NEWS HIGHLIGHTS
Published Studies Related to Agrylin (Anagrelide)
Pharmacokinetics, bioequivalence, tolerability, and effects on platelet counts of two formulations of anagrelide in healthy volunteers and patients with thrombocythemia associated with chronic myeloproliferation. [2009.02]
BACKGROUND: Anagrelide hydrochloride is an anti-thrombotic agent indicated for the treatment of essential thrombocythemia (ET). In various previously published clinical trials of 2 branded formulations of anagrelide in patients with ET at high risk for thrombohemorrhagic events, the rates of adverse events and discontinuation were strikingly divergent between brands. Because the formulations and manufacturers differed, the differences in tolerability, as well as platelet counts, might have been related to differences in pharmacokinetic properties between the 2 formulations. OBJECTIVES: The present series of investigations (1) determined the pharmacokinetic profile of anagrelide and its metabolites; (2) compared the pharmacokinetic profiles of the test and reference formulations of anagrelide; (3) investigated the in vitro release of anagrelide as a marker of intragastric anagrelide release of the test and reference formulations; and (4) compared the platelet-reducing effects of the test and reference formulations in patients with thrombocythemia in 2 longitudinal studies over 4 weeks... CONCLUSIONS: The pharmacokinetic properties, adverse event rates, and in vitro dissolution profile differed between the test and reference anagrelide formulations in these healthy volunteers. In patients with ET or thrombocythemia associated with CMPD, platelet counts did not differ significantly from baseline at 4 weeks when subjects were switched from the reference to the test anagrelide formulation.
Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. [2005.07.07]
BACKGROUND: We conducted a randomized comparison of hydroxyurea with anagrelide in the treatment of essential thrombocythemia... CONCLUSIONS: Hydroxyurea plus low-dose aspirin is superior to anagrelide plus low-dose aspirin for patients with essential thrombocythemia at high risk for vascular events. Copyright 2005 Massachusetts Medical Society.
Atypical Takotsubo syndrome during anagrelide therapy. [2009.07]
Anagrelide is a phosphodiesterase III inhibitor utilized in the treatment of essential thrombocythemia... To our knowledge, this is one of the first reports of an association between anagrelide therapy and Takotsubo cardiomyopathy.
[Retrospective analysis of the efficacy and tolerability of anagrelide in patients with essential thrombocytemia: Spanish registry of essential thrombocytemia] [2009.06.20]
BACKGROUND AND OBJECTIVE: A retrospective analysis of a registration database was used to assess the efficacy and tolerability of anagrelide for treating essential thrombocythemia (ET). The study was conducted by analysing information on response to treatment, time to response and tolerability... CONCLUSIONS: The observed response rates and tolerability profile are similar to those reported previously. Anagrelide is well tolerated and effective in reducing platelets to target levels in patients with ET.
Anagrelide for the treatment of essential thrombocythemia: a survey among European hematologists/oncologists. [2009.02]
Two hundred and fifty hematologists and oncologists (50 each from France, Germany, Italy, Spain and the United Kingdom) participated in this survey to assess the current management of essential thrombocythemia (ET), with particular reference to the use of anagrelide...
Clinical Trials Related to Agrylin (Anagrelide)
Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1
mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)
dose administration under fed conditions.
Fasting Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1
mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)
dose administration under fasting conditions.
A Phase II Study of the Pharmacokinetics of Anagrelide in Elderly and Young ET Patients [Recruiting]
Age related differences in response to a drug could arise from variation in PK and/or
pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of
anagrelide is well established through a well-documented clinical trial programme in patients
of all ages, no formal studies have been carried out to investigate whether the PK profile of
anagrelide and its metabolites is altered with age.
This study is designed to allow comparisons to be made in terms of pharmacokinetics of
anagrelide and its metabolites between elderly (>65 years) and young (18-50 years) ET
patients
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients [Recruiting]
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to
be produced. Platelets are small cells carried around in the blood, which help form blood
clots. When patients have too many platelets, there is a risk of blood clots forming
unnecessarily and excessive bleeding. The aim of this study is to gain additional
information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as
hydroxycarbamide).
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to Xagrid Compared to Other Treatments [Recruiting]
This is an observational safety study being conducted in Europe comparing patients taking
Xagrid to patients taking other cytoreductive treatments. The plan is to enroll at least
1000 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies.
The study will collect data in two phases: the initial 5 year phase will focus on collecting
data related to pre-defined events and Suspected Serious Adverse Reactions (SSARs); the
second 5 year period will be to follow up on pre-defined events and SSARs.
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