VA/Dod CLINICAL PRACTICE GUIDELINE for the MANAGEMENT of DYSLIPIDEMIA
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VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF DYSLIPIDEMIA Department of Veterans Affairs Department of Defense Updated Version 2.0 – 2006 VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia Prepared by: THE MANAGEMENT OF DYSLIPIDEMIA Working Group With support from: The Office of Quality and Performance, VA, Washington, DC & Quality Management Directorate, United States Army MEDCOM Version 1.0 – 1999 Updated Version 2.0 - 2006 Based on evidence reviewed until December 2004. Introduction Page-ii VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia TABLE OF CONTENTS Page INTRODUCTION iv Key Elements vii Guideline Update Working Group viii ALGORITHMS AND ANNOTATIONS Module A: Management of Dyslipidemia - Screening 1 Module B: Management of Dyslipidemia - Initiation of Therapy 17 Module C: Management of Dyslipidemia - Follow-up of Therapy 56 APPENDICES: Appendix A: Guideline Development Process Appendix B: 10-Year CV-Risk Assessment Appendix C: Medical Nutrition Therapy Appendix D: Exercise Appendix E: Pharmacologic Therapy: Drug Information Appendix F: Pharmacologic Therapy: Summary of Supporting Studies Appendix G: Acronym List Appendix H: Participant List Appendix I: Bibliography Introduction Page-iii VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia INTRODUCTION This clinical practice guideline (CPG) on the management of dyslipidemia is intended to promote reduction of cardiovascular risk via evidence-based management of dyslipidemia, thereby improving clinical outcomes. It can assist primary care providers or specialists in the detection of high blood cholesterol, assessment of the global risk for cardiovascular disease (CVD), determination of treatment goals and appropriate therapies, and delivery of individualized interventions. Although it was developed for a broad range of clinical settings, it should be applied with enough flexibility to accommodate local practice and individual situations. The guideline was developed under the auspices of the Veterans Health Administration (VHA) and the Department of Defense (DoD) pursuant to directives from the Department of Veterans Affairs. VHA and DoD define clinical practice guidelines as: “Recommendations for the performance or exclusion of specific procedures or services derived through a rigorous methodological approach that includes the following: 1. Determination of appropriate criteria, such as effectiveness, efficacy, population benefit, or patient satisfaction; and 2. Literature review to determine the strength of the evidence in relation to these criteria.” Dyslipidemia is widely regarded as a major risk factor for coronary heart disease (CHD) and atherosclerotic cardiovascular disease (ASCVD) (NCEP ATP-III, 2002). It is thus a serious public health problem in the DoD, the VHA healthcare system, and in the nation at large. The Global Burden of Disease Study has estimated that cardiovascular disorders are currently the second leading worldwide cause of disability adjusted life years (the sum of lost life due to mortality and years of life adjusted for the severity of disability) in industrialized countries (Murray, 1997). Projections into the future suggest that cardiovascular disorders will rise to become the most important cause of disability adjusted life years. Based on the above statistics, there is little doubt that dyslipidemia is a major risk factor for morbidity and mortality within the DoD and VHA communities. In the development of this guideline update, the Working Group heavily relied on the following evidence based guidelines: USPSTF 2001: U.S. Preventive Services Task Force. Screening for Lipid Disorders: Recommendations and Rationale. Am J Prev Med 2001;20(3S):73-76 (http://www.elsevier.com/locate/ajpmonline). NCEP ATP-III, 2002: Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002, 106, (25), 3143-421. Lipid-related risk factors for ASCVD include high levels of total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C) and low levels of high-density lipoprotein cholesterol (HDL-C) (NCEP III, 2002). Other risk factors include age, male sex, high blood pressure, tobacco use, diabetes mellitus, and family history of premature CHD (ACP, 1998). Because the range of CVD 10-year absolute risk is wide, targeted screening for patients at high absolute risk to develop CVD is recommended. All adults— regardless of age—with a history of CVD should undergo lipoprotein screening. For asymptomatic individuals (i.e., for primary prevention), available evidence supports cholesterol screening only if other characteristics place them at high-risk. The debate over