Risk	LDL Goal (mg/dl)
Without CHD and with 0-1 risk factor	< 160
Without chd and with 2 or more risk factors	< 130
With CHDa, b	< 100

CHD = coronary heart disease.

aSee Table 2 for risk factor assessment.

bAccording to the American Diabetes Association (ADA) guidelines and 2001 National Cholesterol Education Program guidelines, the recommended LDL level for patients with diabetes is < 100 mg/dl. However, when patients were enrolled in this study, the 2001 NCEP guidelines were not published, and Bay Pines Veterans Affairs Medical Center PharmCare clinic treated these patients according to the ADA goal of < 100 mg/dl.

Positive risk factors

Age

Men >/= 45 yrs

Women >/= 55 yrs or premature menopause without       estrogen replacement therapy

Family history of premature CHD (definite myocardial       infarction or sudden death before 55 yrs of age in father       or other male first-degree relative, or before 65 years of       age in mother or other female first-degree relative)

Current cigarette smoking

Hypertension (blood pressure >/= 140/90 mm Hg or taking    antihypertensive drug)

Low HDL level (< 35 mg/dl)a

Negative risk factor

High HDL level (>/= 60 mg/dl)

CHD = coronary heart disease; HDL = high-density lipoprotein cholesterol.

a2001 National Cholesterol Education Program guidelines recommend that an HDL level of < 40 mg/dl be considered a risk factor.

LDL Level (mg/dl)				Change
NCEP Goala	ADA Goala	Daily Simvastatin	Alternate-Day Simvastatin
< 160	NAb	136	129	-7
< 130	< 100	106	81c	-25c
< 130	NAb	113	135d	+22d
< 130	< 100	92	97	+5
< 100	NAb	88	110	+22
< 100	NAb	96	82	-14
< 100	NAb	85	89	+4
< 100	< 100	87	95	+8
< 100	< 100	89	82	-7
< 130	NAb	80	70d	-10d
< 100	NAb	96	79	-17
< 100	NAb	97	81	-16
< 130	< 100	96	91e	-5e
< 130	< 100	98	NAf	NAf
< 100	NAb	70	67	-3

LDL = low-density lipoprotein cholesterol; NCEP = National Cholesterol Education Program; ADA = American Diabetes Association; NA = not applicable.

aDuring study enrollment, 2001 NCEP guidelines were not published, and the 1993 NCEP goal of < 100 mg/dl did not include diabetes as a major risk factor for development of coronary artery disease. However, study patients with diabetes were treated according to the ADA goal of < 100 mg/dl.[2, 4, 14]

bPatient did not have diabetes.

cPatient increased caloric intake during treatment period.

dPatient was noncompliant.

ePatient ate more healthful foods and fewer snacks during treatment period.

fPatient dropped out of the study.

	Daily Simvastatin	Alternate-Day Simvastatin	p Value	Normal Range
AST (U/L)	25.2 ± 5.91	24.4 ± 4.6	0.49	5-60
ALT (U/L)	17.3 ± 6.2	15.93 ± 6.8	0.61	7-56
Creatine kinase (U/L)	72.1 ± 35.1	70.3 ± 54	0.65	55-170
Total cholesterol (mg/dl)	167 ± 21.8	165 ± 27	0.66
Triglycerides (mg/dl)	121 ± 45.7	140.8 ± 46.9	0.1
LDL (mg/dl)	95.3 ± 15.2	92 ± 20.2	0.43
HDL (mg/dl)	48.4 ± 12.5	45.4 ± 9.5	0.24

AST = aspartate aminotransferase; ALT = alanine aminotransferase; LDL = low-density lipoprotein cholesterol; HDL = high-density lipoprotein cholesterol.

Values are mean ± SD.

Daily Dosing		Alternate-Day Dosing		Savings ($)
Dose (mg)	AWP ($)	Dose (mg)	AWP ($)
5	53.42	10	35.75	17.67
10	71.59	20	62.45	9.14
20	124.90	40	62.45	62.45
40	124.90	80	62.45	62.45
80	124.90	NAa	NAa	NAa

AWP = average wholesale price.

a160 mg is above the maximum recommended single daily dose of simvastatin, even if taken every other day.