Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis.
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| 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.
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| Authors | Daniel Kantor, Michael B Chancellor, Clayton W Snell, Herbert R Henney 3rd, Adrian L Rabinowicz |
| Journal | Postgraduate medicine (Postgrad Med) Vol. 127 Issue 2 Pg. 218-22 (Mar 2015) ISSN: 1941-9260 [Electronic] England |
| PMID | 25560174 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't) |
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