screening recommendations thus centers on young people without risk factors and older people without a history of CVD. The NCEP ATP-III Guidelines define LDL-C as the primary target of therapy. It also defines elevated serum triglycerides as a risk factor, along with low HDL-C. Obtaining a lipid profile in fasting state is necessary in order to make meaningful decisions. This new approach also emphasizes the focus on the LDL-C level, rather than the TC/HDL ratio as a predictor for outcomes or treatment initiation. Introduction Page-iv VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia Why Does the VA/DoD Guideline Differ from NCEP in their LDL Goals? Most NCEP recommendations are consensus statements designed to guide the broad clinical field of dyslipidemia. Many of the recommendations are based on observational studies with rational inferences based on biologic plausibility. Clinical practice guidelines have to guide practical decision-making in real world practice among patients for whom there are most often no applicable clinical trials, and in whom there is an intricate balance of patient preferences, co-morbidities, medication interactions, and other psychosocial factors. Therefore, the VA/DoD Dyslipidemia Guidelines Working Group was tasked to design a rigorous evidence-based guideline whereby recommendations were based on high quality clinical data (typically randomized controlled trials [RCT] using hard outcomes). The Guideline Working Group’s knowledge of the DoD and VHA clinical practice settings allows for adaptation of these recommendations to our specific system of care. This is the basis upon which there are differences between NCEP and the VA/DoD CPG recommendations. The decisions on treatment will always be guided by clinical judgment of the providers who may strive to achieve lower LDL-C goals for their individual patient. Most high-risk patients (those with CVD or CVD equivalent and LDL-C >100 mg/dL) may benefit from statin therapy, regardless of baseline LDL. However, patients with very high baseline LDLs may have difficulty in achieving an LDL of less than 100 despite moderate to high dose statin therapy (greater than 25 percent reduction in LDL-C). Most recent studies achieving very low treatment LDLs started with low baseline LDL (mean LDL-C in HPS was 131 mg/dL; median LDL-C in PROVE-IT was 106 mg/dL) as opposed to 188 mg/dL in the 4S study. Thus, in those patients with a high LDL at baseline, the full risk- benefit of high dose statin or combination drug therapy required to achieve very low LDL goals is unknown, especially among patients with significant disease comorbidities or concomitant drug therapy. The data from meta-analysis of the major statin RCTs indicate that an LDL-C reduction of 30-40 percent from baseline may be considered a therapeutic strategy for patients who can not meet the above target goals. Changes From Previous Version (1999) Of The Guideline This guideline recommends a global assessment of cardiovascular risk as part of the screening for dyslipidemia. In the past, stratification of lipid lowering therapy was based on risk categories determined by counting risk factors. Atherosclerosis is a disease of many facets and pathological features. In the context of overall management of cardiovascular (CV) risk reduction, management of LDL-C is only one factor of many. A multifactor risk management strategy is necessary to optimize risk. To emphasize treatment of only a single parameter, such as LDL-C, over simplifies the reduction of CVD risk. Counting the number of risk factors without considering their severity also oversimplifies a vastly complex problem. This guideline recommends the calculation of a 10-year CVD risk based on the Framingham model. The high-risk and very high-risk groups that are subject to secondary prevention now include patients with CHD risk equivalence (i.e., diabetes). The evidence gathered in recent years has demonstrated that patients with diabetes have a comparable risk for CVD as patients who already had a myocardial infarction or stroke. The evidence provided by several lipid-lowering RCTs has now provided enough data to base the recommendations for this guideline on absolute risk reductions (as opposed to relative risk reduction in the past). Finally, there is emerging data on the metabolic syndrome as a CVD risk indicator and a variety of treatments that may mitigate CVD risk. This emphasizes the value of recognizing the metabolic syndrome in assessing CVD risk. Specific recommendations for the management of lipid disorders in those with metabolic syndrome have been described in recent national guidelines (NCEP ATP-III). The recommendations emphasize lifestyle management (weight loss,