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Agrylin (Anagrelide Hydrochloride) - Summary



(anagrelide hydrochloride)

Rx only

AGRYLIN® (anagrelide hydrochloride) reduces blood platelet count.

AGRYLIN® Capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events (see CLINICAL STUDIES, DOSAGE and ADMINISTRATION).

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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.

Anagrelide for the treatment of thrombocythaemia in daily clinical practice: a post-marketing observational survey on efficacy and safety performed in Germany. [2010]
BACKGROUND: Myeloproliferative diseases - in particular essential thrombocythaemia (ET) - may be associated with increases in platelet count which put patients at risk of life-threatening complications such as thromboses and severe bleedings... CONCLUSION: Anagrelide was effective in lowering the platelet count and was also well tolerated when used in daily clinical practice. (c) 2010 S. Karger AG, Basel.

Management of refractory essential thrombocythemia with anagrelide in a patient undergoing hemodialysis. [2009.11]
BACKGROUND: Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chronic renal disease...

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.

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Clinical Trials Related to Agrylin (Anagrelide)

Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers [Completed]
According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

Anagrelide Retard in Essential Thrombocythemia [Completed]
The purpose of this study is determine whether Anagrelide Retard is non-inferior to anagrelide immediate release form in treatment of essential thrombocythemia. Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained increase in platelet counts above the normal value (> 450 x 109/L) and increased megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis. Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte development and maturation in humans, without affecting other cell lineages. Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed by AOP Orphan Pharmaceuticals AG. The rationale for developing this new formulation is based on the assumption of having a better tolerability while maintaining an efficacy comparable to that of the immediate release formulation. The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean platelet count measured by a central laboratory/centralized method at 3 time points during the maintenance phase.

Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin´┐Ż 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´┐Ż 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 Study of Anagrelide Controlled Release (GALE-401) in Patients With High Platelet Counts Due to Bone Marrow Disorders [Active, not recruiting]
Anagrelide is a drug that has been shown to slow down how fast platelets are made in the bone marrow, and has been approved by the FDA for treating high platelets counts in patients with bone marrow disorders. Anagrelide Controlled Release ("CR") is a new preparation of anagrelide that is made to dissolve more slowly than currently marketed versions of this drug. Because of this, the anagrelide is taken up into the blood more slowly. Researchers think that this slower release of the drug could help to lower side effects that might be caused by high blood levels when the drug dissolves as quickly as it does with the currently marketed product. The main purposes of this study are to see how well Anagrelide CR can control platelet counts in patients with high platelet levels, to see what kind of side effects it causes, and to measure blood levels of the drug.

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Reports of Suspected Agrylin (Anagrelide) Side Effects

Intentional Overdose (2)Drug Diversion (2)Gastrointestinal Haemorrhage (1)Pain (1)Mucous Stools (1)Headache (1)Haematemesis (1)Tunnel Vision (1)Overdose (1)Chest Pain (1)more >>

Page last updated: 2010-10-05

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