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Hydralazine (Hydralazine Hydrochloride) - Summary

 



HYDRALAZINE SUMMARY

Hydralazine
Hydrochloride Injection,
USP

Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration.

Hydralazine Hydrocloride (hydralazine) is indicated for the following:

Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.


See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Hydralazine

Effects of dihydralazine on renal water and aquaporin-2 excretion in humans. [2009]
CONCLUSIONS: These findings suggest that dihydralazine increases water re-absorption in the distal tubules, independently of vasopressin and of sodium re-absorption. Furthermore, our study does not support an effect of the sympathetic nervous system, the renin-angiotensin system and the natriuretic peptide system on u-AQP2 regulation.

Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial). [2007.08.15]
The benefits of fixed-dose combination isosorbide dinitrate plus hydralazine (ID/H) in African-Americans with heart failure (HF) were established by the African-American Heart Failure Trial (A-HeFT), which was terminated early because of a significant survival benefit of ID/H... In conclusion, these results confirm the good compliance, tolerability, and responsiveness, with low mortality and improved symptoms, during treatment with ID/H observed in A-HeFT.

Isosorbide dinitrate and hydralazine in a fixed-dose combination produces further regression of left ventricular remodeling in a well-treated black population with heart failure: results from A-HeFT. [2007.06]
CONCLUSIONS: A fixed-dose combination of I/H produces regression of LV remodeling when added to background therapy with renin-angiotensin and sympathetic inhibitors in black patients with heart failure. This remodeling benefit may explain at least in part the mortality reduction in A-HeFT.

Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial. [2007.04.03]
CONCLUSIONS: FDC I/H treatment of black patients with moderate to severe HF who were taking neurohormonal blockers produced early and sustained significant improvement in event-free survival and hospitalization for HF in the A-HeFT cohort, with significant reduction in mortality from cardiovascular and pump failure deaths. The treatment effects on the primary composite end point and event-free survival were consistent across subgroups.

Severe hypertension in pregnancy: hydralazine or labetalol. A randomized clinical trial. [2006.09]
OBJECTIVE: The objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy... CONCLUSIONS: This randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.

more studies >>

Clinical Trials Related to 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 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 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

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 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.

more trials >>

Page last updated: 2009-10-20

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