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]

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

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

* 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.
CHD = coronary heart disease

ISSN: 1475-2840