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Topical retapamulin in the management of infected traumatic skin lesions.

Shawar R, Scangarella-Oman N, Dalessandro M, Breton J, Twynholm M, Li G, Garges H - Ther Clin Risk Manag (2009)

Bottom Line: In vitro studies show that retapamulin has high potency against the Gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, and coagulase-negative staphylococci) commonly found in skin and skin-structure infections (SSSIs), including S. aureus strains with resistance to agents such as macrolides, fusidic acid, or mupirocin, and other less common organisms associated with SSSIs, anaerobes, and common respiratory tract pathogens.A 1% concentration of retapamulin ointment has been approved for clinical use as an easily applied treatment with a short, convenient dosing regimen for impetigo.Given the novel mode of action, low potential for cross-resistance with established antibacterial agents, and high in vitro potency against many bacterial pathogens commonly recovered from SSSIs, retapamulin is a valuable enhancement over existing therapeutic options.

View Article: PubMed Central - PubMed

Affiliation: Infectious Disease Center for Excellence in Drug Discovery, GlaxoSmithKline, Collegeville, PA, USA;

ABSTRACT
Retapamulin is a novel semisynthetic pleuromutilin antibiotic specifically designed for use as a topical agent. The unique mode of action by which retapamulin selectively inhibits bacterial protein synthesis differentiates it from other nonpleuromutilin antibacterial agents that target the ribosome or ribosomal factors, minimizing the potential for target-specific cross-resistance with other antibacterial classes in current use. In vitro studies show that retapamulin has high potency against the Gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, and coagulase-negative staphylococci) commonly found in skin and skin-structure infections (SSSIs), including S. aureus strains with resistance to agents such as macrolides, fusidic acid, or mupirocin, and other less common organisms associated with SSSIs, anaerobes, and common respiratory tract pathogens. Clinical studies have shown that twice-daily topical retapamulin for 5 days is comparable to 10 days of oral cephalexin in the treatment of secondarily infected traumatic lesions. A 1% concentration of retapamulin ointment has been approved for clinical use as an easily applied treatment with a short, convenient dosing regimen for impetigo. Given the novel mode of action, low potential for cross-resistance with established antibacterial agents, and high in vitro potency against many bacterial pathogens commonly recovered from SSSIs, retapamulin is a valuable enhancement over existing therapeutic options.

No MeSH data available.


Related in: MedlinePlus

Clinical success rates at follow-up in the per-protocol clinical populations from randomized controlled clinical trials comparing topical retapamulin, 1%, twice daily for 5 days, with placebo in the treatment of impetigo and oral cephalexin, 500 mg, twice daily for 10 days, in the treatment of secondarily infected traumatic lesions (SITLs) and secondarily infected dermatitis (SID). Drawn from data of Koning et al,11 Free et al,30 and Parish et al.31
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f2-tcrm-5-0041: Clinical success rates at follow-up in the per-protocol clinical populations from randomized controlled clinical trials comparing topical retapamulin, 1%, twice daily for 5 days, with placebo in the treatment of impetigo and oral cephalexin, 500 mg, twice daily for 10 days, in the treatment of secondarily infected traumatic lesions (SITLs) and secondarily infected dermatitis (SID). Drawn from data of Koning et al,11 Free et al,30 and Parish et al.31

Mentions: The efficacy, safety, and tolerability of topical retapamulin ointment, 1%, was demonstrated in two identical, randomized, double-blind, double-dummy, active-controlled, multicenter studies in 1904 patients with SITLs. In these studies, the clinical efficacy of retapamulin was high and comparable to that of cephalexin. Using a prespecified non-inferiority margin of 10%, retapamulin ointment, 1%, applied twice daily for 5 days, was shown to be non-inferior to oral cephalexin, 500 mg, twice daily for 10 days in both studies.30 In the per-protocol (PP) analyses, the pooled clinical success rates at follow-up (7–9 days post-therapy) were 89.5% in patients receiving retapamulin, compared with 91.9% for patients treated with cephalexin (treatment difference: −2.5%; 95% confidence interval [CI]: −5.4%, 0.5%) (Figure 2).30 In patients with S. aureus or S. pyogenes at baseline, clinical success rates at follow-up for patients treated with retapamulin and cephalexin were 89.2% (365/409) and 92.6% (63/68), respectively.


