Safety and efficacy of anagrelide in Japanese post-marketing surveillance, with subgroup analyses on the effect of previous cytoreductive therapies, age, and starting dose.
Anagrelide
Essential thrombocythemia
Japanese
Post-marketing surveillance
Journal
International journal of hematology
ISSN: 1865-3774
Titre abrégé: Int J Hematol
Pays: Japan
ID NLM: 9111627
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
14
12
2021
accepted:
27
04
2022
revised:
26
04
2022
pubmed:
28
5
2022
medline:
30
9
2022
entrez:
27
5
2022
Statut:
ppublish
Résumé
In Japan, anagrelide has been approved for use in patients with essential thrombocythemia. Here, the safety and efficacy of anagrelide was assessed in clinical practice as post-marketing surveillance. Subgroup analyses were conducted to compare patients (1) with or without a history of cytoreductive therapy (CRT), (2) <60 or ≥60 years of age, and (3) with an anagrelide starting dose of ≤0.5 mg/day or 1.0 mg/day. Data were collected for all patients who received anagrelide, with an observation period of 12 months after treatment initiation. Of the 648 patients, 54.3% experienced adverse drug reactions (ADRs). The most commonly reported ADRs were headaches, palpitations, and anemia. No significant difference was observed in overall ADRs across patient subgroups. A significantly higher incidence of headaches was observed in patients < 60 years versus those ≥ 60 years (P < 0.001). The incidence of anemia and serious ADRs were significantly higher in patients ≥ 60 years, and those with a history of CRT (P < 0.05). The discontinuation rate at 6 months was significantly lower in patients started at the lower anagrelide dose (P < 0.05). Platelet counts decreased in all analyzed groups. This surveillance showed that anagrelide has a tolerable safety and efficacy profile.
Sections du résumé
BACKGROUND
BACKGROUND
In Japan, anagrelide has been approved for use in patients with essential thrombocythemia. Here, the safety and efficacy of anagrelide was assessed in clinical practice as post-marketing surveillance. Subgroup analyses were conducted to compare patients (1) with or without a history of cytoreductive therapy (CRT), (2) <60 or ≥60 years of age, and (3) with an anagrelide starting dose of ≤0.5 mg/day or 1.0 mg/day.
METHODS
METHODS
Data were collected for all patients who received anagrelide, with an observation period of 12 months after treatment initiation.
RESULTS
RESULTS
Of the 648 patients, 54.3% experienced adverse drug reactions (ADRs). The most commonly reported ADRs were headaches, palpitations, and anemia. No significant difference was observed in overall ADRs across patient subgroups. A significantly higher incidence of headaches was observed in patients < 60 years versus those ≥ 60 years (P < 0.001). The incidence of anemia and serious ADRs were significantly higher in patients ≥ 60 years, and those with a history of CRT (P < 0.05). The discontinuation rate at 6 months was significantly lower in patients started at the lower anagrelide dose (P < 0.05). Platelet counts decreased in all analyzed groups.
CONCLUSIONS
CONCLUSIONS
This surveillance showed that anagrelide has a tolerable safety and efficacy profile.
Identifiants
pubmed: 35624199
doi: 10.1007/s12185-022-03380-2
pii: 10.1007/s12185-022-03380-2
pmc: PMC9515010
doi:
Substances chimiques
Platelet Aggregation Inhibitors
0
Quinazolines
0
anagrelide
K9X45X0051
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
570-578Informations de copyright
© 2022. The Author(s).
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