Risk of cardiovascular events with degarelix versus leuprolide after biochemical relapse of prostate cancer: Exploratory analysis of a randomized controlled trial.
Bibliographic record
Abstract
151 Background: Androgen deprivation therapy (ADT) has been associated with increased cardiovascular (CV) risk in men. A pooled analysis of phase 3 trials comparing LHRH agonists with degarelix in PCa patients indicated a lower risk of CV events or death in those treated with degarelix. We now report the incidence of non-fatal CV events in men with PCa and pre-existing CV disease (CVD) treated with degarelix or leuprolide in the CS37 trial. Methods: CS37 was a prospective, randomized trial comparing intermittent (n=175) and continuous (n=50) degarelix with continuous leuprolide (n=178) in patients with biochemical relapse of PCa in the United States. CV events were retrospectively analyzed up to Month 12 (intermittent arm events censored at Month 7). Cox regression models were used to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI). Results: 143 men (35%) had pre-existing CVD at baseline; 88 treated with degarelix and 55 treated with leuprolide. For degarelix and leuprolide treatment arms, median age (range) was 75 (51–88) and 73 (53–89) years and median BMI (range) 28.0 (17.7–40.7) and 30.1 (23.5–48.3) kg/m2, respectively. A slightly higher proportion of men treated with leuprolide than degarelix had a Gleason score of 7–10 (35 [64%] vs 46 [52%]) and slightly more men treated with degarelix vs leuprolide had hypertension (31 [35%] vs 15 [27%]), diabetes (70 [80%] vs 39 [71%]) and used statin medication (67 [76%] vs 36 [65%]) at baseline. The proportion of men who smoked or had hypercholesterolemia at baseline was similar between treatment arms. During the observation period, a subsequent CV event occurred in 3 (3.4%) men treated with degarelix and 8 (14.5%) treated with leuprolide (HR=0.22; 95% CI 0.05–1.03, p=0.054). Conclusions: Retrospective analysis of men with pre−existing CVD in CS37 identified a lower risk for subsequent CV events in men treated with degarelix vs leuprolide. The difference in CV event risk was seen within 12 months of treatment initiation. Our analysis adds to previous data on CV risk with ADT and supports consideration of CV risk factors when choosing a drug for androgen deprivation.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".