Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate) - Summary

BIDIL SUMMARY

BiDil is a fixed-dose combination of isosorbide dinitrate, a vasodilator with effects on both arteries and veins, and hydralazine hydrochloride, a predominantly arterial vasodilator.

Treatment of Heart Failure in Self-identified Black Patients

BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status.

Limitations of Use

There is little experience in patients with NYHA class IV heart failure.

See all Bidil indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate)

Heart Failure Quiz
Source: MedicineNet Pulmonary Hypertension Specialty [2017.09.19]
Title: Heart Failure Quiz
Category: MedicineNet Quiz
Created: 4/25/2017 12:00:00 AM
Last Editorial Review: 9/19/2017 7:32:02 PM

Congestive Heart Failure (CHF) Symptoms, Stages, and Prognosis
Source: MedicineNet Amyloidosis Specialty [2017.08.11]
Title: Congestive Heart Failure (CHF) Symptoms, Stages, and Prognosis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/11/2017 12:00:00 AM

Prices of Generic Heart Failure Drugs Vary Widely
Source: MedicineNet carvedilol Specialty [2016.11.16]
Title: Prices of Generic Heart Failure Drugs Vary Widely
Category: Health News
Created: 11/15/2016 12:00:00 AM
Last Editorial Review: 11/16/2016 12:00:00 AM

Device Plus 'Aggressive' Drug Strategy May Curb Severe Heart Failure
Source: MedicineNet carvedilol Specialty [2016.11.14]
Title: Device Plus 'Aggressive' Drug Strategy May Curb Severe Heart Failure
Category: Health News
Created: 11/13/2016 12:00:00 AM
Last Editorial Review: 11/14/2016 12:00:00 AM

Could Prescribed NSAID Painkillers Raise Heart Failure Risk?
Source: MedicineNet piroxicam Specialty [2016.09.29]
Title: Could Prescribed NSAID Painkillers Raise Heart Failure Risk?
Category: Health News
Created: 9/28/2016 12:00:00 AM
Last Editorial Review: 9/29/2016 12:00:00 AM

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Published Studies Related to Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate)

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.

A review of isosorbide dinitrate and hydralazine in the management of heart failure in black patients, with a focus on a new fixed-dose combination. [2006.05]
CONCLUSIONS: The findings of these 3 large controlled clinical trials support the efficacy of ISDN and HYD in patients with HE Using a composite end point of mortality, HT hospitalization, and quality of life, the A-HeFT study found benefits to adding the fixed-dose ISDN/HYD combination product to standard therapy in self-identified black patients of African descent with moderate to severe HF.

Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial. [2014]
CONCLUSIONS: Treatment with FDC-I/H was associated with a substantial reduction

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Clinical Trials Related to Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate)

Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets [Not yet recruiting]
This study will investigate cardiovascular parameters using echocardiographic and pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a study drug free day.

A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers [Completed]
This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time.

Genomic Response Analysis of Heart Failure Therapy in African Americans [Not yet recruiting]
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.

Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure [Active, not recruiting]
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.

Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study [Recruiting]
This is a single-blind, randomised, clinical trial assessing the efficacy of Hydralazine and Isosorbidedinitrate combination (oral agents) in HF patients with renal dysfunction.

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