O. Initiate Lipid Lowering Therapy to Achieve Goal

objective

Select an appropriate therapy based on LDL-C baseline level and other risk factors for CVD.

background

Two approaches to therapy are available: lifestyle changes and drug therapy:

Lifestyle changes are the first step of treatment dyslipidemia.  These include dietary changes, smoking cessation, weight loss (if overweight), and exercise.  These changes may reduce cardiovascular disease risk independent of their influence on lipid levels.

Drug therapy should be reserved for those with known CVD and those patients at increased CVD risk failing to reach LDL-C targets with lifestyle modifications.  Statins have been shown to be cost-effective in both these populations.

recommendations

Non-Pharmacologic Therapy

1. Therapeutic lifestyle changes (TLC) should be recommended for ALL patients with dyslipidemia, regardless of risk or baseline LDL-C level.  [C]

Drug Therapy for Secondary Prevention:

2. All patients with a recent ACS should be on at least a moderate dose of statin therapy.  [A]
3. Statin drug therapy should be initiated for patients with previous documented CHD or CVD equivalent (diabetes with other major risk factors) if baseline LDL-C is ≥100 mg/dL.  [A]
4. Statin drug therapy should be initiated for patients with documented DM with no major risk factors if baseline LDL-C is ≥130 mg/dL.  [C]
5. Statin drug therapy may be considered optional for all patients with CHD or CVD equivalent (diabetes with other major risk factors) regardless of LDL-C baseline.  [B]

Drug Therapy for Primary Prevention:

6. Drug therapy should be initiated for high-risk patients (>20%) if baseline LDL is ≥130 mg/dL.  [B]
7. Drug therapy is optional to consider in high-risk patients (>20%) if baseline LDL is 100-129 mg/dL.  [B]
8. Drug therapy may be offered to patients with high-intermediate risk (15-20 percent) if baseline LDL is ≥130 mg/dL.  [B]
9. Drug therapy may be offered to patients with low-intermediate risk (10-14 percent) if baseline LDL is ≥160 mg/dL.  [C]
10. Drug therapy may be offered to low-risk patients (<10 percent) if baseline LDL is ≥190 mg/dL.  [I]

The following table summarizes the lipid lowering strategy for patients in primary prevention. Individual management of cardiovascular risk should be informed mainly by the probable absolute magnitude of treatment benefits. Lowering absolute risk involves modification of multiple risk factors/co-morbidities, not only LDL-C levels. Therefore, these goals should serve as a general guide and clinical judgment should be used to modify the goals as appropriate for each patient.

Table 2. Goals of Lipid Lowering Therapy

	Risk Category	Disease Status or Risk Factors	Calculated 10-Year Risk	TLC	LDL-C Level for Considering Statin Drug Therapy	LDL Goal of Therapy
S e c o n d a r y	Very high	Recent ACS	N/A	All	All	<100  mg/dL <70 optional
		CHD or DM with other risk factors	N/A	All	≥100  mg/dL	<100  mg/dL
		DM with no other risk factors	N/A	All	≥ 130  mg/dL 100-129 optional	<130 mg/dL
P r i m a r y	High	More than 2 RF	> 20%	All	≥130 (or HDL <40) 100-129 optional	<100  mg/dL
	Intermediate	More than 2 RF	15-20%	All	≥ 130  mg/dL	<130  mg/dL
			10-14 % *	All	≥ 160 mg/dL	<130  mg/dL
	Low	0 or 1 RF	N/A	All	≥190  mg/dL	<160  mg/dL
		0 or 1 RF	N/A	N/A	<160	--

LDL-C reduction of 30-40 percent from baseline may be considered an alternative therapeutic strategy for patients who can not meet the above goals.

N/A = Not applicable; TLC = Therapeutic Lifestyle Changes; RF = Risk Factor
*  There is insufficient evidence at this time to recommend routine screening for other risk markers not included in the risk index (e.g., FH, hsCRP, metabolic syndrome, depression), or evidence of significant atherosclerotic burden (e.g., high coronary artery calcification scores, intima medial thickness, abnormal brachial reactivity, or abnormal ankle-brachial index). These risk markers may be useful in the intermediate risk patient for whom it is less convincing that drug therapy would have a meaningful impact on outcomes.

discussion

Initial Therapy: In one prospective secondary prevention trial, the CARE study, a post-hoc analysis found no outcomes benefit when high-dose pravastatin was initiated at a baseline LDL-C <125 mg/dL (Sacks et al., 1996). However, evidence clearly supports initiation of pharmacotherapy when LDL is >130 mg/dL in patients with CHD. In the Heart Protection Study (HPS), the initial LDL-C was approximately 130 mg/dL (HPS, 2002).  Furthermore, in a post-hoc analysis of HPS, those patients presenting with a pretreatment LDL-C of less than 100 mg/dL also achieved a similar benefit in reduction of coronary events with treatment of simvastatin (HPS, 2002).  Based on consensus opinion and post-hoc analysis of HPS it is recommended that statins be initiated for LDL ≥100 mg/dL for secondary CHD prevention.