Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes
In a follow-up study of patients with type 2 diabetes, mortality benefits in those originally assigned to antihypertensive therapy were evident at the end of follow-up, but in-trial glucose differences did not result in long-term benefits in mortality or macrovascular events. Post-trial follow-up st...
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| Veröffentlicht in: | The New England journal of medicine Jg. 371; H. 15; S. 1392 - 1406 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Waltham, MA
Massachusetts Medical Society
09.10.2014
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| ISSN: | 0028-4793, 1533-4406, 1533-4406 |
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| Abstract | In a follow-up study of patients with type 2 diabetes, mortality benefits in those originally assigned to antihypertensive therapy were evident at the end of follow-up, but in-trial glucose differences did not result in long-term benefits in mortality or macrovascular events.
Post-trial follow-up studies involving patients with diabetes have previously shown long-term beneficial effects of earlier periods of intensive glucose control, but not blood-pressure lowering, on a range of outcomes, including mortality and macrovascular events.
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The Epidemiology of Diabetes Interventions and Complications (EDIC) study, an extension of the Diabetes Control and Complications Trial (DCCT) involving young patients with type 1 diabetes and no history of cardiovascular disease, hypertension, or hypercholesterolemia, showed a lower risk of macrovascular events, as well as a sustained benefit with respect to microvascular complications, beyond the period of intensive glucose control.
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The post-intervention follow-up of the . . . |
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| AbstractList | BackgroundIn the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up.MethodsWe invited surviving participants, who had previously been assigned to perindopril–indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events.ResultsThe baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure–lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure–lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI, 0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively.ConclusionsThe benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure–lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. (Funded by the National Health and Medical Research Council of Australia and others; ADVANCE-ON ClinicalTrials.gov number, NCT00949286.) In a follow-up study of patients with type 2 diabetes, mortality benefits in those originally assigned to antihypertensive therapy were evident at the end of follow-up, but in-trial glucose differences did not result in long-term benefits in mortality or macrovascular events. Post-trial follow-up studies involving patients with diabetes have previously shown long-term beneficial effects of earlier periods of intensive glucose control, but not blood-pressure lowering, on a range of outcomes, including mortality and macrovascular events. 1 – 3 The Epidemiology of Diabetes Interventions and Complications (EDIC) study, an extension of the Diabetes Control and Complications Trial (DCCT) involving young patients with type 1 diabetes and no history of cardiovascular disease, hypertension, or hypercholesterolemia, showed a lower risk of macrovascular events, as well as a sustained benefit with respect to microvascular complications, beyond the period of intensive glucose control. 1 The post-intervention follow-up of the . . . In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up. We invited surviving participants, who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events. The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure-lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI, 0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively. The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. (Funded by the National Health and Medical Research Council of Australia and others; ADVANCE-ON ClinicalTrials.gov number, NCT00949286.). In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up.BACKGROUNDIn the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up.We invited surviving participants, who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events.METHODSWe invited surviving participants, who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events.The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure-lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI, 0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively.RESULTSThe baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure-lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI, 0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively.The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. (Funded by the National Health and Medical Research Council of Australia and others; ADVANCE-ON ClinicalTrials.gov number, NCT00949286.).CONCLUSIONSThe benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. (Funded by the National Health and Medical Research Council of Australia and others; ADVANCE-ON ClinicalTrials.gov number, NCT00949286.). |
