PMID- 21685488 OWN - NLM STAT- MEDLINE DCOM- 20111014 LR - 20220317 IS - 1460-2091 (Electronic) IS - 0305-7453 (Linking) VI - 66 IP - 9 DP - 2011 Sep TI - Efficacy and safety of tigecycline: a systematic review and meta-analysis. PG - 1963-71 LID - 10.1093/jac/dkr242 [doi] AB - BACKGROUND: Tigecycline is a novel glycylcycline that exhibits broad-spectrum antibacterial activity. Recently, the US FDA issued a warning concerning increased mortality with tigecycline in randomized controlled trials (RCTs). METHODS: We conducted a systematic review and meta-analysis of RCTs that compared tigecycline with any other antibiotic regimen for the treatment of any infection. A comprehensive search, without publication status or other restrictions, was conducted. The primary outcome was overall 30 day mortality. The secondary outcome included clinical and microbiological failure, superinfections and adverse events (AEs). The trials' risks of bias and their effects on results were assessed. Two reviewers independently extracted the data. Individual trials' relative risks (RRs) were pooled using a fixed effect meta-analysis. RESULTS: Fifteen trials (7654 patients) were included. Overall mortality was higher with tigecycline compared with other regimens [RR 1.29, 95% confidence interval (CI) 1.02-1.64, without heterogeneity]. The type of infection assessed and the trials' reported risks of bias did not affect this result. Clinical failure was significantly higher with tigecycline (RR 1.16, 95% CI 1.06-1.27) and non-statistically significant higher rates of microbiological failure were demonstrated (RR 1.13, 95% CI 0.99-1.30). Development of septic shock was significantly more frequent with tigecycline (RR 7.01, 95% CI 1.27-38.66). Superinfections were significantly more common with tigecycline and so were AEs, including all AEs and AEs requiring discontinuation. CONCLUSIONS: In the light of the increased mortality, probably explained by decreased clinical and microbiological efficacy, clinicians should avoid tigecycline monotherapy in the treatment of severe infections and reserve it as a last-resort drug. FAU - Yahav, Dafna AU - Yahav D AD - Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tiqva, Israel. dafna.yahav@gmail.com FAU - Lador, Adi AU - Lador A FAU - Paul, Mical AU - Paul M FAU - Leibovici, Leonard AU - Leibovici L LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20110618 PL - England TA - J Antimicrob Chemother JT - The Journal of antimicrobial chemotherapy JID - 7513617 RN - 0 (Anti-Bacterial Agents) RN - 70JE2N95KR (Tigecycline) RN - FYY3R43WGO (Minocycline) SB - IM CIN - J Antimicrob Chemother. 2011 Dec;66(12):2892-3; author reply 2895-6. PMID: 21862475 CIN - J Antimicrob Chemother. 2011 Dec;66(12):2893-5; author reply 2895-6. PMID: 21921075 MH - Anti-Bacterial Agents/*adverse effects/*therapeutic use MH - Bacterial Infections/*drug therapy/microbiology/mortality MH - Confidence Intervals MH - Humans MH - Minocycline/adverse effects/*analogs & derivatives/therapeutic use MH - Randomized Controlled Trials as Topic MH - Shock, Septic/etiology MH - Tigecycline MH - Treatment Failure MH - Treatment Outcome EDAT- 2011/06/21 06:00 MHDA- 2011/10/15 06:00 CRDT- 2011/06/21 06:00 PHST- 2011/06/21 06:00 [entrez] PHST- 2011/06/21 06:00 [pubmed] PHST- 2011/10/15 06:00 [medline] AID - dkr242 [pii] AID - 10.1093/jac/dkr242 [doi] PST - ppublish SO - J Antimicrob Chemother. 2011 Sep;66(9):1963-71. doi: 10.1093/jac/dkr242. Epub 2011 Jun 18.