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CP-192 Evaluation study at 2 weeks after starting fampridine in multiple sclerosis patients
  1. A Rodriguez Palomo,
  2. A Llorente Romeo,
  3. A Martinez Torron,
  4. FJ Alvarez Manceñido,
  5. A Rodriguez Ferreras,
  6. F Cossio Carbajo,
  7. E Lazaro Lopez,
  8. C Carriles Fernandez,
  9. C Martinez-Mugica Barbosa
  1. Hospital Universitario Central de Asturias, Hospital Pharmacy, Oviedo, Spain

Abstract

Background Fampridine has been approved for improvement in walking capacity in adult multiple sclerosis (MS) patients with an Expanded Disability Status Scale (EDSS) score of 4–7.

Purpose To evaluate the use, effectiveness and side effects of fampridine in MS patients 2 weeks after treatment initiation.

Material and methods All patients diagnosed with MS who started treatment with fampridine (since its inclusion into the hospital formulary, May 2014) were included in a descriptive, retrospective and observational study. Variables collected were: age, gender, year of evolution, clinical forms of MS and EDSS. Timed 25 foot walk test (T25FW) and 12 item MS walking scale (MSWS-12) were performed before beginning treatment and after 2 weeks of treatment, and were compared. In order to show effectiveness, patients must present more than a 20% improvement in T25FW and an increase of at least 6 points in the MSWS-12.

Results In this study, all evaluated patients (n = 78) at the beginning of the study had creatinine clearance >80 mL/min, no previous seizures episodes and accomplished medical data sheet requirements. Median age was 56 years (range 33–74) and 67.0% were women.

Patients showed the following clinical evolved forms of MS: relapsing-remitting 29.5%, primary progressive 21.8% and secondary progressive (SP) 48.7%. Median progression of disease was 15 years (4–44). Median EDSS was 6 (3.5–7).

After T25FW and MSWS-12 evaluations, 62.8% (n = 49) met the criteria for effectiveness (16.3% were on the lower limits of approval by at least 1 test, T25FW or MSWS-12). However, 70.5% (n = 55 patients) continued with fampridine treatment although 16.4% (n = 9) did not meet the criteria for drug effectiveness and should have suspended it.

Within the group of patients where there was no effectiveness, 55.2% had the SP form of MS.

The most common side effects reported were: dysarthria, constipation, stomach pain, insomnia and nervousness. Adverse reactions that induced treatment discontinuation in 3 patients were: sudden death in a cardiac patient, trigeminal neuralgia, seizures and facial paralysis.

Conclusion The percentage of fampridine treatment responders was higher than in pivotal trials (MS-F203 and MS-F204). There are no scientific data indicating that patients who do not respond to control tests must continue with treatment and adverse reactions to fampridine can lead to treatment discontinuation.

References and/or Acknowledgements

  1. http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002097/WC500109956.pdf

References and/or AcknowledgementsNo conflict of interest.

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