Chest
Volume 128, Issue 4, October 2005, Pages 1980-1988
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Clinical Investigations
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

https://doi.org/10.1378/chest.128.4.1980Get rights and content

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.

Section snippets

Materials and Methods

This randomized, double-blind, parallel-group study took place at 105 centers in 14 countries. The study was performed in accordance with Good Clinical Practice guidelines and was approved by the independent ethics committee of each center. All patients provided written informed consent prior to enrollment.

Results

A total of 650 patients from 14 countries were enrolled into the study between March 14, 2001, and January 11, 2002 (Argentina, n = 28; Australia/New Zealand, n = 44; Belgium, n = 24; Brazil, n = 5; Canada, n = 54; Chile, n = 21; Germany, n = 82; Italy, n = 16; Mexico, n = 18; South Africa, n = 72; Spain, n = 4; Turkey, n = 18; United States, n = 264). Of these, 554 patients were randomized to receive treatment with either telithromycin, 800 mg qd for 5 days (n = 272), or clarithromycin, 500 mg

Discussion

In this study, a 5-day treatment course of telithromycin, 800 mg qd, was as effective and as well tolerated as a 10-day course of clarithromycin, 500 mg bid, for the treatment of AECB in adult patients. Furthermore, in a prospective, blinded evaluation of health-care resource utilization, telithromycin treatment was associated with significantly fewer RTI-related hospitalizations (defined as “AECB-related” plus “other respiratory-related” hospitalizations), significantly fewer AECB-related ED

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    This study was sponsored by sanofi-aventis, USA.

    Dr. Mandell has received funding from Aventis, Bayer, Ortho- McNeil, Pfizer, and Wyeth. Dr. Nusrat is employed by sanofiaventis, and Dr. Chang and Dr. Rangaraju are former employees of sanofi-aventis. Dr. Fogarty has received funding from Astra- Zeneca, Aventis, Bayer, Boehringer, GlaxoSmithKline, Lilly, Ortho-McNeil, Organon, Pfizer, and Sepracor.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

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