Title |
Safety of trovafloxacin in treatment of lower respiratory tract infections
|
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Published in |
European Journal of Clinical Microbiology & Infectious Diseases, June 1998
|
DOI | 10.1007/bf01691582 |
Pubmed ID | |
Authors |
D. Williams, S. Hopkins |
Abstract |
Safety and toleration of oral trovafloxacin has been assessed in Phase III trials in patients with acute lower respiratory tract infections. Patients were treated orally with either trovafloxacin 100 or 200 mg (n=881) or a comparator (500 or 1000 mg amoxicillin, or 625 mg amoxicillin/clavulanic acid; n = 593). Adverse events were recorded in 112 (12.7%) trovafloxacin- and 74 (12.5%) comparator-treated patients. Frequency of effects on the autonomic nervous, musculoskeletal, respiratory, special senses, urinary and reproductive systems was <1%. Photosensitivity reactions were not reported in trovafloxacin-treated patients. Central or peripheral nervous system adverse effects (headache and dizziness) were slightly more common in trovafloxacin-treated patients (4.4% vs 1.9%). Patients treated with comparators experienced gastrointestinal events more frequently (6.1% vs 8.3%). Comparable incidences of adverse events were reported in patients > or = 65-years-old. Most events were mild to moderate in severity. Treatment was discontinued because of an adverse event in 18 (2%) trovafloxacin- and four (0.7%) comparator-treated patients. Despite the high prevalence of risk factors, serious adverse events were rare and the mortality rate over the 35-day study period was low: trovafloxacin 0.8%, comparator agents 1.5%. Laboratory test abnormalities were recorded in less than 1% of patients in either treatment group. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 17 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 3 | 18% |
Student > Doctoral Student | 2 | 12% |
Student > Bachelor | 2 | 12% |
Unspecified | 2 | 12% |
Student > Master | 2 | 12% |
Other | 3 | 18% |
Unknown | 3 | 18% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 59% |
Unspecified | 2 | 12% |
Biochemistry, Genetics and Molecular Biology | 2 | 12% |
Nursing and Health Professions | 1 | 6% |
Unknown | 2 | 12% |