Excerpt

This evidence report was commissioned by the Agency for Healthcare Research and Quality (AHRQ) to address the following key questions: Key Question 1. For patients who require intensive lipid-modifying therapy, what are the comparative long-term benefits and rates of serious adverse events of coadministration of different lipid-modifying agents (i.e., a statin plus another lipid-modifying agent) compared with higher dose statin monotherapy? Key Question 2. Do these regimens differ in reaching LDL targets (or other surrogate markers), short-term side effects, tolerability, and/or adherence? Key Question 3. Compared with higher dose statins and to one another, do combination regimens differ in benefits and harms within subgroups of patients?

Contents

• Preface
• Acknowledgments
• Executive Summary
• 1. Introduction
  • Background
  • Scope and Key Questions
• 2. Methods
  • Topic Development
  • Search Strategy
  • Study Selection
  • Data Extraction
  • Quality Assessment
  • Applicability
  • Rating the Body of Evidence
  • Evidence Synthesis
• 3. Results
  • Search Results
  • Data Synthesis and Pooling
  • Statin Plus Ezetimibe Combination Therapy Versus Statin Monotherapy
  • Statin Plus Fibrate Combination Therapy Versus Statin Monotherapy
  • Statin Plus Niacin Combination Therapy Versus Statin Monotherapy
  • Statin Plus Bile Acid Sequestrant Combination Therapy Versus Statin Monotherapy
  • Statin Plus Omega-3 Fatty Acid Versus Statin Monotherapy
  • Applicability of the Body of Evidence for All Comparisons
• 4. Summary and Discussion
  • Clinical Outcomes
  • Serious Adverse Events
  • Surrogate Outcomes
  • Adherence and Harms
  • Limitations
• 5. Conclusions
• 6. Remaining Issues
  • Key Question 1: For patients who require intensive lipid-modifying therapy, what are the comparative long-term benefits, and rates of serious adverse events of coadministration of different lipid-modifying agents (i.e. a statin plus another lipid-modifying agent) compared with higher dose statin monotherapy?
  • Key Question 2: Do these regimens differ in reaching LDL-targets (or other surrogate markers), short-term side effects, tolerability, and/or adherence?
  • Key Question 3: Compared with higher dose statins, and to one another, do combination regimens differ in benefits and harms within subgroups of patients?
• Abbreviations
• Appendixes
  • Appendix A. Search Strategies
  • Appendix B. Excluded Studies
  • Appendix C. Drugs Included in the Review and Label Information
  • Appendix D. Planned Analyses
  • Appendix E. Within-Trial, Within-Treatment Pooling of Multiple Treatment Group Data
  • Appendix F. Included Evidence
  • Appendix G. Forest and Funnel Plots
  • Appendix H. GRADE Tables, Assessing the Evidence
  • Appendix I. References
  • Appendix J. Peer Reviewers
  • Appendix K. Literature Search 2009 Update (August 2008 to May 2009) Including the Update Flow Chart and List of Included and Excluded Records

Suggested citation:

Sharma M, Ansari MT, Soares-Weiser K, Abou-setta AM, Ooi TC, Sears M, Yazdi F, Tsertsvadze A, Moher D. Comparative Effectiveness of Lipid-Modifying Agents. Comparative Effectiveness Review No. 16. (Prepared by the University of Ottawa Evidence-based Practice Center under contract No. 290-02-0021.) Rockville, MD: Agency for Healthcare Research and Quality. September 2009. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.

Dr. Sharma has participated in advisory boards and received speaker‘s honoraria from Pfizer, Astra-Zeneca, and Merck/Schering Plough. None of the other investigators has any affiliations or financial involvement that conflicts with the material presented in this report.

This report is based on research conducted by the University of Ottawa Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0021). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

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