| Author | Lisheng, Liu Perkovic, Vlado Heller, Simon Hirakawa, Yoichiro Matthews, David R Joshi, Rohina Mancia, Giuseppe Colagiuri, Stephen Poulter, Neil MacMahon, Stephen Rodgers, Anthony Billot, Laurent Hamet, Pavel Mogensen, Carl E Zoungas, Sophia Monaghan, Helen Grobbee, Diederick Williams, Bryan Woodward, Mark Neal, Bruce Glasziou, Paul Harrap, Stephen Chalmers, John Cooper, Mark E Li, Qiang Patel, Anushka Marre, Michel Arima, Hisatomi |
| Author_xml | – sequence: 1 givenname: Sophia surname: Zoungas fullname: Zoungas, Sophia organization: The authors' affiliations are listed in the Appendix – sequence: 2 givenname: John surname: Chalmers fullname: Chalmers, John organization: The authors' affiliations are listed in the Appendix – sequence: 3 givenname: Bruce surname: Neal fullname: Neal, Bruce organization: The authors' affiliations are listed in the Appendix – sequence: 4 givenname: Laurent surname: Billot fullname: Billot, Laurent organization: The authors' affiliations are listed in the Appendix – sequence: 5 givenname: Qiang surname: Li fullname: Li, Qiang organization: The authors' affiliations are listed in the Appendix – sequence: 6 givenname: Yoichiro surname: Hirakawa fullname: Hirakawa, Yoichiro organization: The authors' affiliations are listed in the Appendix – sequence: 7 givenname: Hisatomi surname: Arima fullname: Arima, Hisatomi organization: The authors' affiliations are listed in the Appendix – sequence: 8 givenname: Helen surname: Monaghan fullname: Monaghan, Helen organization: The authors' affiliations are listed in the Appendix – sequence: 9 givenname: Rohina surname: Joshi fullname: Joshi, Rohina organization: The authors' affiliations are listed in the Appendix – sequence: 10 givenname: Stephen surname: Colagiuri fullname: Colagiuri, Stephen organization: The authors' affiliations are listed in the Appendix – sequence: 11 givenname: Mark E surname: Cooper fullname: Cooper, Mark E organization: The authors' affiliations are listed in the Appendix – sequence: 12 givenname: Paul surname: Glasziou fullname: Glasziou, Paul organization: The authors' affiliations are listed in the Appendix – sequence: 13 givenname: Diederick surname: Grobbee fullname: Grobbee, Diederick organization: The authors' affiliations are listed in the Appendix – sequence: 14 givenname: Pavel surname: Hamet fullname: Hamet, Pavel organization: The authors' affiliations are listed in the Appendix – sequence: 15 givenname: Stephen surname: Harrap fullname: Harrap, Stephen organization: The authors' affiliations are listed in the Appendix – sequence: 16 givenname: Simon surname: Heller fullname: Heller, Simon organization: The authors' affiliations are listed in the Appendix – sequence: 17 givenname: Liu surname: Lisheng fullname: Lisheng, Liu organization: The authors' affiliations are listed in the Appendix – sequence: 18 givenname: Giuseppe surname: Mancia fullname: Mancia, Giuseppe organization: The authors' affiliations are listed in the Appendix – sequence: 19 givenname: Michel surname: Marre fullname: Marre, Michel organization: The authors' affiliations are listed in the Appendix – sequence: 20 givenname: David R surname: Matthews fullname: Matthews, David R organization: The authors' affiliations are listed in the Appendix – sequence: 21 givenname: Carl E surname: Mogensen fullname: Mogensen, Carl E organization: The authors' affiliations are listed in the Appendix – sequence: 22 givenname: Vlado surname: Perkovic fullname: Perkovic, Vlado organization: The authors' affiliations are listed in the Appendix – sequence: 23 givenname: Neil surname: Poulter fullname: Poulter, Neil organization: The authors' affiliations are listed in the Appendix – sequence: 24 givenname: Anthony surname: Rodgers fullname: Rodgers, Anthony organization: The authors' affiliations are listed in the Appendix – sequence: 25 givenname: Bryan surname: Williams fullname: Williams, Bryan organization: The authors' affiliations are listed in the Appendix – sequence: 26 givenname: Stephen surname: MacMahon fullname: MacMahon, Stephen organization: The authors' affiliations are listed in the Appendix – sequence: 27 givenname: Anushka surname: Patel fullname: Patel, Anushka organization: The authors' affiliations are listed in the Appendix – sequence: 28 givenname: Mark surname: Woodward fullname: Woodward, Mark organization: The authors' affiliations are listed in the Appendix |
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| ContentType | Journal Article |
| Contributor | Adderkin, A Chretien, P Kean, M Carreras, A Stack, P Calvert, D Hamet, P Baume, R Van Nierop, S Moses, R Heller, S Chalmers, J van Gaal, W Pape, A Russell, A Cooper, M E Hancock, S Nattrass, N Ma, L Y Pan, C Y Proietto, J Michitiuc, I Mogensen, C E Glasziou, P Matthews, D Poynten, A Armenis, M Davoren, P Billot, L Tang, R K Hay, L Zoungas, S Grobbee, D Kim, R Siddal, R Septer-Bijleveld, E Marre, M Zhao, X M Suiker, A Shekary, N England, M Williams, B Gough, J Woodward, M Neal, B Molenaar, E Darnell, D Guertin, M-R MacMahon, S Thiagarajah, S McIntyre, D Mancia, G Bhadresa, Y Jerums, G Monaghan, H Poulter, N Turner, F Bompoint, S Brouwer, B Rodgers, A Fulcher, G Naidu, B Joshi, R Colagiuri, S Caruana, M Jacklin, C Wang, W Guerrero, J Brugman Twigg, S Diaz-Guilas, S Gilbert, M Rayment, G Patel, A Thirunavukkarasu, N MacIsaac, R Webb, A Liu, L S Davis, T Sawyer, J Harrap, S Fernandez, M Wooninck, S Li, Q Wilson, A Park, M |
