Propecia Causes No Statistically Significant Change in Sexual Function, Says 2004 Tosti Study

Propecia Causes No Statistically Significant Change in Sexual Function, Says 2004 Tosti Study

The central finding of a 2004 study led by Italian researcher Dr. Antonella Tosti, in which he and his team investigated sexual dysfunction in hair loss patients being treated for androgenetic alopecia, was that there was no statistically significant change in sexual function after four to six months of treatment with finasteride 1mg (Propecia).

The researchers used a questionnaire, called the abridged 5-item version of the International Index of Erectile Function (IIEF-5), to measure sexual function in the men in the study. The questionnaire, which is considered an internationally valid diagnostic tool for distinguishing between men with and without erectile dysfunction, asks the patients 15 questions on the topics of: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. By administering the questionnaire both before and after treatment with finasteride, the researchers were able to determine if sexual function was impaired by the treatment.

The result of this investigation in the sexual function of 186 patients was that, “the erectile function of all patients remained stable after 4 to 6 months of treatment with finasteride 1 mg.”

Interestingly, the research team found that sexual side effects were actually less common than reported in the clinical trials of the drug. They suggest that this difference was potentially due to the fact that subjects in the clinical trials were made aware of the potential for sexual side effects, and were asked about these side effects upon each visit, which led to higher reporting of side effects than what would otherwise be the case.

Reference:

Tosti A, Pazzaglia M, Soli M, Rossi A, Rebora A, Atzori L, Barbareschi M, Benci M, Voudouris S, Vena GA. Evaluation of Sexual Function With an International Index of Erectile Function in Subjects Taking Finasteride for Androgenetic Alopecia. Arch Dermatol. 2004;140:857-858.

Download the Tosti study of erectile function and finasteride

Posted by Robert M. Bernstein M.D.

10-Year Finasteride Study: First to Investigate Long-Term Effects and Safety

The 2011 study published by a research team led by Dr. Alfredo Rossi, is the first comprehensive investigation on long-term safety and efficacy of finasteride 1mg (Propecia).

In “Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up,” the Italian research team sought to fill a gap in our understanding of the long-term effects of treating hair loss with Propecia. The study tracked hair growth in 118 men between the ages of 20 and 61, with mild to moderate hair loss, who were treated with 1mg finasteride. These patients were evaluated before treatment and then again at 1, 2, 5, and 10 years on treatment.

The result of testing found not only that Propecia works and is safe for use, but there were some other interesting findings as well. Only 14% patients experienced a worsening of hair loss, while 86% benefited from the treatment over this extended time period and efficacy of the drug was found not to reduce over time for the majority of patients.

One of the most interesting findings is that patients who had hair growth in their first year of treatment are more likely than others to have better hair growth after 5 years. About half of patients experienced good hair growth in their first year, and about 53% of those patients went on to see improved growth over time. However, of the group with unchanged or worse results in their first year, only 25% saw improved hair growth after 5 years. After 10 years, almost 69% of patients who experienced growth in their first year experienced continued growth. Only 32% of those who saw unchanged or worse results after their first year had growth at 10 years.

The authors concluded that a patient’s response to finasteride in the first year is a pretty good indicator of how effective long-term treatment will be for the patient. The better growth he experiences in his first year, the more likely he will have continued growth beyond 5 years of treatment.

Among other findings, the age of a patient did have a statistically significant effect on the outcome, as patients older than 30 years had better hair growth in the long term. On the topic of side effects, 7 subjects (5.9%) experienced them, and some of those patients remained in the study because of what they perceived as the benefits of the treatment.

In conclusion, the authors found that Propecia is a safe and effective hair loss medication, even when used long-term. It is effective in patients older than 40 years and it is particularly beneficial for patients over 30 and who are in early stages of hair loss. Perhaps the most important finding is that a patient’s response to finasteride after the first year of treatment can be an indicator of the patient’s success with the drug in the long-term.

Reference:

Rossi A, Cantisani C, Scarnò M, Trucchia A, Fortuna MC, Calvieri S. Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up. Dermatol Ther 2011; Jul-Aug;24(4):455-61.

Download the Rossi study of finasteride long-term effects

Posted by Robert M. Bernstein M.D.

Sato Finasteride Study Points to Long-term Safety, Efficacy in Use of Propecia

Led by Dr. A. Sato, a Japanese team of medical researchers published the largest finasteride study ever performed, “Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia.” It investigated the effects of finasteride over a 3 1/2 year period in men with androgenetic alopecia, or common baldness.

The study found that patients who had experienced hair loss for an extended period of time and were treated with finasteride exhibited notable hair growth. While a fairly small proportion of patients with a hair loss duration over 10 years exhibited “greatly increased” growth, 85% of patients with hair loss duration of more than 15 years experienced “moderate” or “slightly increased” growth. Physicians have thought that people with advanced hair loss do not respond as well as patients in the early stages of hair loss. However, in light of the results of this study, that determination should be reconsidered.

Further, the same study found that the initial age of a hair loss patient at the time of commencing treatment has little to no effect on the outcome. While the efficacy studies that are included in the Propecia package insert were conducted in men 18 to 41 years old, men over 41 appear to respond as well as the younger group. Adverse reactions occurred in only 0.7% of the study population and the Sato study found no increase in adverse safety events over time.

