Omadacycline
Omadacycline is a tetracycline antibiotic available in the US for treatment of acute bacterial skin and skin structure infections (ABSSSIs) due to Staphylococcus aureus (including MRSA), Staphylococcus lugdunensis, Streptococcus anginosus group, Streptococcus pyogenes, Enterococcus faecalis, Klebsiella pneumoniae, and Enterobacter cloacae.[68]Gallagher JC. Omadacycline: a modernized tetracycline. Clin Infect Dis. 2019 Aug 1;69(suppl 1):S1-5.
https://academic.oup.com/cid/article/69/Supplement_1/S1/5541766
http://www.ncbi.nlm.nih.gov/pubmed/31367739?tool=bestpractice.com
[69]Lan SH, Lin WT, Chang SP, et al. Novel tetracyclines versus alternative antibiotics for treating acute bacterial infection: a meta-analysis of randomized controlled trials. Antibiotics (Basel). 2019 Nov 22;8(4):10.3390/antibiotics8040233.
https://www.mdpi.com/2079-6382/8/4/233/htm
http://www.ncbi.nlm.nih.gov/pubmed/31766782?tool=bestpractice.com
A submission was also made to the European Medicines Agency (EMA) in 2018 on the basis of two phase 3 studies in patients with ABSSSIs.[70]O'Riordan W, Green S, Overcash JS, et al. Omadacycline for acute bacterial skin and skin-structure infections. N Engl J Med. 2019 Feb 7;380(6):528-38.
https://www.nejm.org/doi/full/10.1056/NEJMoa1800170
http://www.ncbi.nlm.nih.gov/pubmed/30726689?tool=bestpractice.com
[71]O'Riordan W, Cardenas C, Shin E, et al; OASIS-2 Investigators. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019 Oct;19(10):1080-90.
http://www.ncbi.nlm.nih.gov/pubmed/31474458?tool=bestpractice.com
However, the application was withdrawn by the manufacturer in 2019.
Prostaglandin E1
The 2007 TASC II consensus document on the management of peripheral arterial disease (PAD) does not recommend prostaglandin E1 or any other prostanoids for the management of limb-threatening ischaemia.[62]Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease. Int Angiol. 2007 Jun;26(2):81-157.
http://www.ncbi.nlm.nih.gov/pubmed/17489079?tool=bestpractice.com
One Cochrane review showed no effect of prostanoids on the incidence of total amputations (high-quality evidence).[72]Vietto V, Franco JV, Saenz V, et al. Prostanoids for critical limb ischaemia. Cochrane Database Syst Rev. 2018 Jan 10;(1):CD006544.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006544.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/29318581?tool=bestpractice.com
However, in patients with advanced PAD unsuitable for any other form of intervention, prostanoids have been shown to relieve rest pain and ulcer healing, although with a higher incidence of adverse events (moderate-quality evidence).[72]Vietto V, Franco JV, Saenz V, et al. Prostanoids for critical limb ischaemia. Cochrane Database Syst Rev. 2018 Jan 10;(1):CD006544.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006544.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/29318581?tool=bestpractice.com
Stimulation of angiogenesis
This treatment involves the administration of angiogenic growth factors, as recombinant protein or naked DNA, to augment the collateral circulation and enhance blood flow to ischaemic tissues. Another approach is the autologous implantation of bone marrow mononuclear cells to stimulate angiogenesis, or multiple intramuscular injections of autologous granulocyte colony-stimulating factor.[73]Huang P, Li S, Han M, et al. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60.
https://care.diabetesjournals.org/content/28/9/2155.long
http://www.ncbi.nlm.nih.gov/pubmed/16123483?tool=bestpractice.com