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Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Sparfloxacin Multicenter ABECB Study Group.
Chest. 1998 Jul; 114(1):120-30.Chest

Abstract

STUDY OBJECTIVE

Comparison of efficacy and safety of sparfloxacin vs ofloxacin for treatment of acute bacterial exacerbations of chronic bronchitis (ABECB).

DESIGN

Multicenter, double-blind, randomized study.

SETTING

Sixty-eight private offices and outpatient clinics in the United States and Canada.

PATIENTS

Seven hundred ninety-eight adults with ABECB, as confirmed by the acute onset of new (or worsened from the immediate premorbid state) cough and sputum production.

INTERVENTIONS

Randomization 1:1 to sparfloxacin, 400 mg on day 1, then 200 mg once daily, or ofloxacin, 400 mg twice daily, with matching comparator placebos, given concurrently for 10 consecutive days.

RESULTS

The primary efficacy parameter was overall response in the bacteriologically evaluable population. Overall success rates in this population were 85.3% and 89.3% for sparfloxacin and ofloxacin, respectively. The two-sided 95% confidence interval was -9.9, 1.9, indicating that sparfloxacin was statistically equivalent to ofloxacin. The all-treated population analysis was similar to that in the evaluable population. Bacterial eradication rates were similar in both treatment groups for Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Enterobacter cloacae, and Staphylococcus aureus. The frequency of adverse events overall was comparable in the two treatment groups. The sparfloxacin group had a lower frequency of digestive and nervous system adverse events, but a higher frequency of photosensitivity reactions than the ofloxacin group.

CONCLUSIONS

Once-daily oral treatment with 200 mg sparfloxacin (after initial 400 mg dose) is as effective as twice-daily treatment with 400 mg ofloxacin in patients with ABECB.

Authors+Show Affiliations

Medical Research Center, New Orleans, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9674458

Citation

DeAbate, C A., et al. "Sparfloxacin Vs Ofloxacin in the Treatment of Acute Bacterial Exacerbations of Chronic Bronchitis: a Multicenter, Double-blind, Randomized, Comparative Study. Sparfloxacin Multicenter ABECB Study Group." Chest, vol. 114, no. 1, 1998, pp. 120-30.
DeAbate CA, Henry D, Bensch G, et al. Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Sparfloxacin Multicenter ABECB Study Group. Chest. 1998;114(1):120-30.
DeAbate, C. A., Henry, D., Bensch, G., Jubran, A., Chodosh, S., Harper, L., Tipping, D., & Talbot, G. H. (1998). Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Sparfloxacin Multicenter ABECB Study Group. Chest, 114(1), 120-30.
DeAbate CA, et al. Sparfloxacin Vs Ofloxacin in the Treatment of Acute Bacterial Exacerbations of Chronic Bronchitis: a Multicenter, Double-blind, Randomized, Comparative Study. Sparfloxacin Multicenter ABECB Study Group. Chest. 1998;114(1):120-30. PubMed PMID: 9674458.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Sparfloxacin Multicenter ABECB Study Group. AU - DeAbate,C A, AU - Henry,D, AU - Bensch,G, AU - Jubran,A, AU - Chodosh,S, AU - Harper,L, AU - Tipping,D, AU - Talbot,G H, PY - 1998/7/23/pubmed PY - 1998/7/23/medline PY - 1998/7/23/entrez SP - 120 EP - 30 JF - Chest JO - Chest VL - 114 IS - 1 N2 - STUDY OBJECTIVE: Comparison of efficacy and safety of sparfloxacin vs ofloxacin for treatment of acute bacterial exacerbations of chronic bronchitis (ABECB). DESIGN: Multicenter, double-blind, randomized study. SETTING: Sixty-eight private offices and outpatient clinics in the United States and Canada. PATIENTS: Seven hundred ninety-eight adults with ABECB, as confirmed by the acute onset of new (or worsened from the immediate premorbid state) cough and sputum production. INTERVENTIONS: Randomization 1:1 to sparfloxacin, 400 mg on day 1, then 200 mg once daily, or ofloxacin, 400 mg twice daily, with matching comparator placebos, given concurrently for 10 consecutive days. RESULTS: The primary efficacy parameter was overall response in the bacteriologically evaluable population. Overall success rates in this population were 85.3% and 89.3% for sparfloxacin and ofloxacin, respectively. The two-sided 95% confidence interval was -9.9, 1.9, indicating that sparfloxacin was statistically equivalent to ofloxacin. The all-treated population analysis was similar to that in the evaluable population. Bacterial eradication rates were similar in both treatment groups for Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Enterobacter cloacae, and Staphylococcus aureus. The frequency of adverse events overall was comparable in the two treatment groups. The sparfloxacin group had a lower frequency of digestive and nervous system adverse events, but a higher frequency of photosensitivity reactions than the ofloxacin group. CONCLUSIONS: Once-daily oral treatment with 200 mg sparfloxacin (after initial 400 mg dose) is as effective as twice-daily treatment with 400 mg ofloxacin in patients with ABECB. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/9674458/Sparfloxacin_vs_ofloxacin_in_the_treatment_of_acute_bacterial_exacerbations_of_chronic_bronchitis:_a_multicenter_double_blind_randomized_comparative_study__Sparfloxacin_Multicenter_ABECB_Study_Group_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)47627-5 DB - PRIME DP - Unbound Medicine ER -