Augmentin ES Eradicates Bacteria Causing Ear Infection

(40th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy) Results of a multicenter trial demonstrated that Augmentin ES (a new high-dose formulation of amoxicillinclavulanate [Augmentin]) was effective in eradicating between 95 and 100 percent of the three most common bacteria that cause middle ear infection in children (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis), while maintaining the same safety profile as Augmentin. Augmentin ES was given to 521 children (ages three to 48 months) with middle ear infection twice daily for 10 days. Bacterial eradication was measured by repeat tympanocentesis (culturing middle ear fluid before and four to six days after initiating antibiotic therapy) in patients in whom S. pneumoniae was present. Results showed that Augmentin ES eradicated 97 percent of penicillin-resistant S. pneumoniae bacteria, 100 percent of penicillin-susceptible and intermediate-resistant S. pneumoniae bacteria, 95 percent of H. influenzae bacteria and 100 percent of M. catarrhalis bacteria, including drug-resistant strains. Symptoms of middle ear infections were improved or eliminated in approximately 93 percent of children with infection caused by S. pneumoniae alone or in combination with other bacteria, including more than 90 percent of patients with infection caused by drug-resistant S. pneumoniae. Clinical success was achieved in 90 percent of children with infection caused by H. influenzae, M. catarrhalis or Streptococcus pyogenes. Augmentin ES was well-tolerated, with the most commonly reported adverse events being diarrhea, vomiting, diaper rash and fever.—Alejandro hoberman, m.d., et al.,University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

Synvisc Effective Treatment for Knee and Hip Osteoarthritis

(64th Annual Meeting of the American College of Rheumatology) Results of two separate studies provided evidence that adding hylan G-F 20 (Synvisc) to a standard treatment regimen in patients with osteoarthritis of the knee or hip significantly reduces pain and improves function and quality of life compared with standard treatment alone. Synvisc, a viscosupplementation product, is a drug-free treatment for osteoarthritis in which fluid that resembles the joint fluid of healthy persons 18 to 27 years of age is injected directly into the knee or hip to restore the biochemical properties of joint fluid. In a prospective, randomized, multisite study, 255 patients with radiographically confirmed osteoarthritis of the knee were randomized to appropriate care with Synvisc (127 patients) or appropriate care without Synvisc (128 patients) and evaluated over a one-year period. Patients who received Synvisc were statistically superior to patients in the appropriate care-only group for all primary and secondary pain and mobility effectiveness measures and quality-of-life measures. Primary effectiveness was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index 3.0 (WOMAC) pain score. Secondary effectiveness was measured by the percentage of improved patients, global assessment of knee osteoarthritis, overall osteoarthritis and overall health. Quality of life was measured using the Short-Form 36 health-related quality-of-life questionnaire and Health Utilities Index (HUI) preference-based quality-of-life questionnaire. Patients receiving Synvisc had a statistically significant decrease in gastrointestinal side effects. Another open, prospective, multicenter study evaluated the efficacy of Synvisc in treating patients with hip osteoarthritis. Patients were included if they were at least 40 years of age, had hip osteoarthritis for at least one year, were grade II or III on the Kellgren-Lawrence scale (indicating mild to moderate radiologic changes) and had a walking pain score of 50 mm to 90 mm on a 100-mm visual analog scale (VAS) [indicating moderate to severe pain]). All 57 patients received an initial injection of 2 mL of Synvisc into the hip under fluoroscopic control, and 32 of these patients received a second and final injection at either 30, 60 or 90 days postinjection if their mean walking pain score returned to a pretreatment level. Efficacy and safety were measured on days 7, 30, 60 and 90 after each injection. Primary efficacy was measured by assessing walking pain on VAS. Forty-five percent of patients demonstrated sufficient walking pain relief to require only one injection and patients receiving two injections showed significant decreases in walking pain at the end of the study. Secondary efficacy was measured by patient self-rating assessments of pain using the WOMAC pain score and patient and physician global evaluations on VAS, and all showed statistically significant trends in patients receiving Synvisc. Safety was measured by local and systemic tolerance at each visit, with transient target hip painful locations being reported after the injections. No serious systemic adverse effects were noted.—charles goldsmith, m.sc., ph.d., et al.,McMaster University, Hamilton, Ontario, Canada, and endre balazs, m.d.,Biomatrix, Ridgefield, New Jersey.

Bacteria That Cause UTI Most Susceptible to Ciprofloxacin

(Interscience Conference on Antimicrobial Agents and Chemotherapy) According to results of a study, bacteria that commonly cause urinary tract infection (UTI) were more susceptible and least resistant to fluoroquinolone ciprofloxacin compared with cephalothin, trimethoprim-sulfamethoxazole (TMP-SMX) and nitrofurantoin. Ciprofloxacin was the only antimicrobial for which the single drug resistance rate never exceeded 1 percent. During 1999, more than 9,500 UTI bacterial isolates (including Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis) were collected from 202 hospitals in the United States and tested for their susceptibility and resistance to these four antibiotics. Isolates of all three types of bacteria were highly susceptible to ciprofloxacin: 97 percent to E. coli, 96 percent to K. pneumoniae and 87 percent to P. mirabilis strains. Corresponding values for the other three antibiotics were not as consistent. Cephalothin had susceptibility rates of 70 percent to E. coli, and 89 percent to K. pneumoniae and P. mirabilis; TMP-SMX had susceptibility rates of 83 percent to E. coli, 90 percent to K. pneumoniae and 83 percent to P. mirabilis; nitrofurantoin had susceptibility rates of 99 percent to E. coli, 61 percent to K. pneumoniae and zero percent to P. mirabilis. Ciprofloxacin had the lowest overall rating of single drug resistance. Resistance to ciprofloxacin was found in 0.3 percent of strains of E. coli, 0.5 percent of K. pneumoniae and 0.8 percent of P. mirabilis. Comparatively, cephalothin was 6 percent resistant to E. coli, 1.4 percent to K. pneumoniae and 0.3 percent to P. mirabilis; TMP-SMX was 12 percent resistant to E. coli, 5 percent to K. pneumoniae and 1.2 percent to P. mirabilis; nitrofurantoin was 0.2 percent resistant to E. coli, 9 percent to K. pneumoniae and 100 percent to P. mirabilis.—daniel sahm, ph.d., MRL Reference Laboratory, Herndon, Virginia.