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| |  ACCP: Biaxin XL (Clarithromycin) May Produce Less Severe Gastrointestinal Side Effects Than Augmentin (Amoxicillin/Clavulanate) ABBOTT PARK, IL -- October 25, 2000 -- Data from a study presented at the annual meeting of the American College of Chest Physicians shows patients treated for acute bacterial exacerbation of chronic bronchitis (AECB) with once-daily Biaxin® XL (clarithromycin extended-release tablets) for seven days experienced significantly less-severe gastrointestinal (GI) side effects than those taking another leading antibiotic, Augmentin® (amoxicillin/clavulanate), for 10 days. In this study, which was designed to compare the safety and efficacy of the two medications, the treatments were equally effective in treating AECB. Overall incidence of treatment-related adverse events was shown to be similar, with a significant difference in abnormal taste reported by more patients taking Biaxin XL. In addition, significantly more patients taking Biaxin XL gave a response of "excellent" or "very good" when asked, "How do you feel today?" at study days 10-12 than those taking Augmentin. "These data regarding the tolerability of Biaxin XL are consistent with previous studies that show Biaxin XL is a well-tolerated treatment option," said Antonio Anzueto, M.D., associate professor of medicine, Division of Pulmonary Disease/Critical Care Medicine, University of Texas Health Science Center at San Antonio. "In addition, Biaxin XL offers patients the convenience of once-a-day dosing in a shorter course of therapy." Biaxin XL is a once-daily formulation of Abbott Laboratories' widely prescribed advanced-generation macrolide antibiotic, Biaxin® (clarithromycin) tablets, and was approved by the U.S. Food and Drug Administration (FDA) in March 2000 for mild to moderate infections in adults for the treatment of acute maxillary sinusitis (AMS) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and acute bacterial exacerbation of chronic bronchitis (AECB) caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not been established. In adult clinical trials in both AMS and AECB, Biaxin XL tablets taken once daily resulted in clinical cure rates comparable to those of the immediate-release formulation, Biaxin tablets, taken twice daily. In this Phase IV study, 287 outpatients over 40 years of age with AECB and chronic obstructive pulmonary disease (COPD) were randomly assigned to an investigator-blinded dose of either Biaxin XL (two 500-mg. tablets, once daily) for seven days (142 patients) or Augmentin (875-mg. tablet, twice daily) for 10 days (145 patients). Subjects were contacted by telephone on study days 2-3 (Evaluation 1) to assess changes in clinical signs and symptoms. Subjects returned to the clinic on study days 10-12 (Evaluation 2), or within 48 hours after premature discontinuation of study drug, and on study days 17-21 (Evaluation 3) for clinical assessments. An analysis of data from the study included a severity score for GI events. Based on severity scores ranging from 1 (mild) to 3 (severe), Biaxin XL received a mean score of 1.16, which was significantly lower than the Augmentin mean score of 1.58 (p value = 0.016). Biaxin XL was well-tolerated with 1 percent of patients (two of 142) discontinuing due to drug-related adverse events compared with 6 percent (eight of 145) of those taking Augmentin. Premature discontinuation for any reason was significantly less in Biaxin XL-treated patients, with only four of 142 patients (3 percent) stopping therapy compared to 17 of 145 Augmentin-treated patients (12 percent) (p value = 0.005). Among the most frequently reported adverse events with Biaxin XL and Augmentin were diarrhea (8 percent and 12 percent, respectively) and nausea (5 percent and 3 percent, respectively). A statistically significant difference was noted in abnormal taste, which was reported by more patients taking Biaxin XL than Augmentin (6 percent and 1 percent, respectively) (p value = 0.010). An analysis of results in clinically evaluable patients found that efficacy in the treatment of AECB was comparable between the two study medications. Data showed 117 of 137 patients taking Biaxin XL (85 percent) achieved clinical cure compared to 116 of 133 patients taking Augmentin (87 percent). The clinical cure diagnosis is based on resolution or improvement of signs and symptoms associated with AECB, without the need for additional therapy. This analysis was conducted among clinically evaluable patients, which included those who were diagnosed with AECB at the start of the study, took the medication for at least three days, had not taken other antimicrobial agents prior to starting the study and attended the final study visit. In addition to physician assessment of efficacy of the two study medications, patients were asked to assess their condition by answering a questionnaire. A statistically significant difference was observed in patients' assessment of overall condition based on responses to the question, "How do you feel today?" at study days 10-12. Responses were chosen from a five-point scale ranging from "excellent" to "poor." Of clinically evaluable patients, 58 of 137 patients taking Biaxin XL (42 percent) answered "excellent" or "very good," compared with 38 of 133 patients taking Augmentin (29 percent) (p value = 0.041). Patients were monitored for improvement or resolution of pretreatment signs and symptoms throughout the study. At study days 10-12, no significant differences were noted in improvement or resolution of sputum (phlegm) production and appearance, dyspnea (shortness of breath), crackling, wheezing, headache, fever or cough. However, a significant difference was observed at study days 10-12 in the volume of sputum produced. Of the clinically evaluable patients treated with Biaxin XL, 115 of 135 (85 percent) showed resolution or improvement in the amount of sputum produced compared to 97 of 129 patients (75 percent) taking Augmentin (p value = 0.045). By Evaluation 3 (study days 17-21), clinical signs and symptoms of AECB resolved in patients treated with either study medication. Chronic bronchitis is the seventh most prevalent of all chronic conditions. It is characterized by the presence of mucus-producing cough and obstructed airflow for at least three consecutive months a year for two successive years. In patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic, Biaxin XL tablets are contraindicated. Concomitant administration with Propulsid® (cisapride), Orap® (pimozide), or Seldane® (terfenadine) is contraindicated due to the potential for cardiac arrhythmias. Biaxin XL tablets should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate. Biaxin XL tablets may elevate digoxin serum concentration. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. The dose of clarithromycin should be halved or the dosing interval doubled in patients with severe renal impairment (CrCl<30mL/minute). Related Links: Biaxin (clarithromycin) and Augmentin (amoxicillin/clavulanate).
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