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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 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 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.

Hydralazine and Valproate Added to Chemotherapy for Breast Cancer [Terminated]
Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.

Hydralazine as Demethylating Agent in Breast Cancer [Recruiting]
This study will be conducted as a phase I/II clinical trial. In addition to determining the maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully completed, the phase II trial to evaluate the efficacy of hydralazine in producing a demethylation effect will begin.

Hydralazine as a Demethylating Agent in Rectal Cancer [Withdrawn]
Clinically feasible dose of Hydralazine for ~ 3 months, by virtue of its demethylating effect, will:

1. Result in re-expression of epigenetically silenced TSGs in rectal cancer specimens.

2. Decrease the global methylation in primary cancer cells compared to pre-treatment

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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