I-Jardiance isiza abantu abadala abalandela ukuhluleka kwenhliziyo okubuhlungu

Abantu abadala abalaliswe esibhedlela ngenxa yokwehluleka kwenhliziyo okuyingozi babenethuba elingama-36% ngaphezulu lokuthola inzuzo yomtholampilo ezinsukwini ezingama-90 uma beqaliswe nge-Jardiance® (empagliflozin) kulandela ukuzinza nangaphambi kokukhishwa koketshezi uma kuqhathaniswa ne-placebo esigabeni sesi-III sovivinyo lwe-EMPULSE, u-Boehringer Ingelheim no-Eli Lilly and Company. (NYSE: LLY) imenyezelwe namuhla. Inzuzo yomtholampilo ibonise isiphetho esiyinhloko esiyinhlanganisela esihlanganisa ukufa kwembangela yonke, imvamisa yezehlakalo zokuhluleka kwenhliziyo, isikhathi sokuya esigamekweni sokuqala sokuhluleka kwenhliziyo kanye nezimpawu njengoba kukalwa yi-Kansas City Cardiomyopathy Questionnaire Questionnaire total symptom score (KCCQ-TSS). Okutholakele kushicilelwe ku-Nature Medicine futhi kwethulwa e-American Heart Association's Late-Breaking Scientific Sessions 2021.            

"Izinyanga zokuqala ezilandela ukulaliswa esibhedlela ngenxa yokuhluleka kwenhliziyo yisikhathi esisengozini ikakhulukazi ezigulini," kusho u-Adriaan Voors, uProfesa we-Cardiology, i-University Medical Center, i-Groningen, i-Netherlands, kanye nomphenyi oyinhloko we-EMPULSE. “Imiphumela yamanje ayimihle, okugcizelela isidingo esiphuthumayo sokuthuthukiswa kokwelashwa ezigulini ezilaliswa esibhedlela ukuze kuvinjelwe ukuqhubeka nokulaliswa esibhedlela noma ukufa. Le nzuzo ebalulekile yomtholampilo nge-empagliflozin uma iqhathaniswa ne-placebo izothuthukisa ukuqonda kwethu ukwelashwa kokwehluleka kwenhliziyo phakathi nesigaba sokuqala sokukhishwa.

Ukwehluleka kwenhliziyo kuyimbangela ehamba phambili yokulaliswa esibhedlela, kubalwa ngaphezu kwesigidi esingu-1 ngonyaka e-US Imiphumela yalabo abangeniswe esibhedlela ngenxa yokwehluleka kwenhliziyo impofu, futhi ngaphezu kwe-30% yeziguli ezibuyiselwe zingakapheli izinsuku ezingu-90 phakathi kuka-2010 no-2017. , ngokweNational Readmission Database.

Inzuzo yonke yomtholampilo nge-Jardiance ibifana kulabo abanokuhluleka kwenhliziyo okusha noma osekuvele kukhona, kulabo abanesifo sikashukela noma abangenaso kanye nalabo abanengxenyana yokukhipha egciniwe noma encishisiwe. Esiphethweni sesibili sokuhlola, i-Jardiance ithuthukise kakhulu i-KCCQ-TSS kusukela kwesisekelo kuze kube usuku lwama-90 ngamaphuzu angu-4.5 uma iqhathaniswa ne-placebo.

Imiphumela yokuphepha ye-EMPULSE ibihambisana nephrofayili yokuphepha esungulwe kahle ye-Jardiance. Amazinga okuhluleka kwe-renal abikwe umphenyi ayengu-7.7% ku-Jardiance uma kuqhathaniswa no-12.1% we-placebo, futhi kube khona izehlakalo ezifanayo eziphansi ze-hypoglycemia kuwo womabili amaqembu (1.9% we-Jardiance vs. 1.5% we-placebo). Amazinga okuncipha kwevolumu abengu-12.7% uma kuqhathaniswa no-10.2%, ngokulandelana.

"Sikhuthazwa inzuzo yokuqala nebalulekile yomtholampilo ebonwa ku-EMPULSE nge-Jardiance lapho iqalwa kubantu abadala abanesifo senhliziyo nge-ejection egcinwe noma encishisiwe ingxenyenamba ngaphambi kokukhishwa esibhedlela, okuhlanganisa ukuthuthukiswa kwendawo yokugcina ehlanganisa ukufa, ukulaliswa esibhedlela kanye nekhwalithi yokuphila," kusho u-Mohamed Eid, MD, MPH, MHA, iphini likamongameli, i-Clinical Development & Medical Affairs, i-Cardio-Metabolism & Respiratory Medicine, i-Boehringer Ingelheim Pharmaceuticals, Inc. kuzuzisa abantu abanezimo eziningi ze-cardio-renal-metabolic okudingeka kakhulu kubo izinketho ezengeziwe zokwelapha.”

"Imiphumela ye-EMPULSE yengeza esisindweni esikhulayo sobufakazi obuvela ohlelweni lwethu lwe-EMPOWER olusekela indima engaba khona ye-Jardiance ezimweni eziningi ezithinta inhliziyo, izinso kanye nesistimu ye-metabolic," kusho uJeff Emmick, MD, Ph.D., iphini likamongameli, Ukuthuthukiswa Komkhiqizo, uLilly. "Inzuzo yomtholampilo kanye nemiphumela yokuphepha engaguquki ekhonjiswe esigabeni esisengozini ngemuva kokukhishwa esibhedlela iphakamisa ukuthi ukuqaliswa esibhedlela nge-Jardiance ezigulini ezifanele kungathuthukisa imiphumela phakathi nalezi zinyanga ezibucayi."

Muva nje, i-US Food and Drug Administration (i-FDA) igunyaze i-Jardiance ukuze yehlise ingcuphe yokufa kwenhliziyo nemithambo yegazi kanye nokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo kubantu abadala abanokwehluleka kwenhliziyo okusekelwe kudatha evela kuhlolo lwe-EMPEROR-Preserved®. Lesi sinqumo siphawula ukugunyazwa kwe-FDA kwe-US yesithathu kwe-Jardiance okuvela ohlelweni lwe-EMPOWER.