From the Guidelines
Dutasteride is primarily indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate, as it has been shown to reduce prostate size and improve urinary symptoms by inhibiting both type 1 and type 2 isoenzymes of 5-alpha-reductase 1.
Key Points
- The standard dose of dutasteride is 0.5 mg taken orally once daily with or without food.
- Improvement in symptoms typically begins within 3-6 months of continuous treatment, and the medication should be continued long-term for sustained benefit.
- Patients should be aware that dutasteride can affect PSA levels (reducing them by approximately 50%), which should be considered during prostate cancer screening 1.
- Common side effects include decreased libido, erectile dysfunction, ejaculation disorders, and breast tenderness or enlargement.
- The medication is contraindicated in women, especially those who are pregnant or may become pregnant, due to the risk of birth defects in male fetuses.
Mechanism of Action
Dutasteride works by inhibiting both type 1 and type 2 isoenzymes of 5-alpha-reductase, which prevents the conversion of testosterone to dihydrotestosterone (DHT), thereby reducing prostate size and improving urinary symptoms 1.
Clinical Evidence
The REDUCE trial showed that dutasteride reduced the risk of clinical progression of BPH, including a decrease in the incidence of acute urinary retention and the need for BPH-related surgery 1.
Important Considerations
When used for BPH, it is essential to consider the potential effects on PSA levels and to inform patients about the possible impact on prostate cancer screening 1.
Comparison with Other Treatments
Dutasteride has been compared to other treatments for BPH, including finasteride, and has been shown to have similar efficacy in reducing prostate size and improving urinary symptoms 2.
From the FDA Drug Label
Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery. Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
The indication for Dutasteride (generic name) is the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The main goals of treatment with dutasteride are to:
- Improve symptoms
- Reduce the risk of acute urinary retention (AUR)
- Reduce the risk of the need for BPH-related surgery. Dutasteride can be used as monotherapy or in combination with an alpha-adrenergic antagonist, such as tamsulosin 3, 4, 5.
From the Research
Indication for Dutasteride
The indication for dutasteride is for the treatment of moderate to severe symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate 6, 7, 8, 9.
Key Benefits
- Improves symptoms of BPH 6, 7, 8, 9
- Reduces the risk of acute urinary retention (AUR) 6, 7, 8
- Reduces the need for BPH-related surgery 6, 7, 8
- Decreases total prostate volume (TPV) 6
Patient Population
Dutasteride is approved for use in men with moderate to severe symptomatic BPH and an enlarged prostate 6, 7, 8, 9. It has also been investigated for its efficacy in reducing the risk of prostate cancer in at-risk men 6 and as a treatment to extend the time to progression in men with low-risk localized prostate cancer 6.
Combination Therapy
Dutasteride can be used in combination with an α-blocker, such as tamsulosin, for the management of symptomatic BPH 7, 9. This combination therapy has been shown to improve symptoms and reduce the risk of AUR and BPH-related surgery to a greater extent than either drug alone 7.
Safety and Tolerability
Dutasteride is generally well-tolerated, with common side effects including sexual dysfunction (reduced libido, impotence, and gynecomastia) 6, 8, 9. The overall adverse event profile for combination therapy with dutasteride and tamsulosin is consistent with those reported for both monotherapies 7.