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Dyspnea relief should be key target for HF patients
27 August 2010
MedWire News: Results from the Pre-RELAX-AHF study suggest that relief from dyspnea in patients with acute heart failure (AHF) is often incomplete and may lead to poor prognosis.
Marco Metra (University of Brescia, Italy) and team found a trend toward improvement in both dyspnea and HF symptoms in patients given relaxin, a naturally occurring vasodilator.
In the Preliminary study of RELAX in Acute Heart Failure (Pre-RELAX-AHF), the researchers randomly assigned 232 individuals admitted to hospital with AHF to receive relaxin at a dose of 10, 30, 100, or 250 µg/kg/day, or placebo and then followed them up for 180 days. Treatment with other drugs was allowed at the treating-physicians’ discretion.
Dyspnea severity and relief was assessed at various time points using a visual analog scale (VAS) where patients were asked to draw a horizontal line across a 100-mm vertical line to indicate their breathing, with 100 mm being the best health state and 0 mm the worst. The seven-point Likert scale was also used to assess changes in dyspnea from baseline.
Early dyspnea relief (within first 24 hours) occurred in only 25% of the overall cohort, in 23% of the placebo group and 26% of the relaxin-treated group. At 14 days, 70% of patients overall had moderately or markedly better dyspnea.
At baseline VAS was 42.3 mm. By Day 5 it had increased by 14.3 mm in the placebo group versus 23.3 mm in the overall relaxin group. Average relative improvements from baseline in VAS area under the curve (AUC) through Day 5, were 31.7% and 50.0% in placebo- and relaxin-treated patients, respectively.
Worsening HF symptoms were seen in 21% of the placebo group and 14% of the combined relaxin treatment groups at Day 5.
“Lack of dyspnea relief and presence of worsening heart failure were associated with slower improvement in clinical signs of congestion and worse short- and intermediate-term outcomes,” write Metra et al.
“This suggests that, beyond being the main measure of AHF related to patients’ symptoms, these endpoints are also related to prognosis and hence may be regarded as important and meaningful targets of therapy.”
The researchers add that the trend toward improvement in dyspnea and reduction in HF worsening achieved by relaxin administration “suggest that a further improvement in symptoms and outcomes with new therapies is possible.”
The most effective 30 µg/kg/day dose is currently being investigated further in the ongoing phase III RELAX-AHF study.
The results of this study are published in the European Journal of Heart Failure.