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Apresoline (Hydralazine Hydrochloride) - Summary

 
 



APRESOLINE SUMMARY

Apresoline hydrochloride®

Apresoline, hydralazine hydrochloride USP, is an antihypertensive, available as 10-, 25-, 50-, and 100-mg tablets for oral administration.

Apresoline (hydralazine) is indicated for the following:

Essential hypertension, alone or as an adjunct.


See all Apresoline indications & dosage >>

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.

more studies >>

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.

more trials >>

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 >>


Page last updated: 2011-12-09

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