American Diabetes Association

Table 2—

Comparison of model and trial results: for trials of CAD

Name of trial	Population	Outcome	Years	Initial size	Treatment group	Result (%)
Name of trial	Population	Outcome	Years	Initial size	Treatment group				Model	Trial
LIPID^*	Acute MI within 3–36 months, “broad range” of lipid levels	CHD death	6	4,502	Placebo	7.5	8.3
	Acute MI within 3–36 months, “broad range” of lipid levels				4,512	Pravastatin	6.5	6
		Myocardial infarction	6	4,502	Placebo	14.4	15.6
				4,512	Pravastatin	11	12
HHS^*	Middle aged men, dyslipidemia	Myocardial infarction	5	2,030	Placebo	4.2	4.1
				2,051	Gemfibrozil	3	2.7
4S	History of angina or acute myocardial infarction	Myocardial infarction	5.4	2,223	Placebo	23.8	25
	History of angina or acute myocardial infarction				2,221	Simvastatin	14.2	16
SHEP^*	Isolated systolic hypertension	CAD events	4.5	2,371	Placebo	5.8	5.9
				2,365	Antihypertensive^†	4.5	4.3
LRC^*	Primary hypercholesterolemia	Myocardial infarction	4.5	1,543	Placebo	5.4	6
				1,543	Cholestyramine	4	5
MRC^*	Mild hypertension	Myocardial infarctions	4	8,677	Placebo	4.5	4.5
				8,677	Antihypertensive^‡	3.3	3.4
WOSCOPS^*	Very high risk and hyper-cholesterolemia	Myocardial infarctions	5	3,293	Placebo	5.2	7.9^§
	Very high risk and hyper-cholesterolemia				3,302	Pravastatin	2.6	5
		Coronary heart disease deaths	5	2,078	Placebo	1.9	1.7
				2,081	Pravastatin	1.1	1.2
VA-HIT	Previous CAD, low HDL	Myocardial infarctions	5	1,264	Placebo	25.2	23
				1,267	Gemfibrozil	17.8	19.7
		Coronary heart disease death	5	1,264	Placebo	10.2	9.6
				1,267	Gemfibrozil	8.7	8.4
		Stroke	5	1,264	Placebo	4.2	6.6
				1,267	Gemfibrozil	3.5	5.2

Name of trial	Population	Outcome	Years	Initial size	Treatment group	Result (%)
Name of trial	Population	Outcome	Years	Initial size	Treatment group				Model	Trial
LIPID^*	Acute MI within 3–36 months, “broad range” of lipid levels	CHD death	6	4,502	Placebo	7.5	8.3
	Acute MI within 3–36 months, “broad range” of lipid levels				4,512	Pravastatin	6.5	6
		Myocardial infarction	6	4,502	Placebo	14.4	15.6
				4,512	Pravastatin	11	12
HHS^*	Middle aged men, dyslipidemia	Myocardial infarction	5	2,030	Placebo	4.2	4.1
				2,051	Gemfibrozil	3	2.7
4S	History of angina or acute myocardial infarction	Myocardial infarction	5.4	2,223	Placebo	23.8	25
	History of angina or acute myocardial infarction				2,221	Simvastatin	14.2	16
SHEP^*	Isolated systolic hypertension	CAD events	4.5	2,371	Placebo	5.8	5.9
				2,365	Antihypertensive^†	4.5	4.3
LRC^*	Primary hypercholesterolemia	Myocardial infarction	4.5	1,543	Placebo	5.4	6
				1,543	Cholestyramine	4	5
MRC^*	Mild hypertension	Myocardial infarctions	4	8,677	Placebo	4.5	4.5
				8,677	Antihypertensive^‡	3.3	3.4
WOSCOPS^*	Very high risk and hyper-cholesterolemia	Myocardial infarctions	5	3,293	Placebo	5.2	7.9^§
	Very high risk and hyper-cholesterolemia				3,302	Pravastatin	2.6	5
		Coronary heart disease deaths	5	2,078	Placebo	1.9	1.7
				2,081	Pravastatin	1.1	1.2
VA-HIT	Previous CAD, low HDL	Myocardial infarctions	5	1,264	Placebo	25.2	23
				1,267	Gemfibrozil	17.8	19.7
		Coronary heart disease death	5	1,264	Placebo	10.2	9.6
				1,267	Gemfibrozil	8.7	8.4
		Stroke	5	1,264	Placebo	4.2	6.6
				1,267	Gemfibrozil	3.5	5.2

Not used to build physiology model;

†

step 1: Chlorthalidone, step 2: Atenolol;

‡

Bendrofluazide or propranolol;

difference between model results and trial results statistically significant, P < 0.01;

‖difference between model results and trial results statistically significant, P < 0.05.