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Diabetes Trials Unit University of Oxford WebSite: http://www.dtu.ox.ac.uk/lds Lipids in Diabetes Study
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ldssk01.1 Trial Design 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
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ldssk01.2 Exclusion Criteria 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
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ldssk01.3 Subject Characteristics at Entry n=1616 (May 2000) Mean SD Male67%… Caucasian90%… Current smoker14%… Age (y)608 BMI (kg/m 2 )30.3 6.0 Blood pressure (mm Hg)144/8319/11 Duration of diabetes (y)*84 to 13 * Median, IQR
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ldssk01.4 Baseline Biochemistry n=1616 (May 2000) Mean SD Total cholesterol (mmol/L)5.00.8 HDL cholesterol (mmol/L)1.20.3 LDL cholesterol (mmol/L)3.10.7 Triglyceride (mmol/L)*1.50.9 to 2.6 HbA 1c (%)*8.37.3 to 9.4 * Median, IQR
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ldssk01.5 n=1616 (May 2000) Mean SD Total cholesterol (mg/dL)19531 HDL cholesterol (mg/dL)4712 LDL cholesterol (mg/dL)12127 Triglyceride (mg/dL)*13380 to 231 HbA 1c (%)*8.37.3 to 9.4 Baseline Biochemistry * Median, IQR
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ldssk01.6 2 x 2 Factorial Randomisation CerivastatinPlacebo 2,500 Fenofibrate Fenofibrate Fenofibrate(1250) Cerivastatin Placebo 2,500 Placebo Placebo Placebo(1250) 2,5002,5005,000 Cerivastatin Placebopatients in total Cerivastatin arm Fenofibrate arm
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ldssk01.7 Composite Primary Endpoint Fatal myocardial infarction including sudden death or Non-fatal myocardial infarction or Coronary or peripheral artery revascularisation First occurrence of:
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ldssk01.8 Secondary Outcomes 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
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ldssk01.9 Surrogate Outcomes Microalbuminuria Digital electrocardiographic changes Visual acuity Lipid profile
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ldssk01.10 Health Economics 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)
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ldssk01.11 Power of the Study Allocated AllocatedPower at cerivastatinplacebo2p<0.01 * Number randomised2,5002,500… Number evaluable (96%)2,4002,400… LDS primary endpoint17925590% * assuming a 30% reduction in events with cerivastatin and adjusting for factorial design
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ldssk01.12 Schedule Study commenced1999 Two year recruitment until2001 Four monthly follow up of all subjects for five years Closeout and publication in2006
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ldssk01.13 Conclusions 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
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