Topical retapamulin in the management of infected traumatic skin lesions.

Shawar R, Scangarella-Oman N, Dalessandro M, Breton J, Twynholm M, Li G, Garges H - Ther Clin Risk Manag (2009)

Clinical success rates at follow-up in the per-protocol clinical populations from randomized controlled clinical trials comparing topical retapamulin, 1%, twice daily for 5 days, with placebo in the treatment of impetigo and oral cephalexin, 500 mg, twice daily for 10 days, in the treatment of secondarily infected traumatic lesions (SITLs) and secondarily infected dermatitis (SID). Drawn from data of Koning et al,11 Free et al,30 and Parish et al.31
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2697516&req=5

f2-tcrm-5-0041: Clinical success rates at follow-up in the per-protocol clinical populations from randomized controlled clinical trials comparing topical retapamulin, 1%, twice daily for 5 days, with placebo in the treatment of impetigo and oral cephalexin, 500 mg, twice daily for 10 days, in the treatment of secondarily infected traumatic lesions (SITLs) and secondarily infected dermatitis (SID). Drawn from data of Koning et al,11 Free et al,30 and Parish et al.31
Mentions: The efficacy, safety, and tolerability of topical retapamulin ointment, 1%, was demonstrated in two identical, randomized, double-blind, double-dummy, active-controlled, multicenter studies in 1904 patients with SITLs. In these studies, the clinical efficacy of retapamulin was high and comparable to that of cephalexin. Using a prespecified non-inferiority margin of 10%, retapamulin ointment, 1%, applied twice daily for 5 days, was shown to be non-inferior to oral cephalexin, 500 mg, twice daily for 10 days in both studies.30 In the per-protocol (PP) analyses, the pooled clinical success rates at follow-up (7–9 days post-therapy) were 89.5% in patients receiving retapamulin, compared with 91.9% for patients treated with cephalexin (treatment difference: −2.5%; 95% confidence interval [CI]: −5.4%, 0.5%) (Figure 2).30 In patients with S. aureus or S. pyogenes at baseline, clinical success rates at follow-up for patients treated with retapamulin and cephalexin were 89.2% (365/409) and 92.6% (63/68), respectively.

Bottom Line: In vitro studies show that retapamulin has high potency against the Gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, and coagulase-negative staphylococci) commonly found in skin and skin-structure infections (SSSIs), including S. aureus strains with resistance to agents such as macrolides, fusidic acid, or mupirocin, and other less common organisms associated with SSSIs, anaerobes, and common respiratory tract pathogens.A 1% concentration of retapamulin ointment has been approved for clinical use as an easily applied treatment with a short, convenient dosing regimen for impetigo.Given the novel mode of action, low potential for cross-resistance with established antibacterial agents, and high in vitro potency against many bacterial pathogens commonly recovered from SSSIs, retapamulin is a valuable enhancement over existing therapeutic options.

View Article: PubMed Central - PubMed

Affiliation: Infectious Disease Center for Excellence in Drug Discovery, GlaxoSmithKline, Collegeville, PA, USA;

ABSTRACT
Retapamulin is a novel semisynthetic pleuromutilin antibiotic specifically designed for use as a topical agent. The unique mode of action by which retapamulin selectively inhibits bacterial protein synthesis differentiates it from other nonpleuromutilin antibacterial agents that target the ribosome or ribosomal factors, minimizing the potential for target-specific cross-resistance with other antibacterial classes in current use. In vitro studies show that retapamulin has high potency against the Gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, and coagulase-negative staphylococci) commonly found in skin and skin-structure infections (SSSIs), including S. aureus strains with resistance to agents such as macrolides, fusidic acid, or mupirocin, and other less common organisms associated with SSSIs, anaerobes, and common respiratory tract pathogens. Clinical studies have shown that twice-daily topical retapamulin for 5 days is comparable to 10 days of oral cephalexin in the treatment of secondarily infected traumatic lesions. A 1% concentration of retapamulin ointment has been approved for clinical use as an easily applied treatment with a short, convenient dosing regimen for impetigo. Given the novel mode of action, low potential for cross-resistance with established antibacterial agents, and high in vitro potency against many bacterial pathogens commonly recovered from SSSIs, retapamulin is a valuable enhancement over existing therapeutic options.

No MeSH data available.


Related in: MedlinePlus