title: Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis.
abstract: Urinary tract infections (UTIs) were reported frequently with dalfampridine extended-release (dalfampridine-ER) 10 mg relative to placebo in previous multiple sclerosis (MS) studies. The objective of this study was to determine whether dalfampridine-ER is associated with increased incidence of confirmed UTIs in MS patients. This post hoc analysis used UTI data from a study comparing the 4-week safety and efficacy of 5 mg (n = 144) and 10 mg (n = 142) twice-daily dalfampridine-ER versus placebo (n = 143). To confirm UTIs, three clinical assessments were used: standard urinalysis (leukocytes > 5/high-power field); urine culture (≥ 100,000 and ≥ 10,000 colony-forming units [CFUs]/mL) for those who reported UTIs as adverse events (AEs) or had positive urinalysis; and UTI symptomatology. Fisher's exact test assessed statistical significance. The proportion of patients who reported UTIs as AEs in the placebo and dalfampridine-ER 5 mg and 10 mg groups were 5.6%, 6.3%, and 9.9%, respectively. In comparison, those with laboratory-confirmed UTIs were lower: ≥ 100,000 CFUs/mL: 4.2%, 2.8%, and 2.8%; and ≥ 10,000 CFUs/mL: 4.2%, 3.5%, and 4.9%, respectively (no significant statistical difference across treatments). The proportion of patients with confirmed UTI was similar between dalfampridine-ER and placebo, thus suggesting that the treatment does not increase the risk of UTIs.
authors.affiliation: Neurologique Foundation, Inc. , Ponte Vedra Beach, FL , USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kantor
authors.forename: Michael B
authors.initials: MB
authors.lastname: Chancellor
authors.forename: Clayton W
authors.initials: CW
authors.lastname: Snell
authors.forename: Herbert R
authors.initials: HR
authors.lastname: Henney
authors.forename: Adrian L
authors.initials: AL
authors.lastname: Rabinowicz
mesh_terms: D015761:4-Aminopyridine / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D026902:Potassium Channel Blockers / Q000008:administration & dosage; D014552:Urinary Tract Infections; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D026902:Potassium Channel Blockers; D015761:4-Aminopyridine
keywords: 4-aminopyridine; MS relapse; dalfampridine; multiple sclerosis; urinary tract infection