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Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review

Anthony D Bai1, Adam S Komorowski2, Carson K L Lo3

  • 1Division of Infectious Diseases, McMaster University, Hamilton, Ontario, Canada anthony.bai@medportal.ca.

Antimicrobial Agents and Chemotherapy
|September 9, 2020
PubMed

Insights

Novel antibiotics face potential reduced effectiveness, but a review of 175 noninferiority trials found this risk to be rare. This systematic review assessed antibiotic treatment effects and control arm efficacy in noninferiority studies.

Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • Evidence-Based Medicine

Background:

  • Novel antibiotics are crucial for combating antimicrobial resistance.
  • Noninferiority trials are commonly used to approve new antibiotics.
  • Concerns exist regarding the long-term effectiveness of antibiotics approved via noninferiority trials.

Purpose of the Study:

  • To systematically review noninferiority trials of novel antibiotics.
  • To assess the risk of reduced antibiotic effectiveness over time.
  • To evaluate two specific scenarios that could lead to decreased efficacy.

Main Methods:

  • Systematic review of 175 noninferiority antibiotic trials.
  • Analysis of treatment effects for novel versus older antibiotics.
  • Evaluation of control arm effectiveness in sequential trials.

Main Results:

  • The scenarios leading to reduced effectiveness of novel antibiotics were found to be rare.
  • Treatment effects in novel antibiotic studies were not consistently worse than older antibiotics.
  • Decreasingly effective control arms were infrequently observed in noninferiority trials.

Conclusions:

  • The risk of novel antibiotics becoming less effective due to the assessed scenarios appears low.
  • Current noninferiority trial designs for antibiotics are generally robust.
  • Further monitoring of antibiotic effectiveness in real-world settings is warranted.
Keywords:
anti-infective agentsantibacterial agentsnoninferiority trialssystematic review

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