Medical experts say the results, presented Sunday at the American Heart Association meeting, show there is a lesson to be learned about the effectiveness of small studies over all.
The drug, nesiritide, brand name Natrecor, was approved after small studies in carefully selected patients. It seemed to soothe a terrible heart-failure symptom — patients’ lungs fill with fluid and they feel as if they are drowning.
But the large study, with real-world patients, found no significant effect on that symptom.
A few years after its approval, nesiritide fell out of use because small studies seemed to indicate an increased risk of kidney problems and an increased death rate.
The large study showed those risks, too, were wrong.
“Once again, small studies give us the wrong answers,” said Dr. Robert M. Califf, a Duke cardiologist who directed the large study. “There was no safety issue at all.”
“To me, the really important message is that the drug got very widely used for reasons that are incorrect, and then it got bashed for reasons that are incorrect,” Dr. Califf said. “Unless we do these kinds of large clinical trials we are engaged in a comedy of errors,” he added.
The question of how to evaluate rare side effects that seem to arise in small studies plagues medical researchers. Most drug studies are not designed to assess rare effects, but as more drugs are sold to huge numbers of people who often take them for years, the question has become increasingly pressing.
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