101. Linomide in the treatment of multiple sclerosis: MRI results from prematurely terminated phase-III trials.
- Author
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Tan IL, Lycklama à Nijeholt GJ, Polman CH, Adèr HJ, and Barkhof F
- Subjects
- Adjuvants, Immunologic adverse effects, Adolescent, Adult, Cardiovascular Diseases chemically induced, Humans, Hydroxyquinolines adverse effects, Middle Aged, Treatment Outcome, Adjuvants, Immunologic therapeutic use, Hydroxyquinolines therapeutic use, Magnetic Resonance Imaging, Multiple Sclerosis, Chronic Progressive diagnosis, Multiple Sclerosis, Chronic Progressive drug therapy, Multiple Sclerosis, Relapsing-Remitting diagnosis, Multiple Sclerosis, Relapsing-Remitting drug therapy
- Abstract
Due to an unexpected increase in serious cardiovascular events in MS patients treated with Linomide, a synthetic immunomodulator, two phase-III multinational relapsing remitting (RR) and secondary progressive (SP) MS trials had to be discontinued. MRI results of 413 patients who participated for at least 3 months were analysed. Patients received placebo, 2.5 or 5 mg Linomide. Scans were performed at pre-enrolment, month 3 and termination. The number and volume of enhancing lesions (ELV), and the number of active scans were evaluated. At month 3, the decrease in the number of enhancing lesions in the placebo group was 11%, compared with 15% in the 2.5 mg group (P=0.027) and 23% in the 5 mg group (P=0.057). Using the percentage of active scans as outcome parameter, the odds ratio for improvement between placebo and 2.5 mg group was 1.62 (P=0.14); between placebo and 5 mg Linomide group 3.58 (P=0.003). At termination, a rebound effect was noted in the 2.5 mg group (P=0.01). Analysis of the ELV showed no significant difference between placebo and treatment groups. Although Linomide has unacceptable side effects, it seems to have a modest effect on MS disease activity, as measured by MRI. Multiple Sclerosis (2000) 6, 99 - 104
- Published
- 2000
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