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Assessment of the safety of glucocorticoid regimens in combination with abiraterone acetate: A randomized, open-label phase 2 study

JAMA Oncology Jul 03, 2019

Attard G, et al. - Through an open-label, phase 2 randomized clinical trial of 164 men with metastatic castration-resistant prostate cancer (mCRPC), the experts intended to assess the safety of abiraterone acetate (an approved drug for use in combination with either prednisone, 5 mg, twice daily or prednisone, 5 mg, once daily recording improvements in overall survival for the former in patients with mCRPC) with 4 glucocorticoid regimens. No mineralocorticoid excess was observed in 24 of 34 patients, 14 of 38 patients, 21 of 35 patients, and 26 of 37 patients who administered abiraterone acetate, 1000 mg, daily with prednisone, 5 mg, twice daily, once daily, or 2.5 mg twice daily, or dexamethasone, 0.5 mg, once daily, respectively. An elevation in serum insulin and homeostatic model assessment of insulin resistance was observed in the dexamethasone group, while total bone mineral density declined. Hence, for the primary endpoint, abiraterone acetate with prednisone, 5 mg, twice daily or dexamethasone, 0.5 mg, once daily coincided the prespecified threshold whereas abiraterone acetate with prednisone, 5 mg, once daily or 2.5 mg twice daily could not reach the threshold. Furthermore, abiraterone acetate in combination with dexamethasone seemed to be especially active but might not be related to adverse metabolic consequences.
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