Six-month study shows treatment with gemifloxacin reduces hospitalizations, use of medical resources and recurrences of chronic bronchitis compared to clarithromycin
Hamilton, Ontario, Canada, September 18, 2000 -- An investigational new antibiotic, gemifloxacin mesylate (Factive®), produced significant long-term clinical and health economic outcomes compared to clarithromycin in acute exacerbations of chronic bronchitis (AECB), according to a study involving McMaster University researchers and presented today at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy. The study, Gemifloxacin Long-term Outcomes in Bronchitis Exacerbations (GLOBE), showed that 30 percent fewer patients treated for five days with gemifloxacin experienced recurrences of chronic bronchitis requiring antibiotic treatment compared to patients treated for seven days with clarithromycin, a commonly-used treatment for the condition. A greater reduction was also seen in related hospitalizations in the gemifloxacin arm of the study compared to the clarithromycin arm.
"The GLOBE study presents groundbreaking data confirming that the choice of antibiotic can have an impact on long-term health outcomes and overall patient success rates," said Lionel Mandell, M.D., Professor of Medicine at McMaster University. "Patients enrolled in the GLOBE study exhibited not only less frequent exacerbations of chronic bronchitis with gemifloxacin treatment, but also exhibited reduced hospitalization rates compared to a commonly-used antibiotic."
Thirty percent fewer gemifloxacin-treated patients in the GLOBE study demonstrated recurrence of AECB requiring antibiotic treatment compared to the clarithromycin group at six months. The proportion of patients whose initial AECB resolved and who had experienced no further recurrences by week 26 was 71.0 percent (120 out of 169 patients) in the gemifloxacin arm compared with 58.5 percent (100 out of 171 patients) in the clarithromycin arm.
In the study, researchers identified a reduction in RTI-related hospitalization during a six-month period following the start of gemifloxacin therapy compared to clarithromycin. The number of patients hospitalized for AECB following start of therapy was 2.3 percent for the gemifloxacin arm of the study and 6.3 percent for the clarithromycin arm.
"It's important to have strong evidence to support the use of new highly active treatments," said Dr. Mandell. "The antibiotic studied in GLOBE, gemifloxacin, offers physicians a powerful new therapy for respiratory infections, which is particularly important as bacterial resistance continues to grow worldwide."
The double-blind phase III study was conducted over a six-month period and involved 438 patients (214 were treated with 320mg of gemifloxacin once daily for five days and 224 were treated with 500 mg of clarithromycin twice daily for seven days). Participants in both groups had similar histories of systemic steroid use, smoking and acute exacerbations of bronchitits. The study assessed clinical status and use of health care resources.
McMaster University is one of Canada's leading research institutions and is located in Hamilton, Ontario. Its Faculty of Health Sciences is recognized internationally for its leading edge research, innovation and excellence in education.
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Editor's Note: Factive® is a registered trademark of SmithKline Beecham.