Abstract | OBJECTIVE: The objective of this study was to compare the efficacy and safety of two clarithromycin formulations given for 5 days to patients with acute bacterial exacerbation of chronic bronchitis (ABECB). PATIENTS AND METHODS: This was a double-blind, randomized, multicenter study of ambulatory patients between 40 and 75 years of age with a medical history of chronic bronchitis, chronic obstructive pulmonary disease and a presumptive diagnosis of ABECB who met Anthonisen Type 1 criteria (increased dyspnea, increased sputum volume and increased sputum purulence). Eligible patients received a 5-day course of clarithromycin extended-release (ER) 500 mg once daily or clarithromycin immediate-release (IR) 250 mg twice daily. Clinical cure, bacteriological cure and pathogen eradication rates were determined at the end of therapy and at a follow-up visit. RESULTS: Clinical cure rates were similar at the test-of-cure visit for evaluable patients in the clarithromycin ER group (97%, 298/307) and clarithromycin IR group (98%, 300/307) (95% CI (-3.2, 1.9)). The bacteriological cure rate was 89% and the pathogen eradication rate was 90% in both treatment groups. Resolution or improvement in cough, sputum production, sputum volume and sputum appearance was observed in > 90% of evaluable patients in each treatment group. The incidence of study drug-related adverse events was 6.6% (23/351) in the clarithromycin ER group and 5.4% (19/352) in the clarithromycin IR group. The most frequently occurring study drug-related adverse events were abdominal pain, diarrhea and taste perversion. CONCLUSION:
Clarithromycin ER 500 mg once daily for 5 days is equivalent to clarithromycin IR 250 mg twice daily for 5 days in treating adults with ABECB. Both regimens were effective in resolving clinical signs and symptoms of ABECB and eradicating the target pathogens, and were well tolerated.
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Authors | Piotr Nalepa, Malgorzata Dobryniewska, Todd Busman, Gerard Notario |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 19
Issue 5
Pg. 411-20
( 2003)
ISSN: 0300-7995 [Print] England |
PMID | 13678478
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Delayed-Action Preparations
- Clarithromycin
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Topics |
- Acute Disease
- Adult
- Aged
- Analysis of Variance
- Anti-Bacterial Agents
(administration & dosage, pharmacology)
- Bacterial Infections
(drug therapy, microbiology)
- Bronchitis, Chronic
(drug therapy, microbiology)
- Clarithromycin
(administration & dosage, pharmacology)
- Delayed-Action Preparations
- Double-Blind Method
- Drug Resistance, Bacterial
- Humans
- Middle Aged
- Patient Compliance
- Treatment Outcome
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