Finasteride Switching Protocols: How to Transition From or To Other Drugs in Class

At a glance

  • Switch evidence / EPICS included an optional dutasteride phase after 48 weeks [1]
  • Finasteride 1 mg dosing / One tablet once daily, with or without food [2]
  • Serum DHT on finasteride 1 mg / About 65% suppression within 24 hours [2]
  • Serum DHT on dutasteride 0.5 mg / 94.7% vs 70.8% with finasteride 5 mg at 24 weeks [3]
  • PSA on finasteride 1 mg / Mean 0.7 to 0.5 ng/mL at month 12, men 18 to 41 [2]
  • Sexual adverse events, year 1 / 3.8% vs 2.1% on placebo (p=0.04) [2]
  • Finasteride plus topical minoxidil / 94.1% improved at 12 months vs 80.5% on finasteride alone and 59% on minoxidil alone [4]

What makes a finasteride switch different from other drug swaps

Finasteride and dutasteride act on the same enzyme, 5-alpha reductase, which converts testosterone to dihydrotestosterone. Finasteride is a competitive inhibitor of the type II isozyme with roughly 100-fold selectivity over type I; type II accounts for about two-thirds of circulating DHT and type I for about one-third [2]. Dutasteride inhibits both isozymes [3].

The difference in depth of DHT suppression between the two drugs is measurable. In a 24-week randomized trial of 399 men with benign prostatic hyperplasia, dutasteride 0.5 mg lowered serum DHT by 94.7% and finasteride 5 mg by 70.8%, with wider variation on finasteride [3]. At the scalp, a 42-day biopsy study of 249 men with androgenetic alopecia found scalp DHT fell 64.1% on finasteride 1 mg and serum DHT fell 71.4% [5].

Is there a protocol for switching from finasteride to dutasteride?

In the EPICS trial, men randomized to finasteride 5 mg or dutasteride 0.5 mg for 48 weeks could then enter an optional 24-month open-label phase in which all received dutasteride 0.5 mg once daily [1]. The trial also compared the two drugs when each was taken continuously [1].

For hair, a network meta-analysis of 23 studies found dutasteride 0.5 mg daily produced the greatest 24-week increase in total hair count and beat finasteride 1 mg daily by a mean difference of 7.1 hairs per cm2 (95% CI 5.1 to 9.3) [6]. A direct randomized comparison of 416 men aged 21 to 45 assigned dutasteride at 0.05, 0.1, 0.5 or 2.5 mg, finasteride 5 mg, or placebo for 24 weeks; dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks [7]. The 416-man trial compared dutasteride doses with finasteride 5 mg, which is five times the 1 mg Propecia dose [7][2].

For BPH, the EPICS trial randomized 813 men to dutasteride 0.5 mg and 817 to finasteride 5 mg for 12 months and found no significant difference between them in prostate volume reduction, AUA symptom index scores or maximum urinary flow, with a similar percentage of adverse events [1].

The labels also cover PSA interpretation on finasteride. The Proscar label states that finasteride lowers PSA by approximately 50% within six months, that a new PSA baseline should be established at least six months after starting, and that an isolated PSA in a man treated six months or more should be doubled for comparison with normal ranges [8]. The Propecia label reports mean PSA falling from 0.7 to 0.5 ng/mL at month 12 in men aged 18 to 41, and states that any confirmed increase from the lowest value on treatment should be evaluated even if the number is still in the normal range [2].

Is there a protocol for switching from dutasteride to finasteride?

We found no label or trial that gives one. What is documented is finasteride's own behavior: mean terminal half-life about 5 to 6 hours in men aged 18 to 60 and about 8 hours in men over 70, while the type II enzyme complex turns over slowly, with a half-life of roughly 30 days, so the effect on DHT outlasts the drug's time in blood [2].

On tolerability, a meta-analysis of 15 randomized placebo-controlled trials in 4,495 men with androgenetic alopecia found a 1.57-fold relative risk of sexual dysfunction with 5-alpha reductase inhibitors (95% CI 1.19 to 2.08); for finasteride 1 mg alone the relative risk was 1.66 (1.20 to 2.30) and for dutasteride 0.5 mg it was 1.37 (0.81 to 2.32), which did not reach statistical significance [9].

What happens when finasteride is stopped?

The Propecia label is direct: continued use is recommended to sustain benefit, and withdrawal of treatment leads to reversal of effect within 12 months [2]. In the three 12-month controlled trials in men aged 18 to 41 (945 on finasteride, 934 on placebo), drug-related decreased libido occurred in 1.8% versus 1.3%, erectile dysfunction in 1.3% versus 0.7% and ejaculation disorder in 1.2% versus 0.7%; 3.8% versus 2.1% reported one or more of these (p=0.04), 1.2% versus 0.9% discontinued for them, and resolution occurred in men who stopped and in most who continued [2]. The postmarketing section also lists sexual dysfunction that continued after discontinuation, described as voluntary reports of uncertain frequency [2]. Safety reporting in this literature has been criticized: a review of 34 finasteride trials for hair loss found none had adequate safety reporting [10].

