The Pharmaceutical Journal
Vol 270 No 7239 p326
8 March 2003

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Milrinone shows promise for heart surgery children

A clinical trial of the heart failure drug milrinone (Primacor) has shown that it is a safe and effective prophylactic treatment for children who need congenital heart surgery.

The drug, which is a phosphodiesterase inhibitor, is used to treat adults with acute heart failure and has been used to treat children who develop low cardiac output syndrome (LCOS) following heart surgery.

However, researchers from the Children's Hospital of Philadelphia suggested that, because LCOS occurs frequently in paediatric patients after surgery for congenital heart defects, prophylactic use of milrinone might improve cardiac function and lower the risk of morbidity and mortality. The 238 children taking part in the trial were randomly divided into three groups — one received low-dose milrinone, one received high-dose milrinone, and the remaining group received placebo (see Panel).

The researchers found that high-dose milrinone reduced the risk of LCOS compared with placebo (relative risk reduction 55 per cent, P=0.023). Risk was further reduced in the group of patients who followed the trial protocol closely — 9.6 per cent of children receiving high-dose milrinone developed LCOS compared with 26.7 per cent of children given placebo (relative risk reduction 64 per cent, P=0.007).

Dr Gil Wernovsky, medical director of the cardiac intensive care unit at the hospital and one of the study investigators, pointed out that many drugs used by paediatricians have not been thoroughly tested in children. "We cannot assume that children are just small adults," he said. He added that the trial "provides hard evidence" for using milrinone in children.

The researchers point out that although hypotension, thrombocytopenia, and arrhythmias have been reported in adult patients treated with milrinone, they occurred infrequently during the trial (Circulation 2003;107:996).