The overall LUTS cohort included 462,400 men who met study inclusion and exclusion criteria. Age-standardized prevalence of LUTS was estimated to be 12.2% in men aged 40 years and older. Of these, 128,951 individuals were newly treated for LUTS during the study period and were included in the treatment patterns cohort, while 196,576 individuals had no pre-index diagnoses or treatments and were included in the New LUTS cohort. At index, the mean age was 61.3 years in the LUTS cohort and 58 and 59 years in the treatment patterns cohort and New LUTS cohort, respectively. Comorbidity burden was similar, with a mean Elixhauser score of 2.1 in the LUTS cohort and 2.0 in the treatment patterns and New LUTS cohorts.
Presence of BPH diagnostic codes was more common than OAB codes in the LUTS cohort (42.3% BPH only vs. 6.6% OAB only, with 19.2% having both). For OAB, diagnosis was found to be more common than OAB treatment (25.8% with any OAB diagnosis vs. 7.0% with any OAB treatment), while for BPH, treatment was more common than diagnosis (61.5% with any BPH diagnosis vs. 73.7% with any BPH treatment) (Table 1).
Within the treatment patterns cohort, over 39 months mean follow-up, 17,123 (13.3%) went on to receive two or more lines of therapy. The most common first-line treatments were BPH treatments, including alpha-blockers (76.7%) and tadalafil (16.1%), followed by OAB therapy with antimuscarinics (4.2%). Antimuscarinic therapies predominated OAB treatment across lines of therapy. Among the 13.3% who went on to receive second-line therapy, alpha-blockers continued to be the most frequently prescribed (26.0%) followed by antimuscarinics (20.7%) (Table 2).
Following first-line, 2.8% switched from BPH to OAB medication, while 1% switched from OAB to BPH medication; 0.4% had OAB and BPH in combination. Among those who received OAB-specific medication as first-line and for whom further lines of therapy were observed, the majority moved on to receive a BPH medication, and a small proportion moved on to OAB + BPH combination therapy. In addition, of the men who received OAB-specific medication as their first-line, the proportion either discontinuing (any treatment for LUTS) or moving onto BPH procedure was less for mirabegron compared to antimuscarinics. A higher proportion of men who received alpha-blockers as their first-line discontinued treatment for LUTS altogether (62.4%), compared to men who received either antimuscarinics (55.5%) or mirabegron (47.2%) as their first-line of therapy. Moreover, in the men who received alpha blockers as first-line, only 3.7% moved on to OAB-specific medication and only 0.7% moved on to a combination medical therapy for BPH and OAB, while 62.4% discontinued treatment for LUTS.
In the New LUTS cohort, among those untreated at index date, the median time to initiating treatment was 128 days (interquartile range 21-466 days). Similar to the treatment patterns cohort, the most common first-line treatment in this cohort was alpha-blocker monotherapy (76.9%), followed by tadalafil monotherapy (16.4%). Among patients in the New LUTS cohort initiating a first-line of therapy, 12.8% went on to receive a second-line of therapy, and 6.6% a third-line.