BiDil

Direct Vasodilators Isosorbide dinitrate 20 mg and hydralazine 37.5 (BiDil) 1-2 tablets three times a day Minoxidil (Loniten) Hydralazine Heart failure (isosorbide dinitrate + hydralazine in African-Americans) A-HeFT66 Edema (minoxidil) Tachycardia Lupus-like syndrome (hydralazine) ... 

These population changes have important implications for pharmacotherapy. It is now widely accepted that genetic differences between the various ethnic groups are quite small and probably less than individual differences. The recent experience with the newly approved congestive heart failure medication, BiDil, suggests that even minor differences can have significant pharmacological consequences. 

Subsequently the medication was approved for self identified African Americans by the Federal Drug Administration (FDA), the first time a medication was approved for a specific racial group (US Food and Drug Administration, 2005). This combination was then marketed as BiDil. The approval led to a great deal of controversy and discussion, much of it critical, about the FDA decision. The findings from these trials, however, provide evidence that ethnicity can make a difference in clinical treatment response (Sankar 8c Kahn, 2005). 

Sankar, P. Kahn, J. (2005). BiDil Race medicine or race marketing Health Affairs, web exclusive (http //content.heaIthaffairs.org/cgi/content/abstract/hlthaff.w5.455). 

US Food and Drug Administration (2005). FDA approves BiDil heart failure drug for Black patients. Press Release, June 23, 2005. www.fda.gov/bbs/topics/NEWS/2005/NEW01190.html [Accessed October 4,2005]. 

The combination of nitrates and hydralazine improves the composite endpoint of mortality, hospitalizations for HF, and quality of life in African Americans who receive standard therapy. A fixed-dose combination product is available that contains ISDN 20 mg and hydralazine 37.5 mg (BiDil). Practice guidelines recommend adding ISDN and hydralazine as part of standard therapy in African Americans with moderately severe to severe HF. The combination may also be reasonable for patients of other ethnicities with persistent symptoms despite optimized therapy with an ACE inhibitor (or ARB) and /Tblocker. The combination is also appropriate as first-line therapy in patients unable to tolerate ACE inhibitors or ARBs because of renal insufficiency, hyperkalemia, or possibly hypotension. 

Isosorbide Dinitrate Hydralazine (BiDil) [Antianginal, Antihypertensive/Vasodilator, Nitrate] Uses HF in African Amer-icans improve survival functional status, prolong time between hospitalizations Action Relaxes vascular smooth muscle peripheral vasodilator Dose Initially 1 tab tid PO (if not tol ated reduce to 1/2 tab tid), titrate >3-5 d as tolerated Max 2 tabs tid Caution [C, /-] recent MI, syncope, hypovolemia, hypotension, hep impair Contra For children, concomitant use w/ PDE5 inhibitors (sildenafil) Disp Tabs SE HA, dizziness, orthostatic hypotension, sinusitis, GI distress, tach, paresthesia, amblyopia Interactions t Risk of severe hypotension W/ antihypertensives, ASA, CCBs, MAOIs, phenothiazides, sildenafil, tadalafil, vardenafil, EtOH X pressor response Wf i -1- effects W7 NSAIDs EMS Use ASA, antihypertensives and CCBs w/ caution, may t hypotension concurrent Viagra-type drug use can lead to profound hypotension concurrent EtOH use can t effects OD May cause N/V, profound hypotension, skin flushing, HA from ICP, bradycardia, confusion, and circulatory collapse activated charcoal may be effective, epi use is contraindicated... 

Hydralazine plus isosorbide dinitrate fixed dose (BiDil)... 

Consider BiDil, a drug and a situation considered elsewhere, notably in the context of evidence-based medicine in Chapter 10. It is a drug combating... 

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