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Imikhiqizo

I-APIS-Drug Peptide GLP-1 Semaglutide

Incazelo emfushane:

I-Semaglutide iyi-analogue entsha ye-GLP-1 (i-glucagon-like peptide -1) eyakhiwe yi-NovoNordisk, inkampani yaseDenmark.I-Semaglutide iyifomu lomthamo osebenza isikhathi eside ngokususelwa esakhiweni esiyisisekelo se-liraglutide, esinomthelela ongcono ekwelapheni isifo sikashukela sohlobo 2.I-Semaglutide inemiphumela enenzuzo ezingxenyeni eziningi ezibalulekile, kufaka phakathi ama-pancreas, inhliziyo nesibindi.


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Mayelana Nale Nto

I-Semaglutide cishe i-agonist ephumelela kakhulu ye-GLP-1.
Njengamanje, izidakamizwa ezijwayelekile zokwehlisa isisindo emakethe zifaka i-orlistat evela eRoche, i-liraglutide evela eNovo Nordisk kanye ne-semaglutide.

I-Wegovy, i-analogue ye-GLP-1 ye-Novo Nordisk, yagunyazwa yi-FDA ngo-2017 ukwelapha uhlobo 2 sikashukela.NgoJuni 2021, i-FDA igunyaze inkomba yokuncipha kwe-Wegovy.

Ngo-2022, unyaka wokuqala ophelele wokuthengisa ngemuva kokufakwa kuhlu kwe-Wegovy, i-Wegovy yazuza ama- $ 877 wezigidi ngezinkomba zokuncipha kwesisindo.

Ngokufakwa kuhlu kwe-semaglutide, ukuphathwa kwe-subcutaneous kanye ngesonto kuye kwathuthukisa kakhulu ukulandelwa kweziguli, futhi umphumela wokulahlekelwa isisindo uyabonakala.Umphumela wokulahlekelwa isisindo emavikini angu-68 uphakeme ngo-12.5% ​​kunalowo we-placebo (14.9% vs 2.4%), futhi uye waba umkhiqizo wenkanyezi emakethe yokulahlekelwa isisindo isikhathi.

Ngekota yokuqala ka-2023, i-Wegovy ithole imali engenayo eyizigidi ezingama-670 zamadola aseMelika, ikhuphuke ngo-225% unyaka nonyaka.

Ukuvunyelwa kwesibonakaliso sokulahlekelwa isisindo se-semaglutide ngokuyinhloko kusekelwe ocwaningweni lwesigaba III olubizwa ngokuthi STEP.Isifundo se-STEP sihlola ikakhulukazi umphumela wokwelapha we-subcutaneous injection ye-semaglutide 2.4mg kanye ngesonto uma kuqhathaniswa ne-placebo ezigulini ezikhuluphele.

I-Dispaly yomkhiqizo

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Kungani Khetha Thina

Ucwaningo lwe-STEP lufake nenani lezivivinyo, lapho cishe iziguli ezingabantu abadala ezingaba ngu-4,500 ezikhuluphele ngokweqile zabuthwa, okuhlanganisa:
Isifundo se-STEP 1 (ukungenelela kwendlela yokuphila okusizwayo) kuqhathanise ukuphepha kweviki le-68 nokusebenza komjovo we-subcutaneous we-semaglutide 2.4mg kanye ngesonto nge-placebo ku-1961 abantu abadala abakhuluphele noma abakhuluphele ngokweqile.

Imiphumela ibonise ukuthi ukuguqulwa okujwayelekile kwesisindo somzimba kwakuyi-14.9% eqenjini le-semaglutide kanye ne-2.4% eqenjini le-PBO.Uma kuqhathaniswa ne-PBO, imiphumela emibi ye-semaglutide yamathumbu ivame kakhulu, kodwa iningi lazo lidlula futhi linganciphisa ngaphandle kokumisa unomphela uhlobo lokwelapha noma ukukhuthaza iziguli ukuba zihoxise ocwaningweni.Ucwaningo lwe-STEP1 lubonisa ukuthi i-semaglutide inomphumela omuhle wokulahlekelwa isisindo ezigulini ezikhuluphele.

