Page last updated: 2024-10-28

hydroxyurea and Ventricular Dysfunction, Left

hydroxyurea has been researched along with Ventricular Dysfunction, Left in 2 studies

Ventricular Dysfunction, Left: A condition in which the LEFT VENTRICLE of the heart was functionally impaired. This condition usually leads to HEART FAILURE; MYOCARDIAL INFARCTION; and other cardiovascular complications. Diagnosis is made by measuring the diminished ejection fraction and a depressed level of motility of the left ventricular wall.

Research Excerpts

ExcerptRelevanceReference
" There were no significant differences in adverse events between treatment groups, and no reports of malignant transformation."3.01Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia. ( Achenbach, H; Egyed, M; Gercheva, L; Gotic, M; Kvasnicka, HM; Warzocha, K; Wu, J, 2021)
"Cardiac abnormalities seen in sickle cell anemia (SCA) include diastolic dysfunction, which has been shown to be associated with high morbidity and early mortality."1.91Longitudinal effect of disease-modifying therapy on left ventricular diastolic function in children with sickle cell anemia. ( Hankins, JS; Joshi, V; Kang, G; Martinez, HR; Okhomina, VI; Rai, P, 2023)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's2 (100.00)2.80

Authors

AuthorsStudies
Rai, P1
Okhomina, VI1
Kang, G1
Martinez, HR1
Hankins, JS1
Joshi, V1
Gotic, M1
Egyed, M1
Gercheva, L1
Warzocha, K1
Kvasnicka, HM1
Achenbach, H1
Wu, J1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.[NCT00202644]Phase 4150 participants (Actual)Interventional2006-01-13Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With Thrombotic and Haemorrhagic Events

Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment. (NCT00202644)
Timeframe: From the signing of informed consent until the last study-related visit (Month 36)

Interventionparticipants (Number)
Anagrelide30
Hydroxyurea16

Percentage of Participants With Complete Response

A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart. (NCT00202644)
Timeframe: Baseline up to Month 36

Interventionpercenatge of participants (Number)
Anagrelide58.9
Hydroxyurea58.8

Percentage of Participants With Partial Response

A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart. (NCT00202644)
Timeframe: Baseline up to Month 36

Interventionpercentage of participants (Number)
Anagrelide21.9
Hydroxyurea27.9

Platelet Count at Month 6

Platelet count was evaluated. (NCT00202644)
Timeframe: Month 6

Intervention10^9 platelets per liter (Mean)
Anagrelide418.6
Hydroxyurea396.0

Time to Complete Response

Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal). (NCT00202644)
Timeframe: Baseline up to Month 36

Interventiondays (Median)
Anagrelide177.0
Hydroxyurea123.0

Time to Partial Response

Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal). (NCT00202644)
Timeframe: Baseline up to Month 36

Interventiondays (Median)
Anagrelide61.0
Hydroxyurea47.0

Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time

The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function. (NCT00202644)
Timeframe: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36

,
Interventionpercentage of ejection fraction (Mean)
BaselineChange from baseline at Month 1Change from baseline at Month 2Change from baseline at Month 3Change from baseline at Month 6Change from baseline at Month 9Change from baseline at Month 12Change from baseline at Month 18Change from baseline at Month 24Change from baseline at Month 30Change from baseline at Month 36
Anagrelide66.40.51.20.1-0.5-0.8-0.8-2.0-1.8-1.8-1.7
Hydroxyurea66.9-1.10-0.4-0.6-1.5-0.6-1.2-1.7-0.2-0.6

Change From Baseline in Platelet Counts at Month 3 and 36

Platelet count was evaluated throughout the study. (NCT00202644)
Timeframe: Baseline and Month 3 and 36

,
Intervention10^9 platelets per liter (Mean)
Change from baseline at Month 3Change from baseline at Month 36
Anagrelide575.3531.0
Hydroxyurea462.2462.8

Change From Baseline in Red Blood Cell Count Over Time

Red blood cell count was evaluated throughout the study. (NCT00202644)
Timeframe: Baseline and Month 6, 12, 18, 24, 30 and 36

,
Intervention10^12 cells per liter (Mean)
BaselineChange from baseline at Month 6Change from baseline at Month 12Change from baseline at Month 18Change from baseline at Month 24Change from baseline at Month 30Change from baseline at Month 36
Anagrelide4.757-0.227-0.246-0.225-0.299-0.295-0.366
Hydroxyurea4.787-1.467-1.398-1.323-1.281-1.339-1.362

Change From Baseline in White Blood Cell Count Over Time

White blood cell count was evaluated throughout the study. (NCT00202644)
Timeframe: Baseline and Month 6, 12, 18, 24, 30 and 36

,
Intervention10^9 cells per liter (Mean)
BaselineChange from baseline at Month 6Change from baseline at Month 12Change from baseline at Month 18Change from baseline at Month 24Change from baseline at Month 30Change from baseline at Month 36
Anagrelide9.13-0.38-1.00-1.18-1.24-1.00-1.63
Hydroxyurea10.20-5.02-4.79-4.46-4.82-4.59-4.46

Trials

1 trial available for hydroxyurea and Ventricular Dysfunction, Left

ArticleYear
Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia.
    Cardiovascular toxicology, 2021, Volume: 21, Issue:3

    Topics: Adolescent; Adult; Aged; Biopsy; Blood Platelets; Bone Marrow Examination; Echocardiography; Europe;

2021

Other Studies

1 other study available for hydroxyurea and Ventricular Dysfunction, Left

ArticleYear
Longitudinal effect of disease-modifying therapy on left ventricular diastolic function in children with sickle cell anemia.
    American journal of hematology, 2023, Volume: 98, Issue:6

    Topics: Adolescent; Anemia, Sickle Cell; Child; Child, Preschool; Echocardiography; Erythrocyte Transfusion;

2023