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Diabetes Trials Unit University of Oxford WebSite: http://www.dtu.ox.ac.uk/lds

L ipids in D iabetes S tudy. Diabetes Trials Unit University of Oxford WebSite: http://www.dtu.ox.ac.uk/lds. Academic, investigator-led, clinical-outcome trial 5,000 type 2 diabetic patients, aged 40 to 75 years “Primary” intervention - no clinical evidence of CHD

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Diabetes Trials Unit University of Oxford WebSite: http://www.dtu.ox.ac.uk/lds

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  1. Lipids inDiabetesStudy Diabetes Trials UnitUniversity of Oxford WebSite: http://www.dtu.ox.ac.uk/lds

  2. Academic, investigator-led, clinical-outcome trial 5,000 type 2 diabetic patients, aged 40 to 75 years “Primary” intervention - no clinical evidence of CHD Double-blind, placebo-controlled, 2x2 factorial randomisation Cerivastatin 0.4 mg/day, micronised fenofibrate 200 mg/day 30 UK clinical centres, five year follow-up Funded by an educational grant from Bayer Trial Design

  3. Thought to require lipid-lowering therapy LDL cholesterol >4.1 mmol/L (160 mg/dL) Triglyceride >4.5 mmol/L (400 mg/dL) Impaired renal/hepatic function History of myopathy or cholelithiasis Life threatening disease Pregnancy Exclusion Criteria

  4. Subject Characteristics at Entry n=1616 (May 2000) Mean SD Male 67% … Caucasian 90% … Current smoker 14% … Age (y) 60 8 BMI (kg/m2) 30.3 6.0 Blood pressure (mm Hg) 144/83 19/11 Duration of diabetes (y)* 8 4 to 13 * Median, IQR

  5. Baseline Biochemistry n=1616 (May 2000) Mean SD Total cholesterol (mmol/L) 5.0 0.8 HDL cholesterol (mmol/L) 1.2 0.3 LDL cholesterol (mmol/L) 3.1 0.7 Triglyceride (mmol/L)* 1.5 0.9 to 2.6 HbA1c (%)* 8.3 7.3 to 9.4 * Median, IQR

  6. Baseline Biochemistry n=1616 (May 2000) Mean SD Total cholesterol (mg/dL) 195 31 HDL cholesterol (mg/dL) 47 12 LDL cholesterol (mg/dL) 121 27 Triglyceride (mg/dL)* 133 80 to 231 HbA1c (%)* 8.3 7.3 to 9.4 * Median, IQR

  7. 2 x 2 Factorial Randomisation Cerivastatin arm CerivastatinPlacebo2,500 FenofibrateFenofibrateFenofibrate (1250)(1250) CerivastatinPlacebo2,500 PlaceboPlaceboPlacebo (1250)(1250) 2,5002,500 5,000 Cerivastatin Placebo patientsin total Fenofibrate arm

  8. Fatal myocardial infarction including sudden death or Non-fatal myocardial infarction or Coronary or peripheral artery revascularisation Composite Primary Endpoint First occurrence of:

  9. Fatal or non-fatal stroke Coronary syndromes(fatal or non-fatal myocardial infarction,stable and unstable angina) Heart failure All cause mortality Retinal photocoagulation Renal failure Secondary Outcomes

  10. Microalbuminuria Digital electrocardiographic changes Visual acuity Lipid profile Surrogate Outcomes

  11. Four monthly assessment of: Time off work Concomitant drug treatment Hospital admissions/procedures Health resource utilisation EuroQoL-5 (SF-36 at entry & at 5 years) Health Economics

  12. Allocated Allocated Power at cerivastatin placebo 2p<0.01* Number randomised 2,500 2,500 … Number evaluable (96%) 2,400 2,400 … LDS primary endpoint 179 255 90% Power of the Study * assuming a 30% reduction in events with cerivastatinand adjusting for factorial design

  13. Schedule Study commenced 1999 Two year recruitment until 2001 Four monthly follow up ofall subjects for five years Closeout and publication in 2006

  14. The LDS will demonstrate whether lipid lowering drug therapy reduces cardiovascular events among type 2 patients, many of whom would not be treated on the basis of the current Joint European Recommendations The LDS will provide an evidence-base for the use of statin therapy, fibrate therapy, and combination therapy, for the primary prevention of cardiovascular disease in people with type 2 diabetes Conclusions

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