دورية أكاديمية

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial

التفاصيل البيبلوغرافية
العنوان: Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial
المؤلفون: Del Prato S., Kahn S. E., Pavo I., Weerakkody G. J., Yang Z., Doupis J., Aizenberg D., Wynne A. G., Riesmeyer J. S., Heine R. J., Wiese R. J., Ahmann A. J., Arora S., Ball E. M., Calderon R. B., Butuk D. J., Chaychi L., Chen M. C., Curtis B. M., Chochinov R., Chow C., Cone C. L., Connery L., Cortes-Maisonet G. A., de Souza J., Dungan K., Bradley D., Frias J. P., Gabra N., Gaudiani L., Herandez-Vazquez L., Hsia S. H., Jardula M. R., Klein E. J., Kutner M. E., Loy J., Miranda F. G., Nunez L. D., Mujica-Baella M., Murray A. V., Oliver M. J., Oritz-Carrasquillo R., Palal B., Parke M. T., Philis-Tsimikas A., Purighalla R. S., Rosenstock J., Sathananthan A., Shelton C., Sivalingam K., Sorial E., Soufer J., Stacey H. L., Stonesifer L. D., Stringam S., Van J. T., Vazquez-Tanus J. B., Reyes R., Welch M., Karimjee N., Martin E. E., Arif A., Jennings T. W., Fraser N. J., Bhargava A., Davidson E., Billings L., Barranco-Santana E. A., Dever M. E., Walsh P., Cho A., Chu J. W., Shubrook J., Knouse A. B., Nadar V., Lewy-Alterbaum L., Lillestol M. J., Humiston D. J., White A. J., Mayfield R. K., Bitar F. G., Cereto F., de la Cuesta C., De Teresa Parreno L., Jodar Gimeno E., Mezquita-Raya P., Morales Portillo C. J., Quesada Charneco M., Tinahones Madueno F. J., Tofe Povedano S., Vazquez L., Fajardo Montanana C., Soto Gonzalez A., Mistodie C., Szilagyi I., Filimon A., Mindrescu N. M., Pop L., Pascu M., Negrisanu G. D., Ciomos D., Neacsu V., Thury-Burileanu A., Liberty I., Stern N., Sofer Y., Sack J., Shimon I., Tirosh A., Ishay A., Mosenzon Ninio O., Shehadeh N., Wainstein J., Darawsha M., Skripova D., Pavleova E., Donicova V., Kubincova L., Sosovec D., Merciakova M., El Boreky F., St-Amour E., Yared Z., Blouin F., Ajala B., Aggarwal N. K., Bajaj H., Tailor C., Egan A., O'Mahony J., St. Onge N., Conway J. R., Akerman Augusto G., Borges J. L. C., Gomes Cerqueira M. J. A., Franco D. R., Franco Hirakawa T., Souza F. D., Hissa M. N., Pechmann L. M., Calil Salim C. P., Russo L. A. T., Siqueira J., Sassone S. A., Glenny J. A., Koretzky M., Steinacher A., Solis S. E., Nardone L., Perez Manghi F. C., Orio S. I., Gelersztein E., Fretes J. O., Calella P. R. F., Zaidman C. J., Chertkoff A., Salzberg S., Majul C. R., Nevarez L. A., Violante Ortiz R. M., Banda Elizondo R. G., Arjona Villicana R. D., Gonzalez Galvez G., Calvo C. G., Koscianski A., Rudzki H., Stankiewicz A. W., Sowinski D., Krzyzagorska E., Jozefowska M., Matyjaszek-Matuszek B., Franek E., Skokowska E., Modzelewska A., Szyprowska E., Simpson R. W., Gilfillan C., Colquhoun D. M., Davis T. M., Morbey C., McCarthy S. E., Kaur K., Kemp L., Shea A. J., Khalimov Y. S., Miroshnichenko O. A., Dvoryashina I. V., Karpova I. A., Kunitsyna M. A., Vorokhobina N. V., Galstyan G. R., Bondar I. A., Filippov E. V., Ershova O. B., Ou H. -Y., Tseng S. -T., Chen J. -F., Tien K. -J., Huang C. -N., Chen C. -C., Hwu C. -M., Hsia T. -L., Pagkalos E., Mouslech Z., Bargiota A., Kotsa K.
