Comparing Clinical and Economic Outcomes Associated with Early Initiation of Combination Therapy of an Alpha Blocker and Dutasteride or Finasteride in Men with Benign Prostatic Hyperplasia in the United States.
BACKGROUND
Benign prostatic hyperplasia (BPH) is a common disease in men that is characterized by lower urinary tract symptoms. Pharmacologic treatment with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) is recommended to alleviate symptoms, prevent disease progression that can lead to complications, and reduce health care costs.


OBJECTIVE
To compare clinical, economic, and health care resource utilization outcomes among BPH patients treated with early continuous combination AB and 5ARI therapy (dutasteride vs. finasteride) using administrative claims data from the United States.


METHODS
A retrospective analysis of administrative claims data from 2003-2013 was conducted to compare outcomes between patients with claims for early combination therapy with dutasteride + AB and patients with claims for early finasteride + AB. The study population included males aged older than 50 years with at least 1 medical claim with a diagnosis of BPH and pharmacy dispensing for AB and 5ARI therapies. Outcomes included acute urinary retention (AUR), prostate-related surgery, clinical progression, medical and pharmacy costs, and health care resource utilization. Inverse probability of treatment (IPT) weighted Cox proportional hazards, linear, and Poisson regression models were used to assess the association between outcomes and early combination therapy as appropriate.


RESULTS
A total of 2,778 patients were included in the early finasteride + AB treatment cohort, and 4,125 patients were included in the early dutasteride + AB cohort. Dutasteride users were younger than finasteride users (mean age: 64.8 vs. 67.5 years, P < 0.001) and had a greater mean number of urologist visits (10.7 vs. 7.9, P < 0.001) during baseline. After adjusting for confounding using IPT weighting, no statistically significant difference was observed between dutasteride and finasteride for AUR (hazard ratio [HR] = 0.845, 95% CI = 0.660-1.070, P = 0.1643), prostate-related surgery (HR = 0.806, 95% CI = 0.568-1.171, P = 0.2525), and clinical progression (HR = 0.834, 95% CI = 0.663-1.043, P = 0.1122). While dutasteride was associated with higher pharmacy costs per month (adjusted monthly cost difference = $79, 95% CI = $45-$105), total all-cause medical costs were not significantly different between the 2 cohorts (adjusted monthly cost difference = -$44, 95% CI = -$110-$22).


CONCLUSIONS
Clinical and economic outcomes were similar between the early dutasteride + AB and early finasteride + AB cohorts, with no statistically significant differences detected.


BACKGROUND
Funding for this study was provided by GlaxoSmithKline (HO-14-15325 and AVO110072). Bell and Swensen are employees of GlaxoSmithKline. DerSarkissian, Xiao, Duh, and Lefebvre are employed by Analysis Group, a consulting company that received research grants from GlaxoSmithKline to conduct this study. Study concept and design were contributed by Bell, Swensen, Lefebvre, and Duh. Bell and Duh acquired the data. DerSarkissian and Xiao performed the statistical analysis and interpreted the data along with Lefebvre, Duh, and Bell. DerSarkissian and Bell drafted the manuscript. All authors contributed equally to critically revising the manuscript and providing final approval of the submitted manuscript.
1 Analysis Group, Los Angeles, California.
Maral
M
DerSarkissian
2 Groupe d'analyse, Ltée, Montréal, Québec, Canada.
Yongling
Y
Xiao
3 Analysis Group, Boston, Massachusetts.
Mei Sheng
MS
Duh
2 Groupe d'analyse, Ltée, Montréal, Québec, Canada.
Patrick
P
Lefebvre
4 GlaxoSmithKline, Research Triangle Park, North Carolina.
Andrine R
AR
Swensen
4 GlaxoSmithKline, Research Triangle Park, North Carolina.
Christopher F
CF
Bell
D058891:5-alpha Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D000317:Adrenergic alpha-Antagonists / Q000191:economics* / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D018450:Disease Progression; D000068538:Dutasteride / Q000191:economics* / Q000627:therapeutic use*; D018120:Finasteride / Q000191:economics* / Q000627:therapeutic use*; D017048:Health Care Costs; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000191:economics*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States; D016055:Urinary Retention / Q000191:economics / Q000209:etiology / Q000628:therapy
D058891:5-alpha Reductase Inhibitors; D000317:Adrenergic alpha-Antagonists; D018120:Finasteride; D000068538:Dutasteride
BJU Int. 2007 Aug;100(2):249-53
17617135
Am J Manag Care. 2007 Feb;13 Suppl 1:S10-6
17295600
Curr Med Res Opin. 2009 Nov;25(11):2663-9
19757985
Am J Manag Care. 2008 May;14(5 Suppl 2):S167-71
18611091
Urology. 2003 Feb;61(2):267-73
12597928
Urology. 2013 Dec;82(6):1386-92
24269224
Rev Urol. 2005 Fall;7(4):203-10
16985831
J Urol. 2005 Apr;173(4):1256-61
15758764
Clin Ther. 2013 May;35(5):624-33
23583026
Am J Manag Care. 2008 May;14(5 Suppl 2):S154-9
18611089
Prostate Suppl. 2000;9:4-14
11056496
Int J Impot Res. 2008 Dec;20 Suppl 3:S33-43
19002123
BJU Int. 2015 Sep;116(3):450-9
25565364
Drugs Aging. 2012 Apr 1;29(4):275-84
22428659
Eur Urol. 2015 Sep;68(3):418-25
25465970
Arch Ital Urol Androl. 2013 Dec 31;85(4):200-6
24399122
Curr Opin Urol. 2005 Jan;15(1):35-8
15586028
Urology. 2001 Dec;58(6 Suppl 1):5-16; discussion 16
11750242
BJU Int. 2014 Apr;113(4):623-35
24127818
J Urol. 2003 Aug;170(2 Pt 1):530-47
12853821
Am J Geriatr Pharmacother. 2005 Jun;3(2):103-14
16129387
J Urol. 2008 Feb;179(2):616-21; discussion 621
18082216
Korean J Urol. 2014 Jan;55(1):52-6
24466398
J Chronic Dis. 1987;40(5):373-83
3558716
Am J Manag Care. 2008 May;14(5 Suppl 2):S148-53
18611088
Med Care. 2005 Nov;43(11):1130-9
16224307
N Engl J Med. 2003 Dec 18;349(25):2387-98
14681504
Urology. 2002 Feb;59(2 Suppl 1):1-2
11832306
Eur Urol. 2010 Jan;57(1):123-31
19825505
N Engl J Med. 1998 Feb 26;338(9):557-63
9475762
P T. 2011 Aug;36(8):493-507
21935297
BJU Int. 2011 Mar;107(6):946-54
21332630
Epidemiology. 2000 Sep;11(5):550-60
10955408
Urol Clin North Am. 2009 Nov;36(4):443-59, v-vi
19942044
Prostate. 1992;21(4):297-307
1281322
Ann Pharmacother. 2014 Mar;48(3):343-8
24311727
Am J Manag Care. 2007 Feb;13 Suppl 1:S23-8
17295602
BJU Int. 2008 Sep;102(8):981-6
18549433
Int J Clin Pract. 2008 Jul;62(7):1076-86
18479366
BJU Int. 2011 Aug;108(3):388-94
21631695
Urology. 2009 Apr;73(4):802-6
19193422