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)
Overexpression Of Sodium/Calcium Exchanger Protein Alone Did Not Cause Heart Failure
Source: Biology / Biochemistry News From Medical News Today [2009.11.19]
Researchers from the Center for Translational Medicine at Thomas Jefferson University have found that the overexpression of a sodium/calcium exchanger, without changes in other ion transport pathways commonly observed in heart failure, does not by itself lead to contraction abnormalities in the heart. They presented the data from the study at the American Heart Association Scientific Sessions in Orlando, Fla. Led by Joseph Cheung, M.D., Ph.D.
Aldagen Announces Clinical Data For ALD-201 For Ischemic Heart Failure Presented At AHA
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.19]
Aldagen, Inc. announced that results from a Phase 1 clinical trial of ALD-201, a cell therapy being developed as a treatment for ischemic heart failure, were presented at AHA. In the study, ALD-201 was found to be well-tolerated and to improve myocardial perfusion. The data were presented at the American Heart Association Scientific Sessions 2009 by Emerson C.
Heart Failure Patients' Salt Consumption Lowered By Family Partnership, Education Interventions
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.18]
Educating family members of heart failure (HF) patients about the health benefits of consuming a low-salt diet and providing skills for support and communication can effectively reduce HF patients' sodium consumption, according to an interdisciplinary study led by Emory University cardiovascular nursing researcher Sandra Dunbar, RN, DSN, FAAN, FAHA. Dunbar presented key findings of this study at the annual meeting of the American Heart Association in Orlando.
Heart Failure Patients With Kidney Dysfunction Don't Recover Well After Hospital Discharge
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.18]
Most heart failure patients who develop kidney failure in the hospital do not recover from it before going home and are at increased risk of either being re-hospitalized or dying within the year, according to a Henry Ford Hospital study. The study's gloomy finding is the first time researchers linked long-term health outcomes with declining kidney function in patients hospitalized for heart failure.
American Heart Association Late Breaking Clinical Trial Report: High Dose Of Angiotensin Receptor Blockers Effective In Heart Failure Patients
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.18]
A larger dose of angiotensin receptor blockers (ARBs) is more effective than a smaller dose in heart failure patients, researchers said at the American Heart Association's Scientific Sessions 2009. The Comparison of Low-Dose vs.
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.
Effects of fixed-dose isosorbide dinitrate/hydralazine on diastolic function and exercise capacity in hypertension-induced diastolic heart failure. [2009.09]
Hypertension-induced diastolic heart failure accounts for a large proportion of all heart failure presentations.
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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Page last updated: 2009-11-19
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