For anyone staying on treatment, the label for finasteride 1 mg describes one tablet once daily, with or without food [2].

Should the switch be to minoxidil instead?

One 12-month randomized trial of 450 Chinese men with male pattern hair loss reported improvement in 80.5% of those on finasteride, 59% on 5% topical minoxidil and 94.1% on the two together; adverse reactions were reported in 1.8% of the finasteride group and 6.1% of the minoxidil group [4]. A separate meta-analysis of randomized trials found 1 mg finasteride and topical minoxidil each superior to placebo for hair outcomes in men [11].

Is there a topical or injectable finasteride to switch to?

No. Drugs@FDA lists only oral finasteride tablets, and no topical or injectable finasteride is FDA-approved [12].

Frequently asked questions

Can you switch from finasteride to dutasteride without a break?
We found no label or trial that specifies a break or washout. In the EPICS trial, men assigned finasteride could enter an optional open-label phase on dutasteride after 48 weeks [1]. The Propecia label gives a plasma half-life of about 5 to 6 hours and notes that the type II enzyme complex turns over in about 30 days, so the DHT effect outlasts the drug's time in blood [2].
Is dutasteride stronger than finasteride for hair loss?
In a network meta-analysis of 23 studies, dutasteride 0.5 mg daily produced a greater 24-week increase in total hair count than finasteride 1 mg daily, by a mean difference of 7.1 hairs per cm2 (95% CI 5.1 to 9.3) [6]. In a 416-man 24-week trial, dutasteride 2.5 mg was superior to finasteride 5 mg at 12 and 24 weeks [7].
Will hair loss return if finasteride is stopped?
The Propecia label states that withdrawal of treatment leads to reversal of effect within 12 months and that continued use is recommended to sustain benefit [2].
Can finasteride and minoxidil be used together during a change of treatment?
In a 12-month trial of 450 men, improvement was reported in 94.1% of those on finasteride plus topical minoxidil, compared with 80.5% on finasteride and 59% on minoxidil alone [4].
How does finasteride affect PSA results?
The Proscar label describes a fall of about 50% within six months and says a new PSA baseline should be established at least six months after starting [8]. With Propecia 1 mg, mean PSA fell from 0.7 to 0.5 ng/mL by month 12, and any confirmed rise from the lowest value on treatment should be evaluated [2].

References

  1. Nickel JC, Gilling P, Tammela TL, Morrill B, Wilson TH, Rittmaster RS. Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS). BJU Int. 2011;108(3):388-94. Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS)
  2. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  3. Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab. 2004;89(5):2179-84. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor
  4. Hu R, Xu F, Sheng Y, Qi S, Han Y, Miao Y, et al. Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients. Dermatol Ther. 2015;28(5):303-8. Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients
  5. Drake L, Hordinsky M, Fiedler V, Swinehart J, Unger WP, Cotterill PC, et al. The effects of finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia. J Am Acad Dermatol. 1999;41(4):550-4. The effects of finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia
  6. Gupta AK, Venkataraman M, Talukder M, Bamimore MA. Relative Efficacy of Minoxidil and the 5-α Reductase Inhibitors in Androgenetic Alopecia Treatment of Male Patients: A Network Meta-analysis. JAMA Dermatol. 2022;158(3):266-274. Relative Efficacy of Minoxidil and the 5-α Reductase Inhibitors in Androgenetic Alopecia Treatment of Male Patients: A Network Meta-analysis
  7. Olsen EA, Hordinsky M, Whiting D, Stough D, Hobbs S, Ellis ML, et al. The importance of dual 5alpha-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride. J Am Acad Dermatol. 2006;55(6):1014-23. The importance of dual 5alpha-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride
  8. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  9. Lee S, Lee YB, Choe SJ, Lee WS. Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta-analysis. Acta Derm Venereol. 2019;99(1):12-17. Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta-analysis
  10. Belknap SM, Aslam I, Kiguradze T, Temps WH, Yarnold PR, Cashy J, et al. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis. JAMA Dermatol. 2015;151(6):600-6. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis
  11. Adil A, Godwin M. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. J Am Acad Dermatol. 2017;77(1):136-141.e5. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis
  12. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
Evidence overview for finasteride: Finasteride Switching Protocols: How to Transition From or To Other Drugs in Class