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J Thorac Cardiovasc Surg 2004;127:606
© 2004 The American Association for Thoracic Surgery
Letter to the editor |
Ischemia Research and Education Foundation, San Francisco, CA 94121, USA
My colleagues and I thank Dr Katz for his letter. Please find below our responses to his questions.
First, regarding the morphine-sparing effect, we believe that this not only is statistically significant but clinically meaningful for these patients. As you may be aware, patients undergoing coronary artery bypass grafting have impaired pulmonary function, with most having a protracted smoking history and an increasing number having ventricular dysfunction. Contributing as well are the effects of narcotics, particularly when administered early (<12 hours)—that is, at about the time of tracheal extubation. Thus we believe that morphine-sparring provided by the cyclooxygenase 2 inhibitors parecoxib and valdecoxib is clinically relevant and should not just be evaluated with patient comfort indices, as one might for less severe surgery in healthier patients.
Second, we also believe that the avoidance of morphine-associated physiologic effects is more important here than possible effects on nausea, vomiting, dizziness, sedation, fatigue, and constipation. Please note that in our patients these patient comfort measures are affected not only by the pain reliever administered, but also—and more profoundly—by the effects of extreme reperfusion, hypothermia, and the inherent cytotoxic responses affecting the end-organs with which you have concern: the brain (sedation, dizziness), the gut (nausea, vomiting), and the skeletal muscles and metabolism (fatigue). Generally, then, any analyses, as I believe you suggest, will be heavily confounded by these factors in these patients.
Third, I respectfully disagree with your comments regarding "interpretable pain data." We believe that reporting peak pain intensity difference, calculated for each day of treatment and with a baseline control, and our measures of patient and physician global assessment, are sensitive measures, are interpretable, and are meaningful. For example, regarding the clinical relevance of a 1-unit finding on a 4-unit pain intensity scale, we believe that this is substantive, especially when considering that the control group was designed to be aggressively treated well in excess of that usually practiced. This design was specifically chosen to be conservative, therefore imposing a higher standard for these new pain relievers.
Finally, and importantly, regarding safety, we too believe that our findings regarding infection and inflammation raise serious concerns. We, however, believe that analysis of historical data of similar populations as the placebo group may reveal important insights. We are assured (by the sponsor) that such analyses will be pursued in the near future, and we are committed to performing those analyses independently. Therefore, I reserve response to this important question which you raised until we have performed such analyses. Those results will be given in a second response letter to this Journal,and my group will await your comments after that publication.
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J. Thorac. Cardiovasc. Surg. 2004 127: 605.
J. Thorac. Cardiovasc. Surg. 2004 127: 607.
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