AIM: To determine the minimum effective dose and safety of micafungin in the treatment of HIV-related oesophageal candidiasis. METHOD:A total of 120 patients were enrolled in this open label study of the effects of daily 1 h infusions of micafungin on endoscopically proven fungal oesophagitis. Patients were randomly assigned to receive 12.5, 25, 50, 75 and 100 mg of micafungin daily. Response was evaluated clinically and endoscopically. RESULTS: The protocol defined minimum effective dose of micafungin was 12.5 mg. The percentage of patients experiencing clearing of physical signs and symptoms showed a dose-response relationship and reached 94.7% in the 100 mg dose group. All patients in the 50, 75 and 100 mg dose groups achieved an endoscopically verified improvement in oesophagitis. Adverse effects of micafungin were generally mild and not dose-related. No serious renal, hepatic or drug-related infusion reactions were encountered. CONCLUSION:Micafungin was found to be effective, well-tolerated and safe. The minimum effective dose was found to be 12.5 mg and a significant linear trend in the successful treatment of oesophageal candidiasis was observed across the doses used with 75 and 100 mg dose levels achieving high rates of clinical and endoscopic cure.
RCT Entities:
AIM: To determine the minimum effective dose and safety of micafungin in the treatment of HIV-related oesophageal candidiasis. METHOD: A total of 120 patients were enrolled in this open label study of the effects of daily 1 h infusions of micafungin on endoscopically proven fungal oesophagitis. Patients were randomly assigned to receive 12.5, 25, 50, 75 and 100 mg of micafungin daily. Response was evaluated clinically and endoscopically. RESULTS: The protocol defined minimum effective dose of micafungin was 12.5 mg. The percentage of patients experiencing clearing of physical signs and symptoms showed a dose-response relationship and reached 94.7% in the 100 mg dose group. All patients in the 50, 75 and 100 mg dose groups achieved an endoscopically verified improvement in oesophagitis. Adverse effects of micafungin were generally mild and not dose-related. No serious renal, hepatic or drug-related infusion reactions were encountered. CONCLUSION:Micafungin was found to be effective, well-tolerated and safe. The minimum effective dose was found to be 12.5 mg and a significant linear trend in the successful treatment of oesophageal candidiasis was observed across the doses used with 75 and 100 mg dose levels achieving high rates of clinical and endoscopic cure.
Authors: Nita L Seibel; Cindy Schwartz; Antonio Arrieta; Patricia Flynn; Aziza Shad; Edith Albano; James Keirns; Wendi M Lau; David P Facklam; Donald N Buell; Thomas J Walsh Journal: Antimicrob Agents Chemother Date: 2005-08 Impact factor: 5.191
Authors: J Hiemenz; P Cagnoni; D Simpson; S Devine; N Chao; J Keirns; W Lau; D Facklam; D Buell Journal: Antimicrob Agents Chemother Date: 2005-04 Impact factor: 5.191
Authors: L Ostrosky-Zeichner; D Kontoyiannis; J Raffalli; K M Mullane; J Vazquez; E J Anaissie; J Lipton; P Jacobs; J H Jansen van Rensburg; J H Rex; W Lau; D Facklam; D N Buell Journal: Eur J Clin Microbiol Infect Dis Date: 2005-10 Impact factor: 3.267
Authors: Seong Hyun Jeong; Dae Young Kim; Jun Ho Jang; Yeung-Chul Mun; Chul Won Choi; Sung-Hyun Kim; Jin Seok Kim; Joon Seong Park Journal: Ann Hematol Date: 2015-11-24 Impact factor: 3.673