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Two-Year Statin Therapy Does Not Alter the Progression of Intima- Media Thickness in Patients With Type 2 Diabetes Without Manifest Cardiovascular Disease: Response to Beishuizen Et Al.

Posted on: Sunday, 8 May 2005, 03:00 CDT

COMMENTS AND RESPONSES

We read the recent study by Beishuizen et al. (1), which claims that statin treatment had no effect on intima-media thickness (IMT) in diabetic subjects. We agree that contrary to the suggestions made in the Third Report of the Adult Treatment Panel of the National Cholesterol Education Program (2), diabetes is not always a cardiovascular disease equivalent in terms of cardiovascular event risk and that this risk is more related to the individual level of other cardiovascular risk factors.

However, it is hard to conclude that statins are ineffective in reducing IMT in diabetics subjects on the basis of the reported data because of some relevant methodological problems. The main problem is the change in statins tested during the study. In fact, until now, no trial has demonstrated that statin switch is as efficacious as continuous treatment with a single statin on vascular protection. Then, the LDL cholesterol-lowering effect of 0.4 mg cerivastatin is not equal to that of 20 mg simvastatin. The authors admit that mean LDL cholesterolemia significantly increased after statin switch. At the end of the study, the placebo group was smaller than estimated to be sufficient to detect significant differences between groups. Some randomization problems are also foreseeable by the 87% relative risk reduction in cardiovascular disease rates and by the 100% relative risk reduction in coronary artery disease rates in statin- treated patients after only 24 months of treatment, which is much higher than that observed in the diabetic group of the HPS (Heart Protection Study) (3) or in CARDS (Collaborative Atorvastatin Diabetes Study) (4) (or in any other large statin clinical trial). Moreover, it is not correct to compare the observed results with those obtained with bezafibrate, which is not an antihypercholesterolemic drug and has a completely different pharmacodynamic profile.

In our opinion, on the basis of the reported data, Beishuizen et al. should have concluded that 15.4 months of treatment with 0.4 mg cerivastatin (not generically "statins") is not efficacious in reducing IMT progression in type 2 diabetic subjects.

References

1. Beishuizen ED, Van de Ree MA, Jukema JW, Tamsma JT, van der Vijver JCM, Meinders AE, Putter H, Huisman MV: Two-year statin therapy does not alter the progression of intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease. Diabetes Care 27:2887-2892, 2004

2. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 285: 2486-2497, 2001

3. Collins R, Armitage J, Parish S, Sleigh P, Peto R: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5,963 people with diabetes: a randomised placebo-controlled trial. Lancet 361: 2005-2016, 2003

4. Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH: Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 364:685-696, 2004

ARRIGO F.G. CICERO, MD,1

ANTONIO V. GADDI, MD, PHD1

GIUSEPPE DEROSA, MD, PHD2

From the 1"G Descovich" Atherosclerosis and Metabolic Diseases Research Center, University of Bologna, Bologna, Italy; and the Internal Medicine and Therapeutics Department, University of Pavia, Pavia, Italy.

Address correspondence to Arrigo F.G. Cicero, MD, "G Descovich" Atherosclerosis and Metabolic Diseases Research Center, University of Bologna, Via Massarenti, 9, 40138, Bologna, Italy. E-mail: afgcicero@cardionet.it.

A.F.G.C. has received honoraria from Sankyo Pharma and Bayer. A.V.G. has received honoraria from Sankyo Pharma, Bayer, MSD, Novartis, Pfizer, Fournier Pharma, and Chiesi Farmaceutici and has received research support from MSD, Novartis, and Astra Zeneca. G.D. has received honoraria from Guidotti, Menarini, Aventis, Roche, MSD, Merck SA, and Fournier Pharma.

2005 by the American Diabetes Association.

Copyright American Diabetes Association May 2005

Source: Diabetes Care

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