Dutasteride Side Effects - Surprisingly Low
Article by HairlossTalk.com
June 25, 2004
According to a new major study for Benign Prostatic Hyperplasia, the incidence of side effects with Dutasteride was surprisingly low. See all the side effects and their prevalance in this article...
I got that dutasteride for BPH study last night (the first and so far, the ONLY
published study using dutasteride in humans), and it's interesting to see that
the reported incidence of side-effects of ALL kinds from using the standard 0.5
mg dose of dutasteride for a full 2 years is quite nominal.
Once again, I'm talking about: "Efficacy and Safety of a Dual Inhibitor
of 5-Alpha-Reductase Types 1 and 2 (Dutasteride) In Men With Benign Prostatic
Hyperplasia", Roehrborn et al, Urology 60:434-441, 2002.
Here's all their text comments about side effects, followed by a table at the
end which shows all the data...
Tolerability
Dutasteride was well tolerated. Overall, 75% of the placebo-treated versus 77%
of the dutasteride-treated patients experienced an adverse event (AE) in the
course of the 24-month study. The most common AEs were ear-nose-throat infections,
musculoskeletal pain, and upper respiratory infections.
Drug-related AEs were seen in 14% and 19% of placebo-treated and dutasteride-treated
patients, respectively, with sexually related AEs the most common in both groups.
Impotence, reduced libido, ejaculation disorders, and gynecomastia occurred
more frequently in dutasteride-treated patients (Table III).
Additionally, the diagnosed prostate cancer incidence was 42 (1.9%) of 2158
for the placebo group and 24 (1.1%) of 2167 for the dutasteride group during
the 24 months.
[...]
The majority of AEs reported in the present study were not drug related in the
judgement of the investigators. Of those considered to be related to the drug,
sexually related AEs were the most common.
More patients exposed to dutasteride than placebo experienced impotence, decreased
libido, ejaculation disorders, and gynecomastia in the course of the 24-month
study. However, most of these effects were transient, and the incidence of new
occurrences of each event decreased in the second year.
Additionally, discontinuation because of AEs was rare. These results compare
favorably with the AE profile of the existing type II 5-alpha-reductase inhibitor,
demonstrating that the more pronounced reduction in DHT by the dual inhibitor
of 5ARI does not lead to an increase in the number or severity of AEs.
TABLE III
Drug-related adverse events
| Study
Period |
Sexual
Adverse Event |
Placebo |
Dutasteride |
| |
|
|
|
| Entire study |
Impotence |
86 (4.0) |
158 (7.3)
|
| |
Decreased
libido |
46 (2.1) |
91 (4.2) |
| |
Gynecomastia |
16 (0.7) |
50 (2.3) |
| |
Ejaculation
disorder |
17 (0.8) |
48 (2.2) |
| |
|
|
|
| 0-1 yr |
Impotence |
65 (3.0) |
130 (6.0) |
| |
Decreased
libido |
41 (1.9) |
80 (3.7) |
| |
Gynecomastia |
11 (0.5) |
28 (1.3) |
| |
Ejaculation
disorder |
15 (0.7) |
40 (1.8) |
| |
|
|
|
| 1-2 yr |
Impotence |
21 (1.2) |
29 (1.7) |
| |
Decreased
libido |
6 (0.3) |
11 (0.6) |
| |
Gynecomastia |
5 (0.3) |
23 (1.3) |
| |
Ejaculation
disorder |
2 (0.1) |
9 (0.5) |
(Data presented as the number of patients, with the percentage in parentheses)
HLT
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