Page last updated: 2024-10-28

hydroxyurea and Adverse Drug Event

hydroxyurea has been researched along with Adverse Drug Event in 13 studies

Research Excerpts

ExcerptRelevanceReference
"The goal of this study was to optimize the hydroxyurea dosage in HIV-infected patients, and to minimize the toxicity and maximize the antiviral efficacy of the hydroxyurea-didanosine combination."9.11Lowering the dose of hydroxyurea minimizes toxicity and maximizes anti-HIV potency. ( Asmuth, D; Bakare, N; Blick, G; Farthing, C; Foli, A; Frank, I; Greiger, P; Groff, A; Herman, D; Lisziewicz, J; Lori, F; Lova, L; Norris, D; Peterson, D; Pollard, RB; Rashbaum, B; Schrader, S; Shalit, P; Tennenberg, A; Whitman, L, 2005)
"Elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) have a poor prognosis due to low response rates (26-46%) to standard chemotherapy and high treatment-related mortality (11-31%)."6.73Hydroxyurea, azacitidine and gemtuzumab ozogamicin therapy in patients with previously untreated non-M3 acute myeloid leukemia and high-risk myelodysplastic syndromes in the elderly: results from a pilot trial. ( Alkan, S; Barton, K; Germano, E; Godwin, J; Michaelis, L; Nand, S; Rychlik, K; Smith, S; Stiff, P; Veerappan, R, 2008)
"The goal of this study was to optimize the hydroxyurea dosage in HIV-infected patients, and to minimize the toxicity and maximize the antiviral efficacy of the hydroxyurea-didanosine combination."5.11Lowering the dose of hydroxyurea minimizes toxicity and maximizes anti-HIV potency. ( Asmuth, D; Bakare, N; Blick, G; Farthing, C; Foli, A; Frank, I; Greiger, P; Groff, A; Herman, D; Lisziewicz, J; Lori, F; Lova, L; Norris, D; Peterson, D; Pollard, RB; Rashbaum, B; Schrader, S; Shalit, P; Tennenberg, A; Whitman, L, 2005)
"Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea."2.77Impact of hydroxyurea on clinical events in the BABY HUG trial. ( Alvarez, O; Files, BA; Iyer, R; Kalpatthi, R; Lebensburger, J; Luo, Z; Miller, ST; Seaman, P; Thompson, B; Thornburg, CD; Wang, WC; Ware, RE, 2012)
"Elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) have a poor prognosis due to low response rates (26-46%) to standard chemotherapy and high treatment-related mortality (11-31%)."2.73Hydroxyurea, azacitidine and gemtuzumab ozogamicin therapy in patients with previously untreated non-M3 acute myeloid leukemia and high-risk myelodysplastic syndromes in the elderly: results from a pilot trial. ( Alkan, S; Barton, K; Germano, E; Godwin, J; Michaelis, L; Nand, S; Rychlik, K; Smith, S; Stiff, P; Veerappan, R, 2008)
" We did not observe any significant adverse effects during the treatment period."1.91Evaluation of pharmacological efficacy and safety of hydroxyurea in sickle cell disease: Study of a pediatric cohort from Chhattisgarh, India. ( Chandak, GR; Lad, H; Nahrel, R; Naskar, S; Patra, PK; Punyasri Pasupuleti, SKDB; Sihare, P, 2023)
"Hydroxyurea has proven beneficial in the treatment of SCD and prevention of disease-related complications."1.43Hydroxyurea in Pediatric Patients With Sickle Cell Disease: What Nurses Need to Know. ( Rees, AL, 2016)
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."1.37FDA-approved drug labeling for the study of drug-induced liver injury. ( Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011)
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."1.32Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004)

Research

Studies (13)

TimeframeStudies, this research(%)All Research%
pre-19901 (7.69)18.7374
1990's0 (0.00)18.2507
2000's3 (23.08)29.6817
2010's8 (61.54)24.3611
2020's1 (7.69)2.80

