo se-gallbladder, isifo sezinso nokuzibulala. Ukwengeza, i-Saxenda® ingakwazi ukuphakamisa isilinganiso senhliziyo, futhi i-FDA icebisa ukuthi inqunywe kunoma isiphi isiguli esithola ukwanda okuqhubekayo ekuphumuleni izinga lenhliziyo.
Imiphumela emibi kakhulu ye-Saxenda® eyabonakala ezinkulweni zokwelashwa kwakuyizinyosi, ukuqothulwa, ukuhlanza, isifo sohudo, ukunciphisa ukudla, kanye neshukela ephansi yegazi (i-hypoglycemia).
Ubani Akufanele Awathathe I-Saxenda?
Ngenxa yengozi yezinkinga ze-thyroid, iSaxenda® akufanele ithathwe iziguli ezinezinkinga ezingavamile ze-endocrine ezibizwa ngokuthi i-endocrine neoplasia syndrome type 2 (MEN-2), noma iziguli ezinomlando womuntu siqu noma womndeni wohlobo yomdlavuza we-thyroid owaziwa ngokuthi i-medullary thyroid carcinoma (MTC).
Abanye abangeke bathathe iSaxenda® kubandakanya: izingane (i-FDA okwamanje idinga ukuvivinywa kwemitholampilo ukuhlola ukuphepha nokuphumelela kwabantwana), abesifazane abakhulelwe noma abancancisayo, nanoma ubani oke waba nesisindo esibi sokuphendula nge-liraglutide noma kunoma yikuphi yezingxenye zomkhiqizo we-Saxenda®.
Ezinye izinkathazo
Ngokusho kwenkulumo ye-FDA mayelana nokuvunyelwa kwayo kwe-Saxenda®, le nhlangano idinga izifundo ezilandelayo zokuthungatha le mithi:
- Ukuvivinywa kwemitholampilo ukuhlola ukuphepha, ukusebenza kahle nokulandelela izingane;
- Ukubhaliswa kwecala lomdlavuza we-medullary okungenani iminyaka engu-15;
- Ucwaningo lokuhlola imiphumela engaba khona ekukhuleni, ekuthuthukiseni uhlelo lwesishukela kanye nokuvuthwa ngokocansi kumagundane amancane; futhi
- Ukuhlolwa kweengozi engaba khona yomdlavuza webele emagulini athatha i-Saxenda® ekuvivinyweni okuqhubekayo kwemitholampilo.
Imithombo:
Ukukhishwa kwezindaba ze-FDA. I-FDA ivumela izidakamizwa zokuphathwa kwesisindo Saxenda. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
I-Saxenda ibeka imininingwane. I-Novo Nordisk. www.saxenda.com.