Background Fampridine (4-aminopyridine) improves motor function in people with Multiple Sclerosis (MS). It is a new drug in Spain indicated for symptomatic improvement of walking in adults with several variations of the disease.
Purpose To assess the effectiveness, recorded adverse events and adherence to fampridine in patients with MS.
Materials and methods Retrospective study. Patients with MS and disability score (EDSS) between 4–7, treated with fampridine 10 mg/12 h from April 2012 to September 2013. Effectiveness assessment: timed 25-foot walk (T25FW) and 12-item multiple sclerosis walking scale (MSWS-12) at baseline, 15 days, 3,6,9 and 12 months, responder patient: T25FW decrease ≥20% and/or MSWS-12 ≥ 4–6 points from baseline. Safety assessment: adverse events recorded, visits to emergency services and hospitalisations. Adherence was assessed by the pharmacy dispensing ratio.
Results 19 patients. Average age: 61.9 years, 68.4% women. 26.3% Relapsing Remitting MS, 31.6% Primary Progressive MS and 42.1% Secondary Progressive MS. EDSS, TW25F and MSWS average baseline values: 5.92, 21.06 and 47.89 respectively. 3 patients discontinued treatment: 2 after 15 days and 1 after 9 months due to intolerance/ineffectiveness. At 15th day, (n = 17 (89%)), TW25F was 13.18 (average reduction 34.26%, 88.2% ≥ 20%) and MSWS-12 was 37.41 (70.6% ≥ 4–6 points reduction). 3 months later, (n = 17 (89%)), TW25F was 14.86 (average reduction 33.78%, 78.9% ≥ 20%) and MSWS-12 was 36.65 (82.4% ≥ 4 points reduction and 70.6% ≥ 6). After 1 year of treatment, (n = 16 (84%)), TW25F was 14.56 (average reduction 32.0%, 87.5% ≥ 20%) and MSWS-12 was 40.0 (62.5% ≥ 4–6 points reduction). Global average time reduction at 15 days, 3 and 12 months was 14.2 (average reduction 32.6%). After 1 year EDSS was 5.93. According to the recorded adverse events, 41.1% (7/17) of those who continued treatment after 15 days were hospitalised or visited emergency services, 23.5% (4/17) due to urinary tract infection and 23.5% because of dizziness falls (relationship drug/events not evaluated). Treatment adherence was 98.7%
Conclusions Fampridine produces a clinical hold-in-time improvement in walking ability and mobility. After 1 year, from the whole patients, in 47% there was a reduction >20% in TW25F, together with a reduction in MSWS-12 >6. Fampridine was well tolerated.
In our patients there was a global average of T25FW reduction of 14.2 sec (as a reduction of 32.6% of time), which means 47.2% faster. In the pivotal clinical trials (PCT) there was a 25% reduction.1,2 Our data are referred to a year of treatment and the two PCT just analysed 14 and 9 months respectively.
Additional studies are warranted to assess possible explanations for these discrepancies.
Goodman AD, et al. Lancet 2009;373:732-738
Goodman AD, et al. Ann Neurology 2010;68:494-502
No conflict of interest.
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