Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes (AFORRD)

• Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
• LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:
• Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)

• Proportion of patients who achieve directly measured LDL levels <2.6 mmol/L (<100 mg/dl)
• Primary objective (assessed at 16 weeks) for atorvastatin:
• Primary objective (assessed at 16 weeks) for Omega-3 fatty acid: Proportion of patients
• Proportion of pa

• Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.
• Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.

• Atorvastatin: Proportion (%) of patients who achieve directly measured LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.
• Omega-3 fatty acids: Proportion

The AFORRD trial is asking three important questions:

What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?

Inclusion Criteria:

• They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
• Are not known to have had a cardiovascular event

Exclusion Criteria:

• They are taking prescribed lipid lowering therapy
• Have triglycerides > or = 8.0 mmol/L