Baylor study, part 1 - Penile vascular abnormalities in young men with persistent side effects after finasteride use for the treatment of androgenic alopecia. 2020

Science PFS Research
#1

Penile vascular abnormalities in young men with persistent side effects after finasteride use for the treatment of androgenic alopecia

Mohit Khera et al, 2020

Background: The constellation of persistent sexual, neurological, and physical adverse effects in patients who discontinue 5α-reductase inhibitors (5ARIs) has garnered recent concern. The objective of this study was to evaluate potential penile vascular changes and persistent adverse effects of 5ARIs in men treated for androgenic alopecia (AGA).

Methods: This was a prospective case-control study with 25 subjects with a history of 5ARI use for AGA and 28 controls. Patient self-reported questionnaires including the International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), Patient Health Questionnaire-9 (PHQ-9), the Epworth Sleepiness Scale (ESS) and the Androgen Deficiency in the Aging Male (ADAM) were used. Penile duplex doppler ultrasound (PDDU) results were evaluated in men with a history of 5ARI use.

Results: A significant difference in total IIEF score between the 5ARI (median: 35; IQR: 29–43) and control group (median: 29; IQR: 27–32) (P=0.035) was observed. Seventeen 5ARI subjects (68%) had a vascular abnormality on PDDU. The median (IQR) for total IPSS score for the 5ARI group was 10 [5–16] compared to 3 [2–8] for the controls (P<0.01). The 5ARI group had a higher median total PHQ-9 score than controls [10 (6.5–16) vs. 1 (0–2) (P<0.001)]. Two subjects (8%) committed suicide during or after the study.

Conclusions: While the sexual side effects of 5ARIs are well known, there may be persistent genitourinary, physical, psycho-cognitive, anti-androgenic and penile vascular changes after 5ARI discontinuation. Use of 5ARIs for treatment of AGA may lead to persistent sexual, genitourinary, physical, psycho-cognitive, and anti-androgenic sequelae even after cessation of 5ARI therapy.

Keywords: Finasteride; penile duplex doppler; major depressive disorder; hypogonadism; erectile dysfunction (ED) Submitted Nov 25, 2019.

Accepted for publication Feb 25, 2020. doi: 10.21037/tau.2020.03.21
View this article at: http://dx.doi.org/10.21037/tau.2020.03.21

FULL TEXT: http://tau.amegroups.com/article/view/39898/29694

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I demand immediate transparency from the PFS-Foundation
Baylor study questions
Where is the Harvard Baylor study?
#2

Thanks for posting. This appears to be a more detailed write up of the previously noted presentation by Mirabal. This is clinical research from the patient cohort at Baylor college of medicine.

#3

Is this the Baylor study?

#4

It’s clinical findings from the cohort in that study, yes, but it’s not the gene expression data that will (hopefully) comprise a separate publication

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#5

I’m assuming that this is what we were told was accepted for publication a few weeks ago in that other post?

#6

Do we know for certain the Baylor study included a gene expression investigation or was that wishful thinking?

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#7

This is pretty much nothing new and mostly repeats what’s consensus (in previous studies/articles) anyway isn’t it?

#8

Yes, there is nothing new here with this study, but there is a professional acknowledgement of the problems.

Wow Just saw this in the results!
“Two subjects (8%) committed suicide during or after the study.”

#9

Yes. What their data is, what’s taken the time and whether they will publish it or not, I really don’t know.

There are a few worthwhile things in here. As usual patients are very different in severity and symptoms. Some in the study had minor problems, others described very severe impacts on their lives. This heterogeneity is likely why there was, averagely, little difference between the controls and PFS patients in erectile function scores per IIEF. As we know, symptom domains are not interdependent, and some patients do not have ED or worse. There were 2 suicides in the cohort.

There is a lot more attention paid to the physiological complaints in these patients:

“The musculoskeletal domain results we observed were in line with or more significant than those in other studies”.

They note a broad range of physiological problems reported. This is encouraging, as some recent publications and reviews have been extremely poor in accurately representing the clinical breadth of the syndrome and what patients are actually experiencing. Our survey design accounted for the symptoms described, so to be sure your symptoms are accurately recorded, make sure to take it if you have not.

This publication is also the second to report penile duplex doppler ultrasound results, which found abnormalities in a majority of patients:

In total, 17 of 25 (68%) of subjects in the 5ARI group had some vascular abnormality on penile Doppler ultrasound. Eight of twentyfour (32%) patients had arterial insufficiency [defined as peak systolic velocity <25 cm/sec (17)], while 5 of 25 (20%) patients fell into the “gray zone” of possible ED, defined as a peak systolic velocity between 25–35 cm/sec (17). Four of twenty-four (16%) patients had venous leak, defined as an end diastolic velocity >5 cm/sec (17).

An identified weakness is that they unfortunately did not have PDDU data from the control arm, but penile venous leak is an unambiguously significant finding. I know one of these cases was also one of the suicides.

The conclusion is clear enough:

The present study supports the conclusion that 5ARI use may predispose to persistent sexual, genitourinary, psychocognitive, and anti-androgenic changes even after 5ARI therapy is discontinued.

This is obviously not very enlightening in terms of basic pathomechanisms, but shows physiological penile abnormalities. It should serve to reinforce the case for research actually accounting for the broad and heterogeneous symptom profile.

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#10

Please, man, complete the survey.

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#11

All that Baylor drama was for this then? lol…

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#12

Surely we don’t know any final baylor study results yet but the thought that the next study may also take more than 5 years and not yield results of therapeutic significance is a bit scary. Anyway I agree with axo that it’s important that the recent paper here points out the variety and severity of symptoms.

#13

It can at least put to rest people saying that khera is being influenced by Merck. The study clearly says that 5arI patients had persistent side effects

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#14

I agree that it’s not completely useless, it could be a spark for future studies. It’s just that for all the waiting and drama, it doesn’t really change anything for us for the foreseeable future.

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#15

I was also Dxed with Vascular Leakage. Upon doing some research I found that silencing of AR could cause vascular leakage.

I’m glad this has been published. But its not the meat we are waiting for. The next publication can not take that long, it just can’t.

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#16

Absolutely. This really doesn’t bring anything new to the table, aside from further confirmation of the highly specific and regional physiological damage Finasteride can cause to Penola vascular function with a small subset like ourselves.

#17

Even though it was the expected outcome, I am still disappointed that the article presented neither the cure nor evidence that Khera is a Merck agent.

#18

You’re disappointed Khera isn’t on Team Merck? I’m a little confused.

Either way, I think the fact he published data showing Finasteride can cause penile damage shows that he is not an agent of Merck and working against us.

#19

LOL, it was just a joke.

In past Baylor threads, there were either people who were sure that Merck bought off Khera and everybody at Baylor or that this study was going to be a huge breakthrough. It is definitely a positive contribution, but not as exciting as either group thought.

Hopefully the second part of the study gets underway, but scientific studies always take longer than you expect/hope and we’re living in some pretty strange times.

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#20

I’m a fool, I should’ve read through the sarcasm… I hope the genetic component of the study comes along soon.

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