What are the indications for Avodart (Dutasteride)?

From the Guidelines

Avodart (dutasteride) is primarily indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate, as evidenced by a prostate volume of >30cc or PSA >1.5ng/mL, to reduce symptoms and improve quality of life. The standard dosage is 0.5 mg taken orally once daily, with or without food. Avodart works by inhibiting the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), the hormone primarily responsible for prostate enlargement. By reducing DHT levels, Avodart decreases prostate size and improves urinary flow, as shown in studies such as the Combination of Avodart and Tamsulosin (CombAT) trial 1. It typically takes 3-6 months to achieve maximum benefit. Avodart is also sometimes used off-label for male pattern baldness, though this is not an FDA-approved indication. Important considerations include that it should not be handled by pregnant women due to potential risks to male fetuses, may affect PSA test results (important for prostate cancer screening), and can cause side effects including decreased libido, erectile dysfunction, and ejaculation disorders, as noted in the 2021 AUA guideline on management of lower urinary tract symptoms attributed to benign prostatic hyperplasia 1. Patients should continue taking Avodart even after symptom improvement to maintain benefits, as the medication has been shown to reduce the risk of acute urinary retention and the need for BPH-related surgery, as demonstrated in the REDUCE trial 1.

Some key points to consider when prescribing Avodart include:

• The patient's prostate volume and PSA level, as these factors can influence the effectiveness of the medication 1
• The potential for side effects, such as decreased libido and erectile dysfunction, and the importance of discussing these with the patient 1
• The need for ongoing treatment to maintain benefits, as the medication's effects may diminish if stopped 1
• The importance of monitoring PSA levels and adjusting the interpretation of results accordingly, as Avodart can affect PSA test results 1

Overall, Avodart is a effective treatment option for men with BPH and an enlarged prostate, and can help to improve symptoms and quality of life, as supported by the highest quality evidence available, including the 2021 AUA guideline 1.

From the FDA Drug Label

Dutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. The indications for Avodart (dutasteride) are:

• Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
  • Improve symptoms
  • Reduce the risk of acute urinary retention
  • Reduce the risk of the need for BPH-related surgery
• Treatment of symptomatic BPH in men with an enlarged prostate in combination with the alpha-adrenergic antagonist, tamsulosin 2, 2, 2

From the Research

Avodart Indications

• Avodart, also known as dutasteride, is a medication used to treat moderate to severe symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate 3.
• The medication works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate growth 3.
• Dutasteride is also being investigated for its potential to reduce the risk of prostate cancer in at-risk men and to extend the time to progression in men with low-risk localized prostate cancer 3.

Treatment of BPH

• Dutasteride has been shown to improve urinary symptoms, decrease total prostate volume, and reduce the risk of acute urinary retention (AUR) and BPH-related surgery in men with moderate to severe symptoms of BPH and prostate enlargement 3, 4.
• The combination of dutasteride and tamsulosin has been found to be superior to either drug as monotherapy in improving BPH-related symptoms, peak urinary flow, and BPH-related health status 3, 4.
• Studies have also compared the efficacy and safety of dutasteride with finasteride, another 5-alpha reductase inhibitor, and found that dutasteride is better than finasteride in improving the maximum urinary flow rate (Qmax) of patients with BPH 5, 6.

Reduction of Prostate Cancer Risk

• Dutasteride has been found to reduce the relative risk of prostate cancer diagnosis in men with BPH undergoing annual digital rectal examination (DRE) and prostate-specific antigen (PSA) screening 7.
• The medication has also been shown to reduce the likelihood of biopsy and to have a higher diagnostic yield of prostate cancer on biopsy 7.