Ketek once-daily antibiotic matches common twice-daily CAP treatment
SAN DIEGO, CA., Sept. 27 --Telithromycin treatment in patients with community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae taken once daily for five to 10 days was as active as clarithromycin, a commonly prescribed macrolide, taken twice daily for 10 days, according to data presented at the 42nd annual Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The combined analysis of two Phase III studies showed telithromycin also demonstrated activity against bacteria resistant to erythromycin.
Annually, two to four million cases of CAP result in nearly 10 million physician visits and 500,000 hospitalizations, according to the Infectious Disease Society of America (IDSA). In 1998, the total direct cost of treating CAP in the United States was an estimated $8.4 billion.
"With antibiotic resistance on the rise, managing potentially life-threatening community-acquired pneumonia can be extremely challenging," said John Pullman, MD, Mercury Medical Center, Butte, Mont. "Telithromycin may offer physicians and their patients an alternative to other commonly prescribed antibiotics."
Data were analyzed from two Phase III, multicenter, randomized, double-blind trials of telithromycin vs. clarithromycin for the treatment of CAP in 1,023 patients. In the first study, patients received oral telithromycin 800 mg once daily or clarithromycin 500 mg twice daily for 10 days. In the second study, patients received either telithromycin 800 mg once daily for five or seven days or clarithromycin 500 mg twice daily for 10 days. Telithromycin was clinically and bacteriologically active in 97.1 percent of patients with Streptococcus pneumoniae-associated infections, while clarithromycin was clinically and bacteriologically active in only 90.2 percent. Additionally, telithromycin was active in 88.9 percent of patients with erythromycin-resistant Streptococcus pneumoniae, while clarithromycin was active in 75 percent of these patients.
In June 2001, Aventis received an approvable letter from the US FDA for the use of KETEK(TM) for the following indications: community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB) and acute bacterial sinusitis (AS); the FDA said the drug was not approvable for the treatment of tonsillitis/pharyngitis. Aventis filed a complete response to the FDA's approvable letter in August 2002.
Source: Aventis Pharmaceuticals Inc. www.aventis.com
Posted: September 2002