From rxpgnews.com
FDA Recommends BiDil For Heart Failure In African-Americans
By FDA Advisory Committe
Jun 17, 2005, 09:17
NitroMed�s BiDil (hydralazine/isosorbide dinitrate) should be approved for treatment of heart failure in patients who self-identify themselves as African-American, FDA�s Cardiovascular & Renal Drugs Advisory Committee said at its June 16 meeting.
�I find the evidence is more than adequate to vote for approval,� Committee Chair Steven Nissen (Cleveland Clinic) said.
The data presents a �compelling argument, but only for this population� of self-identified African-Americans, Nissen said, since that is the population that was enrolled in the BiDil African-American Heart Failure Trial (A-HeFT).
The committee voted unanimously to approve BiDil for treatment of heart failure, with all members, except one, agreeing that the indication should be restricted to the African-American group.
Committee consultant Vivian Wang (National Human Genome Research Institute) voted against labeling BiDil for the targeted group, saying that the basis of the drug�s effect in certain patients is biological not racial and the recommendation �will be over-interpreted.�
There was a brief discussion as to whether BiDil should be approved for the general population, since it may benefit patients other than African-Americans.
Several open public hearing speakers put forth the argument that since many drugs are given broad approvals based primarily on white population studies, general approval could be given on the basis of an African-American only study.
Committee member Thomas Fleming (University of Washington) contended that situations are not the same because most trials try to recruit patients from all races, but often fall short, whereas the A-HeFT trial �proactively excluded� all other races. In addition, the earlier V-HeFT studies showed fewer benefits in white patients than blacks, Fleming noted.
While some meeting participants argued that race has no biological basis, Nissen argued that in this case �[we are] using self-identified race as a surrogate for genomics.�
Fleming and some other committee members called the recommendation for approval a �close call� citing the use of a single study and some endpoints that were marginally statistically significant.
However, Fleming said that looking at the totality of evidence there is �considerable consistency here.� He added that the �clearest signal here is heart failure hospitalization.� The signals for reduced mortality and overall hospitalizations were weaker, Fleming said.
BiDil, used with other optimal therapies, showed a 43% reduction in mortality compared to the optimal therapies alone. The A-HeFT trial was stopped early based on an apparent mortality benefit.
However, Fleming said that the results have to be adjusted for lack of power and early looks at the data, which puts the mortality benefit at the limits of statistical significance.
Nissen agreed that the evidence was �on the margin� but added that he was �not as conflicted as some of you are.� He said that the statistical results are good considering that BiDiL was compared to best possible therapy.
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