The effect of androgen deprivation therapy (ADT) on lipid and HbA1C parameters

Abstract

4562 Background: Studies suggest a reduction in prostate cancer-specific mortality with early versus delayed ADT. However, these same studies show no effect on overall mortality, raising the possibility of competing risk factors. Patients receiving ADT are known to be at increased risk for weight gain and truncal obesity, risk factors for insulin resistance and cardiovascular disease. In current practice, ADT is often administered prior to the development of clinical metastases and patients are treated for longer periods of time. Thus it is important to determine if ADT has an effect on lipid parameters. Methods: We analyzed a database collected during studies of Plenaxis compared to Lupron or to Lupron + Casodex. Patients were randomized in a 2:1 fashion to Plenaxis vs Lupron-based therapy. Fasting lipid profiles, glucose measurements, HbA1C levels and body weights were measured at baseline and on treatment days 85, 169. Fewer patients were available for analysis on days 253 and 336. 1,099 patients enrolled in the trial and 226 patients were on lipid lowering agents (statins) at the time of enrollment. One-sample t-tests were used to determine changes between baseline pretreatment values and each subsequent measurement for each treatment group and within each population (statins and no statins) using Bonferri-adjusted p-values of 0.01. Results: In all three treatment groups, there were significant increases in triglycerides, cholesterol and LDL between baseline and day 85 and baseline and day 169. There were also significant increases in HDL. All patients had increases in HbA1C from baseline to day 85. Only patients not on statins demonstrated statistically significant weight gain. No significant changes were observed in fasting glucose levels. Conclusions: ADT may affect both serum lipid values and HbA1C independent of statin therapy or the type of ADT. ADT may also result in increased HDL levels, thus the overall effect of ADT on serum lipids and cardiovascular risk is not certain. Although it is not possible to determine from this study whether these trends persist beyond 6 months, these data suggest that ADT therapy may be associated with risk factors for cardiovascular disease. Larger studies to investigate these parameters are warranted. No significant financial relationships to disclose.