Hospitalization rates among patients with community-acquired pneumonia treated with telithromycin vs clarithromycin: results from two randomized, double-blind, clinical trials.
OBJECTIVE
To compare hospitalization rates among patients with community-acquired pneumonia (CAP) treated with oral telithromycin and clarithromycin, based on pooled data from two randomized, double-blind, multinational clinical trials.


METHODS
Adult patients with CAP eligible for oral therapy (Study 1, n = 448; Study 2, n = 575) received telithromycin 800 mg once daily for 10 (Study 1, 2-arms), 5 or 7 (Study 2, 3-arms) days, or clarithromycin 500 mg twice daily for 10 days. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use, as well as CAP-related length of hospital stay and hospitalization costs, were compared by treatment group (intent to treat populations) up until the late post-therapy visit (Days 31-36). Study investigators blinded to treatment regimen assessed whether hospital admissions were CAP related.


RESULTS
Despite equivalent clinical efficacy for telithromycin vs clarithromycin in the clinically evaluable per-protocol populations (n = 784) (88.8% [428/482] vs 90.1% [272/302]--difference: -1.3%; 95% CI: -6.0, 3.4), telithromycin treatment for 5, 7, or 10 days was associated with significantly fewer CAP-related hospitalizations (p = 0.023) and CAP-related hospital days (p = 0.025) vs clarithromycin (reduction of 2.3 hospitalizations and 23.4 hospital days per 100 patients). Accordingly, estimated CAP-related hospitalization costs were significantly lower (p = 0.025) for telithromycin recipients (30,231 US dollars less per 100 patients). CAP-related hospitalizations, duration of hospital stay, and hospitalization costs for 7- to 10-day telithromycin--the approved dosing regimen for CAP--were significantly lower (p = 0.023, 0.025, and 0.025, respectively) than for clarithromycin.


CONCLUSIONS
Data from this study indicate that telithromycin 800 mg once daily for 5, 7, or 10 days provides an effective therapy for patients with CAP, and may be associated with fewer CAP-related hospitalizations and hospital days than clarithromycin 500 mg twice daily for 10 days. Treatment with telithromycin could, therefore, potentially translate into cost savings in the management of CAP.
Niederman
Michael S
MS
Department of Medicine, Winthrop-University Hospital, Minneola, NY 11501, USA. mniederman@winthrop.org
Chang
Joanne R
JR
Stewart
John
J
Asche
Carl V
CV
Lavin
Bruce
B
Nusrat
Roomi
R
Sullivan
Sean D
SD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data* / Q000639:trends; D006801:Humans; D048628:Ketolides / Q000627:therapeutic use*; D018942:Macrolides / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D048628:Ketolides; D018942:Macrolides; D017291:Clarithromycin; C106791:telithromycin