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Related Concept Videos

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Clinical Significance of Antibiotic Resistance01:25

Clinical Significance of Antibiotic Resistance

Methicillin-resistant Staphylococcus aureus (MRSA) presents a critical public health threat, arising from its capacity to resist β-lactam antibiotics due to acquisition of the mecA gene within the staphylococcal cassette chromosome mec (SCCmec). This gene encodes penicillin-binding protein 2a (PBP2a), which impairs binding efficacy of methicillin and other β-lactams. MRSA has evolved into distinct clonal lineages impacting humans and animals alike, reinforcing its significance within the One...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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The effectiveness of antimicrobial agents depends on various factors influencing their ability to eliminate microbial populations. Larger microbial populations require more time for complete eradication, emphasizing the importance of population size analysis when evaluating antimicrobial efficacy.Microbial resistance to antimicrobial agents varies significantly. Highly resilient microorganisms include endospores, gram-negative bacteria, and non-enveloped viruses, while prions are exceptionally...
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Cefoperazone-treated Mouse Model of Clinically-relevant Clostridium difficile Strain R20291
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Is cefepime safe for clinical use? A Bayesian viewpoint.

Andre C Kalil1

  • 1Infectious Diseases Division, University of Nebraska Medical Center, Omaha, NE 68198-5400, USA. akalil@unmc.edu

The Journal of Antimicrobial Chemotherapy
|April 8, 2011
PubMed
Summary
This summary is machine-generated.

Cefepime may increase mortality in patients with neutropenic fever or skin infections, despite FDA reassurances. Bayesian analysis suggests a significant probability of harm, recommending avoidance in these patient groups.

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A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii
09:17

A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii

Published on: January 2, 2017

Area of Science:

  • Infectious Diseases
  • Pharmacovigilance
  • Clinical Pharmacology

Background:

  • Cefepime hydrochloride is indicated for various infections, including pneumonia, febrile neutropenia, and skin/urinary tract infections.
  • A prior meta-analysis suggested increased cefepime-associated mortality, prompting FDA re-evaluation.
  • The FDA's subsequent alert concluded cefepime remains appropriate, but safety concerns persist.

Purpose of the Study:

  • To re-appraise the safety of cefepime, specifically its association with mortality.
  • To evaluate the probability of increased mortality in patients treated with cefepime using Bayesian methods.
  • To determine the number needed to harm (NNH) for cefepime in specific patient populations.

Main Methods:

  • Bayesian re-appraisal of meta-analysis data from Yahav et al. and FDA re-evaluation.
  • Analysis of trial-level and patient-level data.
  • Calculation of probabilities of increased mortality and NNH for cefepime.

Main Results:

  • Bayesian analysis indicated a high probability of cefepime increasing mortality in neutropenic fever patients (90.9% by FDA trial-level, 80.8% by FDA patient-level, 99.2% by Yahav et al.).
  • NNH estimates for cefepime causing extra deaths in neutropenic fever ranged from 54 to 109.
  • Similar harmful probabilities were noted for skin structure infections, but not for pneumonia, intra-abdominal, or urinary tract infections.

Conclusions:

  • Cefepime use is associated with a significant probability of increased mortality in patients with neutropenic fever.
  • Cefepime should be avoided in patients diagnosed with neutropenic fever or skin structure infections.
  • Further investigation into cefepime's safety profile is warranted, particularly for specific indications.