sustain 6 trial

<>>>/BBox[0 0 567 756]/Length 112>>stream Privacy, Help The median duration of exposure was 21.6 months in SUSTAIN 6 and 15.9 months in PIONEER 6. Outside the submitted work, I.H. �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ �]� �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ 32 0 obj 31 0 obj Listing a study does not mean it has been evaluated by the U.S. Federal Government. x�S�*�*T0T0 B��id��]��%D.� r�s Aims: SUSTAIN 10 compared the efficacy and safety of the anticipated most frequent semaglutide dose (1.0mg) with the current most frequently prescribed liraglutide dose in Europe (1.2mg), reflecting clinical practice. In this post hoc analysis of SUSTAIN 6, once-weekly semaglutide vs placebo reduced the risk of MACE in all subjects included in the trial, regardless of gender, age, or baseline CV risk profile. endstream endobj x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � adobe:docid:indd:d03427a0-e66b-11de-bd24-81ae6252b62b endstream endobj *On-treatment analysis comprising events with onset…, National Library of Medicine Outside of the submitted work, he has received grants and/or personal fees for advisory panels, speakers’ bureaus, and research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, Merck, Novo Nordisk, and Sanofi. 2018 Jun 1;103(6):2291-2301. doi: 10.1210/jc.2018-00070. ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. endobj has received honoraria and/or lecture fees from AstraZeneca, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Novo Nordisk, and Sanofi Aventis. -, Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, et al. x�+� � | 2018 Dec;52(12):1224-1232. doi: 10.1177/1060028018784583. x�+� � | �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ x��A 1 0 obj endobj x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � endobj x�S�*�*T0T0 B��ih��]��D.� r^j Keywords: Please enable it to take advantage of the complete set of features! endstream endstream <>>>/BBox[0 0 567 756]/Length 129>>stream 40 0 obj 24 0 obj In both the CVOTs, trial completion rate was high (SUSTAIN 6: 97.6%; PIONEER 6: 99.7%) with vital status at end-of-trial known for 99.6% of patients in SUSTAIN 6 and 100% in PIONEER 6. ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � <>>>/BBox[0 0 567 756]/Length 129>>stream 47 0 obj Sorli C ; Harashima SI ; Tsoukas GM ; et al. x�S�*�*T0T0 B��i��U�� !D.� _e1 / 39 0 obj Age; Baseline cardiovascular risk; Cardiovascular events; Cardiovascular outcome trial; Gender; SUSTAIN 6; Semaglutide; Type 2 diabetes. xmp.id:F404C54D102068118083E4872A240A24 Other aspects of the trial began to come into focus Monday as well. <>stream x��A endobj x�s <>stream Outside of the submitted work, S.M. endstream Trump’s impeachment trial already shows how far US democracy has been undermined. x�S�*�*T0T0 B��il��]��D.� pa x��A <>>>/BBox[0 0 567 756]/Length 83>>stream 60 0 obj endstream Estimated HRs and associated CIs are from a Cox proportional hazards model with an interaction between treatment (semaglutide, placebo) and subgroups as fixed factors. 303. endstream <>>>/BBox[0 0 567 756]/Length 129>>stream Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial J Clin Endocrinol Metab . ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. reports grants and personal fees from Novo Nordisk during the conduct of the study. reports research grants and/or personal fees from AstraZeneca/Bristol-Myers Squibb, Boehringer Ingelheim, Dexcom, Eli Lilly, GlaxoSmithKline, Insulet Corp, Janssen Pharmaceuticals, Lexicon Pharmaceuticals, Medtronic, Merck & Co Inc, Population Health Research Institute, Roche Pharma, Sanofi, and Takeda. endstream adobe:docid:indd:d03427a0-e66b-11de-bd24-81ae6252b62b doi: 10.1021/acs.jmedchem.5b00726. 