Understanding low sugar from NICE-SUGAR.

n engl j med 367;25 nejm.org december 20, 2012 2449 migraine and headache were collected separately. Of the 800 patients treated with enzalutamide, 3 (0.4%) were reported to have had a migraine. Headaches were reported in 93 patients treated with enzalutamide (11.6%) and in 22 of the 399 patients treated with placebo (5.5%). In the enzalutamide group, the majority of reports were for grade 1 headache that did not require treatment. No patient was treated for headache with glucocorticoids. One patient reporting seizure in AFFIRM reported a headache 5 months before the report of seizure. Berruti et al. state that headaches were not reported as a relevant symptom in patients receiving abiraterone acetate plus prednisone in a recent phase 3 study.1 However, the clinical review of abiraterone acetate by the Food and Drug Administration (new drug application number, 202379) reported a similar frequency of headache in the two study groups (11.9% of patients in the abiraterone-plus-prednisone group and 10.7% of those in the placebo-plus-prednisone group).2 Overall, these data do not support the suggestion by Berruti et al. that the headaches observed in the enzalutamide study reflect migraines, nor that patients who had a headache during treatment with enzalutamide are at increased risk for seizure.