Endocrinology

PCOS linked to higher all-cause and cause-specific mortality in nationwide Finnish cohort

In 9,839 women with PCOS matched 1:3 to controls, median follow-up was 12 years and overall mortality was higher in PCOS (adjusted HR 1.33, 95% CI 1.12–1.59). Deaths from neoplasms and circulatory disease were increased (education-adjusted HRs 1.39 and 1.68, respectively). The effect persisted after adjusting for diagnosed obesity, type 2 diabetes, hypertension, and education level. Findings apply to women with PCOS identified in Finnish health records and support targeting long-term cardiovascular and cancer risk reduction. 1

FDA two-trial paradigm infrequently yields duplicate phase 3 trials; discrepant conclusions occur rarely but matter

Among 9,925 phase 3 trials, duplicated trials occurred in about 5% (498 studies), concentrated in dermatology and ophthalmology. Of duplicated pairs with results available, 17% showed discrepancies in statistical conclusions (35 of 206 pairs). The FDA granted authorization despite discrepancies in 14 cases, and required an additional randomized trial in 8 of those cases. Result: duplicated trials are uncommon and regulatory responses to discrepant findings vary, highlighting interpretive risk when trials disagree. 2

Baseline testosterone predicts docetaxel benefit with RT+ADT in nonmetastatic high-risk prostate cancer

Pooled analysis from two randomized cohorts (n=255 and n=563; median follow-ups ~10.4–10.6 years) found a significant treatment-by-testosterone interaction (p≈.04 in both cohorts). Adding docetaxel to RT and ADT reduced all-cause mortality in men with normal baseline testosterone but not in men with low testosterone. Among men with normal testosterone, those with PSA >20 ng/mL, T3/4 disease, or Gleason 9–10 derived the most benefit. This supports considering baseline testosterone as a predictive biomarker when counseling selected high-risk patients about docetaxel. 3