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AUA Dutasteride Presentation

AUA Conference
by

Michelle Sergi

on 19 November 2013

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Transcript of AUA Dutasteride Presentation

Experience with Non-Daily Use of Dutasteride
Richard Memo, MD, Michelle Sergi, Robert Ricchiuti, MD, Vincent Ricchiuti, MD, Daniel Ricchiuti, MD, and Mark Memo, DO
5 alpha reductase inhibitors
Used for LUTS
Dutasteride's half life is 5 1/2 weeks
Finasteride's half life is 6 hours
Both are approved for daily usage only by the FDA
Primary End Points
Take advantage of long half life of Dutasteride
Assess cost savings and effectiveness of non-daily usage
Comparison of patients without ARI treatment to daily and non-daily ARI
Study Design

Retrospective study
Selection from biopsy billing code (55700)
Continuous evaluation for 2 to 18 years
Study Period: January 1, 2009 through December 31, 2011
Study Design
Inclusion Criteria:
Patients naive to previous cytoreductive treatment before their first biopsy
Initially biopsy negative
LUTS needed treatment
Patient self selection one of three treatment options
Study Design
Patients Included
End Points for Participation:
Biopsy positive for cancer
Non-Compliance/ Inconsistent Follow-Up
Switched to another therapy
Summary
Experience with Non-Daily Dutasteride
Experience with Non-Daily Dutasteride
Experience with Non-Daily Dutasteride
Study Parameters Included in the Presentation
Age

Ethnicity

Dosage

PSA

Compliance
Biopsy Interval Rate

Cancer Rates

Gleason Score

Cost
Experience with Non-Daily Dutasteride
Mechanism of Dutasteride
Experience with Non-Daily Dutasteride
Experience with Non-Daily Dutasteride
Experience with Non-Daily Dutasteride
Experiene with Non-Daily Dutasteride
General Facts
Cytoreduction exposure prior to initial biopsy (66 patients)
Under 2 years/ Initially biopsy positive (126 patients)
Inconsistent follow-ups (318 patients)
Non-Compliance (21 patients)
Experience with Non-Daily Dutasteride
Dihydrotestosterone
Dutasteride + Type I & II 5aR
Testosterone + Type I & II 5aR
Included: 364/896 patients
Experience with Non-Daily Dutasteride
General Facts
Excluded: 532/896 patients
Daily: $1560.00
Three Times a Week: $619.20
Twice per Week: $416.00
Once a Week: $206.40
Experience with Non-Daily Dutasteride
Cost
(per year)
Age by
Treatment Group
Number of Biopsies by
Treatment Group
Cancer Incidence by
Treatment Group
Cancer Grade (Gleason Score) by
Treatment Group
Experience with Non-Daily Dutasteride
Experience with Non-Daily Dutasteride
Percentage of Cancer Incidence
Experience with Non-Daily Dutasteride
Summary
Non-Daily is more cost effective
PSA is lowered more with daily use
Number of biopsies per group were not different
Biopsy intervals in the non-daily group were twice as long as the daily group
Experience with Non-Daily Dutasteride
ANOVA F = 7.09
p = 0.001
Daily
n = 114
Non-Daily
n = 125
No Cytoreduction
n = 125
69 + 10
71 + 9
74 + 9
ANOVA F = 1.43
p = 0.240
Daily
n = 114
Non-Daily
n = 125
No Cytoreduction
n = 125
1.9 + 1.1
1.9 + 1.0
1.7 + 0.9
ANOVA F = 24.18
p < 0.001
49 + 28
94 + 68
61 + 51
ANOVA F = 9.70
p < 0.001
Daily
n = 93
Non-Daily
n = 115
No Cytoreduction
n = 120
-3.5 + 5.8
-1.8 + 2.5
-0.6 + 5.3
= 5.85
p = 0.828
No Cytoreduction
Non-Daily
Daily


No Cytoreduction
Daily
Non-Daily
=9.23
p = 0.010
Cancer incidence among the daily and no cytoreduction groups is at least twice that of non-daily treatment of patients
Although not statistically significant, incidence of higher grade tumors was greatest in daily and no cytoreduction patients
Experience with Non-Daily Dutasteride
Non-Daily Cancer and Gleason Scores
No Treatment (125 patients)
Daily Treatment (114 patients)
Non-Daily Treatment (125 patients)
Dutasteride = 47
Finasteride = 67
Dutasteride 3x/week = 36
Dutasteride 2x/week = 32
Dutasteride Weekly = 57
Ethnicity by
Treatment Group
Change in PSA by
Treatment Group
Group
Group
Group
Mean + St. Dev
Mean + St. Dev
Mean + St. Dev
Biopsy Interval in Months by
Treatment Group
Mean + St. Dev
Mean + St. Dev
Group
Gleason Score
by Percentage
No Cytoreduction
n = 125
Non-Daily
n = 125
Daily
n = 114
White: 120
Non-White: 5
White: 117
Non-White: 8
White: 105
Non-White: 9
ANOVA F = 18.51
p = 0.003
Gleason Score
Percentage of
Cancer Incidence
0.0
0.0
0.0
0.0
100.0
50.0
50.0
33.0
67.0
6
13
21
-
-
Full transcript