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Dut5.4
Dutasteride – Forschung
Überwiegend Mechanismus / Beobachtung
7 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Dutasteride sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2006–2020 mit einer typischen Studiengröße von 4,844 Teilnehmenden.
Basierend auf 7 Studien · 3 Meta-Analysen · 4 RCTs · 12,142 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Hair loss & regrowth
Überwiegend Mechanismus / Beobachtung7 Studien
Men's vitalityVerkleinert die Prostata, verbessert den Harnfluss und die Symptome und senkt das Risiko für akuten Harnverhalt und BPH-Operationen · Monate
Überwiegend Mechanismus / Beobachtung4 Studien
Prostate & BPH
Überwiegend Mechanismus / Beobachtung3 Studien
Safety profile
Zu wenige bewertete Studien1 Studie
Ältere Forschungsbasis
Neueste Studie von 2020 · Neueste Meta-Analyse: 2020
200620132020
1RCTn=6,729 · very large study2010
Cancer was detected in 659 of 3305 men in the dutasteride group vs 858 of 3424 in the placebo group, a relative risk reduction of 22.8% over 4 years; during years 3 and 4 there were 12 Gleason 8–10 tumors in the dutasteride group vs 1 in the placebo group.
Andriole, Bostwick, Brawley, Gomella, Marberger, Montorsi · The New England journal of medicine (2010)
REDUCE: 4-year randomized double-blind placebo-controlled trial in 6729 men at increased prostate-cancer risk
Dutasteride cut overall biopsy-detected prostate cancer by ~23%
But a small excess of high-grade (Gleason 8–10) tumors in years 3–4 — the nuance that blocked a prevention indication
Dutasteride increased target area hair count versus placebo in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks.
Olsen, Hordinsky, Whiting, Stough, Hobbs, Ellis · Journal of the American Academy of Dermatology (2006)
Randomized placebo-controlled trial of 416 men comparing dutasteride doses, finasteride 5 mg, and placebo over 24 weeks
Scalp and serum DHT fell dose-dependently with dutasteride (dual type I + II inhibition)
3RCTn=153 · medium study2010
This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss.
Eun, Kwon, Yeon, Shin, Kim, Ro · Journal of the American Academy of Dermatology (2010)
Phase-III randomized double-blind placebo-controlled trial of 153 men over 6 months
Hair count rose +12.2/cm² with dutasteride 0.5 mg vs +4.7/cm² with placebo (P = .0319)
Superior to placebo on subject, investigator, and panel photographic assessment
Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe LUTS due to BPH and prostatic enlargement.
Roehrborn, Siami, Barkin, Damião, Major-Walker, Nandy · European urology (2010)
CombAT: 4-year multicenter randomized double-blind trial in 4844 men with symptomatic BPH and prostatic enlargement
Dutasteride (and combination with tamsulosin) reduced acute urinary retention and BPH-related surgery
Improved urinary symptoms, peak flow, and prostate volume over 4 years
Analysis results reiterate the efficacy and safety of 5α-reductase inhibitors for the treatment of AGA and may support the approval of dutasteride 0.5 mg as an additional treatment option.
Gupta, Charrette · Journal of dermatological treatment (2014)
Systematic review and network meta-analysis of finasteride and dutasteride RCTs for androgenetic alopecia
Active treatments were similarly effective on hair count and photographic assessment and not significantly different from placebo in eliciting sexual dysfunction
Supports dutasteride 0.5 mg as an effective AGA option
Seventeen randomized controlled trials with 17,494 patients were included; 5α-reductase inhibitors were associated with sexual dysfunction, erectile dysfunction, and decreased libido.
Liu, Zhao, Li, Li, Kang, Luo · The journal of sexual medicine (2016)
Systematic review and meta-analysis of 17 RCTs (17,494 patients) of 5α-reductase inhibitors for BPH and AGA, including 4 dutasteride trials
5ARIs increased sexual-dysfunction risk overall — but the association reached significance only in BPH patients; in men treated for hair loss (AGA) the estimates were not statistically significant (e.g. sexual dysfunction RR 1.21, 95% CI 0.85-1.72)
Quantifies the shared class sexual side-effect risk, while noting the hair-loss-specific signal is weaker and non-significant in the pooled AGA data