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Safety profile of sparfloxacin, a new fluoroquinolone antibiotic.
Clin Ther. 1999 Jan; 21(1):148-59.CT

Abstract

The safety profile of sparfloxacin, a newer fluoroquinolone antibiotic, was examined through an integrated analysis of safety data from 6 multicenter phase III trials. These consisted of 5 double-masked, randomized, comparative trials of sparfloxacin (a 400-mg oral loading dose followed by 200 mg/d for 10 days) versus standard therapies (erythromycin, cefaclor, ofloxacin, clarithromycin, and ciprofloxacin) and I open-label trial (noncomparative) in patients with: community-acquired pneumonia (2 trials); acute bacterial exacerbations of chronic bronchitis (1 trial); acute maxillary sinusitis (2 trials, one of which was the noncomparative trial); and complicated skin and skin-structure infections (1 trial). Overall, 401 (25.3%) of 1585 patients treated with sparfloxacin and 374 (28.1%) of 1331 receiving a comparator regimen experienced at least 1 adverse event considered to be related to the study medication. Photosensitivity reactions, usually of mild-to-moderate severity, were seen more frequently with sparfloxacin (7.4%) than with comparator agents (0.5%), whereas gastrointestinal reactions (diarrhea, nausea, dyspepsia, abdominal pain, vomiting, and flatulence), insomnia, and taste perversion were more common in patients taking comparator drugs (22.3% vs 12.1%, 4.3% vs 1.5%, and 2.9% vs 1.2%, respectively). Analysis of electrocardiographic findings showed that the mean change from baseline in QT interval corrected for heart rate (QTc) was significantly greater in sparfloxacin-treated patients (10 msec) than in patients given comparator drugs (3 msec), but no associated ventricular arrhythmias were detected. Adverse events led to discontinuation of study medication in 104 (6.6%) patients receiving sparfloxacin and 118 (8.9%) given com parator drugs. Sparfloxacin may be considered an appropriate choice for the treatment of certain community-acquired infections for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval.

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Publisher Full Text

Authors+Show Affiliations

Lipsky BA
University of Washington and VA Puget Sound Health Care System, Seattle 98108-1597, USA.
Dorr MB
No affiliation info available
Magner DJ
No affiliation info available
Talbot GH
No affiliation info available

MeSH

AdolescentAdultAgedAnti-Infective AgentsBacterial InfectionsBronchitisClinical Trials, Phase III as TopicCommunity-Acquired InfectionsData Interpretation, StatisticalFemaleFluoroquinolonesHeart RateHumansMaleMiddle AgedPhotosensitivity DisordersPneumonia, BacterialQuinolonesSinusitisSkin Diseases, Bacterial

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10090432

Citation

Lipsky, B A., et al. "Safety Profile of Sparfloxacin, a New Fluoroquinolone Antibiotic." Clinical Therapeutics, vol. 21, no. 1, 1999, pp. 148-59.
Lipsky BA, Dorr MB, Magner DJ, et al. Safety profile of sparfloxacin, a new fluoroquinolone antibiotic. Clin Ther. 1999;21(1):148-59.
Lipsky, B. A., Dorr, M. B., Magner, D. J., & Talbot, G. H. (1999). Safety profile of sparfloxacin, a new fluoroquinolone antibiotic. Clinical Therapeutics, 21(1), 148-59.
Lipsky BA, et al. Safety Profile of Sparfloxacin, a New Fluoroquinolone Antibiotic. Clin Ther. 1999;21(1):148-59. PubMed PMID: 10090432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety profile of sparfloxacin, a new fluoroquinolone antibiotic. AU - Lipsky,B A, AU - Dorr,M B, AU - Magner,D J, AU - Talbot,G H, PY - 1999/3/25/pubmed PY - 1999/3/25/medline PY - 1999/3/25/entrez SP - 148 EP - 59 JF - Clinical therapeutics JO - Clin Ther VL - 21 IS - 1 N2 - The safety profile of sparfloxacin, a newer fluoroquinolone antibiotic, was examined through an integrated analysis of safety data from 6 multicenter phase III trials. These consisted of 5 double-masked, randomized, comparative trials of sparfloxacin (a 400-mg oral loading dose followed by 200 mg/d for 10 days) versus standard therapies (erythromycin, cefaclor, ofloxacin, clarithromycin, and ciprofloxacin) and I open-label trial (noncomparative) in patients with: community-acquired pneumonia (2 trials); acute bacterial exacerbations of chronic bronchitis (1 trial); acute maxillary sinusitis (2 trials, one of which was the noncomparative trial); and complicated skin and skin-structure infections (1 trial). Overall, 401 (25.3%) of 1585 patients treated with sparfloxacin and 374 (28.1%) of 1331 receiving a comparator regimen experienced at least 1 adverse event considered to be related to the study medication. Photosensitivity reactions, usually of mild-to-moderate severity, were seen more frequently with sparfloxacin (7.4%) than with comparator agents (0.5%), whereas gastrointestinal reactions (diarrhea, nausea, dyspepsia, abdominal pain, vomiting, and flatulence), insomnia, and taste perversion were more common in patients taking comparator drugs (22.3% vs 12.1%, 4.3% vs 1.5%, and 2.9% vs 1.2%, respectively). Analysis of electrocardiographic findings showed that the mean change from baseline in QT interval corrected for heart rate (QTc) was significantly greater in sparfloxacin-treated patients (10 msec) than in patients given comparator drugs (3 msec), but no associated ventricular arrhythmias were detected. Adverse events led to discontinuation of study medication in 104 (6.6%) patients receiving sparfloxacin and 118 (8.9%) given com parator drugs. Sparfloxacin may be considered an appropriate choice for the treatment of certain community-acquired infections for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/10090432/Safety_profile_of_sparfloxacin_a_new_fluoroquinolone_antibiotic_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(00)88275-2 DB - PRIME DP - Unbound Medicine ER -