International Journal of Cardiology
Volume 143, Issue 2 , Pages 135-140 , 20 August 2010

Cardiac safety profile of rosiglitazone: A comprehensive meta-analysis of randomized clinical trials

  • Edoardo Mannucci

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • Corresponding Author InformationCorresponding author. Department of Cardiovascular Medicine, Section of Geriatric Cardiology, Azienda Ospedaliero-Universitaria Careggi Via delle Oblate 4, 50141 Florence, Italy. Tel.: +39 055 7949598; fax: +39 055 7949660.
    • ,
  • Matteo Monami

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • ,
  • Mauro Di Bari

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • ,
  • Caterina Lamanna

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • ,
  • Francesca Gori

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • ,
  • Gian Franco Gensini

      Affiliations

    • Unit of Geriatric Medicine, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence
    • ,
  • Niccolò Marchionni

      Affiliations

    • Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence

Received 2 August 2008 ,Revised 20 November 2008 ,Accepted 29 January 2009.

References 

  1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457–2471
  2. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298:1189–1195
  3. Diamond GA, Kaul S. Rosiglitazone and cardiovascular risk. N Engl J Med. 2007;357:938–939
  4. Shuster JJ, Jones LS, Salmon DA. Fixed vs random effects meta-analysis in rare event studies: the rosiglitazone link with myocardial infarction and cardiac death. Stat Med. 2007;26:4375–4385
  5. Mannucci E, Monami M, Marchionni N. Rosiglitazone and cardiovascular risk. N Engl J Med. 2007;357:938–940
  6. Rosen CJ. The rosiglitazone story—lessons from an FDA Advisory Committee meeting. N Engl J Med. 2007;357:844–846
  7. www.fda.gov 2007.
  8. http://ctr.gsk.co.uk/welcome.asp 2007.
  9. Gerstein HC, Yusuf S, Bosch J, et al. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006;368:1096–1105
  10. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–188
  11. Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007;261:293–305
  12. van Doorn M, Kemme M, Ouwens M, et al. Evaluation of proinflammatory cytokines and inflammation markers as biomarkers for the action of thiazolidinediones in type 2 diabetes mellitus patients and healthy volunteers. Br J Clin Pharmacol. 2006;62:391–402
  13. Schindler C, Ferrario C, Jatzke C, et al. Characterization of vascular reactivity in dorsal hand veins after oral rosiglitazone treatment in healthy subjects. Int J Clin Pharmacol Ther. 2008;46:30–39
  14. Rahman S, Ismail AA, Ismail SB, Naing NN, bdul Rahman AR. Effect of rosiglitazone/ramipril on preclinical vasculopathy in newly diagnosed, untreated diabetes and IGT patients: 1-year randomised, double-blind, placebo-controlled study. Eur J Clin Pharmacol. 2007;63:733–741
  15. Evans JM, Donnelly LA, Emslie-Smith AM, Alessi DR, Morris AD. Metformin and reduced risk of cancer in diabetic patients. BMJ. 2005;330:1304–1305
  16. Monami M, Luzzi C, Lamanna C, et al. Three-year mortality in diabetic patients treated with different combinations of insulin secretagogues and metformin. Diabetes Metab Res Rev. 2006;22:477–482
  17. Monami M, Balzi D, Lamanna C, et al. Are sulphonylureas all the same? A cohort study on cardiovascular and cancer-related mortality. Diabetes Metab Res Rev. 2007;23:479–484
  18. Thisted H, Johnsen SP, Rungby J. Sulfonylureas and the risk of myocardial infarction. Metabolism. 2006;55:S16–S19
  19. Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet. 2007;370:1129–1136
  20. Kahn SE, Haffner SM, Heise MA, et al. ADOPT Study Group Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427–2443
  21. Home PD, Pocock SJ, Beck-Nielsen H, et al. RECORD Study Group Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med. 2007;357:28–38
  22. Coats AJ. Ethical authorship and publishing. Int J Cardiol. 2009;131:149–150

PII: S0167-5273(09)00133-8

doi: 10.1016/j.ijcard.2009.01.064

International Journal of Cardiology
Volume 143, Issue 2 , Pages 135-140 , 20 August 2010

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