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

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 ...

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

الإتاحة: https://doi.org/10.1016/S0140-6736Test(18)32261-X
http://hdl.handle.net/10281/280361Test

المؤلفون: Dandona P., Mathieu C., Phillip M., Hansen L., Griffen S. C., Tschope D., Thoren F., Xu J., Langkilde A. M., Proietto J., Stranks S., Chen R., O'Neal D., Pape A., Forbes M., Morbey C., Luger A., Hanusch U., Schnack C., Fliesser-Goerzer E., Hoelzl B., Ebenbichler C., Prager R., Van Gaal L., Vercammen C., Scheen A., Duyck F., Nobels F., Ruige J., Aggarwal N., Woo V., St-Pierre B., Dumas R., Hramiak I., Elliott T., Krarup Hansen T., Henriksen J. E., Gram J., Lihn A., Bruun J., Saltevo J., Taurio J., Strand J., Valle T., Nieminen S., Pietilainen K., Guerci B., Hadjadj S., Cariou B., Verges B., Borot S., Penfornis A., Schaum T., Tschoepe D., Marck C., Horacek T., Rose L., Klausmann G., Luedemann J., Appelt S., Aigner U., Goebel R., Behnke T., Ziegler A. -G., Peterfai E., Kerenyi Z., Oroszlan T., Kiss G. G., Konyves L., Piros G., Mosenzon O., Shehadeh N., Adawi F., Wainstein J., Dotta F., Piatti P., Genovese S., Consoli A., Di Bartolo P., Mannucci E., Giordano C., Lapolla A., Aguilar C., Esteban A., Ruiz B., Ramirez G. M., Pelayo Orozco E., Alejandro C., de Alba S., Medina Pech C., Garza Ruiz J., Sauque Reyna L., Llamas Esperon G., Nevarez Ruiz L. A., Vidrio Velazquez M., Flores Lozano F., Gonzalez Gonzalez J. G., Garcia-Hernandez P. A., Araujo-Silva R., Villeda - Espinosa E., Mistodie C., Popescu D., Constantin C., Nicolau A., Popa B., Timar R., Serafinceanu C., Pintilei E., ALTIERI SOTO, MIGUEL ANGEL, Gimenez M., Merino J., Morales C., Mezquita P., Jendle J., Tengmark B. -O., Eriksson J., Londahl M., Eliasson B., Gunstone A., Heller S., Darzy K., Mansell P., DAVIES, MICHELLE THERESE, Reed R., Browne D., Courtney H., Turner W., Blagden M., McCrimmon R., Bergenstal R., Lane W., Lucas K., White A., BAO, SARA, WHITE, PETER JOHN, Jantzi C., ABOULGHASSEM RASOULI, NASIM, Ervin W., Lewy-Alterbaum L., Handelsman Y., Miranda-Palma B., Cleland A., Fink R., Rodbard H., Nakhle S., Greenberg C., Schorr A., Bays H., Simmons D., Klein E., Kane L., Fishman N., Ipp E., Garg S., Bhargava A., Singh M. Z., Rosenstock J., Thrasher J., Warren M., Young L., Aroda V., Pettus J., Liljenquist D., Busch R., Wise J., Kayne D., Biggs W.

المساهمون: Dandona, P., Mathieu, C., Phillip, M., Hansen, L., Griffen, S. C., Tschope, D., Thoren, F., Xu, J., Langkilde, A. M., Proietto, J., Stranks, S., Chen, R., O'Neal, D., Pape, A., Forbes, M., Morbey, C., Luger, A., Hanusch, U., Schnack, C., Fliesser-Goerzer, E., Hoelzl, B., Ebenbichler, C., Prager, R., Van Gaal, L., Vercammen, C., Scheen, A., Duyck, F., Nobels, F., Ruige, J., Aggarwal, N., Woo, V., St-Pierre, B., Dumas, R., Hramiak, I., Elliott, T., Krarup Hansen, T., Henriksen, J. E., Gram, J., Lihn, A., Bruun, J., Saltevo, J., Taurio, J., Strand, J., Valle, T., Nieminen, S., Pietilainen, K., Guerci, B., Hadjadj, S., Cariou, B., Verges, B., Borot, S., Penfornis, A., Schaum, T., Tschoepe, D., Marck, C., Horacek, T., Rose, L., Klausmann, G., Luedemann, J., Appelt, S., Aigner, U., Goebel, R., Behnke, T., Ziegler, A. -G., Peterfai, E., Kerenyi, Z., Oroszlan, T., Kiss, G. G., Konyves, L., Piros, G., Mosenzon, O., Shehadeh, N., Adawi, F., Wainstein, J., Dotta, F., Piatti, P., Genovese, S., Consoli, A., Di Bartolo, P., Mannucci, E., Giordano, C., Lapolla, A., Aguilar, C., Esteban, A., Ruiz, B., Ramirez, G. M., Pelayo Orozco, E., Alejandro, C., de Alba, S., Medina Pech, C., Garza Ruiz, J., Sauque Reyna, L., Llamas Esperon, G., Nevarez Ruiz, L. A., Vidrio Velazquez, M., Flores Lozano, F., Gonzalez Gonzalez, J. G., Garcia-Hernandez, P. A.

