I found the following on the DNDN board. To me, it sounds as if androgen deprivation, which I consider to be the extreme version of low T, is actually related to high baseline glucose=diabetes. Consequently, if Androxal can increase T, it may also decrease baseline glucose levels, which was recently suggested as an endpoint for the androxal study. Thus, the 'datamining' that RPRX did to find a meaningful clinical endpoint (glucose baseline=a well defined biochemical endpoint) instead of QoL may actually be for real, and not just datamining.
Any comments?
Thanks!
Dr. B.
Androgen Deprivation Therapy For Localized Prostate Cancer And The Risk Of Cardiovascular Mortality
Main Category: Prostate / Prostate Cancer News
Article Date: 11 Nov 2007 - 0:00 PST
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UroToday.com- Androgen deprivation therapy (ADT) is associated with metabolic syndrome, which includes the development of type II diabetes mellitus and coronary artery disease. In the October 17, 2007 issue of the Journal of the National Cancer Institute evaluated whether ADT induced metabolic changes result in an increased risk of cardiovascular (CV) death.
The longitudinal, observational prostate cancer registry CaPSURE was used to study a cohort of 4,892 men. Of these, 1,015 patients were treated with ADT with local therapy and 3,977 men were not treated with ADT. ADT was used in 266 patients who had RP and in 749 men who received nonsurgical treatment. The primary endpoint of the study was death due to CV causes. This was defined as myocardial infarction, sudden cardiac arrest, coronary artery disease, cardiac ischemia, arrhythmia, pulmonary embolism, or stroke.
Median patient age was 64 years and median followup was 3.8 years. Patients receiving radiotherapy, cryotherapy, or brachytherapy as primary treatment in combination with ADT were older than men who had RP. The overall median duration of ADT therapy was 4.1 months. The proportion of patients with baseline hypertension and heart disease were similar among those who did and did not receive ADT. The proportion of patients with baseline diabetes was statistically higher in patients using ADT than in patients not using ADT. Analysis of patients treated with RP, both ADT and older age were associated with significantly increased risks of death from CV causes but the presence of baseline heart disease or diabetes was not. This risk of CV death was evident in patients younger and older than 65 years. The cumulative incidence of death from CV causes among the younger patients using ADT was 3.6%, as compared to 1.2% in those not using ADT. Among patients treated with radiotherapy, brachytherapy, or cryotherapy only older age was associated with an increased risk of death from CV disease. Patients older than age 65 years who were treated with RP and ADT also had higher 5-year estimates of death from CV causes. In multivariable analysis among patients treated with RP, ADT use was associated with increased risk of death from any cause. Older age, Gleason score greater than 8, and presence of baseline diabetes were also associated with an increased risk of death from any cause. Among those who did not undergo RP a shorter time to all-cause mortality was not associated with ADT use but was associated with advancing age.
Tsai HK, D'Amico AV, Sadetsky N, Chen MH, and Carroll PR
J. Natl. Cancer Inst. 99(20): 1516- 1524, October 2007
doi:10.1093/jnci/djm168
Reported by UroToday.com Contributing Editor Christopher P. Evans, M.D
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