| LESCOL® XL Efficacy
LESCOL® XL - Tough on Cholesterol With Proven Tolerability
May help achieve NCEP goal of 30% to 40% LDL-C reduction1
According to NCEP guidelines, many patients will need to reduce their LDL cholesterol by at least 30%-40%. LESCOL® XL can lower LDL-C to within the recommended range in as little as 4 weeks.
Median Percent Change From Baseline With LESCOL® XL
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* 38% median decrease in LDL-C at 4 weeks; 35% median decrease at 24 weeks (n=748).2
† LESCOL® XL 80mg produced median (25th and 75th percentile) % change from baseline in HDL-C of +9 and +12. In patients with TGs ≥ 200mg/dl (n = 239) LESCOL® XL produced a 21% median increase.2
‡ 31% median TG decrease in patients with a baseline TG level ≥ 300mg/dL (n=239).2
These data are a composite from 3 studies consisting of 750 patients treated with LESCOL® XL for up to 24 weeks.
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LESCOL® XL is indicated to reduce elevated total cholesterol (Total-C), LDL-C, TGs, and Apo B levels, and increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipedemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other pharmacological measures has not been adequate.
Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fats and cholesterol.
The effect of LESCOL® XL on cardiovascular mortality has not been determined.
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| Slows progression of coronary atherosclerosis. |
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- Significantly slowed progression of existing coronary lesions by 72% *
* LESCOL® (fluvastatin sodium) 40 mg vs. placebo (measured as change in minimum lumen diameter).3((Herd/p282/Fig.3)) |
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| Reduces the risk of major adverse cardiac events in post-PCI patients |
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* RR indicates relative risk; CI, confidence interval; and MACE, major adverse cardiac event (composite end point of cardiac death, nonfatal myocardial infarction [MI], or reintervention procedure).
† Based on Cox proportional hazards model.
‡ MACE excluding reinterventions (surgical or precutaneous coronary reintervention) occurring in the first 6 months of follow-up for lesions treated at the index procedure.
- Revascularization procedures comprised the majority of the intitial recurrent cardiac events.
-Lescol was associated with a 32% (P=0.002) reduction in risk of late revascularization
procedures.
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References:
1. Grundy SM, Cleeman JI, Merz CNB, et al, for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-239
2. Ballantyne CM, Pazzucconi F, Pintó X, et al. Efficacy and tolerability of fluvastatin extended-release delivery system: a pooled analysis. Clin Ther. 2001;23:177-192.
3. Herd J, Ballantyne C, Farmer J, et al. Effects of fluvastatin on coronary atherosclerosis in patients with mild to moderate cholesterol elevations (Lipoprotein and Coronary Atherosclerosis Study [LCAS]) Am J Cardiol. 1997; 80:279-286.
4. Serruys PW, de Feyter P, Macaya C, et al. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention. JAMA. 2002;287:3215-3222.
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