1249 STATINS SLOW PROSTATE GROWTH: RESULTS FROM THE REDUCTION BY DUTASTERIDE OF CANCER EVENTS (REDUCE) TRIAL
Bibliographic record
Abstract
You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical and Hormonal Therapy1 Apr 20121249 STATINS SLOW PROSTATE GROWTH: RESULTS FROM THE REDUCTION BY DUTASTERIDE OF CANCER EVENTS (REDUCE) TRIAL Roberto Muller, Leah Gerber, Daniel Moreira, Gerald Andriole, J. Kellogg Parsons, Neil Fleshner, and Stephen Freedland Roberto MullerRoberto Muller Durham, NC More articles by this author , Leah GerberLeah Gerber Durham, NC More articles by this author , Daniel MoreiraDaniel Moreira New Hyde Park, NY More articles by this author , Gerald AndrioleGerald Andriole Saint Louis, MO More articles by this author , J. Kellogg ParsonsJ. Kellogg Parsons San Diego, CA More articles by this author , Neil FleshnerNeil Fleshner Toronto, Canada More articles by this author , and Stephen FreedlandStephen Freedland Durham, NC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1567AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Statins are cholesterol-lowering agents with anti-inflammatory and apoptotic properties. We previously found starting a statins was associated with 4.1% reduced PSA levels within 1 year and, given PSA correlates with prostate volume (PV), we hypothesized statins may affect PV. Indeed, a study of 416 men with PV<30mL and PV measured serially by transrectal ultrasound (TRUS) over many years found statin use reduced the risk of a PV >30mL. However, a 6-month trial of atorvastatin vs. placebo showed no effect on PV. We tested if statins were associated with PV changes in REDUCE, a 4-year randomized trial of dutasteride vs. placebo for prostate cancer prevention wherein TRUS PV was obtained from mandated on-study biopsies regardless of PSA. METHODS Men were aged between 50-75 yrs, had a PSA between 2.5-10 ng/mL, a prior negative prostate biopsy, and a pre-study PV of <80cc. PV was obtained from TRUS at 2- and 4-year biopsies and compared to baseline. Of 8122 men in the efficacy population, after excluding PV after prostatic surgery, 6423 men (79.1%) had serial PV data, of which we excluded 330 (5.1%) due to missing data or extreme PV change from baseline. Statin use was assessed at baseline. We used multivariable linear regression to test if statin use was associated with PV changes at 2- and 4-years stratified by placebo and dutasteride arms. Models were adjusted for confounders. RESULTS Of 6093 men, 1032 used statins at baseline (16.9%). They were older (63.3 vs. 62.7 years, P=0.001) but had similar baseline PV (P=0.55) vs. non-statin users. At 2-years, after adjusting for multiple confounders, prostate growth was less for statin users in both the placebo (3.9% decrease in PV growth, P=0.02) and the dutasteride arms (5.0% decrease in PV growth, P<0.001). However, after adjusting for multiple confounders, statin use was not associated with PV growth from the 2- to 4-year time in either the placebo (0.0% change PV growth, P=0.52) and dutasteride arms (0.0% change in PV growth, P=0.64). CONCLUSIONS In men with an elevated PSA and a negative prostate biopsy, statin use was associated with a modest reduction in PV growth, which occurs within 2-years with no further reductions over the next 2 years. The degree of PV growth reduction (∼4%) is consistent with our prior results that statins reduce PSA levels by 4.1% suggesting the declines in PSA in our prior study may be due to reductions in PV. Further prospective studies are needed to confirm these findings as well as to understand the mechanisms by which statins reduce PV. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e505 Peer Review Report Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Roberto Muller Durham, NC More articles by this author Leah Gerber Durham, NC More articles by this author Daniel Moreira New Hyde Park, NY More articles by this author Gerald Andriole Saint Louis, MO More articles by this author J. Kellogg Parsons San Diego, CA More articles by this author Neil Fleshner Toronto, Canada More articles by this author Stephen Freedland Durham, NC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.020 | 0.002 |
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".