Event Rates in Trials of Patients With Type 2 Diabetes
- Anushka Patel, MD, PhD apatel@george.org.au;
- Bruce Neal, MD, PhD;
- John Chalmers, MD, PhDThe George Institute for International HealthUniversity of SydneySydney, Australia
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ALBUMINURIA
- BLOOD GLUCOSE
- CLINICAL TRIALS AS TOPIC
- DATA INTERPRETATION, STATISTICAL
- DIABETES MELLITUS, TYPE 2
- INCIDENCE
- MYOCARDIAL INFARCTION
- OUTCOME ASSESSMENT (HEALTH CARE)
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 …
