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Less Frequent Amoxycillin Dose Effective Against Acute Chronic Bronchitis Exacerbations
A DGReview of :"Randomized, double-blind, double-dummy study comparing the efficacy and safety of amoxycillin 1 g
bd with amoxycillin 500 mg tds in the treatment of acute exacerbations of chronic bronchitis"
Journal of Antimicrobial Chemotherapy Online
01/16/2001
By David Loshak
Amoxycillin 1000 mg twice daily is as effective against acute exacerbation of chronic bronchitis as 500 mg three times daily.
The two regimens show clinical and bacteriological equivalence, say Austrian investigators with the Amoxycillin Bronchitis Study Group. The regimens also have similar safety profiles.
A randomised, multi-centre, double-blind, double-dummy study recruited 395 patients with acute exacerbation of chronic bronchitis. The aim was to compare the efficacy and safety of the two regimens after ten days of treatment.
Patients were assessed on days 3 to 5, on days 12 to 15 (soon after therapy had finished), and at follow-up, on days 28 to 35.
At the end of therapy, 162 of 187 patients (86.6 percent) in the intention-to-treat population achieved clinical success when taking 1000 mg twice daily. This compared with 161 of 188 patients (85.6 percent) in the 500 mg three times daily group.
Success rates were slightly higher in the per-protocol sub-population. Of the 175 receiving 1000 mg twice daily, 156 (89.1 percent) achieved clinical success versus 150 of 162 patients (92.6 percent) in the three times a day group.
With the twice daily group, clinical recurrence rates at follow-up were 14.2 percent in the intention-to-treat population and 13.4 percent in the per protocol sub-population.
With the three times daily group, clinical recurrence rates at follow-up were 12.6 percent in the intention-to-treat population and 13.7 percent in the per protocol sub-population.
Among the clinically evaluable intention-to-treat patients, 219 had at least one pathogen isolated at baseline and were evaluable for bacteriological efficacy.
There was bacteriological success at the end of therapy in 83 of 109 patients (76.2 percent) in the twice-daily group and in 81 of 110 patients (73.7 percent) in the three times daily group.
The most frequent drug-related adverse events, gastrointestinal symptoms, affected 11.2 percent of evaluable patients in the twice daily group and 11.6 percent in the three times daily group.
Journal of Antimicrobial Chemotherapy 2001; 47, 67-76.
"Randomized, double-blind, double-dummy study comparing the efficacy and safety of amoxycillin 1 g
bd with amoxycillin 500 mg tds in the treatment of acute exacerbations of chronic bronchitis"
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