The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

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

ISSN: 1475-2840