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Event Rates in Trials of Patients With Type 2 Diabetes

Anushka Patel, MD, PhD; Bruce Neal, MD, PhD; John Chalmers, MD, PhD
JAMA. 2010;303(8):732-733. doi:10.1001/jama.2010.137
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To the Editor: In their Commentary, Drs Psaty and Prentice1 raised concerns that variation in event rates in recent trials of patients with type 2 diabetes may in part reflect incomplete ascertainment of events in certain trials and, by implication, inadequate quality of these studies. However, the authors made an error in their reporting of the ADVANCE study.2

The Table reported fatal and nonfatal myocardial infarction (MI) rates of 5.5 per 1000 person-years in each of the groups of patients randomized to intensive and less-intensive glucose control. However, the proportion of individuals with a “major coronary event” (nonfatal MI and death due to coronary heart disease) was 5.6% in the intensive control group and 6.1% in the standard control group.2 Over a median of 5 years of follow-up, this represents an event rate of 11.2 and 12.2 per 1000 person-years, respectively. More recent collaborative analyses by investigators representing the ACCORD, ADVANCE, and VADT trials confirmed similar event rates across these studies, using extracted data on fatal or nonfatal MI.3

AUTHOR INFORMATION

Financial Disclosures: Dr Patel reported receiving lecture fees from Servier, Pfizer, and Abbott and receiving grant support from Pfizer, Servier, Sanofi-Aventis, and the National Health and Medical Research Council of Australia. Dr Neal reported receiving lecture fees from Servier and GlaxoSmithKline and grant support from Pfizer and the National Health and Medical Research Council of Australia. Dr Chalmers reported being a member of an advisory board for Servier; receiving lecture fees from Servier, Pfizer, and Daiichi; and receiving grant support from Servier and the National Health and Medical Research Council of Australia.

REFERENCES

Psaty BM, Prentice RL. Variation in event rates in trials of patients with type 2 diabetes.  JAMA. 2009;302(15):1698-1700
PubMedCrossRef
Patel A, MacMahon S, Chalmers J,  et al; ADVANCE Collaborative Group.  Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.  N Engl J Med. 2008;358(24):2560-2572
PubMedCrossRef
Turnbull FM, Abraira C, Anderson RJ,  et al.  Intensive glucose control and macrovascular outcomes in type 2 diabetes.  Diabetologia. 2009;52(11):2288-2298
PubMedCrossRef

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Psaty BM, Prentice RL. Variation in event rates in trials of patients with type 2 diabetes.  JAMA. 2009;302(15):1698-1700
PubMedCrossRef
Patel A, MacMahon S, Chalmers J,  et al; ADVANCE Collaborative Group.  Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.  N Engl J Med. 2008;358(24):2560-2572
PubMedCrossRef
Turnbull FM, Abraira C, Anderson RJ,  et al.  Intensive glucose control and macrovascular outcomes in type 2 diabetes.  Diabetologia. 2009;52(11):2288-2298
PubMedCrossRef
February 24, 2010
David Preiss, MRCP; Naveed Sattar, PhD; John J. McMurray, MD
JAMA. 2010;303(8):732-733.
February 24, 2010
Bruce M. Psaty, MD, PhD; Ross L. Prentice, PhD
JAMA. 2010;303(8):732-733.
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