Exposure–response analyses of tigecycline tolerability in healthy subjects

Passarell, Julie; Ludwig, Elizabeth; Liolios, Kathryn; Meagher, Alison; Grasela, Thaddeus H.; Babinchak, Timothy; Ellis-Grosse, Evelyn J.

doi:10.1016/j.diagmicrobio.2009.06.019

Cited by 12 publications

(7 citation statements)

References 15 publications

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“…In contrast to the current study and these previous reports, another report has documented failure of tigecycline in the acute treatment of MRSA calcaneal osteomyelitis (Polilli et al, 2012); however, this patient had also failed a previous regimen and was plagued by multiple comorbidities, making it difficult to generalize the findings. The preponderance of gastrointestinal side effects noted in our analysis is similar to that seen in prior literature (Passarell et al, 2009;Tasina et al, 2011), although we did not find a dose-response relationship.…”

Section: Discussionsupporting

confidence: 87%

Tigecycline in the management of osteomyelitis: a case series from the bone and joint infection (BAJIO) database

Griffin

Harting

Christensen

2013

Diagnostic Microbiology and Infectious Disease

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Section: Discussionsupporting

confidence: 87%

Tigecycline in the management of osteomyelitis: a case series from the bone and joint infection (BAJIO) database

Griffin

Harting

Christensen

2013

Diagnostic Microbiology and Infectious Disease

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“…An increased incidence of AEs in the hemic and lymphatic system and the body as a whole (including fever, headache, infection, abdominal pain, chills, and pain) were also found in tigecycline-treated patients. Nausea and diarrhea were also confirmed to be the adverse drug reactions most often reported in both healthy volunteers and clinically infected patients in many other studies of tigecycline treatment (14,25,31,34,46). The possibility of tigecycline-induced acute pancreati- on May 8, 2018 by guest http://aac.asm.org/ tis has recently been raised (19,23) and has also been associated with the tetracycline class of antibiotics.…”

Section: Discussionmentioning

confidence: 83%

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Cai

Wang

Liang

et al. 2011

Antimicrob Agents Chemother

173

103

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The aim of this study was to compare the efficacy and safety of tigecycline, a newly developed glycylcycline antibiotic, with those of empirical antibiotic regimens which have been reported to possess good efficacy for complicated skin and skin structure infections (cSSSIs), complicated intra-abdominal infections (cIAIs), community-acquired pneumonia (CAP), and other infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE CI ‫؍‬ 0.69 to 1.07, P ‫؍‬ 0.19). The incidence of adverse events in the tigecycline group was significantly higher than that in the other therapy groups with a statistical margin (for the modified intent-to-treat [mITT] population, OR ‫؍‬ 1.33, 95% CI ‫؍‬ 1.17 to 1.52, P < 0.0001), especially in the digestive system (mITT population, OR ‫؍‬ 2.41, 95% CI ‫؍‬ 1.67 to 3.46, P < 0.00001). No difference regarding all-cause mortality and drug-related mortality between tigecycline and the other regimens was found, although numerically higher mortality was found in the tigecycline group. This meta-analysis provides evidence that tigecycline monotherapy may be used as effectively as the comparison therapy for cSSSI, cIAIs, CAP, and infections caused by MRSA/VRE. However, because of the high risk of mortality, AEs, and emergence of resistant isolates, prudence with the clinical use of tigecycline monotherapy in infections is required.The threat of antimicrobial resistance has been identified as one of the major challenges facing public health, and antimicrobial resistance has increased rates of morbidity and mortality and socioeconomic costs. The rapid rate of microbial evolution underscores the urgent need for development of new agents that overcome existing mechanisms of resistance displayed by multidrug-resistant bacteria.Tigecycline is a first-in-class expanded-broad-spectrum glycylcycline. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit but with a five times higher affinity than that for the tetracyclines (4). In vitro studies demonstrate that it has good activity against many commonly encountered respiratory bacteria, including multiple resistant Gram-positive, Gram-negative, anaerobic, as well as multidrug-resistant (MDR) pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus (VRE), penicillin-resistant Streptococcus pneumoniae (PRSP), and ␤-lactamase-producing Haemophilus influenzae, among others (5). Tigecycline overcomes the two key tetracycline resistance mechanisms (efflux pumps and ribosomal protection) and is unaffected by other bacterial mechanisms of resistance, such as extended-spectrum ␤-lactamases (32).Tigecycline was first approved for use for indications of complicated skin and skin structure infections (cSSSIs) and complicated intra-abdominal infections (cIAIs). Currently, it is approved for use for community-acquired pneumonia (CAP). It has also been found to be effective for the trea...

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“…Across both of the studies in cSSSI patients, nausea was the most common AE; all such events were of mild or moderate intensity and did not lead to treatment discontinuation in any of the completed studies. In contrast, dose-limiting nausea and vomiting occurs with intravenous tigecycline and with both intravenous and oral administration of eravacycline [31][32][33][34][35][36]. Because it is well tolerated, especially with regard to GI effects of nausea and vomiting that are common with many antibiotics, omadacycline may be particularly well suited for treatment of community-acquired bacterial infections, whether they are managed in hospital or as outpatients.…”

Section: Clinical Safety and Tolerabilitymentioning

confidence: 99%

Omadacycline: Development of a Novel Aminomethylcycline Antibiotic for Treating Drug-Resistant Bacterial Infections

2016

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Omadacycline is a first-in-class aminomethylcycline antibiotic that circumvents common tetracycline resistance mechanisms. In vitro omadacycline has potent activity against Gram-positive aerobic bacteria including methicillin-resistant Staphylococcus aureus, penicillin-resistant and multidrug-resistant Streptococcus pneumoniae, and vancomycin-resistant Enterococcus spp. It is also active against common Gram-negative aerobes, some anaerobes and atypical bacteria including Legionella spp. and Chlamydia spp. Ongoing Phase III clinical trials with omadacycline are investigating once daily doses of 100 mg intravenously followed by once-daily doses of 300 mg orally for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. This paper provides an overview of the microbiology, nonclinical evaluations, clinical pharmacology and initial clinical experience with omadacycline.

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Exposure–response analyses of tigecycline tolerability in healthy subjects

Cited by 12 publications

References 15 publications

Tigecycline in the management of osteomyelitis: a case series from the bone and joint infection (BAJIO) database

Tigecycline in the management of osteomyelitis: a case series from the bone and joint infection (BAJIO) database

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Omadacycline: Development of a Novel Aminomethylcycline Antibiotic for Treating Drug-Resistant Bacterial Infections

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