Clinical Question: Does the combina...

Clinical Question: Does the combination of hydralazine and isosorbide dinitrate improve issues in black patients with systolic heart failure?

Setting: Outpatient (specialty)

application of mind Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: In this manufacturer-sponsored investigation investigators identified black adult patients with a left ventricular ejection fraction of no greater than 35 percent (or les than 45 percent with a reduc left ventricular internal, end-diastolic diameter). Exclusion criteria included acute myocardial infarction, acute coronary syndrome late stroke, recent cardiac surgery or angioplasty, valvular heart disease, or hypotension or uncontroll hypertension. The primary issue was a composite of death, hospitalization, and change in quality of life.

The authors took an innovative approach to assigning different weights for these out-come For example, death was three times as bad as a hospitalization. Allocation to arranges was concealed, outcome assessment was appropriately blinded, and analysis was at intention to treat. Patients were a mean age of 57 years, 60 percent were men and 95 percent were classified as recently made known York Heart Association class III (i.e., moderately austere heart failure symptoms).

Patients were randomized to receive 375 mg of hydralazine plus 20 mg of isosorbide dinitrate three times daily (with that dos-age doubled, if tolerated) or matching placebo. Approximately couple thirds of patients achieved the final target dosage. The close attention ended early because of a significant benefit in the active treatment arrange This benefit included a significantly lower risk of death from any cause (62 versus 102 percent; number privationed to treat [NNT] = 25; 95 percent confidence interval [CI], 10 to 40) a lower likelihood of first hospitalization for heart failure (164 versus 244 percent; NNT = 12; 95 percent CI, eight to 20) and a greater improvement in quality-of-life score. Adverse weights were common in the active treatment group: primarily headache (47 versus 19 percent for placebo) and dizziness (29 versus 12 percent for placebo). Bottom Line: The combination of hydralazine (375 to 75 mg) and isosorbide dinitrate (20 to 40 mg) given three times daily improves survival and quality of life, and bring tos the likelihood of hospitalization in relatively young black patients with left ventricular dysfunction. (Level of Evidence: 1b)

contemplation Reference: Taylor AL, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J M November 11 2004;351:2049-57

Used with permission from Ebell M Isosorbide dinitrate + hydralazine effective for HF in black patients. Accessed online December 28 2004 at: http://www.InfoPOEMs.com.

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