Musi waDecember 23, 2014, US Food and Drug Administration (FDA) yakagamuchirwa liraglutide sechisarudzo chekurapa kwekusagadzirwa kwehuwandu husingagumi. Liraglutide iri kutengeswa naNovo Nordisk, Inc., pasi pezita rinonzi Saxenda®. Ichi ndicho chechina chemishonga yokurasikirwa kwemazivi ayo yakagamuchirwa neDFA kubva muna 2012.
Chii chinonzi Saxenda (Liraglutide)?
Saxenda® ijoyi inowanikwa kare mumushandi wepasi semumwe mushonga, Victoza®, iyo inoshandiswa pakurapa rudzi rwechipiri chirwere cheshuga .
Icho chiri chekirasi remishonga inodanwa inozivikanwa seglucagon-yakafanana peptide-1 (GLP-1) agorist receptor. Imwe mishonga iri mukirasi iyi inosanganisira exenatide (Byetta®). Kunyange zvazvo zvose zvinoshandiswa chirwere cheshuga, liraglutide (mukura kwayo yakanyanya sa Saxenda®) ndiyo yekutanga kugamuchira chibvumirano cheDAA kunyanya kuitisa uremu.
Saxenda Ndiani Anotarisirwa?
Saxenda® yakagamuchirwa kuti ishandiswe kune vanhu vakuru vane muviri wehuwandu huwandu (BMI) we30 kana mukuru, kana kune vanhu vakuru vane BMI yevamwe 27 kana kupfuura avo vane rimwe dambudziko reimwe rinorema, zvakadai seshuga, kuwedzerwa kweropa , kana kuti high cholesterol.
Mukuwedzera, Saxenda® inoshandiswa kushandiswa sechirevo chekudya uye yekuita zvekuita kwehutano husingaperi hwekutakura kuvanhu vakuru. Hazvirevi kutora nzvimbo yekudya uye kuita zvekuita.
Inobatsira Sei?
Zvirwere zvitatu zvemakirini akaedza kuongorora kuchengetedzwa uye kubudirira kweSaintenda®. Iyi miedzo yakanyoresa madzimai anenge 4 800 akawandisa uye anowedzera kuwandisa.
Rimwe kliniki yekuongorora iyo yakaongorora varwere vasina chirwere cheshuga yakawana kuwandisa kwekurema kwemazana e4% muvarwere vakatora Saxenda®. Uyu muedzo wakawanawo kuti 62% yevaya vaibatwa naSaintenda® vakarasikirwa zvishoma ne5% yemuviri wavo.
Mune imwe kliniki yeruzhinji yakatarisa varwere vane chirwere chechirwere cheshuga, zvigumisiro zvakaratidza kuti avo vakabata Saxenda® vakarasikirwa ne 3.7% yehuremu hwavo kana zvichienzaniswa nekurapa ne placebo, uye 49% yevaya vanotora Saxenda® vakarashika zvikamu zvishanu zvehutatu hwavo (kuenzaniswa ne16% chete yevaya vanotora placebo).
Nokudaro, zvinoratidzika kuti Saxenda® inogona kunge yakanyanyisa kuburikidza nekurasikirwa kwehutachiona mune varwere vasina chirwere cheshuga chechipiri, kunyange zvazvo chichiri nemigumisiro-kunyange shoma-kugoverwa kwehutano kune avo vane chirwere cheshuga.
Chii Chiri Mhinduro Dzakashata?
Dhiyabhorosi yakabudisa nyevero yebhokisi maziso ku Saxenda®, ichitaura kuti zviremara zvehutano hwetroroid zvakaonekwa mune zvidzidzo pamusoro pemakonzo, asi kuti hazvizivikanwe kana Saxenda® isingagoni kukonzera matumire aya kuvanhu.
Zviremera zvakakomberedzwa zvakataurwa kune varwere vanotora Saxenda® zvinosanganisira pancreatitis (kuputika kwepancreas, iyo inogona kutyisa upenyu), chirwere chenduru, chirwere chepfungwa, uye pfungwa dzekuzviuraya. Uyezve, Saxenda® inogona kukwidza kushaya mwoyo, uye FDA inokurudzira kuti inopedzisira kune chero murwere anoona kuwedzerwa kwakasimba mukuzorodza mwoyo yemuviri.
Zvikamu zvakawandisa zvakanyanya zvinokonzerwa naSaintenda® zvakaratidzwa mumakiriniki kuedza kwaiva nekutsvaga, kuvimbiswa, kurutsa, kurara, kupera kwechido, uye shuga shoma yeropa (hypoglycemia).
Ndiani Asingafaniri Kutora Saxenda?
Pamusana pehutano hwehutachiona hwemaperembudzi ehroroid, Saxenda® haifaniri kutorwa nevarwere vane chirwere chisingawanzoitiki endocrine chinonzi sainzi endocrine neoplasia syndrome type 2 (MEN-2), kana nevarwere vane nhoroondo yemunhu kana mhuri yemhando yekenza yehurosi inozivikanwa se medullary thyroid carcinoma (MTC).
Vamwe vanofanirwa kutora Saxenda® vanosanganisira: vana (iyo FDA inoda kuongororwa kwekliniki kuti iongorore kuchengetedzwa nekubudirira kwevana), vakadzi vane pamuviri kana kunyamwisa, uye ani zvake akambove ane hypersensitivity yakaipa yekuita se liraglutide kana kune yezvibereko zveSaintenda®.
Zvimwe Kunetseka
Maererano nekubudiswa kwemashoko eDAA pamusoro pekubvumirwa kwaSaintenda®, sangano iri rinoda zviitiko zvekutsvaga kwemashambadziro emishonga iyi:
- Mishonga yemakiriniki kuongorora kuchengeteka, kubudirira, uye kubhadhara vana;
- A registry registry of medullary chronic cancer rinotora makore gumi nemashanu;
- Chidzidzo chekuongorora zvinogona kuitika pakukura, mukati mehutano hurongwa hwekuvandudza nekugadzirisa zvepabonde mumakumbo asina kufanira; and
- Kuongororwa kwengozi inogona kuva nekenza yemazamu muvarwere vanotora Saxenda® mukuenderera mberi kwemakiriniki.
Sources:
FDA nhau dzinosunungurwa. FDA inobvumira kuyerwa-kutarisira mishonga yemishonga Saxenda. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
Saxenda inorondedzera ruzivo. Novo Nordisk. www.saxenda.com.