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Comment & Response |

Deaths and Cardiovascular Events in Men Receiving Testosterone—Reply

P. Michael Ho, MD, PhD1; Anna E. Barón, PhD1; Margaret E. Wierman, MD1
[+] Author Affiliations
1VA Eastern Colorado Health Care System, Denver
JAMA. 2014;311(9):964-965. doi:10.1001/jama.2014.401.
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In Reply The study objective was to assess the association of testosterone use with patient outcomes using observational data from clinical practice. Because treatment with testosterone was not randomized, drawing conclusions based on raw event numbers in patients not receiving treatment vs those receiving treatment is not valid.

To account for differences in follow-up (659 940 days of follow-up for treated vs 6 653 821 days for untreated) and the timing of testosterone therapy initiation, we applied Kaplan-Meier methods with testosterone therapy initiation as a time-varying covariate, which considers patients as receiving therapy once they fill an initial prescription (median of 531 days after angiography [time 0]). This contrasts with the standard methods of categorizing use of testosterone therapy at baseline based on whether patients start therapy at any time during follow-up, which incorrectly classifies patients as receiving therapy before they receive it and attenuates treatment effects.1

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References

November 6, 2013
Rebecca Vigen, MD, MSCS; Colin I. O’Donnell, MS; Anna E. Barón, PhD; Gary K. Grunwald, PhD; Thomas M. Maddox, MD, MSc; Steven M. Bradley, MD, MPH; Al Barqawi, MD; Glenn Woning, MD; Margaret E. Wierman, MD; Mary E. Plomondon, PhD; John S. Rumsfeld, MD, PhD; P. Michael Ho, MD, PhD
1The University of Texas at Southwestern Medical Center, Dallas
2VA Eastern Colorado Health Care System, Denver3University of Colorado Denver, Aurora
2VA Eastern Colorado Health Care System, Denver3University of Colorado Denver, Aurora4Colorado Cardiovascular Outcomes Research (CCOR) Consortium, Denver
3University of Colorado Denver, Aurora
JAMA. 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386.
March 5, 2014
Daniel M. Riche, PharmD; William L. Baker, PharmD; Christian A. Koch, MD, PhD
1Department of Pharmacy Practice, University of Mississippi School of Pharmacy, Jackson
2Department of Pharmacy Practice, University of Connecticut, Storrs
3Division of Endocrinology, University of Mississippi Medical Center, Jackson
JAMA. 2014;311(9):963-964. doi:10.1001/jama.2014.386.
March 5, 2014
Sandeep Dhindsa, MBBS; Manav Batra, MBBS; Paresh Dandona, MBBS
1Division of Endocrinology and Metabolism, Texas Tech University Health Sciences Center, Odessa
2Division of Endocrinology and Metabolism, State University of New York, Buffalo
JAMA. 2014;311(9):964. doi:10.1001/jama.2014.389.
March 5, 2014
Abraham Morgentaler, MD; Abdulmaged Traish, PhD; Ravi Kacker, MD
1Harvard Medical School, Boston, Massachusetts
2Division of Urology, Boston University School of Medicine, Boston, Massachusetts
JAMA. 2014;311(9):961-962. doi:10.1001/jama.2014.392.
March 5, 2014
James Katz, MD, MPH; Robert Nadelberg, MD
1Age Management Boston, Boston, Massachusetts
JAMA. 2014;311(9):963. doi:10.1001/jama.2014.395.
March 5, 2014
T. Hugh Jones, BSc, MD, FRCP; Kevin S. Channer, MD, FRCP
1Robert Hague Centre for Diabetes and Endocrinology, Barnsley Hospital NHS Foundation Trust, Barnsley, England
2Sheffield Hallam University, Sheffield, England
JAMA. 2014;311(9):962-963. doi:10.1001/jama.2014.398.
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