Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome |
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| Authors: | E Millefiorini C Gasperini C Pozzilli F D’Andrea S Bastianello M Trojano S Morino V Brescia Morra A Bozzao A Calo’ M L Bernini D Gambi M Prencipe |
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| Institution: | (1) Department of Neurological Science, Universita’“La Sapienza”, Viale Universita’ 30, I-00185 Rome, Italy Tel.: 0039-6-49914716, Fax: 0039-6-4457705, IT;(2) Institute of Neurology, University of L’Aquila, L’Aquila, Italy, IT;(3) Institute of Neurology, University of Bari, Bari, Italy, IT;(4) Institute of Neurology, University Federico II, Naples, Italy, IT;(5) Department of Neurological Sciences, University Federico II, Naples, Italy, IT;(6) Institute of Neurology, University of Chieti, Chieti, Italy, IT |
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| Abstract: | We designed a randomized, placebo-controlled, multicentre trial involving 51 relapsing-remitting multiple sclerosis patients
to determine the clinical efficacy of mitoxantrone treatment over 2 years. Patients were allocated either to the mitoxantrone
group (27 patients receiving IV infusion of mitoxantrone every month for 1 year at the dosage of 8 mg/m2) or to the placebo group (24 patients, receiving IV infusion of saline every month for 1 year) using a centralized randomization
system. Disability at entry and at 12–24 months was evaluated by four blinded neurologists trained in the application of the
Kurtzke Expanded Disability Scale (EDSS). In addition, the number and clinical characteristics of the exacerbations over the
24 months were recorded by the local investigators. MRI, at 0,12 and 24 months, was performed with a 0.2 T permanent unit.
MRI data were analysed by two blinded neuroradiologists. All patients underwent a clinical evaluation. A statistically significant
difference in the mean number of exacerbations was observed between the mitoxantrone group and placebo group both during the
1st and the 2nd year. Although there was no statistically significant benefit in terms of mean EDSS progression over 2 years,
the proportion of patients with confirmed progression of the disease, as measured by a one point increase on the EDSS scale,
was significantly reduced at the 2nd year evaluation in the mitoxantrone group. Forty-two (23 mitoxantrone, 19 placebo) patients
underwent all MRI examinations during the 24-month period. We observed a trend towards a reduction in the number of new
lesions on T2-weighted images in the mitoxantrone group. Our study suggests that mitoxantrone might be effective in reducing
disease activity, both by decreasing the mean number of exacerbations and by slowing the clinical progression sustained by
most patients after 1 year from the end of treatment.
Received: 22 February 1996 Received in revised form: 20 August 1996 Accepted: 20 September 1996 |
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| Keywords: | Multiple sclerosis Mitoxantrone Magnetic resonance imaging |
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