Authors

AuthorsStudies
Matthews, EJ1
Kruhlak, NL1
Weaver, JL1
Benz, RD1
Contrera, JF1
Chen, M1
Vijay, V1
Shi, Q2
Liu, Z2
Fang, H2
Tong, W2
Ding, D1
Kelly, R1
Morgan, RE1
van Staden, CJ1
Chen, Y1
Kalyanaraman, N1
Kalanzi, J1
Dunn, RT1
Afshari, CA1
Hamadeh, HK1
Lad, H1
Naskar, S1
Punyasri Pasupuleti, SKDB1
Nahrel, R1
Sihare, P1
Chandak, GR1
Patra, PK1
Curto-Garcia, N1
Harrison, CN1
Verstovsek, S1
Passamonti, F1
Rambaldi, A1
Barosi, G1
Rosen, PJ1
Rumi, E1
Gattoni, E1
Pieri, L1
Guglielmelli, P1
Elena, C1
He, S1
Contel, N1
Mookerjee, B1
Sandor, V1
Cazzola, M1
Kantarjian, HM1
Barbui, T1
Vannucchi, AM1
Rees, AL1
Nand, S1
Godwin, J1
Smith, S1
Barton, K1
Michaelis, L1
Alkan, S1
Veerappan, R1
Rychlik, K1
Germano, E1
Stiff, P1
Scott, JP1
Thornburg, CD1
Files, BA1
Luo, Z1
Miller, ST1
Kalpatthi, R1
Iyer, R1
Seaman, P1
Lebensburger, J1
Alvarez, O1
Thompson, B1
Ware, RE1
Wang, WC1
Lori, F1
Pollard, RB1
Whitman, L1
Bakare, N1
Blick, G1
Shalit, P1
Foli, A1
Peterson, D1
Tennenberg, A1
Schrader, S1
Rashbaum, B1
Farthing, C1
Herman, D1
Norris, D1
Greiger, P1
Frank, I1
Groff, A1
Lova, L1
Asmuth, D1
Lisziewicz, J1
Jusko, WJ1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort[NCT02887118]82 participants (Actual)Observational2015-12-31Terminated (stopped due to The recruiting centre was no longer presenting new patients for inclusion)
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)[NCT00006400]Phase 3193 participants (Actual)Interventional2000-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in the Renal Function That Was Measured by Diethylenetriaminepentaacetic Acid (DTPA) Glomerular Filtration Rate (GFR)

DTPA GFR was originally a co-primary efficacy outcome for the study. Later in May 29, 2009, this measurement was discontinued because of statistical futility (an extremely small chance that the difference between treatment groups would be statistically significant for this outcome) and the small risk posed by the radiation exposure involved with performing the DTPA GFR test. Subjects who had missing data at baseline or 2 years measurement were excluded from the analysis (29 subjects from the hydroxurea, and 31 subjects from the placebo group excluded). (NCT00006400)
Timeframe: Before initiation of treatment and at 2 years

InterventionmL/min/1.73m^2 (Mean)
Hydroxyurea22.56
Placebo20.74

Change From Baseline in the Renal Function That Was Measured by GFR (Calculated Using New Schwartz Formula)

GFR was calculated using new Schwartz formula: 39.1× [height (cm)/serum creatinine (mg/dL)]0.516 × [1.8/cystatin C]0.294 × [30/blood urea nitrogen]0.169 × [1.099]if male × [height(m)/1.4]0.188. Children with missing baseline or 2 years GFR were excluded from the analysis. (NCT00006400)
Timeframe: Before initiation of treatment and at 2 years

InterventionmL/min/1.73m^2 (Mean)
Hydroxyurea10.57
Placebo14.33

Change From Baseline in the Renal Function That Was Measured by Glomerular Filtration Rate (GFR) (Calculated Using Schwartz Formula)

Schwartz formula used to calculate GFR is: 0.55× height (cm)/serum creatinine (mg/dL). Where height is in cm and serum creatinine is in mg/dL. Children with missing baseline or 2 years GFR were excluded from the analysis. (NCT00006400)
Timeframe: Before initiation of treatment and at 2 years

InterventionmL/min/1.73m^2 (Mean)
Hydroxyurea28.65
Placebo33.36

Trials

4 trials available for hydroxyurea and Adverse Drug Event

ArticleYear
A phase 2 study of ruxolitinib, an oral JAK1 and JAK2 Inhibitor, in patients with advanced polycythemia vera who are refractory or intolerant to hydroxyurea.
    Cancer, 2014, Feb-15, Volume: 120, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Anemia; Contraindications; Drug-Related Side Effects and Adverse Rea