مصطلحات موضوعية: Adult, Benzhydryl Compound, Body Weight, Diabetes Mellitus, Type 1, Drug Therapy, Combination, Female, Glucoside, Glycated Hemoglobin A, Human, Hypoglycemia, Hypoglycemic Agent, Insulin, Male, Middle Aged, Treatment Outcome

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/28919061; info:eu-repo/semantics/altIdentifier/wos/WOS:000413782300019; volume:5; issue:11; firstpage:864; lastpage:876; numberofpages:13; journal:THE LANCET DIABETES & ENDOCRINOLOGY; http://hdl.handle.net/11577/3303263Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85029446459; http://www.journals.elsevier.com/the-lancet-diabetes-and-endocrinologyTest

الإتاحة: https://doi.org/10.1016/S2213-8587Test(17)30308-X
http://hdl.handle.net/11577/3303263Test
http://www.journals.elsevier.com/the-lancet-diabetes-and-endocrinologyTest

المؤلفون: Dandona, P., Mathieu, C., Phillip, M., Hansen, L., Griffen, S. C., Tschöpe, D., Thorén, F., Xu, J., Langkilde, A. M., Proietto, J., Stranks, S., Chen, R., O'Neal, D., Pape, A., Forbes, M., Morbey, C., Luger, A., Hanusch, U., Schnack, C., Fliesser-Goerzer, E., Hoelzl, B., Ebenbichler, C., Prager, R., Van Gaal, L., Vercammen, C., Scheen, André, Duyck, F., Nobels, F., Ruige, J., Aggarwal, N., Woo, V., St-Pierre, B., Dumas, R., Hramiak, I., Elliott, T., Krarup Hansen, T., Henriksen, J. E., Gram, J., Lihn, A., Bruun, J., Saltevo, J., Taurio, J., Strand, J., Valle, T., Nieminen, S., Pietilainen, K., Guerci, B., Hadjadj, S., Cariou, B., Verges, B., Borot, S., Penfornis, A., Schaum, T., Tschoepe, D., Marck, C., Horacek, T., Rose, L., Klausmann, G., Luedemann, J., Appelt, S., Aigner, U., Goebel, R., Behnke, T., Ziegler, A.-G., Peterfai, E., Kerenyi, Z., Oroszlan, T., Kiss, G. G., Konyves, L., Piros, G., Mosenzon, O., Shehadeh, N., Adawi, F., Wainstein, J., Dotta, F., Piatti, P., Genovese, S., Consoli, A., Di Bartolo, P., Mannucci, E., Giordano, C., Lapolla, A., Aguilar, C., Esteban, A., Ruiz, B., Ramirez, G. M., Pelayo Orozco, E., Alejandro, C., de Alba, S., Medina Pech, C., Garza Ruiz, J., Sauque Reyna, L., Llamas Esperon, G., Nevarez Ruiz, L. A., Vidrio Velazquez, M., Flores Lozano, F., Gonzalez Gonzalez, J. G., Garcia-Hernandez, P. A., Araujo-Silva, R., Villeda - Espinosa, E., Mistodie, C., Popescu, D., Constantin, C., Nicolau, A., Popa, B., Timar, R., Serafinceanu, C., Pintilei, E., Soto, A., Gimenez, M., Merino, J., Morales, C., Mezquita, P., Jendle, J., Tengmark, B.-O., Eriksson, J., Londahl, M., Eliasson, B., Gunstone, A., Heller, S., Darzy, K., Mansell, P., Davies, M., Reed, R., Browne, D., Courtney, H., Turner, W., Blagden, M., McCrimmon, R., Bergenstal, R., Lane, W., Lucas, K., White, A., Bao, S., White, J., Jantzi, C., Rasouli, N., Ervin, W., Lewy-Alterbaum, L., Handelsman, Y., Miranda-Palma, B., Cleland, A., Fink, R., Rodbard, H., Nakhle, S., Greenberg, C., Schorr, A., Bays, H., Simmons, D., Klein, E., Kane, L., Fishman, N., Ipp, E., Garg, S., Bhargava, A., Singh, M. Z., Rosenstock, J., Thrasher, J., Warren, M., Young, L., Aroda, V., Pettus, J., Liljenquist, D., Busch, R., Wise, J., Kayne, D., Biggs, W.

