Abstract | STUDY OBJECTIVES: To demonstrate equivalence in the clinical efficacy of telithromycin vs clarithromycin treatment of outpatients with acute exacerbations of chronic bronchitis (AECB), and to compare the tolerability and respiratory-related health-care resource utilization associated with these treatment regimens. DESIGN AND PATIENTS: A randomized, double-blind, multicenter, clinical study was conducted at 105 centers in 14 countries. Adult outpatients (age > or = 30 years) received oral telithromycin, 800 mg qd for 5 days (n = 270), or oral clarithromycin, 500 mg bid for 10 days (n = 282), for the treatment of AECB. Clinical and bacteriologic outcomes were assessed at the posttherapy/test-of-cure (TOC) visit (days 17 to 24; per-protocol population). Health-care resource utilization data were collected for each patient by investigators blinded to study medication up to the late posttherapy visit (days 31 to 36). RESULTS: Clinical cure rates at the posttherapy/TOC visit were comparable between the groups ( telithromycin, 193 of 225 patients [85.8%]; clarithromycin, 206 of 231 patients [89.2%]); bacteriologic outcome was satisfactory for 59 of 72 telithromycin-treated patients (81.9%) vs 63 of 76 clarithromycin-treated patients (82.9%). Health-care resource utilization assessed up to the late posttherapy visit was lower in the telithromycin treatment group than the clarithromycin treatment group, with significantly fewer hospitalizations for respiratory-related causes (one hospitalization vs eight hospitalizations for a total of 4 inpatient days vs 39 inpatient days, respectively), significantly fewer AECB-related emergency department visits (0 vs 8), and fewer unscheduled outpatient visits (11 vs 18). Fewer telithromycin-treated patients reported days lost from work (21 of 91 patients [23.1%]; 133 days) compared with those receiving clarithromycin (30 of 98 patients [30.6%]; 141 days). Telithromycin was well tolerated; adverse events considered possibly related to study medication were reported by 61 of 269 patients (22.7%) and 100 of 280 patients (35.7%) receiving telithromycin and clarithromycin, respectively. CONCLUSIONS: In this study, 5-day telithromycin treatment was as effective and well tolerated as 10-day clarithromycin treatment for patients with AECB, and was associated with a reduced utilization of health-care resources.
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Authors | Charles Fogarty, Ronelle de Wet, Lionel Mandell, Joanne Chang, Manickam Rangaraju, Roomi Nusrat |
Journal | Chest
(Chest)
Vol. 128
Issue 4
Pg. 1980-8
(Oct 2005)
ISSN: 0012-3692 [Print] United States |
PMID | 16236845
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Ketolides
- Clarithromycin
- telithromycin
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Topics |
- Acute Disease
- Adult
- Aged
- Bronchitis
(drug therapy)
- Chronic Disease
- Clarithromycin
(administration & dosage, therapeutic use)
- Disease Progression
- Double-Blind Method
- Drug Administration Schedule
- Female
- Forced Expiratory Volume
- Health Care Rationing
- Humans
- Ketolides
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Single-Blind Method
- Smoking
- Vital Capacity
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