Table 3

Predicted numbers of events and corresponding power in the FIELD study among 9795 people with diabetes, based on a median follow-up of 5 years


Allocated treatment
Power to detect effect at 2P < 0.05*
Risk category
Fenofibrate
Placebo


Primary prevention (7683 with no prior CVD)
     Total CVD events†
298
385
93%
Secondary prevention (2112 with prior CVD)
     Total CVD events
229
288
83%
Men (6139)
     Total CVD events
392
503
98%
Women (3656)
     Total CVD events
133
171
60%
All patients (9795)
     Total CVD events
525
675
99%
     Total CHD events
219
281
80%

* Calculations assume a reduction in risk for each endpoint of around 27% with full compliance, resulting in an observed risk reduction of approximately 22% on intention-to-treat analysis; the risk in the prior CVD group is 2.75 times that for patients with no prior CVD, the risk in men is 1.75 times that in women.

† Expanded endpoint 'total CVD events' comprises cardiovascular death, nonfatal myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke and carotid revascularization.

CVD = cardiovascular, CHD = coronary heart disease

The FIELD Study Investigators Cardiovascular Diabetology 2004 3:9   doi:10.1186/1475-2840-3-9