Prescribing Dutasteride in Males with Balding: Are there any criteria ? Should there be any criteria?

Prescribing Dutasteride in Males

The most effective medical treatments for male balding (at the time of this article being written) are oral finasteride and oral dutasteride. There is no debate about this particular comment. In the present day, as the world grapples with the meaning of “post finasteride syndrome”, dutasteride is increasingly a choice for many physicians where it never might have been a choice before. I see it - and I see more now than I did 2 years ago. I see dutasteride being used and 0.5 mg three times weekly. I see dutasteride used at 2.5 mg once weekly or twice weekly. I see dutasteride being used at 0.5 mg daily. I see dutasteride being used more often - and I too prescribe it more now than I did 10 years ago.

Dutasteride is not formally FDA approved for treating male balding but is still widely used. It’s used “off label” though and certainly has a large number of studies to back up its effectiveness. In some countries, dutasteride does have formal approval.

The public is also increasing asking about dutasteride - and increasingly requesting it. After all, we don’t have a great deal of data implicating dutasteride in the same set of issues that finasteride has. Furthermore, it’s more effective than finasteride. These two points lead many to turn to the drug. Some data suggests side effects like sexual dysfunction are greater with dutasteride than finasteride but certainly not all studies show this. Some in fact, show that side effects of dutasteride are similar to placebo.

We don’t yet fully understand everything behind post finasteride syndrome to even begin to dig into what might be called a post dutasteride syndrome or a general 5 alpha reductase syndrome. More studies are needed.

So, will you prescribe me dutasteride or not?

Many patients come in the clinic wanting to know if I’ll prescribe them dutasteride. Some have been on finasteride and haven’t found that it works - and they want dutasteride. Some don’t want to try finasteride at all - they want dutasteride. Some want both. Some know the dose they want.

it all comes down to understanding the medical evidence and the 20 years of science that comes before. There is not a “yes” or “no” answer to whether I will prescribe dutasteride. I don’t know when a patient walks in the door if these medications are right for them - but I do know before the patient walks out the door if these medications are right for them.

The following are the criteria I use in the clinic for determine if the patient is a candidate for dutasteride. These are my criteria and may not necessary be the guideline principles for everyone.

Top 10 Criteria for Prescribing Dutasteride (Donovan)

1. The patient understands the treatment is life-long if he wishes to maintain active medical treatment of his androgenetic alopecia.

2. The patient is aware of the array of possible side effects that have been reported with use of 5 alpha reductase inhibitors including mood changes, depression, anxiety, sexual dysfunction, enlargement of breast tissue (gynecomastia), penile shrinkage, loss of penile sensation, weight gain, muscle weakness and others. The potential effects of dutasteride on males wishing to father are not completely understood. The patient accepts the risk of these side effects if he chooses to use dutasteride.

3. The patient does not currently have severe depression or currently have severe anxiety that might otherwise present a contraindication to using dutasteride. The patient has not been suicidal in the past or been hospitalized for depression and mental illness within the past 5 years.

4. The patient is aware of reports that some patients have experienced persistent (long lasting) problems even when the drug has been stopped. These are mainly studied in the context of finasteride but should be assumed for now to be relevant to the use of dutasteride. The patient accepts the risk of these side effects if he chooses to use dutasteride.

5. The patient is aware that class action lawsuits have been launched regarding the persistent side effects related to finasteride use.

6. The patient is aware of alternatives for treatment including topical minoxidil, oral minoxidil, topical anti androgens (topical finasteride), low level laser, platelet rich plasma and hair transplantation.

7. The patient has no known issues currently related to male inferility or infertility in a female partner.

8. The patient understands the possibility of dutasteride causing a reduction in sperm count and the rare possibility that these reductions may be permanent or long lasting (even when the drug is stopped). The original dutasteride studies showed that after 6 months of stopping the drug, sperm counts had not returned to normal in all study participants and that the total sperm count in the dutasteride group remained 23% lower than baseline.

   Males who are concerned about the possibility of lower sperm count or fertility issues may consider having baseline semen analysis or baseline FSH, LH, Free T4 and testosterone measurements before starting. These lab tests may provide some guidance about baseline fertility. These issues in point 5 are relevant to males who may wish to father children in the future.

9. The patient does not wish to donate blood and understands that blood donation is not possible for at least 6 months after stopping the drug.

10. The patient understands that dutasteride may affect future prostate cancer screening by affecting the PSA value. These issues need to be discussed at the time of such screen and consideration might be given to baseline screening depending on the age of the patient when starting dutasteride.

Conclusion

I can’t say if a patient is a candidate for starting dutasteride when they walk in the office but after 20-30 minutes I can determine if they are likely to be a good candidate for the drug or not. The answers to the questions and issues above help guide the decision making that goes into figuring out if a patient is a candidate for dutasteride or not. It’s not something that can be ascertained in a matter of a few minutes.

References

Meeker JD, Godfrey-Bailey L, Hauser R. Relationships between serum hormone levels and semen quality among men from an infertility clinic. J Androl 2007;28:397–406.