التفاصيل البيبلوغرافية
| العنوان: |
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial |
| المؤلفون: |
Hernandez A. F., Green J. B., Janmohamed S., D'Agostino R. B., Granger C. B., Jones N. P., Leiter L. A., Rosenberg A. E., Sigmon K. N., Somerville M. C., Thorpe K. M., McMurray J. J. V., Del Prato S., Califf R. M., Holman R., DeMets D., Riddle M., Goodman S., McGuire D., Alexander K., Devore A., Melloni C., Patel C., Kong D., Bloomfield G., Roe M., Tricoci P., Harrison R., Lopes R., Mathews R., Mehta R., Schuyler Jones W., Vemulapalli S., Povsic T., Eapen Z., Dombrowski K., Kolls B., Jordan D., Ambrosy A., Greene S., Mandawat A., Shavadia J., Cooper L., Sharma A., Guimaraes P., Friedman D., Wilson M., Endsley P., Gentry T., Collier J., Perez K., James K., Roush J., Pope C., Howell C., Johnson M., Bailey M., Cole J., Akers T., Vandyne B., Thomas B., Rich J., Bartone S., Beaulieu G., Brown K., Chau T., Christian T., Coker R., Greene D., Haddock T., Jenkins W., Haque G., Marquess M., Pesarchick J., Rethaford R., Stone A., Al Kawas F., Anderson M., Enns R., Sinay I., Mathieu C., Yordanov V., Hramiak I., Haluzik M., Galatius S., Guerci B., Nauck M., Migdalis I., Tan C. B. K., Kocsis G., Giaccari A., Lee M. K., Munoz E. G. C., Cornel J., Birkeland K., Pinto M., Tirador L., Olesinska-Mader M., Shestakova M., Distiller L., Lopez-Sendon J., Eliasson B., Chiang C. -E., Srimahachota S., Mankovsky B., Bethel M. A., Dungan K., Kosiborod M., Alvarisqueta A., Baldovino J., Besada D., Calella P., Cantero M. C., Castano P., Chertkoff A., Cuadrado J., De Loredo L., Dominguez A., Espanol M. V., Finkelstein H., Frechtel G., Fretes J., Garrido Santos N., Gonzalez J., Litvak M., Loureyro J., Maffei L., Maldonado N., Mohr Gasparini D., Orio S., Perez Manghi F., Rodriguez Papini N., Sala J., Schygiel P., Sposetti G., Ulla M., Verra F., Zabalua S., Zaidman C., Crenier L., Debroye C., Duyck F., Scheen A., Van Gaal L., Vercammen C., Damyanova V., Dimitrov S., Kovacheva S., Lozanov L., Margaritov V., Mihaylova-Shumkova R., Nikolaeva A., Stoyanova Z., Akhras R., Beaudry Y., Bedard J., Berlingieri J., Chehayeb R., Cheung S., Conway J., Cusson J., Della Siega A., Dumas R., Dzongowski P., Ferguson M., Gaudet D., Grondin F., Gupta A., Gupta M., Halperin F., Houle P. -A., Jones M., Kouz S., Kovacs C., Landry D., Lonn E., O'Mahony W., Peterson S., Reich D., Rosenbloom A., St-Maurice F., Tugwell B., Vizel S., Woo V., Brychta T., Cech V., Dvorakova E., Edelsberger T., Halciakova K., Krizova J., Lastuvka J., Piperek M., Prymkova V., Raclavska L., Silhova E., Urbanek R., Vrkoc J., Andersen U., Bronnum-Schou J., Hove J., Jensen J. S., Kober L., Kristiansen O. P., Lund P., Melchior T., Nyvad O., Schou M., Boye A., Cadinot D., Gouet D., Henry P., Kessler L., Lalau J. -D., Petit C., Thuan J. -F., Voinot C., Vouillarmet J., Axthelm C., Berger D., Bieler T., Birkenfeld A., Bott J., Busch K., Caca K., Chevts J., Donaubauer T., Erlinger R., Funke K., Grosskopf J., Hagenow A., Hamann M., Hartard M., Heymer P., Huppertz W., Illies G., Jacob S., Jung T., Kahrmann G., Kast P., Kellerer M., Kempe