In summary, the Sato study showed an increased response rate to finasteride 1mg with increasing duration of treatment. In addition, it is effective in a larger portion of the male population with androgenetic alopecia than previously thought.

Reference:

Sato A, Takeda A. Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia. J Dermatol 2012; 39: 27–32.

Download the Sato study on finasteride

Posted by Robert M. Bernstein M.D.

Will Propecia Work Better if Taken at Night or with Food?

Q: What time should I take the Propecia? Does it work better if I take it at night as opposed to the morning and should I take it with meals? — B.J., Garden City, N.Y.

A: It doesn’t matter what time of day you take Propecia and the time can very each day.

The absorption of Propecia (finasteride) is not affected by food, so it can be taken without regard to meals.

Posted by Robert M. Bernstein M.D.

Is Pulsing or Cycling Hair Loss Medication Dosage Effective?

Q: First off thank you for providing this Blog, it is extremely informative and gives people the opportunity to ask questions of one of the most knowledgeable hair transplant surgeons in the world. You are considered the consummate researcher in the field of hair loss, so I ask this question of you. It appears that all the current hair loss drugs, at one point or another, begin to lose their effectiveness. Have you ever entertained the idea of cycling these drugs, or reducing the dosage for a period of time, to prevent the body from becoming acclimated to these drugs and subsequently making adjustments to receptors causing this? This method is commonly used by bodybuilders and others in the sports profession to elicit the maximum effect from the drugs they employ. Though I have not found any studies along these lines, I believe there are valid reasons why this may work. I hope you may be able to share any information on this subject. — Z.Z., Chicago, I.L.

A: Excellent question. I can answer it only indirectly.

It has been our experience that when you discontinue finasteride (Propecia), or decrease the dose to a degree that it no longer works, the patient will begin to shed hair. When the drug is re-started or the dose increased again, the medications will begin working, but the patient now maintains his hair at a lower baseline. He doesn’t seem to regain the amount of hair he has before the medication was stopped. For this reason, we don’t stop and start finasteride. The same argument applies to dutasteride, although we have less experience with this medication. This experience would speak against using pulse therapy for hair loss.

On the other hand, the hair loss medications finasteride and dutasteride do not necessarily need to be used once a day. Although the serum half-life of finasteride is around 6 hours, the tissue half-life is felt to be around two days. Therefore, alternate day dosing with 2 mg of finasteride (or approx. 1/2 of a 5mg tablet) should work just as well as 1mg a day. An average daily dose of less than 1mg, however, does not seem to be as effective. Dutasteride has a half-life of 5 weeks and is found to bind to scalp tissue for many months, so with dutasteride, a dosing of even once a week will most likely be just as effective as once a day.

Note that this regular alternate day dosing is different than pulse dosing. In pulse therapy, the body is given a chance to recover. The principle here is to take advantage of the persistence of the drug in the scalp even after blood levels drop and not to let the scalp recover (which we have found to result in a net loss of hair (as discussed above).

When patients do become acclimated to these drugs (which seem to be common after 3 to 5 years) we increase the daily dose of finasteride gradually up to 5mg and then consider switching to dutasteride 0.5mg a day.

Posted by Robert M. Bernstein M.D.

When Can I Judge the Effectiveness of Treatment with Propecia?

Q: I was wondering why you chose two years as the amount of time one should wait to judge the effectiveness of Propecia. Have you had patients who only saw results after that long? Why does Merck say 3-6 months and Dr. Rassman at New Hair say 6-8 months? I know these numbers aren’t arbitrary, but I’m just wondering what the logic is behind this and how does this relate to planning a hair transplant? — I.P., Hempstead, Long Island, NY

A: The Merck data showed that over 90% of patients had peak response at 1 year and this has been my experience as well.

Most patients show the most dramatic response between 6 to 12 months with some getting additional benefit up to two years. Prior to 6 months, the results are quite variable and there may even be a net loss due to shedding during this period, as the Propecia (finasteride) stimulates a new anagen cycle.

If one is planning to go on Propecia before a hair transplant to minimize any shedding from the surgery and to prevent future hair loss, one should start the medication at least one month prior to the procedure.

If one wants to use Propecia for the purpose of possibly avoiding hair restoration surgery, then one needs to wait at least a year to see if there will be enough regrowth.

Finally, if one is younger (i.e. in the 23-25 age range) one should be on Propecia for at least two years to give it every possible chance of working and see its maximum benefit before considering a hair transplant.

Posted by Robert M. Bernstein M.D.

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Propecia Peak Response

Propecia Causes No Statistically Significant Change in Sexual Function, Says 2004 Tosti Study

10-Year Finasteride Study: First to Investigate Long-Term Effects and Safety

Sato Finasteride Study Points to Long-term Safety, Efficacy in Use of Propecia

Will Propecia Work Better if Taken at Night or with Food?

Is Pulsing or Cycling Hair Loss Medication Dosage Effective?

When Can I Judge the Effectiveness of Treatment with Propecia?

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