|
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 |
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| 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 |
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