H. -P., Khariouzov A., Klausmann G., Klein C., Kleinecke-Pohl U., Kleinertz K., Koch T., Kosch C., Lorra B., Luedemann J., Luttermann M., Maxeiner S., Milek K., Moelle A., Neumann G., Nischik R., Oehrig-Pohl E., Plassmann G., Pohlmeier L., Proepper F., Regner S., Rieker W., Rose L., Samer H., Sauter J., Schaper F., Schiffer C., Schmidt J., Scholz B. -M., Schulze J., Segner A., Seufert J., Sigal H., Steindorf J., Stockhausen J., Stuebler P., Taeschner H., Tews D., Tschoepe D., Wilhelm K., Zeller-Stefan H., Avramidis I., Bousboulas S., Bristianou M., Dimitriadis G., Elisaf M., Kotsa K., Melidonis A., Mitrakou A., Pagkalos E., Papanas N., Pappas A., Sampanis C., Tentolouris N., Tsapas A., Tzatzagou G., Ozaki R., Hajdu C., Harcsa E., Konyves L., Mucsi J., Pauker Z., Petro G., Ples Z., Revesz K., Sandor V., Vass V., Avogaro A., Boemi M., Bonadonna R., Consoli A., De Cosmo S., Di Bartolo P., Dotta F., Frontoni S., Galetta M., Gambineri A., Gazzaruso C., Giorgino F., Lauro D., Orsi E., Paolisso G., Perriello G., Piatti P., Pontiroli A., Ponzani P., Rivellese A. A., Sesti G., Tonolo G., Trevisan R., Ahn C. W., Baik S. -H., Cha B. -S., Chung C. -H., Jang H. C., Kim C. -J., Kim H. S., Kim I. J., Lee E. Y., Lee H. W., Lee K. -W., Moon K. -W., Namgung J., Park K. S., Yoo S. J., Yu J., Llamas E. -A. B., Cervantes-Escarcega J. -L., Flota-Cervera L. F., Gonzalez-Gonzalez J. G., Pascoe-Gonzalez S., Pelayo-Orozco E. S., Ramirez-Diaz S. -P., Saldana-Mendoza A., Jerjes-Diaz C. S., Torres-Colores J. J., Vidrio-Velazquez M., Villagordoa-Mesa J., Beijerbacht H. P., Groutars R. G. E. J., Hoek B. A., Hoogslag P. A. M., Kooy A., Kragten J. A., Lieverse A. G., Swart H. P., Viergever E. P., Ahlqvist J., Cooper J., Gulseth H., Guttormsen G., Wium C., Arbanil H., Calderon J., Camacho L., Espinoza A. D., Garrido E., Luna A., Manrique H., Revoredo F. M., Gonzales R. V., Rincon L. Z., Zubiate C., Ebo G., Morales-Palomares E., Arciszewska M., Banach M., Bijata-Bronisz R., Derezinski T., Gadzinski W., Gajek J., Klodawska K., Krzyzagorska E., Madej A., Miekus P., Opiela J., Romanczuk P., Siegel A., Skokowska E., Stankiewicz A., Stasinska T., Trznadel-Morawska I., Witek R., Aksentyev S., Bondar I., Demidova I., Dreval A., Ershova O., Galstyan G., Garganeeva A., Izmozherova N., Karetnikova V., Kharakhulakh M., Khokhlov A., Kobalava Z., Koshelskaya O., Kosmacheva E., Kostin V., Koziolova N., Kuzin A., Lesnov V., Lysenko T., Markov V., Mayorov A., Moiseev S., Myasoedova S., Petunina N., Rebrov A., Ruyatkina L., Samoylova J., Sazonova O., Shilkina N., Sokolova N., Vasilevskaya O., Verbovaya N., Vishneva E., Vorobyev S., Vorokhobina N., Zanozina O., Zhdanova E., Zykova T., Burgess L., Coetzee K., Dawood S., Lombard L., Makotoko E., Moodley R., Oosthuysen W., Sarvan M., Calvo Gomez C., Cano Rodriguez I., Castro Conde A., Cequier Fillat A., Cuatrecasas Cambra G., de Alvaro Moreno F., De Teresa Parreno L., Delgado Lista J., Dominguez Escribano J. R., Duran Garcia S., Elvira Gonzalez J., Fernandez Rodriguez J. M., Goday Arno A., Gomez Huelgas R., Gonzalez Juanatey J. R., Hernandez Mijares