P166 Real-world efficacy and tolerability of oral dutasteride combined with oral minoxidil for male androgenetic alopecia: a retrospective cohort study

Abstract

Androgenetic alopecia (AGA) affects 80% of men, yet evidence for the efficacy of oral dutasteride combination therapy remains limited, and real-world tolerability data for dutasteride–minoxidil combinations are lacking. The aim of this study was to evaluate the efficacy and tolerability of combined oral dutasteride–­minoxidil in men with AGA and to characterize response predictors including initial shedding. This was a retrospective, single-arm cohort study of 621 men receiving oral dutasteride (0.5 mg) and minoxidil (2.5 mg) as a combined once-daily capsule via a digital health provider. Three blinded clinicians independently graded standardized photographs using the seven-point Global Photographic Assessment (GPA, −3 to +3) and the Hamilton–Norwood staging (HNS, 1–7) at baseline and monthly for up to 12 months. Inter-rater reliability was assessed using intraclass correlation coefficients (ICCs). Mixed-effects models were used to examine change over time, with Cox regression and Kaplan–Meier analysis for time to response. Among 621 patients (mean age 34.2 years, SD 9.5), 1850 photoassessments were analysed over 12 months. Inter-rater reliability was moderate for GPA scores (ICC 0.36–0.53) and good to excellent for HNS (ICC 0.87–0.92). Responder rates increased progressively: 16.4% (month 1), 45.8% (month 3), 61.5% (month 6) and 71.4% (month 9), with significant improvement over the follow-up period [β = 0.08 GPA points per month, 95% confidence interval (CI) 0.07–0.09; P < 0.001]. Hair loss stabilization (stable or improved hair density) was achieved in 95.8% of patients at month 3, rising to 98.5% by month 6. Patients with severe baseline hair loss (HNS 5–7) showed superior response rates to mild cases (49.6% vs. 22.7%; HR 3.80, 95% CI 1.81–7.96; P < 0.001). Initial shedding occurred in 10.5% at 3 months and was associated with reduced likelihood of improvement (23.5% vs. 42.5%; OR 2.39, 95% CI 1.20–5.14; P = 0.01). Adverse effects were uncommon, with a minority reporting low mood (6.3%) or decreased libido (4.2%). In men with AGA, real-world oral dutasteride–minoxidil was well tolerated and associated with near-universal stabilization by month 6 and progressive improvement, including 71.4% responders by month 9.