Magazine article Drug Topics

Latest Studies on New Ketolide Tout Its Efficacy

Magazine article Drug Topics

Latest Studies on New Ketolide Tout Its Efficacy

Article excerpt

HEALTH-SYSTEM EDITION

CLINICAL PRACTICE

To date, the experimental antibiotic telithromycin (Ketek, Aventis) has proved to be as effective as any licensed agent in treating lower respiratory tract infections in nine large randomized double-blind, comparator-- controlled clinical trials.

Telithromycin is the first in a new class of ketolide antibiotics. It differs from its cousins the macrolides by the replacement of one important molecule-cladinose, a sugar molecule believed responsible for the antibacterial properties of macrolides-with a more active keto group. The drug was designed to combat resistant strains of bacteria associated with respiratory tract infections, researchers said.

Thousands of patients world-- wide have been involved in testing this once-daily drug. It is a potential alternative to standard antibiotics that must be taken more often for serious respiratory tract infections. The Food & Drug Administration sent an "approvable" letter to Aventis last year outlining steps required before telithromycin could be marketed for broad use in community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB), and sinusitis. Aventis will address these requirements by including safety data-as well as additional efficacy findings-from a plethora of new studies in its revised drug application to be filed in July.

The latest results, presented at the annual American Thoracic Society International Conference in Atlanta last month, confirmed earlier phase III findings: CAP vanished in seven to 10 days in 92% of patients treated once a day with telithromycin at a dose of 800 mg.

In comparison, 90% of patients taking amoxicillin, clarithromycin Biaxin, Abbott), or trovafloxacin at standard dosages two to three times daily for seven to 10 days, were cured of CAP.

Similarly, 86% of patients with AECB given telithromycin (800 mg) once daily for five days had clinical cures. This compared with 82% for patients on amoxicillin/ clavulanic acid or cefuroxime axetil three times a day for 10 days.

"Telithromycin promises to be a valuable option for physicians treating patients with these serious infections, particularly as resistance to available medications is on the rise," said lead investigator Marcus J. Zervos, M.D., director of research at William Beaumont Hospital, Royal Oak, Mich. "The studies show the drug is equivalent to all comparators tested at standard dosages for up to 10 days."

The studies also showed that telithromycin is consistently effective across all population subsets-notably in patients over age 65 and others at increased risk of morbidity, Zervos pointed out. …

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