Drug for heart failure increases mortality
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《英国医生杂志》
Patients with heart failure who were treated with the drug nesiritide to help them survive a crisis were 80% more likely to die in the month after treatment than were patients who had received traditional drugs for symptoms of acute heart failure. This was the finding of a US study published last week in JAMA ( 2005;293: 1900-5).
The drug's manufacturer Scios, which is part of Johnson & Johnson, released a statement a day after the JAMA study appeared, saying "labelling has been revised to include an expanded analysis of the mortality rates seen in pivotal trials of the congestive heart failure agent."
The company maintains that "a review of Scios' full clinical study data set does not show a statistically significant difference in mortality," but adds that an external review is under way.
The study analysed clinical trial data obtained from the manufacturer of the drug, which is marketed in the United States, Israel, and Switzerland as Natrecor, and from the US Food and Drug Administration. The meta-analysis showed that 35 of 485 patients (7.2%) treated with an infusion of nesiritide died within 30 days, compared with 15 of 377 patients (4%) who were given standard control treatment (hazard ratio 1.8 (95% confidence ratio 0.98 to 3.31)). All the clinical trials on the drug that had been done earlier than those in the meta-analysis had been conducted by Scios.
Two of the study's authors, Dr Jonathan Sackner-Bernstein, from North Shore University Hospital in Manhasset, New York, and Dr Keith Aaronson, from the University of Michigan, Ann Arbor, also published findings in March showing that nesiritide was associated with an increased risk of kidney dysfunction ( Circulation 2005;111: 1487-97).
Dr Sackner-Bernstein said that the study published last week, which was based on data from three clinical trials involving 862 heart failure patients who needed urgent treatment, showed that the risk from the drug was much higher than that previously estimated by the FDA. He thought a randomized controlled clinical trial was needed to define the risks before the drug was widely used. (See p 989.)(David Spurgeon)
The drug's manufacturer Scios, which is part of Johnson & Johnson, released a statement a day after the JAMA study appeared, saying "labelling has been revised to include an expanded analysis of the mortality rates seen in pivotal trials of the congestive heart failure agent."
The company maintains that "a review of Scios' full clinical study data set does not show a statistically significant difference in mortality," but adds that an external review is under way.
The study analysed clinical trial data obtained from the manufacturer of the drug, which is marketed in the United States, Israel, and Switzerland as Natrecor, and from the US Food and Drug Administration. The meta-analysis showed that 35 of 485 patients (7.2%) treated with an infusion of nesiritide died within 30 days, compared with 15 of 377 patients (4%) who were given standard control treatment (hazard ratio 1.8 (95% confidence ratio 0.98 to 3.31)). All the clinical trials on the drug that had been done earlier than those in the meta-analysis had been conducted by Scios.
Two of the study's authors, Dr Jonathan Sackner-Bernstein, from North Shore University Hospital in Manhasset, New York, and Dr Keith Aaronson, from the University of Michigan, Ann Arbor, also published findings in March showing that nesiritide was associated with an increased risk of kidney dysfunction ( Circulation 2005;111: 1487-97).
Dr Sackner-Bernstein said that the study published last week, which was based on data from three clinical trials involving 862 heart failure patients who needed urgent treatment, showed that the risk from the drug was much higher than that previously estimated by the FDA. He thought a randomized controlled clinical trial was needed to define the risks before the drug was widely used. (See p 989.)(David Spurgeon)