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| Copyright | Copyright © 2014 Massachusetts Medical Society. All rights reserved. 2015 INIST-CNRS |
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| DOI | 10.1056/NEJMoa1407963 |
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| References | Holman, RR, Paul, SK, Bethel, MA, Neil, HA, Matthews, DR (r003) 2008; 359 Schulz, KF, Grimes, DA (r008) 2005; 365 Holman, RR, Paul, SK, Bethel, MA, Matthews, DR, Neil, HA (r002) 2008; 359 Kostis, WJ, Cabrera, J, Messerli, FH (r013) 2014; 113 Brouwers, FP, Asselbergs, FW, Hillege, HL (r012) 2011; 161 Patel, A, MacMahon, S, Chalmers, J (r004) 2007; 370 Beckett, N, Peters, R, Tuomilehto, J (r011) 2012; 344 Nathan, DM, Cleary, PA, Backlund, JY (r001) 2005; 353 Hata, J, Arima, H, Zoungas, S (r014) 2013; 8 Patel, A, MacMahon, S, Chalmers, J (r005) 2008; 358 (r007) 2001; 44 Kostis, WJ, Thijs, L, Richart, T, Kostis, JB, Staessen, JA (r009) 2010; 56 Perkovic, V, Heerspink, HL, Chalmers, J (r006) 2013; 83 Appel, LJ, Wright, JT, Greene, T (r010) 2010; 363 r010 r011 r001 r012 r006 r007 r008 r009 r002 r013 r003 r014 r004 r005 25563072 - Semergen. 2015 May-Jun;41(4):228-9. doi: 10.1016/j.semerg.2014.11.005. |
| References_xml | – volume: 353 start-page: 2643 year: 2005 end-page: 2653 ident: r001 article-title: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. publication-title: N Engl J Med – volume: 370 start-page: 829 year: 2007 end-page: 840 ident: r004 article-title: Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. publication-title: Lancet – volume: 44 start-page: 1118 year: 2001 end-page: 1120 ident: r007 article-title: Study rationale and design of ADVANCE: action in diabetes and vascular disease -- preterax and diamicron MR controlled evaluation. publication-title: Diabetologia ;ADVANCE Management Committee – volume: 83 start-page: 517 year: 2013 end-page: 523 ident: r006 article-title: Intensive glucose control improves kidney outcomes in patients with type 2 diabetes. publication-title: Kidney Int – volume: 363 start-page: 918 year: 2010 end-page: 929 ident: r010 article-title: Intensive blood-pressure control in hypertensive chronic kidney disease. publication-title: N Engl J Med – volume: 113 start-page: 676 year: 2014 end-page: 681 ident: r013 article-title: Competing cardiovascular and noncardiovascular risks and longevity in the Systolic Hypertension in the Elderly Program. publication-title: Am J Cardiol – volume: 359 start-page: 1577 year: 2008 end-page: 1589 ident: r002 article-title: 10-Year follow-up of intensive glucose control in type 2 diabetes. publication-title: N Engl J Med – volume: 359 start-page: 1565 year: 2008 end-page: 1576 ident: r003 article-title: Long-term follow-up after tight control of blood pressure in type 2 diabetes. publication-title: N Engl J Med – volume: 365 start-page: 1591 year: 2005 end-page: 1595 ident: r008 article-title: Multiplicity in randomised trials I: endpoints and treatments. publication-title: Lancet – volume: 161 start-page: 1171 year: 2011 end-page: 1178 ident: r012 article-title: Long-term effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria: ten years of follow-up of Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT). publication-title: Am Heart J – volume: 358 start-page: 2560 year: 2008 end-page: 2572 ident: r005 article-title: Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. publication-title: N Engl J Med – volume: 8 start-page: e55807 year: 2013 end-page: e55807 ident: r014 article-title: Effects of the endpoint adjudication process on the results of a randomised controlled trial: the ADVANCE trial. publication-title: PLoS One – volume: 56 start-page: 1060 year: 2010 end-page: 1068 ident: r009 article-title: Persistence of mortality reduction after the end of randomized therapy in clinical trials of blood pressure-lowering medications. publication-title: Hypertension – volume: 344 start-page: d7541 year: 2012 end-page: d7541 ident: r011 article-title: Immediate and late benefits of treating very elderly people with hypertension: results from active treatment extension to Hypertension in the Very Elderly randomised controlled trial. publication-title: BMJ – ident: r011 doi: 10.1136/bmj.d7541 – ident: r003 doi: 10.1056/NEJMoa0806359 – ident: r014 doi: 10.1371/journal.pone.0055807 – ident: r001 doi: 10.1056/NEJMoa052187 – ident: r002 doi: 10.1056/NEJMoa0806470 – ident: r004 doi: 10.1016/S0140-6736(07)61303-8 – ident: r006 doi: 10.1038/ki.2012.401 – ident: r008 doi: 10.1016/S0140-6736(05)66461-6 – ident: r013 doi: 10.1016/j.amjcard.2013.11.013 – ident: r007 doi: 10.1007/s001250100612 – ident: r012 doi: 10.1016/j.ahj.2011.03.028 – ident: r005 doi: 10.1056/NEJMicm066227 – ident: r010 doi: 10.1056/NEJMoa0910975 – ident: r009 doi: 10.1161/HYPERTENSIONAHA.110.160291 – reference: 25563072 - Semergen. 2015 May-Jun;41(4):228-9. doi: 10.1016/j.semerg.2014.11.005. |
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