NEWS HIGHLIGHTS
Published Studies Related to Apresoline (Hydralazine)
Hydralazine for essential hypertension. [2011.11.09]
CONCLUSIONS: Hydralazine may reduce blood pressure when compared to placebo in patients with primary hypertension, however this data is based on before and after studies, not RCTs. Furthermore, its effect on clinical outcomes remains uncertain.
Comparison of the efficacy of nifedipine and hydralazine in hypertensive crisis in pregnancy. [2011.11]
Intravenous hydralazine is a commonly administered arteriolar vasodilator that is effective for hypertensive emergencies associated with pregnancy...
Changes in fetal and maternal Doppler parameters observed during acute severe hypertension treatment with hydralazine or labetalol: a randomized controlled trial. [2011.01]
We evaluated 16 pregnant women with gestational age between 20 and 32 weeks in acute severe hypertension which were randomly allocated to receive either hydralazine or labetalol. Blood pressure and Doppler ultrasound parameters from maternal uterine and fetal middle cerebral and umbilical arteries were assessed during acute severe hypertension and after treatment...
A double-blind, placebo-controlled, randomized phase III trial of chemotherapy plus epigenetic therapy with hydralazine valproate for advanced cervical cancer. Preliminary results. [2010.10.08]
The reversing of epigenetic aberrations using the inhibitors of DNA methylation and histone deacetylases may have therapeutic value in cervical cancer... Molecular correlates with response and survival from this trial are pending to analyze.
Hydralazine for essential hypertension. [2010.08.04]
CONCLUSIONS: Hydralazine may reduce blood pressure when compared to placebo in patients with primary hypertension, however this data is based on before and after studies, not RCTs. Furthermore, its effect on clinical outcomes remains uncertain.
Clinical Trials Related to Apresoline (Hydralazine)
Hydralazine Valproate for Ovarian Cancer [Recruiting]
The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian
cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or
gemcitabine, however, the results need to be improved. Epigenetic aberrations play an
important role in cancer progression by silencing growth regulatory genes and there is now
evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity
of chemotherapy.
Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate
plus topotecan over placebo plus topotecan upon progression-free survival.
Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase
progression-free survival from 6 to 9 months as compared with the same regimen of
chemotherapy plus placebo.
Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer [Completed]
The current standard for locally advanced cervical cancer is concurrent cisplatin-based
chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play
an important role in cancer progression by silencing growth regulatory genes and there is now
evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and
chemotherapy effects.
Objective. To determine response rate, safety and biological effects of hydralazine and
magnesium valproate when added to cisplatin chemoradiation.
Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase
the clinical complete response rate to 95% as compared to 75% as seen in historical controls
treated with cisplatin chemoradiation in FIGO stage IIIB patients.
Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical
carcinoma with no previous treatment will be included. Patients will be typed for acetylator
status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at
40mg/Kg from day - 7 to the end of chemoradiation (external and brachytherapy). Clinical
response rate, safety and transcriptome changes will be analyzed.
Hydralazine Valproate for Cervical Cancer [Recruiting]
The current standard for recurrent, persistent or metastatic cervical cancer is palliative
chemotherapy with cisplatin topotecan, however, the results need to be improved. Epigenetic
aberrations play an important role in cancer progression by silencing growth regulatory
genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition
synergize the cytotoxicity of chemotherapy.
Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate
plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon
progression-free survival.
Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will
increase progression-free survival from 4. 6 to 7. 6 months as compared with the same regimen
of chemotherapy plus placebo.
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy [Recruiting]
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure >
110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication
with severe and even deadly consequences. The management in this population had been
studied, but no consensus has been reached with regards to which treatment is better. Our
study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive
crisis.
Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy [Not yet recruiting]
Transfusional dependence has been associated closely and independently with low survival in
patients with myelodysplastic syndrome (MDS), especially in patients at low risk according
to IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to
treatment with 5-azacytidine has lower cost and possibly as effective with fewer side
effects. The objective of this phase II study is to determine the effectiveness of
combination therapy with hydralazine + Ac. Valproic compared with best supportive care. The
investigators will select 42 patients per group, and after 14 weeks of treatment the
investigators will study in both groups the hematological response (transfusion-dependent,
hemoglobin, cytogenetics and morphology) and treatment safety (adverse reactions and vital
signs) to 1 year after starting treatment. The concentration of hemoglobin, the number of
transfusions, platelets, neutrophils and other continuous variables in both groups will be
compared by Student t or Mann-Whitney, as appropriate. For comparison of cytogenetic and
morphological response and other categorical variables between groups Chi square will be
used. And within each group the investigators will compare each of these variables before
and after treatment by t-test for paired data or Wilcoxon test.
Reports of Suspected Apresoline (Hydralazine) Side Effects
Foetal Exposure During Pregnancy (7),
Blood Pressure Increased (7),
Premature Baby (7),
Maternal Exposure During Pregnancy (7),
Hypertension (7),
Foetal Disorder (6),
Cerebrovascular Accident (6),
Feeling Abnormal (6),
LOW Birth Weight Baby (5),
Premature Delivery (5), more >>
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