52 0 obj Treating type 2 diabetes in COVID-19 patients: the potential benefits of injective therapies. Epub 2018 Feb 1. x�+� � | In subjects with…, Change from baseline in HbA 1c and body weight by gender ( a…, Adverse events by gender in SUSTAIN 6. Epub 2018 Jun 22. x�+� � | Liberia War Crimes: Inconsistent testimonies plague Massaquoi trial One witness said he narrowly escaped with others when Mr Massaquoi allegedly ordered his men to … 45 0 obj 2020 Jun 22;19(1):96. doi: 10.1186/s12933-020-01070-z. Cardiovasc Diabetol. <>stream x��A Adobe InDesign CS6 (Macintosh) 4 0 obj endobj doi: 10.2337/dci18-0033. Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide. 2018 Jun 1;103(6):2291-2301. doi: 10.1210/jc.2018-00070. endobj <>>>/BBox[0 0 567 756]/Length 83>>stream <>stream -, American Diabetes Association Cardiovascular disease and risk management: standards of medical care in diabetes 2019. <>>>/BBox[0 0 567 756]/Length 129>>stream Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Cardiovasc Diabetol. <>>>/BBox[0 0 567 756]/Length 83>>stream Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, Thomsen M, Vilsbøll T, Warren ML, Bain SC; PIONEER 6 Investigators. <>>>/BBox[0 0 567 756]/Length 129>>stream Trial registry Clinicaltrials.gov, Identifying number: NCT01720446, Date of registration: October 29, 2012. PubMed PMID: 27633186. 41 0 obj 50 0 obj �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ Background: �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ 16 0 obj 20 0 obj A total of 3297 subjects were included. <>stream endstream endobj endstream <>stream Semaglutide, a GLP-1 analogue with an extended half-life of approximately 1 week (which permits once-weekly subcutaneous administration),4 is currently in development but not yet approved for the treatment of type 2 diabetes. 27 0 obj FREE Shipping on orders over $25 shipped by Amazon. Regulatory guidance specifies the need to establish the cardiovascular safety of new therapies for type 2 diabetes in order to rule out excess cardiovascular risk.5 The preapproval Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diab… <>>>/BBox[0 0 567 756]/Length 112>>stream ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. After the LEADER trial and SUSTAIN-6, how do we explain the cardiovascular benefits of some GLP-1 receptor agonists? endstream Results: ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. x��A 58 0 obj x��A endstream 2016 Feb 24;15:38. doi: 10.1186/s12933-016-0355-z. With four straight days of gains, the blue-chip Dow has gained 3.6%. doi: 10.1016/S0140-6736(10)60484-9. 19 0 obj During the conduct of the study, L.A.L. Key Results. 36 0 obj 2018;2018(41):2669–2701. Diabetes Obes Metab. �]� endobj Table 1: Summary of Key … 12 0 obj <>stream x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � 42 0 obj x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � endstream Methods: x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � The p-values are 2-sided for test for heterogeneity of treatment between subgroups. endobj 6 0 obj x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � The Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN-6) examines the … 2: Hamm CW, Reimers J, Ischinger T, Rupprecht HJ, … endobj In subjects with a prior MI/stroke (. �]� endstream x�s x�+� � | �]� endstream endstream x�+� � | endobj endobj received research grants to his institution from Novo Nordisk. Outside the submitted work, S.C.B. endobj The p-values are 2-sided for test for heterogeneity of treatment between subgroups. x�+� � | x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � endobj Semaglutide: The Newest Once-Weekly GLP-1 RA for Type 2 Diabetes. x�S�*�*T0T0 B��i��U��D*� :�� endobj 2020 Jul 22;19(1):115. doi: 10.1186/s12933-020-01090-9. <>>>/BBox[0 0 567 756]/Length 129>>stream Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. He also reports research grants from GlaxoSmithKline and personal fees for advisory panels from Servier. endstream Prof Hertzel C Gerstein, MD. Time to MACE and its individual components (CV death, nonfatal MI, nonfatal stroke), hospitalization for unstable angina or heart failure, and revascularization (coronary and peripheral) were analyzed for all subgroups. 