Is HbA1c a valid surrogate for macrovascular and microvascular complications in type 2 diabetes?

被引:36
作者
Bejan-Angoulvant, T. [1 ,2 ,3 ]
Cornu, C. [4 ,5 ,6 ,7 ]
Archambault, P. [8 ]
Tudrej, B. [8 ]
Audier, P. [8 ]
Brabant, Y. [8 ]
Gueyffier, F. [4 ,5 ,6 ,7 ]
Boussageon, R. [8 ]
机构
[1] CHRU Tours, Serv Pharmacol, F-37000 Tours, France
[2] Univ Tours, CNRS, UMR 7292, F-37000 Tours, France
[3] Univ Tours, GICC, F-37000 Tours, France
[4] INSERM, Clin Invest Ctr CIC1407, F-69000 Lyon, France
[5] CHU Lyon, Serv Pharmacol Clin & Essais Therapeut, F-69000 Lyon, France
[6] CNRS, UMR5558, F-69000 Lyon, France
[7] Univ Lyon 1, Fac Med Laennec, F-69376 Lyon 08, France
[8] Univ Poitiers, Dept Med Gen, F-86000 Poitiers, France
关键词
Cardiovascular diseases; Evidence-based medicine; Glycosylated haemoglobin; Hypoglycaemic agents; Meta-regression; Type 2 diabetes mellitus; CARDIOVASCULAR OUTCOMES; GLUCOSE CONTROL; CLINICAL-TRIALS; BLOOD-PRESSURE; END-POINTS; MELLITUS; METAANALYSIS; PREVENTION; DISEASE; ASSOCIATION;
D O I
10.1016/j.diabet.2015.04.001
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Recent recommendations regarding type 2 diabetes (T2D) patients' treatments have focused on personalizing glycosylated haemoglobin (HbA(1c)) targets. Because the relationship between HbA(1c) and diabetes prognosis has been established from large prospective cohorts, it is valid to question the extrapolation from population-based risk reduction estimations to individual predictions. Our study aimed to investigate the relationship between HbA(1c) reductions and clinical outcomes in randomized controlled trials (RCTs), using a meta-regression approach. Included were RCTs comparing intensive vs. standard glucose-lowering regimens for cardiovascular events and microvascular complications in T2D patients. Eight studies (33,396 patients) providing data for HbA(1c) reductions were found. In our meta-regression, HbA(1c) decreases were not significantly associated with reductions in our main study outcomes: total and cardiovascular mortality. They were also not associated with any of the secondary endpoints, including myocardial infarction, stroke and severe hypoglycaemia. Sensitivity analysis showed a significant correlation only between HbA(1c)-lowering and severe hypoglycaemia (P = 0.014). Meta-regression analysis could find no significant association between HbA(1c)-lowering and a decrease in clinical outcomes, thereby questioning the use of HbA(1c) as a surrogate outcome for T2D-related complications. Thus, RCTs vs. placebo are urgently required to evaluate the risk benefit ratios of therapeutic strategies beyond HbA(1c) control in T2D patients. (C) 2015 Elsevier Masson SAS. All rights reserved.
引用
收藏
页码:195 / 201
页数:7
相关论文
共 50 条
[11]   Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial [J].
Colhoun, HM ;
Betteridge, DJ ;
Durrington, PN ;
Hitman, GA ;
Neil, HAW ;
Livingstone, SJ ;
Thomason, MJ ;
Mackness, MI ;
Charlton-Menys, V ;
Fuller, JH .
LANCET, 2004, 364 (9435) :685-696
[12]   A randomized, placebo-controlled trial assessing the effects of rosiglitazone on echocardiographic function and cardiac status in type 2 diabetic patients with New York Heart Association functional class I or II heart failure [J].
Dargie, Henry J. ;
Hildebrandt, Per R. ;
Riegger, Guenter A. J. ;
McMurray, John J. V. ;
McMorn, Stephen O. ;
Roberts, Jeremy N. ;
Zambanini, Andrew ;
Wilding, John P. H. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2007, 49 (16) :1696-1704
[13]   Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events):: a randomised controlled trial [J].
Dormandy, JA ;
Charbonnel, B ;
Eckland, DJA ;
Erdmann, E ;
Massi-Benedetti, M ;
Kmoules, IK ;
Skene, AM ;
Tan, MH ;
Lefébvre, PJ ;
Murray, GD ;
Standl, E ;
Wilcox, RG ;
Wlhelmsen, L ;
Betteridge, J ;
Birkeland, K ;
Golay, A ;
Heine, RJ ;
Korányi, L ;
Laakso, M ;
Mokán, M ;
Norkus, A ;
Pirags, V ;
Podar, T ;
Scheen, A ;
Scherbaum, W ;
Schernthaner, G ;
Schmitz, O ;
Skrha, J ;
Smith, U ;
Taton, J .
LANCET, 2005, 366 (9493) :1279-1289
[14]   Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes [J].
Duckworth, William ;
Abraira, Carlos ;
Moritz, Thomas ;
Reda, Domenic ;
Emanuele, Nicholas ;
Reaven, Peter D. ;
Zieve, Franklin J. ;
Marks, Jennifer ;
Davis, Stephen N. ;
Hayward, Rodney ;
Warren, Stuart R. ;
Goldman, Steven ;
McCarren, Madeline ;
Vitek, Mary Ellen ;
Henderson, William G. ;
Huang, Grant D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (02) :129-U62
[15]  
Gerstein HC, 2000, LANCET, V355, P253
[16]  
Gerstein HC, 2008, NEW ENGL J MED, V358, P2545, DOI 10.1056/NEJMoa0802743
[17]   Glucose Lowering to Control Macrovascular Disease in Type 2 Diabetes Treating the Wrong Surrogate End Point? [J].
Goodarzi, Mark O. ;
Psaty, Bruce M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (17) :2051-2053
[18]   Effect of antihypertensive drug treatment on cardiovascular outcomes in women and men - A meta-analysis of individual patient data from randomized, controlled trials [J].
Gueyffier, F ;
Boutitie, F ;
Boissel, JP ;
Pocock, S ;
Coope, J ;
Cutler, J ;
Ekbom, T ;
Fagard, R ;
Friedman, L ;
Perry, M ;
Prineas, R ;
Schron, E .
ANNALS OF INTERNAL MEDICINE, 1997, 126 (10) :761-+
[19]   What role for intermediate outcomes once cardiovascular prevention is achieved? [J].
Gueyffier, F .
THERAPIE, 2003, 58 (01) :31-36
[20]   Comparison of metformin and insulin versus insulin alone for type 2 diabetes: systematic review of randomised clinical trials with meta-analyses and trial sequential analyses [J].
Hemmingsen, Bianca ;
Lundby, Louise ;
Wetterslev, Jorn ;
Vaag, Allan ;
Gluud, Christian ;
Lund, Soren S. ;
Almdal, Thomas .
BMJ-BRITISH MEDICAL JOURNAL, 2012, 344