ISINYATHELO 2 isifundo (iziguli ezikhuluphele ezinohlobo lwe-2 yesifo sikashukela) siqhathanisa ukuphepha nokusebenza kahle komjovo we-subcutaneous we-semaglutide 2.4 mg kanye ngesonto nge-placebo kanye ne-semaglutide 1.0mg kubantu abadala abayi-1210 abakhuluphele noma abakhuluphele ngokweqile amaviki angama-68.

Imiphumela yabonisa ukuthi isilinganiso sokulinganisa isisindo somzimba samaqembu amathathu okwelapha ashintshile kakhulu, nge -9.6% lapho usebenzisa i-2.4 mg ye-semaglutide, -7% lapho usebenzisa i-1.0mg ye-semaglutide, kanye -3.4% uma usebenzisa i-PBO.Ucwaningo lwe-STEP2 lubonisa ukuthi i-semaglutide iphinde ibonise umphumela omuhle wokulahlekelwa isisindo ezigulini ezikhuluphele ezinesifo sikashukela sohlobo lwe-2.

I-STEP 3 isifundo (i-adjuvant intensive behavioral therapy) iqhathanise umehluko weviki le-68 ekuphepheni nasekusebenzeni kahle phakathi komjovo we-subcutaneous we-semaglutide 2.4 mg kanye ngesonto kanye ne-placebo ehlangene nokwelashwa okujulile kokuziphatha kubantu abadala abangu-611 abakhuluphele noma abakhuluphele.
Emavikini okuqala e-8 ocwaningo, zonke izifundo zithole ukudla okunekhalori ephansi esikhundleni sokudla kanye nokwelashwa okujulile kokuziphatha kulo lonke uhlelo lwamaviki angu-68.Abahlanganyeli kudingeka futhi ukuthi benze imizuzu eyi-100 yokuzivivinya isonto ngalinye, ngokunyuka kwemizuzu engama-25 njalo emavikini amane kanye nemizuzu engama-200 ngesonto.

Imiphumela ibonise ukuthi isisindo somzimba weziguli eziphathwa nge-semaglutide kanye nokwelashwa okunamandla kokuziphatha kwehle ngo-16% uma kuqhathaniswa nesisekelo sokuqala, kanti lelo leqembu le-placebo lehla ngo-5.7%.Kusukela kudatha ye-STEP3, singabona umphumela wokuzivocavoca nokudla ekulahlekelweni kwesisindo, kodwa ngokuthakazelisayo, ukuqinisa indlela yokuphila kubonakala kunomphumela omncane ekuqiniseni umphumela wezidakamizwa we-semaglutide.

Ukuhlolwa kokuqhathanisa

PRODUCT_SHOW (1)

(Ukuqhathaniswa kwesilinganiso sokulahlekelwa kwesisindo phakathi kweqembu le-Semaglutide neqembu le-Dulaglutide)

Umuthi ungakhuphula i-glucose metabolism ngokugqugquzela ama-pancreatic β cells ukuthi akhiphe i-insulin;Futhi vimbela amangqamuzana e-alpha e-pancreas ukuthi akhiphe iglucagon, ngaleyo ndlela anciphise ukuzila kanye noshukela wegazi we-postprandial.

(Ukuqhathaniswa kwesisindo somzimba phakathi kweqembu lokwelashwa kwe-Semaglutide ne-placebo)

PRODUCT_SHOW (2)

Uma kuqhathaniswa ne-placebo, i-Semaglutide inganciphisa ingozi yamaphuzu okuphela ahlanganisiwe (ukufa kokuqala kwenhliziyo, i-infarction ye-myocardial engapheli, i-stroke engapheli) nge-26%.Ngemuva kweminyaka engu-2 yokwelashwa, i-Semaglutide inganciphisa kakhulu ingozi yokushaywa unhlangothi nge-39%, i-myocardial infarction engeyona ebulalayo nge-26% nokufa kwenhliziyo nge-2%.Ngaphezu kwalokho, kungase futhi kunciphise ukudla ngokunciphisa ukudla nokunciphisa ukugaya kwesisu, futhi ekugcineni kunciphise amafutha omzimba, okwenza kube lula ukulahlekelwa isisindo.

Kulolu cwaningo, kwatholakala ukuthi i-phentermine-topiramate kanye ne-GLP-1 receptor agonist kwafakazelwa njengezidakamizwa ezingcono kakhulu zokunciphisa isisindo phakathi kwabantu abadala abakhuluphele futhi abakhuluphele.


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