Lomefloxacin versus Norfloxacin in the Treatment of Uncomplicated Urinary Tract Infections: Three-Day versus Seven-Day Treatment

Neringer, Rune; Forsgren, Arne; Hansson, Christer; Ode, Björn

doi:10.3109/00365549209062463

“…2,4,6,14,17,20,23,24,27,29,38,45,75 Lomefloxacin caused phototoxicity reactions in 1.7-10% of patients during clinical studies. 12,13,76 Sparfloxacin also was associated with a relatively high frequency of these reactions, ranging from 1-2% in Japan and Europe and from 6.9-9.5% in North America, compared with 0.2-0.9% for comparator agents. 4,[24][25][26] Most reactions were mild or moderate, but some were severe.…”

Section: Dermatologicmentioning

confidence: 98%

Fluoroquinolone Adverse Effects and Drug Interactions

Fish

¹

2001

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Extensive pharmacologic and clinical development of quinolone antimicrobial agents has resulted in improved antimicrobial activity, pharmacokinetic features, toxicity, and drug‐drug interaction profiles. Nalidixic acid and other early quinolones had limited use due to poor pharmacokinetics, relatively narrow antimicrobial spectrum of activity, and frequent adverse effects. Beginning with the development of fluoroquinolones, such as norfloxacin and ciprofloxacin, in the 1980s, the agents assumed a greatly expanded clinical role because of their broad antimicrobial spectrum of action, improved pharmacokinetic properties, and more acceptable safety profile. Although the pharmacokinetics and efficacy of the drugs have improved significantly, a major area of continued emphasis is to further reduce the frequency and severity of adverse events and drug‐drug interactions. Older agents such as ciprofloxacin and ofloxacin are still extensively prescribed, but the focus of this article is on the newer fluoroquinolones (levofloxacin and other drugs that have been approved or have been under investigation since approximately 1997).

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“…For example, although mean ages in such studies have varied widely, from 24 to more than 48 years (5,6,10,24,28), the mean age of 36 years in this study is typical of the narrower range of 30 to 40 years for multicenter studies with an upper age limit for enrollment (7,12,19,20) and is appropriate for the disease population (2). In addition, the organisms isolated here, predominantly E. coli (188 of 219; 85.8%) and S. saprophyticus (4.6%), are consistent with the spectrum of pathogens expected in acute uncomplicated UTI (4,31), although a relatively high percentage of E. faecalis (5.0%), which is more commonly associated with nosocomial UTIs (8), was also found.…”

Section: Discussionmentioning

confidence: 93%

Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection With Sparfloxacin Versus Ofloxacin

Henry

¹

,

Ellison

²

,

Sullivan

³

et al. 1999

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The efficacy and safety of a 3-day regimen of sparfloxacin were compared with those of a 3-day regimen of ofloxacin for the treatment of community-acquired acute uncomplicated urinary tract infections. Four hundred nineteen women were enrolled in a randomized, open-label, observer-blinded, multicenter study; 204 received sparfloxacin as a 400-mg loading dose on the first day and 200 mg once daily thereafter, and 215 received ofloxacin as 200 mg twice daily. A total of 383 patients met the criteria for clinical evaluability, and 174 were also bacteriologically evaluable; all treated patients were included in the safety analysis. Escherichia coli (86%) and Staphylococcus saprophyticus (4.6%) were the organisms most commonly isolated. Positive clinical responses were obtained 5 to 9 days after therapy in more than 92% of the patients in each group; sustained clinical cure rates 4 to 6 weeks after therapy were 78.3 and 76.9% in the sparfloxacin and ofloxacin groups, respectively. A positive bacteriologic response was observed in 98% of the bacteriologically evaluable patients in each treatment group at 5 to 9 days posttherapy and in 88.2 and 92.6% of the patients in the sparfloxacin and ofloxacin groups, respectively, 4 to 6 weeks after therapy. Almost 90% of all adverse events were of mild or moderate severity; the most frequent events at least possibly related to drug treatment were those common to the fluoroquinolones, namely, nausea, diarrhea, headache, insomnia, and photosensitivity. Photosensitivity was more frequent in the sparfloxacin group (6.9% versus 0.5% in the ofloxacin group); insomnia was more frequent in the ofloxacin group (3.7% versus 1.0% in the sparfloxacin group). These data suggest that a oncedaily, 3-day regimen of sparfloxacin is effective and generally well tolerated in the treatment of acute uncomplicated urinary tract infections.Standard therapy for acute uncomplicated urinary tract infections (UTIs) consists of a 3-day regimen with trimethoprim-sulfamethoxazole (TMP-SMZ), trimethoprim, or fluoroquinolones. Although TMP-SMZ is often the drug of choice, fluoroquinolones are recommended for patients with recurrent infection, treatment failures, and allergies to other antimicrobial agents (27,31). With the development of resistance, fluoroquinolones may be preferred since UTI pathogens demonstrate lower levels of resistance to fluoroquinolones compared to other therapies such as TMP-SMZ, amoxicillin, and sulfonamides (5, 27).Single-dose regimens have also been tested but have been less effective, with lower cure rates and more frequent recurrences than those achieved with the more optimal 3-to 5-day therapy (5, 21, 27). Short-course treatment offers distinct advantages in terms of patient compliance and convenience, as well as providing cost benefits, fewer side effects, and reduced levels of bacterial exposure to drugs. Sparfloxacin is extremely effective against a broad spectrum of gram-negative and gram-positive organisms (16, 22), including those implicated in UTIs. It is excreted unchang...