المساهمون: Del Prato, S., Kahn, S. E., Pavo, I., Weerakkody, G. J., Yang, Z., Doupis, J., Aizenberg, D., Wynne, A. G., Riesmeyer, J. S., Heine, R. J., Wiese, R. J., Ahmann, A. J., Arora, S., Ball, E. M., Calderon, R. B., Butuk, D. J., Chaychi, L., Chen, M. C., Curtis, B. M., Chochinov, R., Chow, C., Cone, C. L., Connery, L., Cortes-Maisonet, G. A., de Souza, J., Dungan, K., Bradley, D., Frias, J. P., Gabra, N., Gaudiani, L., Herandez-Vazquez, L., Hsia, S. H., Jardula, M. R., Klein, E. J., Kutner, M. E., Loy, J., Miranda, F. G., Nunez, L. D., Mujica-Baella, M., Murray, A. V., Oliver, M. J., Oritz-Carrasquillo, R., Palal, B., Parke, M. T., Philis-Tsimikas, A., Purighalla, R. S., Rosenstock, J., Sathananthan, A., Shelton, C., Sivalingam, K., Sorial, E., Soufer, J., Stacey, H. L., Stonesifer, L. D., Stringam, S., Van, J. T., Vazquez-Tanus, J. B., Reyes, R., Welch, M., Karimjee, N., Martin, E. E., Arif, A., Jennings, T. W., Fraser, N. J., Bhargava, A., Davidson, E., Billings, L., Barranco-Santana, E. A., Dever, M. E., Walsh, P., Cho, A., Chu, J. W., Shubrook, J., Knouse, A. B., Nadar, V., Lewy-Alterbaum, L., Lillestol, M. J., Humiston, D. J., White, A. J., Mayfield, R. K., Bitar, F. G., Cereto, F., de la Cuesta, C., De Teresa Parreno, L., Jodar Gimeno, E., Mezquita-Raya, P., Morales Portillo, C. J., Quesada Charneco, M., Tinahones Madueno, F. J., Tofe Povedano, S., Vazquez, L., Fajardo Montanana, C., Soto Gonzalez, A., Mistodie, C., Szilagyi, I., Filimon, A., Mindrescu, N. M., Pop, L., Pascu, M., Negrisanu, G. D.
سنة النشر: 2021
المجموعة: ARPI - Archivio della Ricerca dell'Università di Pisa
مصطلحات موضوعية: Adult, Aged, Blood Glucose, Body Weight, Cardiovascular Disease, Diabetes Mellitus, Type 2, Female, Gastric Inhibitory Polypeptide, Glycated Hemoglobin A, Human, Hypoglycemic Agent, Insulin Glargine, Male, Middle Aged
الوصف: Background: We aimed to assess efficacy and safety, with a special focus on cardiovascular safety, of the novel dual GIP and GLP-1 receptor agonist tirzepatide versus insulin glargine in adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications. Methods: This open-label, parallel-group, phase 3 study was done in 187 sites in 14 countries on five continents. Eligible participants, aged 18 years or older, had type 2 diabetes treated with any combination of metformin, sulfonylurea, or sodium-glucose co-transporter-2 inhibitor, a baseline glycated haemoglobin (HbA1c) of 7·5–10·5% (58–91 mmol/mol), body-mass index of 25 kg/m2 or greater, and established cardiovascular disease or a high risk of cardiovascular events. Participants were randomly assigned (1:1:1:3) via an interactive web-response system to subcutaneous injection of either once-per-week tirzepatide (5 mg, 10 mg, or 15 mg) or glargine (100 U/mL), titrated to reach fasting blood glucose of less than 100 mg/dL. The primary endpoint was non-inferiority (0·3% non-inferiority boundary) of tirzepatide 10 mg or 15 mg, or both, versus glargine in HbA1c change from baseline to 52 weeks. All participants were treated for at least 52 weeks, with treatment continued for a maximum of 104 weeks or until study completion to collect and adjudicate major adverse cardiovascular events (MACE). Safety measures were assessed over the full study period. This study was registered with ClinicalTrials.gov, NCT03730662. Findings: Patients were recruited between Nov 20, 2018, and Dec 30, 2019. 3045 participants were screened, with 2002 participants randomly assigned to tirzepatide or glargine. 1995 received at least one dose of tirzepatide 5 mg (n=329, 17%), 10 mg (n=328, 16%), or 15 mg (n=338, 17%), or glargine (n=1000, 50%), and were included in the modified intention-to-treat population. At 52 weeks, mean HbA1c changes with tirzepatide were −2·43% (SD 0·05) with 10 mg and −2·58% (0·05) with 15 mg, versus −1·44% (0·03) ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: ELETTRONICO
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/34672967; info:eu-repo/semantics/altIdentifier/wos/WOS:000718312000021; volume:398; issue:10313; firstpage:1811; lastpage:1824; numberofpages:14; journal:THE LANCET; http://hdl.handle.net/11568/1135983Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85118861560
DOI: 10.1016/S0140-6736(21)02188-7
الإتاحة: https://doi.org/10.1016/S0140-6736Test(21)02188-7
http://hdl.handle.net/11568/1135983Test
رقم الانضمام: edsbas.DA758FF2
قاعدة البيانات: BASE