Source: Annual Congress 2002 - Acute exacerbations of COPD: aetiology and therapy
Disease area: Airway diseases, Respiratory infections

Abstract

A 3-day, 1.5 gram AZM regimen (500 mg/day for 3 days) provides comparable drug exposure to 5-day, 1.5 gram AZM (500 mg Day 1, 250 mg/day Days 2-5). 3-Day AZM is approved in Europe for various indications, and offers the advantage of improved compliance.
The efficacy and safety of 3-day, 500 mg qd AZM was compared with standard 10-day 500 mg bid CLA in a randomized, multicenter, double-blind trial in 338 patients (pts) with AECB. Clinical (clin) and bacteriologic (bact) assessments were compared on Day 10-12 and Day 21-24; the primary endpoint was clin response on Day 21-24.
In total, 166 and 172 pts were treated with AZM and CLA, respectively. In the modified intent-to-treat analysis (n=325), Day 21-24 clin cure rates were: AZM 85% and CLA 82% (95% CI -6.2%, 11.5%). Clin success rates on Day 10-12 were: AZM 92% and CLA 94%. Response rates were similar in the clin evaluable subset. Bact response rates are below:

Pathogen	Eradication Rate (%)
	AZM		CLA
	Day 10-12	Day 21-24	Day 10-12	Day 21-24
S pneumoniae	30/31 (97%)	29/32 (91%)	26/29 (90%)	22/28 (79%)
H influenzae	12/14 (86%)	10/14 (71%)	15/17 (88%)	13/16 (81%)
M catarrhalis	11/11 (100%)	11/11 (100%)	18/18 (100%)	13/16 (81%)

Treatment-related adverse events were similar in frequency, the most common were diarrhea (AZM 8.5%; CLA 7.4%) and nausea (AZM 6.0%; CLA 5.4%).
3-Day AZM 500 mg qd was equal in efficacy to 10-day CLA 500 mg bid in AECB in adults, and was well tolerated.

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R. N. Swanson, A. Lainez-Ventosilla, M. C. De Salvo, S. Chodosh, M. W. Dunne (New York, Wayland, United States Of America; La Uruca, Costa-Rica; Buenos Aires, Argentina). 3-day azithromycin (AZM) 500 mg qd versus 10-day clarithromycin (CLA) 500 mg bid for acute exacerbation of chronic bronchitis (AECB) in adults. Eur Respir J 2002; 20: Suppl. 38, 3377

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