Good and bad Heart Study

The largest ever study on heart failure found that a promising drug is safe, as had been feared. But it does not seem very effective.
Medical experts say the findings presented Sunday at a meeting of the American Heart Association, show that there is a lesson on the effectiveness of small studies as a whole.
L ', drug nesiritide, Natrecor was approved brand with small studies in carefully selected patients. It seemed a terrible relieve the symptoms of heart failure - the lungs of patients' fill with fluid and feel as if drowning.
But the large study with real patients, found no significant effect on this symptom.
A few years after its approval, nesiritide was out of service because of small studies suggest an increased risk of kidney disease and mortality has increased.
The large study has shown that these risks were also false.
"Once again, small studies give us wrong answers," said Dr. Robert M. Califf, a cardiologist, the Duke of extensive study undertaken. "There was no safety issue at all."
"For me, the really important news is that the drug was far away, for reasons that are not used properly, then it was for reasons that are not properly addressed," Dr. Califf said. "If such large clinical trials, we want to engage in a comedy of errors," he added.
The question of how rare side effects that seem to result in small studies to evaluate medical scourges. most drug trials are evaluating the impact on rare plants, but more drugs to a large number of people who are often sold for years, the issue becomes more pressing.
The nesiritide story began in 2005, was approved four years after the drug. Initially popular, but it has been a researcher, who asked for two, if it is really safe. Threw data from different studies nesiritide pot. The analysis of the reported damage to kidney function, and find other, higher mortality rates. Sales declined.
Johnson & Johnson, the drug manufacturer assembled a team of experts that the only way to answer the question of security, a large study to be done, he said. Based on the study that Dr. Califf, addressed to each defendant, each of the 450 participating hospitals around the world with heart failure and respiratory problems are recognized. Participants were randomly assigned to receive infusions of saline or nesiritide was obtained. The researchers asked two questions: In the case of patients alive after a month? And they were again taken to the hospital?
The study of the executive committee is still under discussion what was said at the conclusion of M. Califf. No one thinks that the drug is withdrawn from the market, he added, as he can, in some patients to facilitate breathing, even if the drug was not effective for all participants.
"But the big news is that if you do not have the right school, you do not know" about the risks and benefits, said Dr. Califf. "And you are at risk of committing serious errors."
Cardiologists have similar questions about the effectiveness of Zetia, a drug for eight years, cholesterol Mr. Califf is also considered. There was no doubt to combat heart disease has been improved.
The Food and Drug Administration approved Zetia, which lowers LDL or "bad" cholesterol, in 2002. In 2004, the Authority has approved a drug called Vytorin, Zetia and the statin called simvastatin link.
Both are from Merck ago