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Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes …in an academic collaboration with
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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
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Steering Committee Overall responsibility for scientific, professional and 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 DTU Central Laboratory 70 Clinical Centres Trial Organisation
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Aims 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
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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
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Exclusion Criteria Taking prescribed lipid lowering therapy Triglycerides ≥8.0 mmol/L Have specific contraindications to atorvastatin or omega-3 PUFA Have participated in a clinical trial within the last 3 months Are pregnant or lactating females
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AtorvastatinPlacebo 500 Omega-3 Omega-3 Omega-3(250) Atorvastatin Placebo 500 Placebo Placebo Placebo(250) 5005001,000 Atorvastatin Placebopatients in total Atorvastatin (20 mg ) Omega-3 PUFA (1.8 g) 2 x 2 Factorial Randomisation
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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
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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 adherence at 16 weeks and at one year Health economic assessment at 16 weeks and at one year
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Visit Schedule Visit 1: week-2Recruitment Visit 2: week0Randomisation Visit 3: week16Four month evaluation Visit 4: week18Additional medication* Adherence study Visit 5: week32Routine Follow up Visit 6: week52One 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.
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Study will commence in 2004 One year recruitment in 70 UK practices One year follow-up for all subjects Results expected 2006 Contact: Email: aforrd@dtu.ox.ac.ukaforrd@dtu.ox.ac.uk Phone:01865 857 246 Fax:01865 857 256 Web site: www.dtu.ox.ac.uk/aforrd Trial Schedule
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