Medline ® Abstracts for References 40-43
of 'Treatment of community-acquired pneumonia in adults who require hospitalization'
Does empirical therapy with a fluoroquinolone or the combination of aβ-lactam plus a macrolide result in better outcomes for patients admitted to the general ward?
Ruhe J, Mildvan D
Infect Dis Clin North Am. 2013 Mar;27(1):115-32. Epub 2012 Dec 1.
Community-acquired pneumonia (CAP) is a frequent cause of morbidity and mortality in the United States and worldwide, in particular among older patients and those with significant comorbid conditions. Current guidelines recommend therapy with a fluoroquinolone or aβ-lactam plus a macrolide for the treatment of hospitalized adults with CAP who do not require admission to an intensive care unit. This article provides a brief summary and overview of the existing literature on this topic categorized by the main results; the potential implications for future clinical practice and research are discussed.
Division of Infectious Diseases, Beth Israel Medical Center, Albert Einstein College of Medicine, New York, NY 10003, USA. email@example.com
http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm (Accessed September 2, 2010).
no abstract available
Excess deaths associated with tigecycline after approval based on noninferiority trials.
Prasad P, Sun J, Danner RL, Natanson C
Clin Infect Dis. 2012;54(12):1699. Epub 2012 Mar 30.
BACKGROUND: On the basis of noninferiority trials, tigecycline received Food and Drug Administration (FDA) approval in 2005. In 2010, the FDA warned in a safety communication that tigecycline was associated with an increased risk of death.
METHODS: PubMed, EMBASE, Scopus, and ClinicalTrials.gov were searched using the terms "tigecycline" and "randomized controlled trial (RCT)" through April 2011. Excess deaths and noncure rates for both approved and nonapproved indications were examined using meta-analysis.
RESULTS: Ten published and 3 unpublished studies met inclusion criteria (N = 7434). No significant heterogeneity was seen for mortality (I(2 )= 0%; P = .99) or noncure rates (I(2 )= 25%; P = .19). Across randomized controlled trials, tigecycline was associated with increased mortality (risk difference [RD], 0.7%; 95% confidence interval [CI], 0.1%-1.2%; P = .01) and noncure rates (RD, 2.9%; 95% CI, 0.6%-5.2%; P = .01). Effects were not isolated to type of infection or comparator antibiotic regimen, and the impact on survival remained significant when limited to trials of approved indications (I(2 )= 0%;RD, 0.6%; P = .04). A pooled analysis of the 5 trials completed by early 2005 before tigecycline was approved would have demonstrated a similar harmful effect of tigecycline on survival (I(2 )= 0%; RD, 0.7%; P = .06).
CONCLUSIONS: Pooling noninferiority studies to examine survival may help ensure the safety and efficacy of new antibiotics. The association of tigecycline with excess deaths and noncure includes indications for which it is approved and marketed. Tigecycline cannot be relied on in serious infections.
Critical Care Medicine Department, National Institutes of Health, Bethesda, Maryland, USA. firstname.lastname@example.org
US Food and Drug Administration (FDA). FDA drug safety communication: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new boxed warning. http://www.fda.gov/Drugs/DrugSafety/ucm369580.htm (Accessed on October 09, 2013).
no abstract available