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  • Title: Differences between clinical trial efficacy and real-world effectiveness.
    Author: Davidson MH.
    Journal: Am J Manag Care; 2006 Nov; 12(15 Suppl):S405-11. PubMed ID: 17112328.
    Abstract:
    Aggressive lowering of low-density lipoprotein cholesterol (LDL-C) with statin therapy can reduce the incidence of morbidity and mortality from coronary heart disease (CHD) in primary and secondary prevention settings. Indeed, suboptimal statin treatment has been associated with an increased risk of CHD events. Surveys such as the Lipid Treatment Assessment Project (L-TAP) and National Cholesterol Education Program Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II have demonstrated that patients in real-world clinical settings often fail to reach the target goals set forth by the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III). This failure to reach target LDL-C levels in real-world clinical practice presents a therapeutic treatment gap. There may be multiple reasons for this discrepancy: lack of patient follow-up, absence of well-defined protocols (ie, use of low-potency statins in high-risk patients), adherence controls (eg, pill counts, refill records), cost, and lack of patient motivation are a few possibilities. Several large clinical trials since ATP III have shown that these goals are achievable through aggressive statin therapy. This review sets forth compelling data that starting patients on or switching to high-efficacy LDL-C-lowering therapy enhances achievement of NCEP ATP III guidelines outside of the controlled trial setting.
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