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A torvastatin in F actorial with O mega-3 fatty acid R isk R eduction in D iabetes

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…in an academic collaboration with. A torvastatin in F actorial with O mega-3 fatty acid R isk R eduction in D iabetes. Collaborative academic and pharmaceutical study F unded by Pfizer, with data owned, analysed and reported by the University of Oxford Diabetes Trials Unit (DTU)

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Presentation Transcript
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…in an academic collaboration with

Atorvastatin in Factorial withOmega-3 fatty acid RiskReduction in Diabetes

trial design
Collaborative academic and pharmaceutical study

Funded by Pfizer, with data owned, analysed and reported by the University of Oxford Diabetes Trials Unit (DTU)

Multi-centre primary prevention trial in 1,000 patients with type 2 diabetes

Double-blind, placebo-controlled

2 x 2 factorial randomisation to

Atorvastatin (Lipitor 20 mg/day)

Omega 3 PUFA (Omacor 2g/day)

70 UK clinical centres, one year follow-up

Trial Design
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Trial Organisation

Steering Committee

Overall responsibility for scientific, professionaland operational conduct of the study

Diabetes Trials Unit

Study Design and Protocol Dev.

Co-ordinating Centre

Investigator agreements

Ethical/regulatory approval

Data collection and management

Protocol/clinical queries

Statistical analysis/publication

Pfizer UK

Protocol development

Regulatory aspects

Study medication

On-site Monitoring

SAE reporting

70 Clinical Centres

DTU CentralLaboratory

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To determine the:

Range of estimated CHD risk levels typically seen in people with type 2 diabetes in UK general practice

Proportion whose estimated ten-year CHD risk can be reduced below 15% with a 20 mg of atorvastatin or 1.8 g omega-3 PUFA/day

Degree to which atorvastatin and omega-3 PUFA in combination have additive effects

Extent to which therapy adherence can be enhanced using a simple behavioural intervention

Aims
inclusion criteria
Aged 18 years and above

Have had type 2 diabetes for at least 3 months

Not known to have had a cardiovascular event

Have provided written informed consent

Inclusion Criteria
exclusion criteria
Taking prescribed lipid lowering therapy

Triglycerides ≥8.0 mmol/L

Have specific contraindications toatorvastatin or omega-3 PUFA

Have participated in a clinical trialwithin the last 3 months

Are pregnant or lactating females

Exclusion Criteria
2 x 2 factorial randomisation
2 x 2 Factorial Randomisation

Atorvastatin (20 mg )

AtorvastatinPlacebo 500

Omega-3 Omega-3Omega-3

(250)(250)

AtorvastatinPlacebo500

Placebo Placebo Placebo

(250)(250)

500 500 1,000 Atorvastatin Placebo patientsin total

Omega-3PUFA (1.8 g)

primary objectives
Primary Objectives
  • Proportion of subjects whose LDL levels are<2.6 mmol/L at four months
  • Proportion of subjects whose triglycerides are<1.5 mmol/L at four months
secondary objectives
Secondary Objectives
  • Proportion of subjects with LDL levels<2.6 mmol/L at one year
  • Proportion of subjects with triglycerides<1.5 mmol/L at one year
  • Proportion (%) of subjects with estimated ten-year CHD risk <15% at 16 weeks and one year
  • Study medication adherenceat 16 weeks and at one year
  • Health economic assessmentat 16 weeks and at one year
visit schedule
Visit 1: week -2 Recruitment

Visit 2: week 0 Randomisation

Visit 3: week 16 Four month evaluation

Visit 4: week 18 Additional medication* Adherence study

Visit 5: week 32 Routine Follow up

Visit 6: week 52 One year evaluation End of study

* Patients whose estimated CHD risk remains greater than 20% at four months will receive an additional tablet containing 20 mg atorvastatin, whilst the remainder will receive an additional placebo tablet, in double-blind fashion.

Visit Schedule
trial schedule
Trial Schedule
  • Study will commence in 2004
  • One year recruitment in 70 UK practices
  • One year follow-up for all subjects
  • Results expected 2006
  • Contact:
    • Email: [email protected]
    • Phone: 01865 857 246
    • Fax: 01865 857 256
    • Web site: www.dtu.ox.ac.uk/aforrd
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