title: Are nilotinib-associated vascular adverse events an under-estimated problem?
abstract: Vascular adverse events have been reported with nilotinib, a tyrosine kinase inhibitor prescribed for chronic myeloid leukaemia. However, few data specify their incidence, or whether they occur in predisposed patients. Hence, we prospectively studied 30 consecutive patients to assess the frequency of such adverse reactions and determine whether the patients presenting with these adverse events bear predisposing factors. From 3 to 73 months after nilotinib initiation, 10 of the 30 patients experienced vascular events. Three patients of these 10 were devoid of any patent cardiovascular risk factor, except for age. This study points out an occurrence more frequent than expected of vascular adverse events associated with nilotinib (> 30% vs. < 1% in summary of product characteristics), and particularly of vascular events of late onset in patients with no pre-existing risk factors.
authors.affiliation: Department of Pharmacology, Regional Pharmacovigilance Center, Nice, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Stève-Dumont
authors.forename: Bernadette
authors.initials: B
authors.lastname: Baldin
authors.forename: Laurence
authors.initials: L
authors.lastname: Legros
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.forename: Daniel
authors.initials: D
authors.lastname: Re
authors.forename: Fanny
authors.initials: F
authors.lastname: Rocher
authors.forename: Florian
authors.initials: F
authors.lastname: Ajmia
authors.forename: Anne
authors.initials: A
authors.lastname: Spreux
authors.forename: Milou-Daniel
authors.initials: MD
authors.lastname: Drici
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D015331:Cohort Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D011743:Pyrimidines / Q000009:adverse effects*; D012307:Risk Factors; D055815:Young Adult
chemical_list: D011743:Pyrimidines; D011505:Protein-Tyrosine Kinases; C498826:nilotinib
keywords: arteriosclerosis; chronic myeloid leukaemia; lower extremity arterial disease; nilotinib; stenosis; tyrosine kinase inhibitor