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Study: Nitrates in Heart Failure May Do More Harm Than Good

No improvement seen in heart patients compared with placebo

Nitrates don’t improve quality of life or everyday activity levels as intended in patients with heart failure, according to new research published in the New England Journal of Medicine.

Margaret Redfield, MD, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, and her colleagues randomly assigned 110 patients with heart failure and a preserved ejection fraction to a six-week dose-escalation regimen of isosorbide mononitrate (from 30 mg to 60 mg to 120 mg once daily) or placebo, with subsequent crossover to the other group for six weeks. The study’s primary endpoint was the patient’s daily activity level, quantified as the average daily accelerometer units during the 120-mg phase, as assessed by patient-worn accelerometers.

Secondary endpoints included hours of activity per day during the 120-mg phase; daily accelerometer units during all three doses of isosorbide mononitrate; quality-of-life scores; the 6-minute walk distance; and levels of N-terminal pro–brain natriuretic peptide (NT-proBNP).

In the subjects receiving the 120-mg dose of isosorbide mononitrate, compared with the placebo group, there was a nonsignificant trend toward lower daily activity (−381 accelerometer units; P = 0.06) and a significant decrease in hours of activity per day (−0.30 hours; P = 0.02). During all three doses of isosorbide mononitrate, activity was significantly lower than that in the placebo group (−439 accelerometer units; P = 0.02). Activity levels decreased progressively and significantly with increased doses of isosorbide mononitrate, but not with placebo. There were no significant between-group differences in the 6-minute walk distance, quality-of-life scores, or NT-proBNP levels.

“This study should change practice,” Redfield said. “Long-acting nitrates should not be used for symptom relief in heart failure.”

Sources: Medical Xpress; December 10, 2015; and New England Journal of Medicine; December 10, 2015.

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