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Why maximum tolerated dose?

Hans G Stampfer1, Genevieve M Gabb2, Simon B Dimmitt3,4

  • 1Division of Psychiatry, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Crawley, Western Australia.

British Journal of Clinical Pharmacology
|June 21, 2019
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Summary
This summary is machine-generated.

Clinicians often prescribe the maximum tolerated dose (MTD) of medications, but evidence for improved outcomes is lacking. This review examines the origins and potential issues with MTD prescribing, suggesting the effective dose 50 (ED50) may balance efficacy and safety.

Keywords:
clinical pharmacologydosing outcomeseffective dose 50maximum tolerated dose

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Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Drug Dosing

Background:

  • The traditional "start low and go slow" approach to drug dosing is often abandoned in clinical practice.
  • Clinicians frequently prescribe the maximum tolerated dose (MTD) for acute and severe conditions, and sometimes even for prevention (e.g., hypercholesterolemia).
  • There is a lack of robust evidence demonstrating that MTD improves patient outcomes compared to other dosing strategies.

Purpose of the Study:

  • To explore the historical origins of prescribing medications at MTD.
  • To identify potential problems and drawbacks associated with the MTD approach.
  • To evaluate alternative dosing guidance, such as the effective dose 50 (ED50), for optimizing drug therapy.

Main Methods:

  • Literature review and critical analysis of existing pharmacological and clinical guidelines.
  • Examination of the evidence base supporting MTD prescribing in various disease states.
  • Discussion of the theoretical underpinnings and practical implications of MTD.

Main Results:

  • The MTD approach is prevalent but often lacks strong empirical support for superior efficacy or improved outcomes.
  • Potential risks and adverse effects may be increased when prescribing at MTD without clear benefit.
  • The effective dose 50 (ED50) is presented as a potentially useful metric for achieving a better balance between therapeutic efficacy and patient safety.

Conclusions:

  • The routine prescription of maximum tolerated doses (MTD) in clinical practice warrants critical re-evaluation.
  • Evidence supporting the universal benefit of MTD over other dosing strategies is limited, particularly in preventive care.
  • The effective dose 50 (ED50) offers a promising alternative for guiding drug selection to optimize the balance between efficacy and safety in pharmacological treatment.