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Long-term Efficacy and Safety

Chris H. Polman, MD, PhD; Frits W. Bertelsmann, MD, PhD; Arie C. van Loenen, PharmD; Johan C. Koetsier, MD, PhD

Arch Neurol. 1994;51(3):292-296.

Abstract
Objective
To study the long-term efficacy and safety of 4-aminopyridine in patients with multiple sclerosis.

Design
Case series, follow-up varying from 6 to 32 months.

Setting
University referral center.

Patients
Thirty-one patients with definite MS, 23 of them being exposed to long-term administration (6 to 32 months) of 4-aminopyridine, since they showed a favorable initial response to the drug.

Interventions
Long-term oral treatment with 4-aminopyridine in daily doses of up to 0.5 mg/kg of body weight.

Main Outcome Measures
Neurologic functions and symptoms as reported by the patients; side effects.

Results
Twenty of 23 patients who showed a favorable initial response benefited from long-term administration. Ambulation and fatigue (each in 13 patients) and visual function (in five patients) were most frequently reported to be improved. Three major side effects did occur during a follow-up of 406 patient months: a generalized epileptic seizure in two patients and hepatitis in one.

Conclusions
Although a substantial proportion of patients with multiple sclerosis seem to benefit from long-term administration of 4-aminopyridine, additional studies are needed to clarify the exact value of the drug.

Author Affiliations
From the Departments of Neurology (Drs Polman, Bertelsmann, and Koetsier) and Pharmacy (Dr van Loenen), Free University Hospital, Amsterdam, the Netherlands.

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