Skip to main content

Advertisement

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

From: 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]

   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%
  1. * 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.
  2. † Expanded endpoint 'total CVD events' comprises cardiovascular death, nonfatal myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke and carotid revascularization.
  3. CVD = cardiovascular, CHD = coronary heart disease