Treatment with Ketek Leads to Fewer Hospitalizations Than Clarithromycin in Outpatients Treated for Acute Exacerbations of Chronic Bronchitis (AECB)

CHICAGO -- Data presented at the 43rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) show that outpatients with AECB, who were treated with Ketek (telithromycin) experienced significantly fewer respiratory-related hospitalizations (admissions) and AECB related emergency room visits than patients who were treated with Biaxin (clarithromycin), a commonly prescribed antibiotic. The study showed that AECB related unscheduled office visits were also lower when Ketek was administered compared to clarithromycin.

Chronic bronchitis is a highly prevalent condition that affects more than 14 million people in the U.S. alone. Patients with chronic bronchitis often experience acute exacerbations of the disease. The clinical management of AECB represents a major clinical and economic burden for healthcare providers, with total annual US AECB healthcare costs estimated to be 1.7 billion. Up to 75 percent of all cases of AECB are bacterial in etiology, with Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis being the most commonly implicated pathogens.

"It is clear that hospitalization is the largest contribution to the overall cost of treating AECB," said Lionel Mandell, chief of the Division of Infectious Diseases at McMaster University. "These data suggest that the first line use of Ketek could represent a significant cost savings for patients and lessen the burden on AECB health-related resources."

The randomized, double blinded multi-center clinical trial was performed to compare the efficacy and safety of Ketek and clarithromycin in AECB. The analysis presented now is a comparison of the respiratory-related healthcare resource utilization in adult patients with AECB. The study included 552 outpatients with AECB and patients were randomized to receive Ketek (800 mg) once daily for 5 days or receive clarithromycin (500 mg) two times daily for 10 days. Clinical and economic outcomes were followed for 4 weeks. The study demonstrated that there were significantly fewer respiratory-related hospitalizations among patients randomized to receive Ketek (1 for Ketek vs 8 for clarithromycin; p=0.04). The study also showed that there were significantly fewer AECB-related emergency room visits among patients randomized to receive Ketek (0 for Ketek vs 8 for clarithromycin; p=<0.01). The number of AECB-related unscheduled outpatient visits was also lower for Ketek albeit not significant (11 for Ketek vs 18 for clarithromycin, respectively). The estimated differences in the cost of additional respiratory-related care between the two treatment groups was approximately $146 per patient. This analysis did not include the cost of the study drug. The study also showed that the five-day course treatment with Ketek (800 mg) once daily was comparable to a standard 10 day course of clarithromycin in the outpatient treatment of AECB.

The resource utilization reductions noted in this study are consistent with the findings from two other randomized CAP trials comparing clarithromycin presented earlier this year.

Ketek is the first in a new class of antibiotics known as ketolides. It was designed to deliver targeted coverage in community-acquired upper and lower respiratory tract infections. In clinical trials, the most commonly reported side effects (2 percent or more) were diarrhea, nausea and vomiting.

On January 27, 2003, Aventis received an approvable letter from the U.S. Food and Drug Administration (FDA) for Ketek Tablets for the treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis. In the approvable letter, the FDA requested that Aventis provide additional analyses and information prior to marketing approval. The Agency has not required additional clinical studies. Aventis is currently preparing a response to the FDA's approvable letter.

Source: Aventis