From the Guidelines
The advantages of fixed drug combinations (FDCs), excluding cheaper cost, increased efficacy, better compliance, and reduced resistance, include simplified treatment regimens and earlier achievement of treatment targets.
- FDCs can be given in low dose ranges, which are more likely to be free of side effects compared to full dose monotherapy 1.
- They can also avoid the frustration of searching for effective monotherapies in patients with very high blood pressure values or organ damage 1.
- Additionally, FDCs can reduce the risk of patients taking only one drug, which can help prevent the development of resistance 1.
- The use of FDCs can also enable early identification of nonadherence and adverse drug reactions 1.
- Furthermore, FDCs can simplify treatment and optimize compliance by allowing the administration of two agents in a single tablet 1.
- In the context of tuberculosis treatment, FDCs can prevent the spread of drug resistance when used in combination with directly observed therapy (DOT) 1.
- In general, FDCs can improve treatment outcomes by reducing the complexity of treatment regimens and improving patient adherence 1.
From the Research
Advantages of Fixed Drug Combinations
The advantages of fixed drug combinations (FDCs) include:
- Reduced pill burden compared to separate pills, which can simplify treatment regimens and improve medication concordance 2, 3
- Greater convenience for patients, as FDCs can reduce the number of pills to be taken and improve tolerability 3, 4
- Potential for synergy and increased efficacy, as well as reduced side effects 4
- Improved medication concordance, as patients are more likely to adhere to a simplified treatment regimen 2, 3
- Reduced risk of adverse reactions relative to higher dose monotherapy 2
Specific Advantages in Certain Therapeutic Areas
In the treatment of type 2 diabetes mellitus (T2DM), FDCs can offer several advantages, including:
- Simplification of complex treatment regimens, which can lead to improved glycaemic control 2, 3
- Reduced dose frequency and improved tolerability, particularly with FDCs containing metformin extended-release (XR) 3
- Equivalent efficacy with reduced dose frequency and potentially fewer gastrointestinal events compared to standard immediate-release (IR) formulations 3
Regulatory Considerations
The regulatory approval process for FDCs involves consideration of several factors, including:
- The potential advantages and disadvantages of the combination, including increased compliance, convenience, and cost savings, as well as reduced flexibility in dosing and potential increased risks of adverse effects 5
- The need for each component to make a contribution to the claimed effects, and for the dosage of each component to be safe and effective for a significant patient population requiring concurrent therapy 5