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Abstract: Poster Presentations |

ASSESSMENT OF THE EFFICACY AND SAFETY OF SINGLE-DOSE EXTENDED-RELEASE (ER) CEFUROXIME AXETIL IN ADULT INDIAN PATIENTS WITH ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS (AECB) FREE TO VIEW

Anish A. Desai, MD*; A B. Mishra, MD; G. Bhatia, MD; R. S. Murlidaharn, MD; G. S. Kadam, MD; Ashish S. Gawde, MD; Vidyagauri P. Baliga, PhD
Author and Funding Information

Glenmark Pharmaceuticals Ltd, Mumbai, India


Chest


Chest. 2005;128(4_MeetingAbstracts):370S. doi:10.1378/chest.128.4_MeetingAbstracts.370S-b
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Abstract

PURPOSE:  Cefuroxime axetil possesses activity against Streptococcus pneumoniae Moraxella catarrhalis and Hemophilus influenzae and has beta-lactamase stability. It is therefore useful in the treatment of acute exacerbations of chronic bronchitis. An extended-release (ER)preparation of cefuroxime axetil has been recently formulated. The present study evaluated the efficacy, tolerability and safety of this new ER- formulation of Cefuroxime in adult Indian patients with AECB.

METHODS:  Adults patients(n=125) with clinically and radiologically confirmed AECB were enrolled in this prospective, multicentric, open label, non-comparative Phase III study after obtaining informed consent. The study was approved by the respective Institutional Review Boards. Patients fulfilling the selection criteria received 1g. ER-Cefuroxime axetil once-daily for 10 days. Efficacy outcomes included clinical and bacteriological response at the end of therapy. Safety was assessed by monitoring.

RESULTS:  Following therapy with ER –Cefuroxime, there was a significant reduction in body temperature, chills, dyspnea, chest pain by Day 3 which further improved on Day 10. There was a significant improvement in the quantity, consistency, nature and odour of sputum, intensity of cough and ausculatory findings by Day 3 which was sustained till the end of study. The effects of therapy on primary outcome measures are depicted in Table 1. Adverse events were reported by only 12% of the study population.

CONCLUSION:  ER-Cefuroxime axetil 1g. once daily was effective and safe in the treatment of AECB.

CLINICAL IMPLICATIONS:  ER-Cefuroxime axetil 1g. once daily is a useful therapeutic option in the treatment of Acute exacerbations of Chronic bronchitis. Table 1—

Effect of Therapy With ER-Cefuroxime Axetil in Patients With AECB

Clinical response% of patientsBacteriological response% of patientsCure71.8%Clearance64.5%Improvement25.8%Partial clearance28.3%Failure2.4%Failure3.2%Not-evaluable–Colonization/Not evaluable4%

DISCLOSURE:  Anish Desai, None.

Wednesday, November 2, 2005

12:30 PM - 2:00 PM


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