Novel antibiotic provides rapid relief from symptoms of tonsillitis/pharyngitis, study shows
Ketek® (telithromycin), a novel compound from a new family of antibiotics, administered once daily for five days to patients suffering from tonsillitis/pharyngitis, provided equivalent clinical and bacteriological outcomes as those observed in patients receiving a 10-day course of treatment with penicillin V, a new study shows.
The more rapid symptom relief achieved with Ketek®, the first antibiotic from the ketolide family to be developed for clinical use, may suggest a potential for a faster return to usual activities, and fewer days lost from work or school, for people with tonsillitis/pharyngitis resulting from group A b-haemoliytic streptococcus (GABHS) bacteria. GABHS is the most common bacterial cause of tonsillitis/pharyngitis.
The study results, reported today at the 11th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Istanbul, Turkey, were among several scientific presentations involving Ketek®.
"This is an important study as it demonstrates the clinical and bacteriological effectiveness and symptom relief of Ketek® in treating what is a very common upper respiratory tract infection," said Dr. Joanne Chang, Aventis Pharma.
The double-blinded study enrolled 396 patients between the ages of 15 and 65 with clinical signs and symptoms of acute tonsillopharyngitis, and who either had a positive streptococcal A antigen test or a positive throat culture for GABHS. These patients were randomized (198 patients to each group) to receive either 800 mg once daily Ketek® followed by placebo for five days, or penicillin V 500 mg three-times daily for 10 days. Clinical and bacteriological outcomes were assessed at post-therapy (days 16-21) and late post-therapy (days 38-45).
At the post-therapy visit, bacteriological outcome was satisfactory in 79.7 percent and 79.3 percent of patients, and clinical cure was achieved in 85.9 percent and 85.8 percent of patients in the Ketek® (198 patients) and penicillin V (197 patients) groups respectively.
On treatment - five days for the Ketek® group and 10 days for the penicillin group -- the improvement from baseline in total symptom score was statistically significantly greater in the Ketek® group than in the penicillin group (-7.7 to -7.0; p=.042), indicating faster resolution of symptoms in the Ketek® group. By the end of the treatment period of 10 days, and at follow-up periods, symptom scores in the two groups were equivalent.
Adverse events reported were similar between the two groups with diarrhea and nausea being the most commonly reported effects.
Tonsillopharyngitis causes significant discomfort to patients and is one of the most frequent reasons for physician consultations, and for lost time from work or school.
Ketolides are a novel addition to the macrolide-lincosamide-streptogramin (MLSb) group of antibiotics. Ketek® is specifically designed to offer optimal broad-spectrum coverage in both upper and lower RTIs - including those caused by resistant strains - with a short and reliable treatment regimen. Ketek® combats resistant bacteria by inhibiting the protein synthesis necessary for bacterial reproduction, binding 10 times tighter than macrolides at two different sites on bacterial ribosomes. In vitro data also suggest that Ketek® has a low propensity to induce bacterial resistance. Please note that in vitro activity does not necessarily correlate to clinical response. Ketek® is currently under review by health authorities in Europe and the U.S. for the treatment of community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB), acute sinusitis, and tonsillitis/pharyngitis.
Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of € 22.3 billion and employed around 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhône-Poulenc SA of France. Corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.
Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and the central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania, USA.
Statements in this news release other than historical information are forward-looking statement subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.