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Table 4 Unconfounded randomized controlled trials of lipid-lowering therapy, showing numbers of subjects with diabetes

From: The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

Study Population Year of primary publication Therapy Total no. No. with diabetes Reference
4S Prior CHD 1994 Simvastatin 20–40 mg 4444 202 20, 38
CARE Prior CHD 1996 Pravastatin 40 mg 4159 586 21
Post-CABG* Prior CHD 1997 Lovastatin 40–80 mg vs 2.5–5 mg 1351 122 39, 40
LIPID Prior CHD 1998 Pravastatin 40 mg 9014 1077 6, 23
GISSI-P* Prior CHD 2000 Pravastatin 20 mg 4271 582 41
GREACE* Prior CHD 2002 Atorvastatin 10–80 mg 1600 313 42
PROSPER Mixed 2002 Pravastatin 40 mg 5804 623 43
ALLHAT-LLT* Mixed 2002 Pravastatin 20–40 mg 10355 3638 27
HPS Mixed 2003 Simvastatin 40 mg 20536 5963 24, 25
ASCOT-LLA Mixed 2003 Atorvastatin 10 mg 10305 2532 26
WOSCOPS Primary 1995 Pravastatin 40 mg 6595 76 22
AFCAPS/TexCAPS Primary 1998 Lovastatin 20–40 mg 6605 1 55 44
CARDS Primary 2004 Atorvastatin 10 mg 2838 2838 28
Total – – Any statin 87877 18707  
VA-HIT Prior CHD 1999 Gemfibrozil 1200 mg 2531 769 29, 30, 32
BIP Prior CHD 2000 Bezafibrate 400 mg 3090 309 31
DAIS Mixed 2001 Fenofibrate 200 mg 418 418 33
LEADER Mixed 2002 Bezafibrate 400 mg 1568 268 45
SENDCAP Primary 1998 Bezafibrate 400 mg 164 164 46
HHS Primary 1992 Gemfibrozil 1200 mg 4081 135 14, 15
Total – – Any fibrate 11852 2063  
  1. * No placebo used; lipid lowering compared with less treatment in Post-CABG study, with no treatment in GISSI-P study, and with usual care in ALLHAT-LLT and GREACE studies.
  2. CHD = coronary heart disease
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