2014
Hydroxyurea, azacitidine and gemtuzumab ozogamicin therapy in patients with previously untreated non-M3 acute myeloid leukemia and high-risk myelodysplastic syndromes in the elderly: results from a pilot trial.
    Leukemia & lymphoma, 2008, Volume: 49, Issue:11

    Topics: Aged; Aged, 80 and over; Aminoglycosides; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized;

2008
Impact of hydroxyurea on clinical events in the BABY HUG trial.
    Blood, 2012, Nov-22, Volume: 120, Issue:22

    Topics: Acute Chest Syndrome; Anemia, Sickle Cell; Antisickling Agents; Child, Preschool; Double-Blind Metho

2012
Impact of hydroxyurea on clinical events in the BABY HUG trial.
    Blood, 2012, Nov-22, Volume: 120, Issue:22

    Topics: Acute Chest Syndrome; Anemia, Sickle Cell; Antisickling Agents; Child, Preschool; Double-Blind Metho

2012
Impact of hydroxyurea on clinical events in the BABY HUG trial.
    Blood, 2012, Nov-22, Volume: 120, Issue:22

    Topics: Acute Chest Syndrome; Anemia, Sickle Cell; Antisickling Agents; Child, Preschool; Double-Blind Metho

2012
Impact of hydroxyurea on clinical events in the BABY HUG trial.
    Blood, 2012, Nov-22, Volume: 120, Issue:22

    Topics: Acute Chest Syndrome; Anemia, Sickle Cell; Antisickling Agents; Child, Preschool; Double-Blind Metho

2012
Lowering the dose of hydroxyurea minimizes toxicity and maximizes anti-HIV potency.
    AIDS research and human retroviruses, 2005, Volume: 21, Issue:4

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; CD4-CD8 Ratio; Didanosine; Drug Therapy, Combination; Drug-Re

2005

Other Studies

9 other studies available for hydroxyurea and Adverse Drug Event

ArticleYear
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
    Current drug discovery technologies, 2004, Volume: 1, Issue:4

    Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru

2004
FDA-approved drug labeling for the study of drug-induced liver injury.
    Drug discovery today, 2011, Volume: 16, Issue:15-16

    Topics: Animals; Benchmarking; Biomarkers, Pharmacological; Chemical and Drug Induced Liver Injury; Drug Des

2011
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
    Toxicological sciences : an official journal of the Society of Toxicology, 2013, Volume: 136, Issue:1

    Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily

2013
Evaluation of pharmacological efficacy and safety of hydroxyurea in sickle cell disease: Study of a pediatric cohort from Chhattisgarh, India.
    Pediatric hematology and oncology, 2023, Volume: 40, Issue:4

    Topics: Anemia, Sickle Cell; beta-Thalassemia; Child; Drug-Related Side Effects and Adverse Reactions; Fetal

2023
An updated review of the JAK1/2 inhibitor (ruxolitinib) in the Philadelphia-negative myeloproliferative neoplasms.
    Future oncology (London, England), 2018, Volume: 14, Issue:2

    Topics: Aged; Animals; Blood Cell Count; Clinical Trials, Phase III as Topic; Disease Models, Animal; Diseas

2018
Hydroxyurea in Pediatric Patients With Sickle Cell Disease: What Nurses Need to Know.
    Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses, 2016, Volume: 33, Issue:5

    Topics: Adolescent; Anemia, Sickle Cell; Antisickling Agents; Child; Child, Preschool; Drug-Related Side Eff

2016
Hydroxurea and sickle cell disease: Its been a long, long time coming.
    Pediatric blood & cancer, 2010, Volume: 54, Issue:2

    Topics: Adolescent; Age Factors; Anemia, Sickle Cell; Antisickling Agents; Child; Child, Preschool; Drug-Rel

2010
Pharmacodynamic principles in chemical teratology: dose-effect relationships.
    The Journal of pharmacology and experimental therapeutics, 1972, Volume: 183, Issue:3

    Topics: Abnormalities, Drug-Induced; Adsorption; Cyclophosphamide; Dose-Response Relationship, Drug; Drug-Re

1972