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Second look at drug reverses promise
BIRMINGHAM, England-A Japanese drug’s once-bright future for congestive heart failure seems to have been dashed by a big new trial.
In a 3,833-patient study undertaken at the behest of the FDA, the 60-mg dose of investigational vesnarinone (Arkin, Otsuka) led to a significant 26% rise in mortality, vs. a 62% drop in a 477-patient randomized study published in 1993 in the New England Journal.
The new study, chaired by Dr. Jay Cohn of the University of Minnesota, also found the 30-mg dose of the inotropic drug caused a 14% nonsignificant excess of deaths among patients followed longer than a year. The results, discussed in the corridors at the European Society of Cardiology meeting here, will be given in November at the American Heart Association’s sessions. “To see the absolute reversal is quite surprising,” says Dr. Cohn. -Larry Husten
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