A., Jimenez Diaz V. A., Jodar Gimeno E., Lucas Morante T., Marazuela M., Martell Claros N., Mauricio Puente D., Mena Ribas E., Merino Torres J. F., Mezquita Raya P., Nubiola Calonge A., Ordonez Sanchez X., Pascual Izuel J. M., Perea Castilla V., Perez Perez A., Perez Soto I., Quesada Charneco M., Quesada Simon A., Redon Mas J., Rego Iraeta A., Rodriguez Alvarez M., Rodriguez Rodriguez I., Saban Ruiz J., Soto Gonzalez A., Tinahones Madueno F., Trescoli Serrano C., Ulied Arminana A., Bachus E., Berndtsson Blom K., Eliasson K., Koskinen P., Larnefeldt H., Lif-Tiberg C., Linderfalk C., Lund G., Lundman P., Moris L., Olsson A., Salmonsson S., Sanmartin Berglund J., Sjoberg F., Soderberg S., Torstensson I., Chen J. -F., Tien K. J., Tseng S. -T., Tu S. -T., Wang C. -Y., Wang J. -H., Phrommintikul A., Yamwong S., Jintapakorn W., Hutayanon P., Sansanayudh N., Bazhan L., Fushtey I., Grachova M., Katerenchuk V., Korpachev V., Kravchun N., Larin O., Mykhalchyshyn G., Myshanych H., Oleksyk O., Orlenko V., Pashkovska N., Pertseva N., Petrosyan O., Smirnov I., Vlasenko M., Zlova T., Aye M., Baksi A., Balasubramani M., Beboso R., Blagden M., Bundy C., Cookson T., Copland A., Emslie-Smith A., Green F., Gunstone A., Issa B., Jackson-Voyzey E., Johnson A., Maclean M., McKnight J., Muzulu S., O'Connell I., Oyesile B., Patterson C., Pearson E., Philip S., Smith P., Sukumaran U., Abbas J., Aggarwala G., Akhter F., Andersen J., Anglade M., Argoud G., Ariani M., Ashdji R., Bakhtari L., Banerjee S., Bartlett A., Baum H., Bays H., Beasley R., Belfort de Aguiar R., Benjamin S., Bhagwat R., Bhargava A., Bode B., Bratcher C., Briskin T., Brockmyre A., Broughton R., Brown J., Budhraja M., Cannon K., Carr J., Cathcart H., Cavale A., Chaykin L., Cheung D., Childress R., Cohen A., Condit J., Cooksey E., Cornett G. M., Dauber I., Davila W., De Armas L., Dean J., Detweiler R., Diaz E., Di Giovanna M., Dor I., Drummond W., Eagerton D., Earl J., Eaton C., Ellison H., Farris N., Fiel T., Firek A., First B., Forgosh L., French W., Gandy W., Garcia R., Gill S., Gordon M., Guice M., Gummadi S., Hackenyos J., Hairston K., Hanson L., Harrison L., Hartman I., Heitner J., Hejeebu S., Hermany P., Hernandez-Cassis C., Hidalgo H., Higgins A., Ibrahim H., Jacobs S., Johnson D., Joshi P., Kaster S., Kellum D., Kim C., Kim E., Kirby W., Knouse A., Kulback S., Kumar M., Kuruvanka T., Labroo A., Lasswell W., Lentz J., Lenzmeier T., Lewis D., Li Z., Lillestol M., Little R., Lorraine R., McKeown-Biagas C., McNeill R., Mehta A., Miller A., Moran J., Morawski E., Nadar V., O'Connor T., Odio A., Parker R., Patel R., Phillips L., Raad G., Rahman A., Raikhel M., Raisinghani A., Rajan R., Rasouli N., Rauzi F., Rohr K., Roseman H., Rovner S., Saba F., Sachson R., Schabauer A., Schneider R., Schuchard T., Sensenbrenner J., Shlesinger Y., Singh N., Sivalingam K., Stonesifer L., Storey D., Suh D., Tahir M., Tan A., Tan M., Taylon A., Thakkar M., Tripathy D., Uwaifo G., Vedere A., Venugopal C., Vo A., Welch M., Welker J., White A., Willis J., Wynne A., Yazdani S., Price L., Lokhngina Y., Xing W., Overton R., Stewart