Abstract
ObjectiveTo assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign prostatic hyperplasia (BPH).MethodsThis non-interventional retrospective cohort study used claims data from the Korea Health Insurance Review and Assessment-National Patient Sample database. Patients with BPH ≥ 40 years of age receiving combination therapy (dutasteride 0.5 mg and tamsulosin 0.4 mg daily) or dutasteride 0.5 mg, or tamsulosin 0.4 mg daily dose between 2012 and 2017 were included. The frequency, duration of treatment and risk of any adverse event (AE) or serious AE (SAE) was compared for combination therapy versus each monotherapy using non-inferiority testing.ResultsOf 14,755 eligible patients, 1529 (10.4%) received combination therapy, 6660 (45.1%) dutasteride monotherapy, and 6566 (44.5%) tamsulosin monotherapy. The proportion of patients treated with combination therapy exceeded the pre-specified 3% threshold for ‘frequent’ use. Safety results indicated a similar risk of any AE and SAE irrespective of treatment group. The adjusted relative risk for any AE over the treatment observation period comparing combination therapy with dutasteride monotherapy was 1.07 (95% confidence interval [CI] 1.03, 1.12), and with tamsulosin monotherapy was 0.98 (95% CI 0.95, 1.02) demonstrating non-inferiority. The adjusted relative risk for any SAE was 1.07 (95% CI 0.66, 1.74) and 0.90 (95% CI 0.56, 1.45), compared with dutasteride and tamsulosin monotherapy, respectively. Although the SAE results did not statistically demonstrate non-inferiority of combination therapy based on pre-specified margins, the 95% CI for the risk ratio estimates included the null with a lower limit below the non-inferiority margins, indicating no meaningful differences in SAE risk between groups. Absolute SAE risks were low.ConclusionCombination therapy with dutasteride and tamsulosin is frequently used in real-world practice in South Korea for treatment of BPH and demonstrates a safety profile similar to either monotherapy.
Highlights
Benign prostatic hyperplasia (BPH) is one of the most common non-malignant conditions in older men [1, 2]
Current data are limited for Southeast Asia, the overall incidence of BPH in South Korea was reported to be 2105 per 100,000 men based on data from patients diagnosed with BPH in 2008, using a nationwide South Korean database, Health Insurance Review and Assessment (HIRA) [5]
Patients treated with free combination therapy were more likely to have polyuria (13.9% vs 9.9%, standardized difference = 12.6%), a higher number of symptoms or findings associated with BPH (0.3% vs 0.2%, standardized difference = 11.0%), and BPH with lower urinary tract symptoms (LUTS) (17.9% vs 12.3%, standardized difference = 15.7%), than those treated with dutasteride 0.5 mg
Summary
Benign prostatic hyperplasia (BPH) is one of the most common non-malignant conditions in older men [1, 2]. A nationwide survey from the United States (US) reported BPH prevalence of 25% in men > 50 years of age [3]. In a population-based, cross-sectional survey conducted in the US, the United Kingdom (UK) and Sweden, symptoms suggestive of possible BPH were highly prevalent in men, reported in up to 46% of the population studied [4]. BPH prevalence increases with age, from 14.8% in men aged 40–49 years to 36.8% in those ≥ 80 years [1]. Current data are limited for Southeast Asia, the overall incidence of BPH in South Korea was reported to be 2105 per 100,000 men based on data from patients diagnosed with BPH in 2008, using a nationwide South Korean database, Health Insurance Review and Assessment (HIRA) [5]. The prevalence of BPH increased with age; the highest incidence was in patients ≥ 70 years of age
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