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Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: a 5-year prospective study.

AbstractBACKGROUND:
From 2001, a French multicentre study was conducted prospectively in a large cohort of MS patients and annually updated up to at least 5 years after initiation of MITOX therapy.
OBJECTIVE:
To determine long-term safety profile of mitoxantrone (MITOX) in multiple sclerosis (MS).
METHODS:
Eight hundred and two patients from 12 MS centres (308 relapsing-remitting, 352 secondary progressive and 142 primary progressive) received MITOX monthly for 6 months (87%) or every 3 months (13%). Patients underwent clinical and haematologic evaluations before every MITOX infusion and every 6-12 months up to 5 years after MITOX start. Echocardiograms were performed at the start and end of MITOX and up to 5 years after.
RESULTS:
The cohort was followed for 5354 patient-years (mean). One out of 802 patients (0.1%) presented with acute congestive heart failure and 39 out of 794 patients (4.9%) presented with asymptomatic left ventricular ejection fraction reduction under 50% (persistent in 11 patients (28%), transient in 27 patients (69%), on the last scan at year 5 in 1 patient). Two cases of therapy-related leukaemia (0.25%) were detected 20 months after MITOX start (one death and one with 8 years confirmed remission). Of the 317 women treated before the age of 45, 17.3% developed a persistent age-dependant amenorrhea.
CONCLUSION:
This large cohort with at least 5 years of follow-up provided good insights into the long-term safety profile of MITOX in MS.
AuthorsE Le Page, E Leray, G Edan, French Mitoxantrone Safety Group
JournalMultiple sclerosis (Houndmills, Basingstoke, England) (Mult Scler) Vol. 17 Issue 7 Pg. 867-75 (Jul 2011) ISSN: 1477-0970 [Electronic] England
PMID21325016 (Publication Type: Journal Article, Multicenter Study)
Chemical References
  • Immunologic Factors
  • Mitoxantrone
Topics
  • Adult
  • Amenorrhea (chemically induced)
  • Female
  • France
  • Heart Failure (chemically induced, physiopathology)
  • Humans
  • Immunologic Factors (administration & dosage, adverse effects)
  • Leukemia (chemically induced)
  • Male
  • Middle Aged
  • Mitoxantrone (administration & dosage, adverse effects)
  • Multiple Sclerosis, Chronic Progressive (diagnosis, drug therapy)
  • Multiple Sclerosis, Relapsing-Remitting (diagnosis, drug therapy)
  • Prospective Studies
  • Risk Assessment
  • Risk Factors
  • Stroke Volume (drug effects)
  • Time Factors
  • Treatment Outcome
  • Ventricular Dysfunction, Left (chemically induced, physiopathology)
  • Ventricular Function, Left (drug effects)
  • Young Adult

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