The combination of 2 drug entities in one dosage form is known as a fixed-dose combination product (FDCP). For the treatment of type 2 diabetes, there are 2 products that combine a sulfonylurea with metformin, 2 that combine metformin with a thiazolidinedione, 1 that combines metformin with a Dipeptidyl-Peptidase 4 (DPP-4) Inhibitor, and 2 that combine a thiazolidinedione with a sulfonylurea. For treatment of hyperlipidemia, 2 FDCPs are available: Vytorin and Advicor. Advicor is a combination of an HMG-CoA Reductase Inhibitor (statin) - lovastatin with an extended release formulation of niacin, while Vytorin is a combination of another statin, simvastatin, and a newer drug ezetimibe. Although the individual components of the FDCPs in this report have been shown to improve health outcomes, we believe it is still important to show whether outcomes are the same under the conditions of the FDCP where it is suggested that adherence and convenience are improved but dose adjustments are more difficult. The purpose of this review is to determine whether the purported advantages of taking 1 pill rather than 2 to treat hyperlipidemia and type 2 diabetes outweigh the potential disadvantages of not being able to adjust the doses of the two drugs separately.

Contents

• Part I
  • Introduction
  • Methods
• Part II. Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes
  • Results
  • Summary
• Part III. Fixed Dose Combination Drug Products for the Treatment of Hyperlipidemia
  • Scope
  • Results
  • Summary
  • Acknowledgements
• References
• Appendixes
  • Appendix A. Systematic review of Fixed-dose Combination Drug Products (FDCP) for the treatment of diabetes and hyperlipidemia
  • Appendix B. Search strategies
  • Appendix C. Quality assessment methods of the Drug Effectiveness Review Project
  • Appendix D. Excluded studies for type 2 diabetes
  • Appendix E. Studies pending review
• Evidence Tables

The authors would like to thank David Smith, PhD and Eric Johnson PhD for their expert advice and contributions during the key question and analytic framework development phases and again during the peer review and public comment periods. We also thank our peer reviewers for taking the time to provide meaningful clinical and methodologic insight prior to finalization of this report.

The funding source, the Center for Evidence-based Policy, is supported by 17 organizations, including 15 state Medicaid programs. These organizations selected the topic and had input into the Key Questions for this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

Suggested citation:

McDonagh M, Peterson K, Thakurta SG, Dana, T. Drug Class Review on Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia. 2007. http://www.ohsu.edu/drugeffectiveness/reports/final.cfm

The Agency for Healthcare Research and Quality has not yet seen or approved this report.

The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.