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Combination Therapy Versus Intensification of Statin Monotherapy: An Update
Comparative Effectiveness Reviews, No. 132
Investigators: Anne K Monroe, MD, MSPH, Kimberly A Gudzune, MD, MPH, Ritu Sharma, BSc, Yohalakshmi Chelladurai, MBBS, MPH, Padmini D Ranasinghe, MD, MPH, Mohammed T Ansari, MBBS, MMedSc, MPhil, and Karen A Robinson, PhD.
Author Information and AffiliationsStructured Abstract
Objective:
To assess the benefits and harms of combination of statin and other lipid-modifying medication compared to intensification of statin monotherapy. This is an update to a 2009 review.
Data sources:
The search for the prior review included MEDLINE® from 1966 to May 2009, Embase® from 1980 to May 2009, and the Cochrane Library to the third quarter of 2008. Additional searches of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from May 2008 to July 2013 were conducted for the update.
Review methods:
Paired investigators independently screened search results to assess eligibility. Investigators abstracted data sequentially and assessed risk of bias independently. Investigators graded the strength of evidence (SOE) as a group.
Results:
All evidence for clinical outcomes (mortality, acute coronary events, and revascularization procedures) were graded as insufficient when comparing lower potency combination therapy with higher potency statin monotherapy. Results of effects on surrogates—low-density lipoprotein (LDL-c) and high-density lipoprotein (HDL-c)— and on serious adverse events are summarized below:
Bile acid sequestrants (BAS): There was moderate SOE from four trials that a low-potency statin combined with a BAS lowered LDL-c up to 14 percent more than mid-potency statin monotherapy.
Ezetimibe: Moderate SOE from 11 trials favors mid-potency statin with ezetimibe for lowering LDL-c, with reduction up to 18 percent more compared to high-potency statin monotherapy among general populations. Low SOE from 11 trials favors mid-potency statin with ezetimibe for raising HDL-c, with increase up to 6 percent more compared to high-potency statin monotherapy.
Fibrates: There is insufficient evidence to compare combination therapy with fibrate and statin to intensification of statin monotherapy regardless of statin potency.
Niacin: There is insufficient evidence to compare combination therapy with niacin and statin to intensification of statin monotherapy on lowering LDL-c, regardless of statin potency. Moderate SOE from three trials found that low-potency statin with niacin raises HDL-c up to 27 percent more than mid-potency statin monotherapy.
Omega-3 fatty acids: No relevant trials were found.
Conclusions:
Although many studies looked at intermediate outcomes, few studies addressed the question of which approach produces better clinical outcomes. Combination of statin with ezetimibe or bile acid sequestrant lowered LDL-c better than intensification of statin monotherapy, but evidence for clinical outcomes (mortality, acute coronary events, and revascularization procedures) was insufficient across all potency comparisons for all combination therapy regimens. Additional studies evaluating long-term clinical benefits and harms are needed to better inform clinical decisionmaking, patient choice, and clinical practice guidelines.
Contents
- Preface
- Acknowledgments
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Discussion
- Key Findings and Implications
- Evidence
- Important Unanswered Questions
- Findings in Relationship to What Is Already Known
- Applicability
- Implications for Clinical and Policy Decisionmaking
- Limitations of the Comparative Effectiveness Review Process
- Strengths and Limitations of the Evidence Base
- Future Research Needs
- Conclusions
- References
- Appendix A Acronyms and Abbreviations
- Appendix B Detailed Search Strategies
- Appendix C Screening and Data Abstraction Forms
- Appendix D List of Excluded Articles
- Appendix E Evidence Tables
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-0007-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
Suggested citation:
Monroe AK, Gudzune KA, Sharma R, Chelladurai Y, Ranasinghe PD, Ansari MT, Robinson KA. Combination Therapy Versus Intensification of Statin Monotherapy: An Update. Comparative Effectiveness Review No. 132. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2012-00007-I.) AHRQ Publication No. 14-EHC013-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00007-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, 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 health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
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.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
This report may periodically be assessed for the urgency to update. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
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540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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