IngentaConnect Efficacy and Safety of Ciprofloxacin Oral Suspension Versus Trime...

Abstract:

J Am Geriatr Soc 49:1606–1613, 2001. OBJECTIVES:

To compare the efficacy and safety of ciprofloxacin (CIP) oral suspension to trimethoprim/sulfamethoxazole (TMP/SMX) oral suspension among older women with acute urinary tract infections (UTIs). DESIGN:

Prospective, randomized, open-label, multicenter study of older women (age 65 and older). SETTING:

Community and nursing home. PARTICIPANTS:

A total of 261 older women were evaluable for safety. Of these, 172 (86 community, 86 nursing home) were evaluable for clinical and bacteriological efficacy. INTERVENTION:

Patients were randomized to a 10-day regimen of either CIP (250mg/5mL twice daily) or TMP/SMX (160/800mg/20mL twice daily). MEASUREMENTS:

Clinical response 4 to 10 days posttherapy. RESULTS:

For the efficacy-valid population, posttherapy clinical resolution was statistically superior following CIP (97%) versus TMP/SMX (85%) (95% CI = 2.0–21.3; P = .009). Eradication of pretreatment bacterial isolates posttherapy was also higher following CIP (95%) versus TMP/SMX (84%) (95% CI = 2.7–21.3; P = .019). For the intent-to-treat population, posttherapy clinical resolution was significantly higher in the CIP group (96%) than in the TMP/SMX group (87%) (95% CI = 0.2–16.7; P = .025). Safety was assessed in the intent-to-treat population and the incidence of drug-related adverse events were significantly lower following CIP (17%) than following TMP/SMX (27%) (P = .047). Premature discontinuation due to these events was also less prevalent with CIP than with TMP/SMX (2% vs 11%, respectively) (P = .004). CONCLUSION:

CIP suspension showed higher clinical success and bacteriological eradication rates than did TMP/SMX for both community-based and nursing home–residing older women with acute UTIs. Furthermore, CIP suspension was associated with significantly lower rates of adverse events and premature discontinuations compared with TMP/SMX suspension.

Keywords: ciprofloxacin oral suspension; TMP/SMX suspension; acute urinary tract infection; cystitis; older female

Document Type: Research article

Affiliations: 1: Gurwin Jewish Geriatric Center, Commack, New York; 2: Welborn Clinical Research, Evansville, Indiana; and 3: Bayer Corporation Pharmaceutical Division, West Haven, Connecticut.

Efficacy and Safety of Ciprofloxacin Oral Suspension Versus Trimethoprim-Sulfamethoxazole Oral Suspension for Treatment of Older Women with Acute Urinary Tract Infection