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Clinical Investigations: COPD |

Five-Day Telithromycin Once Daily Is as Effective as 10-Day Clarithromycin Twice Daily for the Treatment of Acute Exacerbations of Chronic Bronchitis and Is Associated With Reduced Health-Care Resource Utilization*

Charles Fogarty, MD; Ronelle de Wet, MB, ChB; Lionel Mandell, MD; Joanne Chang, MD, PhD; Manickam Rangaraju, MD; Roomi Nusrat, MD
Author and Funding Information

*From Spartanburg Pharmaceutical Research (Dr. Fogarty), Spartanburg, SC; 10 NHC Health Centre (Dr. de Wet), Johannesburg, South Africa; McMaster University (Dr. Mandell), Hamilton, ON, Canada; sanofi-aventis (Drs. Chang and Nusrat), Bridgewater, NJ; and sanofi-aventis (Dr. Rangaraju), Romainville, France.

Correspondence to: Charles Fogarty, MD, Spartanburg Pharmaceutical Research, 126 Dillon St, Spartanburg, SC 29307; e-mail: cmf@bonetesting.com



Chest. 2005;128(4):1980-1988. doi:10.1378/chest.128.4.1980
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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 ≥ 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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