PMID- 25560174
OWN - NLM
STAT- MEDLINE
DCOM- 20150908
LR  - 20150224
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 127
IP  - 2
DP  - 2015 Mar
TI  - Assessment of confirmed urinary tract infection in patients treated with 
      dalfampridine for multiple sclerosis.
PG  - 218-22
LID - 10.1080/00325481.2015.1000229 [doi]
AB  - 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.
FAU - Kantor, Daniel
AU  - Kantor D
AD  - Neurologique Foundation, Inc. , Ponte Vedra Beach, FL , USA.
FAU - Chancellor, Michael B
AU  - Chancellor MB
FAU - Snell, Clayton W
AU  - Snell CW
FAU - Henney, Herbert R 3rd
AU  - Henney HR 3rd
FAU - Rabinowicz, Adrian L
AU  - Rabinowicz AL
LA  - eng
SI  - ClinicalTrials.gov/NCT01328379
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150106
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Potassium Channel Blockers)
RN  - BH3B64OKL9 (4-Aminopyridine)
SB  - IM
MH  - 4-Aminopyridine/administration & dosage/therapeutic use
MH  - Adult
MH  - Aged
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/*drug therapy
MH  - Potassium Channel Blockers/administration & dosage
MH  - Urinary Tract Infections
MH  - Young Adult
OTO - NOTNLM
OT  - 4-aminopyridine
OT  - MS relapse
OT  - dalfampridine
OT  - multiple sclerosis
OT  - urinary tract infection
EDAT- 2015/01/07 06:00
MHDA- 2015/09/09 06:00
CRDT- 2015/01/07 06:00
PHST- 2015/01/07 06:00 [entrez]
PHST- 2015/01/07 06:00 [pubmed]
PHST- 2015/09/09 06:00 [medline]
AID - 10.1080/00325481.2015.1000229 [doi]
PST - ppublish
SO  - Postgrad Med. 2015 Mar;127(2):218-22. doi: 10.1080/00325481.2015.1000229. Epub 
      2015 Jan 6.