Cardiovascular Outcomes in Trials of Oral Diabetes Medications - A Systematic Review

被引:243
作者
Selvin, Elizabeth [1 ]
Bolen, Shari [2 ]
Yeh, Hsin-Chieh [2 ]
Wiley, Ciystal [2 ]
Wilson, Lisa M. [2 ,3 ]
Marinopoulos, Spyridon S. [2 ]
Feldman, Leonard [2 ]
Vassy, Jason [4 ]
Wilson, Renee [2 ,3 ]
Bass, Eric B. [2 ,3 ]
Brancati, Frederick L. [2 ]
机构
[1] Johns Hopkins Med Inst, Dept Epidemiol, Welch Ctr Prevent Epidemiol & Clin Res, Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD 21287 USA
[2] Johns Hopkins Univ, Sch Med, Div Gen Internal Med, Dept Med, Baltimore, MD 21218 USA
[3] Johns Hopkins Univ, John Hopkins Evidence Based Practice Ctr, Baltimore, MD 21218 USA
[4] Washington Univ, Sch Med, Dept Med, St Louis, MO 63110 USA
基金
美国国家卫生研究院;
关键词
D O I
10.1001/archinte.168.19.2070
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: A wide variety of oral diabetes medications are currently available for the treatment of type 2 diabetes mellitus, but it is unclear how these agents compare with respect to long-term cardiovascular risk. Our objective was to systematically examine the peer-reviewed literature on the cardiovascular risk associated with oral agents (second-generation sulfonylureas, biguanides, thiazolidinediones, and meglitinides) for treating adults with type 2 diabetes. Methods: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials, from inception through January 1.9, 2006. Forty publications of controlled trials that reported information on cardiovascular events (primarily myocardial infarction and stroke) met our inclusion criteria. Using standardized protocols, 2 reviewers serially abstracted data from each article. Trials were first described qualitatively. For comparisons with 4 or more independent trials, results were pooled quantitatively using the Mantel-Haenszel method. Results are presented as odds ratios (ORs) and corresponding 95% confidence intervals (CIS). Results: Treatment with metformin hydrochloride was associated with a decreased risk of cardiovascular mortality (pooled OR, 0.74; 95% CI, 0.62-0.89) compared with any other oral diabetes agent or placebo; the results for cardiovascular morbidity and all-cause mortality were similar but not statistically significant. No other significant associations of oral diabetes agents with fatal or nonfatal cardiovascular disease or all-cause mortality were observed. When compared with any other agent or placebo, rosightazone was the only diabetes agent associated with an increased risk of cardiovascular morbidity or mortality, but this result was not statistically significant (OR, 1.68; 95% CI, 0.92-3.06). Conclusions: Meta-analysis suggested that, compared with other oral diabetes agents and placebo, metformin was moderately protective and rosiglitazone possibly harmful, but lack of power prohibited firmer conclusions. Larger, long-term studies taken to hard end points and better reporting of cardiovascular events in short-term studies will be required to draw firm conclusions about major clinical benefits and risks related to oral diabetes agents.
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收藏
页码:2070 / 2080
页数:11
相关论文
共 68 条
[1]   The revised CONSORT statement for reporting randomized trials: Explanation and elaboration [J].
Altman, DG ;
Schulz, KF ;
Moher, D ;
Egger, M ;
Davidoff, F ;
Elbourne, D ;
Gotzsche, PC ;
Lang, T .
ANNALS OF INTERNAL MEDICINE, 2001, 134 (08) :663-694
[2]   Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes - A 6-month randomized placebo-controlled dose-response study [J].
Aronoff, S ;
Rosenblatt, S ;
Braithwaite, S ;
Egan, JW ;
Mathisen, AL ;
Schneider, RL .
DIABETES CARE, 2000, 23 (11) :1605-1611
[3]   Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes mellitus: A 24-week, multicenter, randomized, double-blind, parallel-group study [J].
Bailey, CJ ;
Bagdonas, A ;
Rubes, J ;
McMorn, SO ;
Donaldson, J ;
Biswas, N ;
Stewart, MW .
CLINICAL THERAPEUTICS, 2005, 27 (10) :1548-1561
[4]   Comparison of uptitration of gliclazide with the addition of rosiglitazone to gliclazide in patients with type 2 diabetes inadequately controlled on half-maximal doses of a sulphonylurea [J].
Baksi, A ;
James, RE ;
Zhou, B ;
Nolan, JJ .
ACTA DIABETOLOGICA, 2004, 41 (02) :63-69
[5]   Rosiglitazone in Type 2 diabetes mellitus: an evaluation in British Indo-Asian patients [J].
Barnett, AH ;
Grant, PJ ;
Hitman, GA ;
Mather, H ;
Pawa, M ;
Robertson, L ;
Trelfa, A .
DIABETIC MEDICINE, 2003, 20 (05) :387-393
[6]   Improving the quality of reporting of randomized controlled trials - The CONSORT statement [J].
Begg, C ;
Cho, M ;
Eastwood, S ;
Horton, R ;
Moher, D ;
Olkin, I ;
Pitkin, R ;
Rennie, D ;
Schulz, KF ;
Simel, D ;
Stroup, DF .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1996, 276 (08) :637-639
[7]  
BOLEN S, 2007, COMP EFFECTIVENESS R, V8
[8]   Systematic review: Comparative effectiveness and safety of oral medications for type 2 diabetes Mellitus [J].
Bolen, Shari ;
Feldman, Leonard ;
Vassy, Jason ;
Wilson, Lisa ;
Yeh, Hsin-Chieh ;
Marinopoulos, Spyriclon ;
Wiley, Crystal ;
Selvin, Elizabeth ;
Wilson, Renee ;
Bass, Eric B. ;
Brancati, Frederick L. .
ANNALS OF INTERNAL MEDICINE, 2007, 147 (06) :386-399
[9]  
CARLSON RF, 1993, CLIN THER, V15, P788
[10]   Preventative effects of rosiglitazone on restenosis after coronary stent implantation in patients with type 2 diabetes [J].
Choi, D ;
Kim, SK ;
Choi, SH ;
Ko, YG ;
Ahn, CW ;
Jang, YS ;
Lim, SK ;
Lee, HC ;
Cha, BS .
DIABETES CARE, 2004, 27 (11) :2654-2660