| Trial name or title | Atorvastatin in Factorial with Omega‐3 fatty acid Risk Reduction in Diabetes (AFORRD) |
| Methods | RCT |
| Participants | Patients with type 2 diabetes with no known CVD and not taking lipid‐lowering therapy, adults (> 18 years) N: intervention 397, control 403 (analysed intervention 371, control 361) |
| Interventions | Each for 12 months: Arm 1: atorvastatin (Lipitor 20 mg/d) and olive oil placebo (2 g/d) Arm 2: omega‐3 (Omacor 2 g/d: 46% EPA, 38% DHA) and placebo tablets for atorvastatin Arm 3: atorvastatin (Lipitor 20 mg/d) and Omega‐3 (Omacor 2 g/d: 46% EPA, 38% DHA) Arm 4: placebo tablets for atorvastatin and olive oil placebo (2 g/d) |
| Outcomes | Primary: lipid profiles Secondary: phytosterol changes, HbA1c, estimated CVD risk using the UK Prospective Diabetes Study risk engine |
| Starting date | Registered on trials registry: 4 April 2004 Study start date: 1 November 2004 Estimated study completion date: 31 July 2006 |
| Contact information | Rury Holman, Oxford Centre for Diabetes |
| Notes | ISRCTN76737502 Rury Holman contacted in 2016: confirmed results are not yet published, but planned |
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