Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis : Implications for natural history and early-phase treatment trials

Serial contrast magnetic resonance imaging (MRI) has played an increasingly important role in understanding natural-history and early-treatment trials of multiple sclerosis patients. The purpose of this study is to determine whether the serial administration of gadopentetate dimeglumine at the conve...

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Bibliographic Details
Published in:	Neurology Vol. 48; no. 4; pp. 832 - 835
Main Authors:	TRESLEY, R. M, STONE, L. A, FIELDS, N, MALONI, H, MCFARLAND, H, FRANK, J. A
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott Williams & Wilkins 01-04-1997
Subjects:	Adult Biological and medical sciences Clinical Trials, Phase I as Topic Clinical Trials, Phase II as Topic Contrast Media - administration & dosage Contrast Media - adverse effects Contrast media. Radiopharmaceuticals Drug Administration Schedule Female Gadolinium DTPA Hemoglobins - analysis Humans Longitudinal Studies Male Medical sciences Middle Aged Multiple Sclerosis - blood Multiple Sclerosis - diagnosis Organometallic Compounds - administration & dosage Organometallic Compounds - adverse effects Pentetic Acid - administration & dosage Pentetic Acid - adverse effects Pentetic Acid - analogs & derivatives Pharmacology. Drug treatments Retrospective Studies Safety Human Nervous system diseases Multiple sclerosis Monthly Paramagnetic contrast agent Gadolinium complex Exploration Administration schedule Nuclear magnetic resonance imaging Blood Inflammatory disease Central nervous system disease Medical imagery Gadopentetic acid
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Summary:	Serial contrast magnetic resonance imaging (MRI) has played an increasingly important role in understanding natural-history and early-treatment trials of multiple sclerosis patients. The purpose of this study is to determine whether the serial administration of gadopentetate dimeglumine at the conventional dose has any demonstrable effect on routine hematologic or serum chemistries. This study followed 56 patients with multiple sclerosis in a longitudinal natural-history trial using contrast-enhanced MRI scans over a four-year period between 1988 and 1993. Patients received between 3 and 53 doses of gadopentetate dimeglumine at 0.1 mmol/kg intravenously. A retrospective review of regular blood screening tests over this period identified no significant effect either on routine hematologic studies, as defined by complete blood count (hemoglobin, hematocrit, platelet and white blood cell counts, and mean corpuscular volume); standard serum chemistry studies, including electrolytes (sodium, potassium, chloride) and renal and liver function tests; or serum iron profiles. We conclude, therefore, that serial contrast-enhanced MRIs can be used safely as an outcome measure for Phase I/II evaluations of new therapies for multiple sclerosis.
ISSN:	0028-3878 1526-632X
DOI:	10.1212/WNL.48.4.832