I-FDA ivuma iTrijardy XR yohlobo lwesibini lweswekile

Iindaba

Iindaba ezimnandi kubantu abadala abanesifo seswekile sesi-2: Unokhetho olutsha lonyango olufumanekayo lokunciphisa iswekile yegazi. Ulawulo lwezoKutya kunye noLawulo lweeDrug (i-FDA) lubhengeze ukwamkelwa kweTrijardy XR. Ipilisi entsha yokudibanisa kathathu ibandakanya ezintathu amayeza seswekile kwimiyalelo yokufumana yonke imihla:

• Iswekile yeglucophage ( metformin HCl ), enkulu
• I-Tradjenta (linagliptin), idipeptidyl peptidase-4 (DPP-4) inhibitor
• Intlanganisela (empagliflozin), isodium-glucose co-transporter 2 (SGLT2) inhibitor

Le pilisi ayililo iyeza elitsha-kukuphindwaphindwa kwezinto ezintathu esele zikhona, utshilo uGqirha Marie Bellantoni, ugqirha we-endocrinologist oqinisekisiweyo webhodi kwiziko le-Endocrinology kwiziko lonyango iMercy eBaltimore, eMaryland.

Nangona kunjalo, into elula inokubangela umdla.

Ukuya kwinqanaba lokuba nantoni na ephucula ukubambelela kwesigulana kumayeza kulungile-iipilisi azisebenzi ukuba azingeni kwisigulana-ke oku kuluncedo, utshilo uGqirha Bellantoni. Abanye abantu baziva bengoyiki xa bethatha iipilisi ezimbalwa.

Yintoni iTrijardy XR?

Amanye amayeza aqulathwe kwi-Trijardy XR anokuvakala uqhelekile kuwe, ukuba wena okanye umntu omthandayo unohlobo lweswekile yesi-2. Usenokuba uthathe enye okanye zonke ezi zinto ngaxa lithile.

IMetformin iqeshwa njengonyango lodidi lokuqala kubantu abanesifo seswekile sesi-2. Inceda ukuthoba amanqanaba eswekile yegazi ngokunciphisa ukuxhathisa kwe-insulin yomzimba wakho. Iyanciphisa inani leswekile eveliswa sisibindi sakho kunye nokufunxwa komzimba wakho kwiswekile. Abanye abantu bathatha i-metformin yodwa, kodwa abanye mabayithathe kunye namanye amayeza eswekile.

I-Tradjenta yenzelwe ukunceda abantu abanesifo seswekile sesi-2 ukulawula amanqanaba eswekile yegazi, kunye nokuzilolonga kunye nokutya. Kuyanceda ukunciphisa amanqanaba eswekile yegazi ngokunciphisa inani leswekile ekhutshwe sisibindi kunye nokwandisa inani le-insulin eveliswe yipancreas. Ihlala imiselwe abantu abasele bethatha amayeza eswekile kunye nokwenza utshintsho kwindlela yokuphila kodwa bafuna uncedo ukufezekisa iithagethi zabo ze-A1C. (I-A1C ilinganisa amanqanaba eswekile yegazi yomntu kwisithuba seenyanga ezintathu.) Iyafumaneka kwithebhulethi yakanye yentsuku zonke.

Intlanganisela Elinye ichiza elinokunceda abantu behlise amanqanaba eswekile yegazi kunye nokutya kunye nokuzilolonga, kodwa inokunciphisa umngcipheko wokufa kwentliziyo yomntu kubantu abanesifo seswekile sesi-2 nesifo sentliziyo. Ithebhulethi yansuku zonke eza ngeendlela ezimbini (i-10 mg kunye ne-25 mg) kwaye inokuthathwa kunye namanye amayeza amaninzi, kubandakanya i-metformin, i-insulin, i-beta blockers, i-ACE inhibitors, kunye ne-statins.

Imilinganiselo ye-Trijardy XR

I-Trijardy XR, ethengiswa yi-Boehringer Ingelheim Pharmaceuticals, Inc. kunye no-Eli Lilly kunye neNkampani, ziya kufumaneka ngeedosi ezine:

• 5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl eyandisiweyo-yokukhululwa
• 10 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl eyandisiweyo-yokukhululwa
• 12.5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl eyandisiweyo-yokukhululwa
• 25 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl eyandisiweyo-yokukhululwa

Ngokwabavelisi, iTrijardy XR yipilisi yokuqala yokudibanisa kathathu yokubandakanya iJardiance. I-Jardiance yavunywa okokuqala yi-FDA ngo-2014, kodwa ukuvunywa kwayo yandiswa ngasekupheleni kuka-2016 ukwamkela ukusetyenziswa kwayo ukunciphisa umngcipheko wokufa kwentliziyo.

Izilumkiso zeTrijardy XR

I-Trijardy XR ayenzelwanga abantu abanesifo seswekile sokuqala okanye abantu abane-ketoacidosis yeswekile. Umenzi ulumkisa ukuba iyeza alifundwanga kubantu abanepancreatitis , ngoko ayikhuthazwa into yokuba abantu abanale meko. Umvelisi ukwalumkisa abantu abaphuhlisa iimpawu ze-lactic acidosis enxulumene ne-metformin ukuyeka ukuthatha iyeza kwangoko. Akufanelekanga ukuba isetyenziswe kwabo baneengxaki ezinzima zezintso, izifo zesifo sokugqibela, okanye abo bakwi-dialysis.

Elinye icala elinokubakho lokudityaniswa kathathu med kunokuba nzima ngakumbi ukufumanisa ukuba leliphi na ichiza elinoxanduva lokufumana impendulo engalunganga, utshilo uGqirha Bellantoni.

Ukusetyenziswa kwengqiqo kokudityaniswa kwamachiza amathathu kuya kuba semva kokuba isigulana sibonakalise ukusebenza kunye nokunyamezelwa kweziyobisi ezinikezwe ngokwahlukeneyo, utshilo, emva koko bayakuxabisa ngokwenyani ukuncipha kwenani lokuphinda kugcwaliswe likopishi ekufuneka belenzile.

Okwangoku, lukhetho olutsha oluthembisayo. Siyakholelwa ukuba iTrijardy XR inamandla okunceda abantu abadala abanesifo seswekile 2 ukuba baphathe ngokufanelekileyo unyango lwabo, ngakumbi abo bathatha amanye amayeza kwaye basebenze kwiinguqulelo eziyimfuneko kwindlela yokuphila, uGqirha Mohamed Eid, usekela-mongameli woPhuhliso lweKlinikhi kunye neMicimbi yezoNyango, Cardio- IMetabolism kunye neMedicine yokuphefumla yeBoehringer Ingelheim Pharmaceuticals, Inc. yatsho kwingxelo ebhengeza ukuvunywa.