2018;41(Suppl 1):S1–S135. x�s <>stream endstream <>>>/BBox[0 0 567 756]/Length 129>>stream endobj endstream <>stream endobj <>stream <>>>/BBox[0 0 567 756]/Length 83>>stream <>>>/BBox[0 0 567 756]/Length 112>>stream Unable to load your collection due to an error, Unable to load your delegates due to an error. <>>>/BBox[0 0 567 756]/Length 83>>stream Only 2 left in stock - order soon. Tuchscherer RM, Thompson AM, Trujillo JM. T.G., T.H., and I.H. �]� <>stream endobj xmp.iid:CB0475B9082068118083B77DE1B68EFB My girlfriend noticed the difference and that's the test that matters most. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. 9 0 obj received research grants to her institution and consulting fees from Novo Nordisk during the conduct of the study. 2016-10-27T12:32:41-04:00 13 0 obj endobj Diabetes Metab. x��A endobj 49 0 obj Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. endstream endstream <>>>/BBox[0 0 567 756]/Length 83>>stream ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. endstream 55 0 obj What was prominent was the very robust effect in … The SUSTAIN 7 trial investigated semaglutide in a different population to SUSTAIN 6, and excluded patients with pre-existing proliferative retinopathy and maculopathy requiring acute treatment. <>stream endobj Time from baseline to first confirmed MACE in SUSTAIN 6. 34 0 obj Lancet Diabetes Endocrinol. Without side effects !!! 1: Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T; SUSTAIN-6 Investigators.. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Estimated HRs and associated CIs are from a Cox proportional hazards model with an interaction between treatment (semaglutide, placebo) and subgroups as fixed factors. endstream proof:pdf $19.95 $ 19. 51 0 obj xmp.did:86B3B2EAF996E6118529DC407F2F8C13 x�+� � | Gastrointestinal adverse events in all treatment groups were more common among women than men, but rates of premature treatment discontinuation were similar for both genders. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. endstream The Supreme Court has ruled that zonal valuation of land set by the Bureau of Internal Revenue should not be the only basis for determining the just compensation in the government’s expropriation of privately-owned landholdings. <>>>/BBox[0 0 567 756]/Length 83>>stream 29 0 obj endobj endobj Read our disclaimer for details. He has also received a research grant from Novo Nordisk and Boehringer Ingelheim. Outside the submitted work, she has received grants and/or personal fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, GI Dynamics, Intarcia, Mannkind, Merck, Mylan, Novartis, NovoNordisk, Pfizer, Sanofi, TARGETPharma, and Valeritas. x�+� � | x�s Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis. 2016 Nov 10;375(19):1834-1844. E.J. It really is Insane. endobj x�s I.L. -, Lau J, Bloch P, Schäffer L, Pettersson I, Spetzler J, Kofoed J, et al. *On-treatment analysis comprising events with onset from the date of first dose to either the end-of-treatment follow-up visit, the date of last dose plus 42 days, the end-of-trial follow-up visit, or the date of withdrawal from trial, whichever came first (semaglutide males: n = 1007; semaglutide females: n = 635; placebo males: n = 987; placebo females: n = 657). endstream endstream 2017 Apr;43 Suppl 1:2S3-2S12. endobj �]� Subjects were censored at their planned end-of-trial visit, last direct subject-site contact or all-cause death of the subject, whichever occurred first. <>>>/BBox[0 0 567 756]/Length 129>>stream �@��b��5�=b`g��qm�s�p.L`�`&zy�v��a��s�7�5�c�t��S��x#/��ҧsp8(:/�@80��s��8a��ax:�!�"�oC�d�`��3�A{Bg��. Ahrén B, Masmiquel L, Kumar H, Sargin M, Karsbøl JD, Jacobsen SH, Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. endstream Longo M, Caruso P, Maiorino MI, Bellastella G, Giugliano D, Esposito K. Cardiovasc Diabetol. -, Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, et al. endstream Treatment differences in hospitalization for unstable angina or heart failure, and revascularization in SUSTAIN 6. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. ��w3T�PI�2T0 BC##=Cc#��\.��T��r׼��ļ��Ң��4�Ԕ��̼T͐,.�. �]� �]� 18 0 obj x��1�0�ݧ�#,��D�l��Р�VqZ�G� ��w:��A��m��!o��2�[Iϱ��p�>��8.��zR�)&��)g��iYup�ˋ�B_�| � endstream <>stream �]� 37 0 obj Clipboard, Search History, and several other advanced features are temporarily unavailable. FILE - In this July 7, 2015, file photo, Commissioner Bruce Castor, a former Montgomery County, Pa., District Attorney, speaks during an interview with The Associated Press in Norristown, Pa. Former President Donald Trump stands trial before the Senate on an impeachment charge that accuses him of inciting the deadly Jan. 6 riot at the U.S. Capitol. �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ Compared with placebo, semaglutide reduced the risk of the first occurrence of MACE and each MACE component consistently across all subgroups (gender, age, and baseline CV risk profile). x�+� � | FOIA endstream 33 0 obj Dagenais GR, Rydén L, Leiter LA, Lakshmanan M, Dyal L, Probstfield JL, Atisso CM, Shaw JE, Conget I, Cushman WC, Lopez-Jaramillo P, Lanas F, Munoz EGC, Pirags V, Pogosova N, Basile J, Sheu WHH, Temelkova-Kurktschiev T, Raubenheimer PJ, Keltai M, Hall S, Pais P, Colhoun HM, Riddle MC, Gerstein HC. The majority of subjects (60.7%) were male; 43% were > 65 years of age; 41.5% had a history of MI or stroke; and 76.8% had established CVD. x�s endstream 2020 Nov 25;19(1):199. doi: 10.1186/s12933-020-01179-1. x�S�*�*T0T0 B��id��]��1D.� pa Research Feed. 23 0 obj Expert commentary: While EMPA-REG had robust reduction in the CV-death, all-cause death and hHF, there … <>stream %PDF-1.3 SUSTAIN-6 Investigators: ... or both. endobj Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Med Chem. x�S�*�*T0T0 B��i��U��D*� 8� Management of hyperglycemia in type 2 diabetes, 2018. Careers. from application/x-indesign to application/pdf 2010;375:2215–2222. 38 0 obj Adobe PDF Library 10.0.1; modified using iText 4.2.0 by 1T3XT Prevention and treatment information (HHS). Hertzel C Gerstein. American Diabetes Association Standards of medical care in diabetes 2018. Analysis of time from randomization to first event adjudication committee-confirmed event. x�S�*�*T0T0 B��ih��]�� D.� pa endstream Additional analyses were performed for gender and age to investigate change from baseline in HbA1c and body weight, as well as tolerability. endstream x��A 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. <>stream report that they are full-time employees of Novo Nordisk A/S. <>>>/BBox[0 0 567 756]/Length 129>>stream endobj endobj Alfayez OM, Almohammed OA, Alkhezi OS, Almutairi AR, Al Yami MS. Cardiovasc Diabetol. Adverse events by gender in SUSTAIN 6. endobj �0F�}N�/$vB݊v��\ �Ԥ$��oo��=��U��N��m�.�z��kI�F?b�(~Κ�.x:y\O0�!��_/��KX��H�i�܂�}U��^�s�5r�8�Y=��{+ x�s x��A <>>>/BBox[0 0 567 756]/Length 83>>stream The key CV outcome results are summarized in Table 1. See this image and copyright information in PMC. <>>>/BBox[0 0 567 756]/Length 112>>stream 17 0 obj Regarding SUSTAIN-6 specifically, Dr Zinman said: "It's exciting to have another positive trial with respect to cardiovascular outcomes. N Engl J Med. <>>>/BBox[0 0 567 756]/Length 83>>stream The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.58 to 0.95; P<0.001 for noninferiority). Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. 57 0 obj <>>>/BBox[0 0 567 756]/Length 112>>stream 28 0 obj 7 0 obj 25 0 obj x��A 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4. He also reports grants and personal fees as a consultant and/or speaker from Amgen, AstraZeneca, Boehringer Ingelheim, Faes Farma, Fresenius, Janssen Pharmaceuticals, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Sanofi, Shire, and UCB. The Lagos State government and the NPA, last Tuesday, disclosed the commencement of a three-month trial on enforcement and compliance of the …