M., Stead J., Lindsay A., Patel V., Ross J., Soffer J., Daga S., Sowell M., Patel P., Garvey L., Ackert J., Abraham S., Sabol M. B., Altobelli D., Ha J., Kulkarni M., Noronha D., Casson E., Zang E., Sandhu C., Kumar R., Chen D., Taft L., Ye J., Shannon J., Wilson T., Babi C., Miller D., Russell R., Bull G., Hereghty B., Fernandez-Salazar E., Longley T., Donaldson J., Jarosz M., Murphy K., Adams P., James R., Richards J., Sedani S., Althouse D., Watson D., Lorimer J., Lauder S., Schultheis R., Womer T., Wraight E., Li W., Price-Olsen E., Watson A., Kelly A., McLaughlin P., Fleming J., Schubert J., Schleiden D., Harris T., Prakash R., Breneman J., Deshpande S., Saswadkar A., Kumari A., Shitut A., Raorane A., Karmalkar A., Mhambrey A., Bhosale A., Vaphare A., Patil A. P., Khandelwal C., Shaik F., Nadar M., Karka M., Kadgaonkar N., Gupta N., Aher N., Potnis O., Naicker P., Shinde R., Sharma R., Godse R., Solanki S., Sahu S., Dumbre S., Kumar S., Patil S., Mandal T. |
| المساهمون: |
Hernandez, A, Green, J, Janmohamed, S, D'Agostino, R, Granger, C, Jones, N, Leiter, L, Rosenberg, A, Sigmon, K, Somerville, M, Thorpe, K, Mcmurray, J, Del Prato, S, Califf, R, Holman, R, Demets, D, Riddle, M, Goodman, S, Mcguire, D, Alexander, K, Devore, A, Melloni, C, Patel, C, Kong, D, Bloomfield, G, Roe, M, Tricoci, P, Harrison, R, Lopes, R, Mathews, R, Mehta, R, Schuyler Jones, W, Vemulapalli, S, Povsic, T, Eapen, Z, Dombrowski, K, Kolls, B, Jordan, D, Ambrosy, A, Greene, S, Mandawat, A, Shavadia, J, Cooper, L, Sharma, A, Guimaraes, P, Friedman, D, Wilson, M, Endsley, P, Gentry, T, Collier, J, Perez, K, James, K, Roush, J, Pope, C, Howell, C, Johnson, M, Bailey, M, Cole, J, Akers, T, Vandyne, B, Thomas, B, Rich, J, Bartone, S, Beaulieu, G, Brown, K, Chau, T, Christian, T, Coker, R, Greene, D, Haddock, T, Jenkins, W, Haque, G, Marquess, M, Pesarchick, J, Rethaford, R, Stone, A, Al Kawas, F, Anderson, M, Enns, R, Sinay, I, Mathieu, C, Yordanov, V, Hramiak, I, Haluzik, M, Galatius, S, Guerci, B, Nauck, M, Migdalis, I, Tan, C, Kocsis, G, Giaccari, A, Lee, M, Munoz, E, Cornel, J, Birkeland, K, Pinto, M, Tirador, L, Olesinska-Mader, M, Shestakova, M, Distiller, L |
| بيانات النشر: |
Lancet Publishing Group |
| سنة النشر: |
2018 |
| المجموعة: |
Università degli Studi di Milano-Bicocca: BOA (Bicocca Open Archive) |
| مصطلحات موضوعية: |
alanine aminotransferase, albiglutide, bilirubin, placebo, antidiabetic agent, glucagon like peptide 1, rGLP-1 protein |
| الوصف: |
Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| العلاقة: |
info:eu-repo/semantics/altIdentifier/pmid/30291013; info:eu-repo/semantics/altIdentifier/wos/WOS:000448414700030; volume:392; issue:10157; firstpage:1519; lastpage:1529; numberofpages:11; journal:THE LANCET; http://hdl.handle.net/10281/280361Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85055101508 |
| DOI: |
10.1016/S0140-6736(18)32261-X |
| الإتاحة: |
https://doi.org/10.1016/S0140-6736Test(18)32261-X
http://hdl.handle.net/10281/280361Test |
| حقوق: |
info:eu-repo/semantics/closedAccess |
| رقم الانضمام: |
edsbas.1679517C |
| قاعدة البيانات: |
BASE |