المصدر: The Lancet Diabetes and Endocrinology, 5 (11), 864-876 (2017)

مصطلحات موضوعية: Article, Human health sciences, Endocrinology, metabolism & nutrition, Sciences de la santé humaine, Endocrinologie, métabolisme & nutrition

الوصف: Background Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor approved for the treatment of type 2 diabetes. We aimed to assess the efficacy and safety of dapagliflozin as an add-on to adjustable insulin in patients with inadequately controlled type 1 diabetes. Methods DEPICT-1 was a double-blind, randomised, parallel-controlled, three-arm, phase 3, multicentre study done at 143 sites in 17 countries. Eligible patients were aged 18–75 years and had inadequately controlled type 1 diabetes (HbA1c between ≥7·7% and ≤11·0% [≥61·0 mmol/mol and ≤97·0 mmol/mol]) and had been prescribed insulin for at least 12 months before enrolment. After an 8 week lead-in period to optimise diabetes management, patients were randomly assigned (1:1:1) using an interactive voice response system to dapagliflozin 5 mg or 10 mg once daily, given orally, or matched placebo. Randomisation was stratified by current use of continuous glucose monitoring, method of insulin administration, and baseline HbA1c. The primary efficacy outcome was the change from baseline in HbA1c after 24 weeks of treatment in the full analysis set, which consisted of all randomly assigned patients who received at least one dose of study drug. An additional 55 patients who were incorrectly and non-randomly allocated to only dapagliflozin treatment groups were included in the safety analysis set. This study was registered with ClinicalTrials.gov, number NCT02268214; data collection for the present analysis was completed on Jan 4, 2017, and a 28 week extension phase is ongoing. Findings Between Nov 11, 2014, and April 16, 2016, 833 patients were assigned to treatment groups and included in safety analyses (dapagliflozin 5 mg [n=277] vs dapagliflozin 10 mg [n=296] vs placebo [n=260]; 778 of these patients were randomly assigned and included in the full analysis set for efficacy analyses (259 vs 259 vs 260; difference due to randomisation error affecting 55 patients). Mean baseline HbA1c was 8·53% (70 mmol/mol; SD 0·67% [7·3 mmol/mol]). At week 24, both doses of dapagliflozin significantly reduced HbA1c compared with placebo (mean difference from baseline to week 24 for dapagliflozin 5 mg vs placebo was −0·42% [95% CI −0·56 to −0·28; p<0·0001] and for dapagliflozin 10 mg vs placebo was −0·45% [−0·58 to −0·31; p<0·0001]). Among patients in the dapagliflozin 5 mg (n=277), dapagliflozin 10 mg (n=296), and placebo (n=260) groups, the most common adverse events were nasopharyngitis (38 [14%] vs 36 [12%] vs 39 [15%]), urinary tract infection (19 [7%] vs 11 [4%] vs 13 [5%]), upper respiratory tract infection (15 [5%] vs 15 [5%] vs 11 [4%]), and headache (12 [4%] vs 17 [6%] vs 11 [4%]). Hypoglycaemia occurred in 220 (79%), 235 (79%), and 207 (80%) patients in the dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo groups, respectively; severe hypoglycaemia occurred in 21 (8%), 19 (6%), and 19 (7%) patients, respectively. Adjudicated definite diabetic ketoacidosis occurred in four (1%) patients in the dapagliflozin 5 mg group, five (2%) in the dapagliflozin 10 mg group, and three (1%) in the placebo group. Interpretation Our results suggest that dapagliflozin is a promising adjunct treatment to insulin to improve glycaemic control in patients with inadequately controlled type 1 diabetes. Funding AstraZeneca and Bristol-Myers Squibb. © 2017 Elsevier Ltd

العلاقة: urn:issn:2213-8587; urn:issn:2213-8595

الوصول الحر: https://orbi.uliege.be/handle/2268/235347Test