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Volume 44, Number 2, April 2011

Efficacy and safety of tigecycline monotherapy compared with vancomycin-aztreonam in the treatment of complicated skin and skin structure infections in patients from India and Taiwan


Yin-Ching Chuang, Chia-Ming Chang, Sacchidanand Aradhya, Bheerappa Nagari, Vishwanath Pai, Nathalie Dartois, Sylvie Jouve, Angel Cooper


Received: September 4, 2009    Revised: May 4, 2010    Accepted: May 16, 2010   

 

Corresponding author:

Chi-Mei Medical Center, 901 Chung-Hua Rd, Yung-Kang Dist., Tainan City 710, Taiwan.
E-mail address: chuangkenneth@hotmail.com (Y.-C. Chuang).



 

Background and purpose: 

To compare the monotherapy of tigecycline with vancomycin-aztreonam in hospitalized patients from India and Taiwan with complicated skin and skin structure infections (cSSSIs).



 

Methods:

Safety and efficacy data were analyzed for Indian (n = 86) and Taiwanese (n = 41) patients hospitalized with cSSSIs who participated in two international Phase 3, randomized, double-blind studies.

 



 

Results:

Patients were treated for 5–14 days. Cure rates at the test-of-cure assessment (12–92 days post-therapy) were generally similar between tigecycline and vancomycin-aztreonam in the clinically evaluable populations (India, 83.3% vs. 75.8%; Taiwan, 78.6% vs. 90%) and in the clinical modified intent-to-treat populations (India, 78.6% vs. 66.7%; Taiwan, 73.3% vs. 75.0%). Nausea and vomiting occurred more frequently with tigecycline, but overall safety and tolerability were comparable between the two treatments.



 

Conclusion:

Tigecycline monotherapy is a safe and effective therapy for cSSSIs in geographically distinct populations in Asia.



 

Key words:

Complicated skin and skin structure infections, Efficacy, India, Taiwan, Tigecycline