Once again, the modest increase in HR in the face of decreased BP could not really be well interpreted by the cardiac docs. The question of outliers for HR was a concern. It seemed clear to me all along that a cardiac outcomes trial would be required, but whether it will be required before or after the drug is on the market remains a question. I was a bit worried about a cardiac outcomes trial being a requirement for approval. Obviously, having the individual components available as generics is likely on the minds of the FDA vis a vis a preapproval cardiac outcomes trial.
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