Drugs 45 (Suppl. 3): 435-436, 1993 0012-6667/93/0300-0435/$1.00/0 © Adis International LImIted. All rights reserved.

DRSUP5516g

Once-Daily Administration of Lomefloxacin for Infections in Older Patients A Summary of Worldwide Controlled Clinical Trials

Jack D. McCue and Emad Rizk Baystate Medical Center, Tufts University School of Medicine, Springfield, Maryland, USA

Oral antimicrobials [such as lomefloxacin (Maxaquin, Uniquin)] that demonstrate a broad spectrum of activity against the major bacterial pa­thogens in urinary and respiratory infections, good tissue penetration, 100% bioavailability, and a long half-life allowing once-daily administration may circumvent the need for intravenous antibiotic therapy in many elderly patients.

We examined the multicentre data accumulated over the last 5 years comparing the types of pa­thogens cultured and the response to once-daily

therapy with lomefloxacin in a total of 5255 eva­luable younger and older patients.

1. Results

Table I lists data documenting the clinical suc­cess and bacterial eradication in evaluable patients with uncomplicated or complicated urinary tract infection (UTI) and acute exacerbations of chronic bronchitis. Single-dose lomefloxacin 400 mg/day was used in all trials. The comparator drugs used were as follows: cotrimoxazole [trimethoprim/sulfa­methoxazole] OS or norfloxacin 400mg twice daily for uncomplicated UTI; cotrimoxazole OS, nor­floxacin 400mg, or ciprofloxacin 500mg twice daily for complicated UTI; amoxicillin 500mg or cefa­c10r 250mg 3 times daily for acute exacerbations of chronic bronchitis. Table II compares adverse drug reactions in patients taking lomefloxacin and other quinolones in these trials, according to age group.

A comparison of the bacterial pathogens cul­tured in these infections showed no significant dif­ference by age group. In uncomplicated UTI, it was apparent that the patients were younger and the spectrum of pathogens was narrower. Complicated UTI occurred rarely in young patients - the spec­trum of pathogens was much broader, and the patients were predominantly from the group aged >65 years. The spectrum of pathogens cultured from patients with acute exacerbations of chronic

Table I. Clinical success rates and bacteriological eradication rates in patients treated with lomefloxacin or alternative agents (control) in 3 indications

Patient age Acute exacerbation of chronic Uncomplicated urinary tract infection Complicated urinary tract infection (years) bronchitis (%) [no. of patients] (%) [no. of patients] (%) [no. of patients]

lomefloxacin control lomefloxacin control lomefloxacin control

Clinical success < 65 96.4 [225] 93.9 [105] 98.6 [415] 95.7 [399] 96.6 [89] 92.7 [96] > 65 93.3 [90] 91.3 [69] 100 [30] 94.4 [36] 91.8 [97] 93.5 [93]

Bacterial eradication < 65 91.5 [214] 88.4 [153] 98.1 [417] 97.3 [401] 95.7 [92] 89.2 [102] > 65 93.4 [91] 78.1 [70] 100 [30] 94.4 [36] 92.9 [98] 84.9 [93]

Table II. Percentage of adverse events according to age in patients treated with lomefloxacin or other quinolones

Adverse event < 65 years of age ;;. 65 years of age

lomefloxacin quinolones lomefloxacin quinolones

Gastrointestinal 7.9 10.1 5.5 6.6 Central nervous system 7.1 6.8 4.3 4.0 Skin 5.9 2.8 2.0 2.0

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obstructive lung disease was very broad, but the patients were a relatively younger group. We con­cluded, therefore, that the disease process was a more important determinant of the breadth of the spectrum of bacterial pathogens than age.

2. Conclusions

Lomefloxacin 400mg once daily was at least as effective as the comparator antibiotics (ciproflox­acin, cotrimoxazole, norfloxacin, amoxicillin, ce­faclor) in the treatment of uncomplicated UTI, complicated UTI, and acute exacerbations of

Drugs 45 (Suppl. 3) /993

chronic bronchitis in large, multicentre, controlled trials conducted during the past 5 years. When data were analysed according to age, the older age group responded to lomefloxacin therapy at least as well as the younger patients in all infectious conditions treated.

Adverse events were uncommon, with no dif­ference in the elderly patients when adverse events associated with lomefloxacin and other quinolones were compared.

Correspondence and reprints: Dr J.D. McCue. General Medicine Geriatrics Section, Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199. USA.