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“…The characteristics of the study population described here are similar to those reported in other recent short-course clinical trials for acute uncomplicated UTI in younger females. For example, although mean ages in such studies have varied widely, from 24 to more than 48 years (5,6,10,24,28), the mean age of 36 years in this study is typical of the narrower range of 30 to 40 years for multicenter studies with an upper age limit for enrollment (7,12,19,20) and is appropriate for the disease population (2). In addition, the organisms isolated here, predominantly E. coli (188 of 219; 85.8%) and S. saprophyticus (4.6%), are consistent with the spectrum of pathogens expected in acute uncomplicated UTI (4,31), although a relatively high percentage of E. faecalis (5.0%), which is more commonly associated with nosocomial UTIs (8), was also found.…”

Section: Discussionmentioning

confidence: 93%

Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection with Sparfloxacin versus Ofloxacin

Henry

¹

,

Ellison

²

,

Sullivan³

et al. 1998

Antimicrob Agents Chemother

29

0

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The efficacy and safety of a 3-day regimen of sparfloxacin were compared with those of a 3-day regimen of ofloxacin for the treatment of community-acquired acute uncomplicated urinary tract infections. Four hundred nineteen women were enrolled in a randomized, open-label, observer-blinded, multicenter study; 204 received sparfloxacin as a 400-mg loading dose on the first day and 200 mg once daily thereafter, and 215 received ofloxacin as 200 mg twice daily. A total of 383 patients met the criteria for clinical evaluability, and 174 were also bacteriologically evaluable; all treated patients were included in the safety analysis. Escherichia coli (86%) andStaphylococcus saprophyticus (4.6%) were the organisms most commonly isolated. Positive clinical responses were obtained 5 to 9 days after therapy in more than 92% of the patients in each group; sustained clinical cure rates 4 to 6 weeks after therapy were 78.3 and 76.9% in the sparfloxacin and ofloxacin groups, respectively. A positive bacteriologic response was observed in 98% of the bacteriologically evaluable patients in each treatment group at 5 to 9 days posttherapy and in 88.2 and 92.6% of the patients in the sparfloxacin and ofloxacin groups, respectively, 4 to 6 weeks after therapy. Almost 90% of all adverse events were of mild or moderate severity; the most frequent events at least possibly related to drug treatment were those common to the fluoroquinolones, namely, nausea, diarrhea, headache, insomnia, and photosensitivity. Photosensitivity was more frequent in the sparfloxacin group (6.9% versus 0.5% in the ofloxacin group); insomnia was more frequent in the ofloxacin group (3.7% versus 1.0% in the sparfloxacin group). These data suggest that a once-daily, 3-day regimen of sparfloxacin is effective and generally well tolerated in the treatment of acute uncomplicated urinary tract infections.

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Lomefloxacin versus Norfloxacin in the Treatment of Uncomplicated Urinary Tract Infections: Three-Day versus Seven-Day Treatment

Cited by 41 publications

References 5 publications

Fluoroquinolone Adverse Effects and Drug Interactions

Fluoroquinolone Adverse Effects and Drug Interactions

Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection With Sparfloxacin Versus Ofloxacin

Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection with Sparfloxacin versus Ofloxacin

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