Response to Letter Regarding Article “Effects of the Selective Estrogen Receptor Modulator Raloxifene on Coronary Outcomes in the Raloxifene Use for the Heart Trial: Results of Subgroup Analyses by Age and Other Factors”
We thank Dr Choi and colleagues for their correspondence and intriguing hypothesis. Unfortunately, we do not have the additional data with which to confidently test the hypothesis stated. We do not have robust osteoporosis data in the Raloxifene Use for the Heart (RUTH) study; we did not systematically measure bone mineral density. In addition, few women (<10% before data lock) reported osteoporosis as a secondary condition. Approximately 15% reported postbaseline use of bone-active agents. For reported fractures, we did not collect data on whether or not the study participant was osteoporotic. Therefore, with such small numbers, these would not be informative (or even appropriate) subgroup analyses. Although we all believe this is a very interesting hypothesis, we cannot address this question with data from the RUTH trial.1
Dr Collins served as a principal investigator at a clinical site for the RUTH trial and received consulting fees from Eli Lilly, Berlex, Merck, Pantarhei, and Pfizer; lecture fees from Berlex, Merck, Pfizer, Novo Nordisk, and Organon; and grant support from Eli Lilly, Organon, and Merck. Dr Barrett-Connor received salary support from Eli Lilly for serving as principal investigator and as an investigator at a clinical site for the RUTH trial; served on paid advisory boards for Merck, Eli Lilly, Procter & Gamble, and Amgen; and received grant support from Amgen. Dr Mosca reports having no conflicts. Dr Grady received salary support, by means of contracts with the University of California, San Francisco, from Berlex, Eli Lilly, Merck, Pfizer, and Wyeth-Ayerst Research and consulting fees for chairing a data and safety monitoring board at Organon. Dr Kornitzer received grant support and lecture fees from Eli Lilly, Merck, Bristol-Meyers Squibb, Sandoz, and AstraZeneca. Dr Wenger received salary support from Eli Lilly for serving as co-principal investigator and as principal investigator at a clinical site for the RUTH trial; consulting fees from Eli Lilly, CV Therapeutics, NitroMed, Schering-Plough, and the Leadership Council for Improving Cardiovascular Care; speaker’s fees from Pfizer, Novartis, Merck, Eli Lilly, and NitroMed; and research grants or contracts (or having served on trial steering committees) for Eli Lilly, AstraZeneca, and Pfizer. Dr Geiger, Dr Dowsett, Dr Effron and Dr Amewou-Atisso are full-time employees and stockholders of Eli Lilly. No other potential conflict of interest relevant to this article was reported.
Collins P, Mosca L, Geiger MJ, Grady D, Kornitzer M, Amewou-Atisso MG, Effron MB, Dowsett SA, Barrett-Connor E, Wenger NK. Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for the Heart trial: results of subgroup analyses by age and other factors. Circulation. 2009; 119: 922–930.