An Open Label, Multi-Center, Non-Interventional Post-Marketing Surveillance to Monitor the Safety and Efficacy of ALTARGOⓇ (Retapamulin) Administered in Korean Patients According to the Prescribing Information
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background: With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS). Objective: This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices. Methods: Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015. All subjects had bacterial skin infections of locally approved prescribing information accordingly. The study mainly focused on safety issues in the local target population (3,612 eligible subjects). And, drug effectiveness was also evaluated by physicians. Results: The incidence of adverse events (AEs) and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects). Conclusion: Topical retapamulin is to be well-tolerated and effective in patients with bacterial skin infections of locally approved prescribing information.
Abstract
Background: With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS). Objective: This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices. Methods: Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015. All subjects had bacterial skin infections of locally approved prescribing information accordingly. The study mainly focused on safety issues in the local target population (3,612 eligible subjects). And, drug effectiveness was also evaluated by physicians. Results: The incidence of adverse events (AEs) and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects). Conclusion: Topical retapamulin is to be well-tolerated and effective in patients with bacterial skin infections of locally approved prescribing information.
참고문헌 (26)
- Champney WS, "Retapamulin inhibition of translation and 50S ribosomal subunit formation in staphylococcus aureus cells", Antimicrob Agents Chemother, 51, pp.3385~3387 (2007)[DOI]
- Wolf R, "Emergency dermatology", pp.376~ (2011), Cambridge University Press
- Jones RN, "Activity of retapamulin (SB-275833), a novel pleuromutilin, against selected resistant gram-positive cocci", Antimicrob Agents Chemother, 50, pp.2583~2586 (2006)[DOI]
- [URL]
- Kirst HA, "Developing new antibacterials through natural product research", Expert Opin Drug Discov, 8, pp.479~493 (2013)[DOI]
- Yang LP, "Retapamulin: a review of its use in the management of impetigo and other uncomplicated superficial skin infections", Drugs, 68, pp.855~873 (2008)[DOI]
- Tang YZ, "Pleuromutilin and its derivatives-the lead compounds for novel antibiotics", Mini Rev Med Chem, 12, pp.53~61 (2012)[DOI]
- Scangarella-Oman NE, "Microbiological profile of a new topical antibacterial: retapamulin ointment 1%", Expert Rev Anti Infect Ther, 7, pp.269~279 (2009)[DOI]
- Jacobs MR, "Retapamulin: a semisynthetic pleuromutilin compound for topical treatment of skin infections in adults and children", Future Microbial, 2, pp.591~600 (2007)[DOI]
- Parish LC, "Retapamulin: a new topical antibiotic for the treatment of uncomplicated skin infections", Drugs Today (Barc), 44, pp.91~102 (2008)[DOI]
- "Physician's desk reference 2009. 63rd ed", ~ (2008)
- Novak R, "Are pleuromutilin antibiotics finally fit for human use?", Ann N Y Acad Sci, 1241, pp.71~81 (2011)[DOI]
- Stevens DL, "Practice guidelines for the diagnosis and management of skin and soft-tissue infections", Clin Infect Dis, 41, pp.1373~1406 (2005)[DOI]
- Silverberg N, "Uncomplicated skin and skin structure infections in children: diagnosis and current treatment options in the United States", Clin Pediatr (Phila), 47, pp.211~219 (2008)[DOI]
- Gould IM, "New insights into meticillin-resistant staphylococcus aureus (MRSA) pathogenesis, treatment and resistance", Int J Antimicrob Agents, 39, pp.96~104 (2012)[DOI]
- TEX> (retapamulin ointment), 1%, "Prescribing information: <TEX>$ALTABAX^{(R)}$<", pp.2012, Food and Drug Administration (FDA)
- Koning S, "Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial", Br J Dermatol, 158, pp.1077~1082 (2008)[DOI]
- Oranje AP, "Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study", Dermatology, 215, pp.331~340 (2007)[DOI]
- Tomayko JF, "The safety and efficacy of topical retapamulin ointment versus placebo ointment in the treatment of secondarily infected traumatic lesions: a randomized, double-blind superiority study", Adv Skin Wound Care, 26, pp.113~121 (2013)[DOI]
- Parish LC, "Topical retapamulin ointment (1%, wt", wt) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: results of a randomized controlled trial, 2006, pp.55, 1003~1013
- Davies J, "Origins and evolution of antibiotic resistance", Microbiol Mol Biol Rev, 74, pp.417~433 (2010)[DOI]
- Biedenbach DJ, "Susceptibility of staphylococcus aureus to topical agents in the United States: a sentinel study", Clin Ther, 36, pp.953~960 (2014)[DOI]
- 박세영, "The Prevalence, Genotype and Antimicrobial Susceptibility of High- and Low-Level Mupirocin Resistant Methicillin-Resistant Staphylococcus aureus", Annals of Dermatology, 24(1), pp.32~38 (2012), 대한피부과학회
- 박상현, "In Vitro Antimicrobial Activities of Fusidic Acid and Retapamulin against Mupirocin- and Methicillin-Resistant Staphylococcus aureus", Annals of Dermatology, 27(5), pp.551~556 (2015), 대한피부과학회
- Harrington AT, "In vitro activity of retapamulin and antimicrobial susceptibility patterns in a longitudinal collection of methicillin-resistant staphylococcus aureus isolates from a veterans affairs medical center", Antimicrob Agents Chemother, 60, pp.1298~1303 (2015)
- Free A, "Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin", Skinmed, 5, pp.224~232 (2006)[DOI]