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Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated

Thangavel Mahalingam Vijayakumar1, Jayasutha Jayram1, Vishnu Meghana Cheekireddy1

  • 1Department of Pharmacy Practice, SRM College of Pharmacy, SRM University, Kattankulathur, Tamil Nadu, India.

Current Therapeutic Research, Clinical and Experimental
|August 2, 2017
PubMed
Abstract

Insights

Fixed-dose combinations (FDCs) of oral hypoglycemic agents improve glycemic control in type 2 diabetes mellitus (T2DM) when monotherapy fails. FDCs offer better adherence and fewer adverse events than dual therapy, making them effective add-on treatments.

Area of Science:

  • Pharmacology
  • Endocrinology
  • Clinical Pharmacy

Background:

  • Type 2 diabetes mellitus (T2DM) management often requires combination therapy due to progressive insulin resistance.
  • Fixed-dose combinations (FDCs) of oral hypoglycemic agents (OHAs) provide a convenient option for add-on therapy.
  • Monotherapy may not achieve sustained glycemic control in T2DM patients over time.

Purpose of the Study:

  • To systematically review current evidence on the safety, efficacy, and bioavailability of FDCs for T2DM.
  • To evaluate the role of FDCs as an add-on therapy in T2DM management.
  • To assess the benefits of FDCs compared to individual OHA formulations.

Main Methods:

  • Comprehensive literature search across multiple databases (PubMed, Scopus, Embase, etc.).
  • Inclusion of studies focusing on safety, efficacy, and bioavailability of OHA FDCs.
  • Keywords used: FDCs, combination therapy, T2DM management, add-on therapy.

Main Results:

  • FDCs significantly reduce HbA1c and fasting plasma glucose levels in T2DM patients.
  • FDCs are bioequivalent to their individual components and improve patient adherence.
  • FDCs demonstrate a favorable safety profile with fewer serious adverse events compared to dual therapy.

Conclusions:

  • Metformin is a common component in T2DM FDCs.
  • Limited data exists on the safety and efficacy of newer OHAs in FDC formulations, such as SGLT2 inhibitors.
  • Emerging FDCs show promise as improved treatment options for T2DM.
Keywords:
bioavailabilityfixed-dose combinationsglycemic controlhyperglycemiamonotherapy

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