BIDIL SUMMARY
BiDil ®
(isosorbide dinitrate and hydralazine hydrochloride)
Tablets
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.
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. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
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NEWS HIGHLIGHTSMedia Articles Related to Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate)
Neuregulin Growth Factors and Function in Heart Failure
Source: Medscape Cardiology Headlines [2013.06.12]
This promising early-phase trial shows that growth factors that interact directly with cardiomyocytes can promote enhanced repair and improved function of cardiac muscle.
Medscape Cardiology
New Survey Data Reveal Need For Specialist Nurse Support In Management Of Patients With Heart Failure In UK
Source: Cardiovascular / Cardiology News From Medical News Today [2013.06.08]
One year after the publication of the European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012,[i] awareness amongst UK healthcare professionals varies dramatically.[ii] Results of a new survey commissioned by Pfizer found that just 36% of GPs are aware of the guidelines compared to 92.9% of cardiologists, 82...
Advanced Heart Failure Still Kills 1 in 3 Within Three Years: Study
Source: MedicineNet Clinical Trials Specialty [2013.05.31]
Title: Advanced Heart Failure Still Kills 1 in 3 Within Three Years: Study
Category: Health News
Created: 5/30/2013 4:36:00 PM
Last Editorial Review: 5/31/2013 12:00:00 AM
In End-Stage Heart Failure, Levosimendan Improves Event Free Survival By 50 Percent
Source: Urology / Nephrology News From Medical News Today [2013.05.29]
Ambulatory levosimendan improves event free survival by 50% compared to placebo, according to results from the LevoRep Study presented during a late breaking trial session of the Heart Failure Congress 2013...
Male 'Menopause' Accelerated By Heart Failure
Source: Endocrinology News From Medical News Today [2013.05.28]
Heart failure accelerates the aging process and brings on early andropausal syndrome (AS), according to research presented at the Heart Failure Congress 2013. AS, also referred to as male 'menopause', was four times more common in men with heart failure...
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.
Hydralazine does not ameliorate nitric oxide resistance in chronic heart failure. [2010.04]
PURPOSE: The A-HeFT trial demonstrated incremental survival with hydralazine/isosorbide dinitrate combination in African-American patients with chronic heart failure (CHF). It has been suggested that hydralazine might enhance nitric oxide (NO)-mediated effects of organic nitrates by decreasing superoxide (O (2) (-) ) formation, one of the factors inducing NO resistance. We evaluated whether hydralazine therapy potentiates nitrate-induced vasodilation and inhibition of platelet aggregation by ameliorating NO resistance... CONCLUSION: The results of the present study do not support the assumption that hydralazine could be viewed as a "NO enhancer"; there is no evidence of attenuation of NO resistance by hydralazine treatment.
Clinical Trials Related to Bidil (Hydralazine Hydrochloride / Isosorbide Dinitrate)
African-American Heart Failure Trial [Completed]
A placebo-controlled trial of BiDil added to standard therapy in African-American patients
with heart failure.
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