No Effect of Statin Therapy on Silent Myocardial Ischemia in Patients With Type 2 Diabetes Without Manifest Cardiovascular Disease

  1. Edith D. Beishuizen, MD1,
  2. J. Wouter Jukema, MD, PHD2,
  3. Jouke T. Tamsma, MD, PHD1,
  4. Marcel A. van de Ree, MD, PHD3,
  5. J. Carel M. van der Vijver, MD, PHD4,
  6. Hein Putter, PHD5,
  7. Arie C. Maan, PHD2,
  8. A. Edo Meinders, MD, PHD1 and
  9. Menno V. Huisman, MD, PHD1
  1. 1Department of General Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands
  2. 2Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
  3. 3Department of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands
  4. 4Department of Internal Medicine, Leyenburg Hospital, the Hague, the Netherlands
  5. 5Department of Biostatistics, Leiden University Medical Center, Leiden, the Netherlands
  1. Address correspondence and reprint requests to Edith D. Beishuizen, Department of General Internal Medicine, C1-R41, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, Netherlands. E-mail: e.d.beishuizen{at}lumc.nl

Abstract

OBJECTIVE—Coronary artery disease is the most important cause of mortality in patients with type 2 diabetes. We aimed to determine the prevalence of silent myocardial ischemia (SMI) and the effect of statin therapy on SMI in type 2 diabetic patients without manifest cardiovascular disease.

RESEARCH DESIGN AND METHODS—A randomized, placebo-controlled, double-blind trial was performed in 250 patients with type 2 diabetes without manifest cardiovascular disease. Patients were given either 0.4 mg cerivastatin or placebo daily. In August 2001, when cerivastatin was withdrawn from the market, cerivastatin 0.4 mg was replaced by 20 mg simvastatin without deblinding the study. The primary end point was the change in ischemic episodes, duration, and burden as measured by 48-h ambulatory electrocardiography (AECG) over 2 years.

RESULTS—At baseline, 47 of 233 (20%) evaluable ambulatory electrocardiograms showed evidence of ischemia. After 2 years, there was a trend toward more ischemia in both treatment groups, without significant differences between the changes in ischemic parameters (episodes P = 0.498; duration P = 0.697; burden P = 0.798) in the two treatment groups. Cardiovascular events occurred in 12 patients in the placebo group and in two patients in the statin group (P = 0.006). There was no relationship between these cardiovascular events and the presence of SMI at baseline.

CONCLUSIONS—SMI occurred in 20% of type 2 diabetes patients without manifest cardiovascular disease. There was no effect from 2 years of statin therapy on SMI. In contrast, we observed a significantly lower cardiovascular event rate on statin therapy. AECG may not be a proper tool for risk stratification in patients with type 2 diabetes.

Footnotes

  • A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    • Accepted April 5, 2005.
    • Received December 23, 2004.
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  1. doi: 10.2337/diacare.28.7.1675 Diabetes Care July 2005 vol. 28 no. 7 1675-1679
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