From the Guidelines
Dutasteride is recommended for treating benign prostatic hyperplasia (BPH) at a standard dosage of 0.5 mg taken orally once daily, with or without food. This medication works by inhibiting both types of 5-alpha-reductase enzymes, which prevents the conversion of testosterone to dihydrotestosterone (DHT), thereby reducing prostate size and improving urinary symptoms 1. Patients should take dutasteride consistently at approximately the same time each day, and should expect that clinical benefits may take 3-6 months to become noticeable. The capsules should be swallowed whole and not crushed or opened, as contact with the contents can irritate mucous membranes. It's essential to note that dutasteride can affect PSA levels, reducing them by approximately 50% after 6-12 months of treatment, which should be considered when screening for prostate cancer 1.
Some key points to consider when prescribing dutasteride include:
- The medication is most effective in patients with enlarged prostates, with a minimum prostate volume of >30cc or PSA >1.5ng/mL necessary for a reliable response 1.
- Dutasteride reduces the risk of acute urinary retention and the need for BPH-related surgery, with the absolute benefit increasing with rising prostate volume or serum PSA 1.
- Common side effects may include decreased libido, erectile dysfunction, ejaculation disorders, and breast tenderness or enlargement 1.
- Pregnant women or those who may become pregnant should not handle dutasteride due to potential risks to male fetuses 1.
- Treatment is typically long-term, and stopping the medication may result in a return of symptoms as the prostate begins to enlarge again 1.
Overall, dutasteride is a effective treatment option for BPH, with a strong evidence base supporting its use 1.
From the FDA Drug Label
1 INDICATIONS AND USAGE
1.1 Monotherapy 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.
The recommended treatment and dosage for benign prostatic hyperplasia (BPH) using Dutasteride is 0.5 mg once daily.
- The primary 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
- Combination therapy with dutasteride and an alpha-adrenergic antagonist, such as tamsulosin, may be considered for the treatment of symptomatic BPH in men with an enlarged prostate 2.
- The effectiveness of dutasteride in reducing the risk of AUR and BPH-related surgical intervention, improving BPH-related symptoms, decreasing prostate volume, and increasing maximum urinary flow rates has been demonstrated in clinical trials 2.
From the Research
Recommended Treatment and Dosage for Benign Prostatic Hyperplasia (BPH) using Dutasteride
- The recommended dosage of dutasteride for the treatment of BPH is 0.5 mg once daily 3, 4, 5, 6.
- Dutasteride can be used as monotherapy or in combination with an α-blocker, such as tamsulosin, for the management of symptomatic BPH 4, 5, 6.
- Combination therapy with dutasteride and tamsulosin has been shown to result in significantly greater improvements in lower urinary tract symptoms (LUTS) and peak urinary flow rate (Qmax) compared to monotherapy with either agent 4, 5.
Efficacy and Safety of Dutasteride
- Dutasteride has been shown to be effective in improving urinary symptoms, reducing prostate volume, and improving Qmax in men with BPH 3, 4, 5, 6.
- Dutasteride is generally well-tolerated, but common adverse events include erectile dysfunction, decreased libido, and breast tenderness 3, 4, 5, 6.
- Long-term dutasteride therapy has been associated with increased blood glucose, glycated hemoglobin (HbA1c), total cholesterol, and low-density lipoprotein-cholesterol (LDL-C) levels, as well as worsened erectile dysfunction 7.
Considerations for Treatment
- A new prostate-specific antigen (PSA) baseline should be established after 6 months of therapy with dutasteride for clinical decision making 6.
- The relationship between dutasteride and high-grade prostate cancer is not clear, and dutasteride is not approved for prostate cancer chemoprevention 6.
- Physicians should discuss the potential adverse effects of long-term dutasteride therapy with their patients prior to instituting this form of treatment 7.