From the Guidelines
Asymptomatic enlarged prostate does not necessarily require treatment with tamsulosin and dutasteride (Duodart), and the decision to treat should be based on individual patient factors, including symptom severity, quality of life, and risk of progression. According to the AUA guideline on management of benign prostatic hyperplasia 1, 5 alpha-reductase inhibitors like dutasteride are appropriate and effective treatments for patients with lower urinary tract symptoms (LUTS) associated with demonstrable prostatic enlargement. However, for asymptomatic patients, the guideline suggests that 5 alpha-reductase inhibitors may be considered to prevent progression of the disease, but the potential disadvantages, such as side effects, should be weighed against the patient's baseline risk of progression.
- Key considerations in treatment decisions include:
- Symptom severity and impact on quality of life
- Prostate size and PSA levels
- Risk of progression to complications like urinary retention or need for surgery
- Potential side effects of medication, such as sexual dysfunction
- The AUA guideline also notes that finasteride, another 5 alpha-reductase inhibitor, can reduce the size of the prostate, increase peak urinary flow rate, and reduce BPH symptoms, but it is less effective than alpha blockers in improving LUTS 1.
- Regular monitoring with urological check-ups is essential to track any symptom development or prostate changes over time, allowing for timely intervention if necessary.
- In the absence of symptoms, the general approach is to monitor the condition rather than immediately starting medication therapy, unless there are specific concerns that warrant preventive treatment, as determined by the patient's healthcare provider.
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.
Treatment Indication: The FDA drug label indicates that dutasteride and tamsulosin are used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
- Key Point: There is no mention of treating asymptomatic BPH.
- Clinical Decision: Based on the available information, dutasteride and tamsulosin are not indicated for asymptomatic BPH, even if the prostate is enlarged 2, 2, 2.
From the Research
Enlarged Prostate Treatment
The treatment of an enlarged prostate with tamsulosin and dutasteride (Duodart) is typically considered for men with symptomatic benign prostatic hyperplasia (BPH) [(3,4,5)].
Asymptomatic Cases
However, the provided studies do not directly address the use of tamsulosin and dutasteride in asymptomatic cases. The studies focus on men with moderate to severe symptoms of BPH and prostate enlargement [(3,4,5,6)].
Combination Therapy
Combination therapy with dutasteride and tamsulosin has been shown to be effective in improving symptoms and reducing the risk of BPH progression in men with symptomatic BPH [(3,4,5,6)]. The benefits of combination therapy include:
- Improved lower urinary tract symptoms (LUTS) [(3,4,6)]
- Reduced risk of BPH progression [(3,4,5)]
- Improved health-related quality of life [(3,4)]
Key Findings
Key findings from the studies include:
- The CombAT trial demonstrated that combination therapy with dutasteride and tamsulosin improved LUTS and reduced the risk of BPH progression compared to monotherapy [(3,5,6)]
- The CONDUCT study showed that combination therapy with dutasteride and tamsulosin was more effective than watchful waiting with initiation of tamsulosin therapy if symptoms did not improve 4
- Tamsulosin has been shown to be effective in improving LUTS and is well-tolerated 7