NgoDisemba 23, 2014, i-ligululude evunyiweyo ye-US Food and Drug Administration (FDA) ikhethwa njengeyonyango lokulawula ubunzima obungapheliyo. I-Liraglutide ithengiswa nguNovo Nordisk, Inc., phantsi kwegama le-Saxenda®. Esi sisisisi sesine sokulahleka kwesisindo esivunywe yi-FDA ukususela ngo-2012.
Yintoni i-Saxenda (iLiraglutide)?
I-Saxenda® iyinjenge esele ifumaneka kwi dose ephantsi njengenye isilwayo, i-Victoza®, ebuye isetyenziswe kunyango lwe-2 lweswekile .
Ikwaseklasini yezilwanyana ezibizwa ngokuba yi-biochemically njengeglucagon-njenge-peptide-1 (GLP-1) i-agonists ye-receptor. Elinye iziyobisi kule klasi liquka ukugqithisa (Byetta®). Nangona zonke zisetyenziselwa isifo sikashukela, i-liraglutide (kwi dose yayo ephakamileyo njengoSaintenda®) ngowokuqala ukufumana imvume ye-FDA ngokukhethekileyo yokulawula ubunzima.
I-Saxenda Injongo Yani?
I-Saxenda® ivunyiwe ukuba isebenzise abantu abadala nge-index ye-mass mass (BMI) engama-30 okanye ngaphezulu, okanye kubantu abadala abane-BMI yabangama-27 okanye ngaphezulu abanesifo esisodwa esisisigxina, njengesifo sikashukela, uxinzelelo lwegazi , okanye i-cholesterol ephezulu.
Ukongeza, i-Saxenda® isetyenziswe ukuba isetyenziswe kwisondlo kunye nokuzivocavoca ukulawulwa kobunzima obungapheliyo kubantu abadala. Akunakutshintshwa ukutshintsha ukutya kunye nokuzilolonga.
Usebenza Njani?
Izilingo ezintathu zonyango ziye zavavanya ukhuseleko nokusebenza kwe-Saxenda®. Ezi zilingo zabhalisa malunga nama-4,800 abagqithisileyo kunye nezigulane ngaphezu komzimba.
Olunye uvavanyo lweklinikhi oluhlolisayo izigulane ezingenaso iswekile lifumene ukulahleka kwesisindo esiphakathi kwe-4.5% kwizigulana ezithatha iSaxenda®. Olu vavanyo lwafumanisa ukuba ama-62% abo baphathwa nge-Saxenda® balahlekelwa ubuncinane ubuncinane be-5% womzimba wabo.
Kwilinye ilingo leklinikhi elijonge izigulane ezine-type 2 zeswekile, iziphumo zibonisa ukuba abo baphathwa nge-Saxenda® balahlekelwa ngu-3.7% wesisindo sabo xa kuthelekiswa nophathwe ne-placebo, kwaye ama-49% abo bathatha iSaxenda® balahlekelwa ubuncinane ubuncinane be-5% (xa kuthelekiswa na-16% kuphela abo bathatha indawo ye-placebo).
Ngaloo ndlela, kubonakala ukuba iSaxenda® inokuba yinto ephumelelayo ngakumbi ekulahlekeni kwesisifo kwizigulane ezingenayo uhlobo lwesifo sikashukela, nangona sisenokuba nomphumo-nokuba sisigxina sinokulawulwa kwesisifo sabasifo sikashukela.
Ziziphi iimpembelelo?
I-FDA ikhiphe isilumkiso sebhokisi emnyama kwi-Saxenda®, ithi iingcambu zegciwane le-thyroid ziye zaphawulwa kwizifundo kwiigulane, kodwa ukuba akungaziwa nokuba okanye iSaxenda® ingabangela ukuba izidumbu zibe ngabantu.
Iziphumo ezibi kakhulu eziye zaxelwa kwizigulane ezithatha i-Saxenda® ziquka i- pancreatitis (ukuvuvukala kwepascreas, engasongela ubomi), isifo se-gallbladder, isifo sesifo kunye neengcinga zokuzibulala. Ukongezelela, i-Saxenda® inokuphakamisa izinga lentliziyo, kwaye i-FDA icebisa ukuba inqunywe nasiphi na isigulane esinokunyuka okuqhubekayo ekuphumuleni izinga lentliziyo.
Iziphumo eziqhelekileyo ezisecaleni ze-Saxenda® eziye zabonwa kwizilingo zesikliniki kwakuyi-nausea, ukuqunjelwa, ukuhlanza, uhudo, ukunciphisa ukutya, kunye neshukela eliphantsi kwegazi (u-hypoglycemia).
Ngubani Akufanele Awathathe iSaxenda?
Ngenxa yengozi yeengxaki zesifo se-thyroid, i-Saxenda® ayifanele ithathwe zizigulane ezinesifo esingaqhelekanga se-endocrine esibizwa ngokuba yi-endocrine neoplasia syndrome type 2 (MEN-2), okanye ngabagulane abanembali yabo okanye yentsapho yolu hlobo umdlavuza we-thyroid obizwa ngokuba yi-medullary thyroid carcinoma (MTC).
Abanye abamele bangathathi iSaxenda® kubandakanya: abantwana (i-FDA okwangoku ifuna iimvavanyo zeklinikhi ukuvavanya ukhuseleko kunye nokusebenza kwabantwana), abafazi abakhulelweyo okanye abancelisayo, nabani na owake waba ne-hypersensitivity reaction response to liraglutide okanye nayiphi yeengxenye zeemveliso zeSaintenda®.
Ezinye iinkxalabo
Ngokutsho kwe-FDA ukukhululwa kweendaba malunga nokuvunywa kwayo kwe-Saxenda®, i-arhente idinga le zilandelayo zifundo zokumaketha i-post this marketing:
- Uvavanyo lwezonyango ukuvavanya ukhuseleko, usebenze, kunye ne-dosing kubantwana;
- Ubhaliso lwee-registry zomdlavuza we-thyroid ubuncinane obuncinane iminyaka eyi-15;
- Uphononongo ukuvavanya iziphumo ezinokukhula, intsebenziswano yophuhliso lwentlaba kunye nokuvuthwa kwezesondo kwiimvenge ezingapheliyo; kwaye
- Uvavanyo lomngcipheko wokuba nomhlaza wesifuba kwizigulane ezithatha iSaxenda® kwizilingo eziqhubekayo zonyango.
Imithombo:
FDA ukukhululwa kweendaba. I-FDA iyavuma ukusetyenziswa kwesigxina solawulo lwe-Saxenda. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
I-Saxenda inquma ulwazi. Novo Nordisk. www.saxenda.com.