In Clinical Trials:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.
From clinical trials with AVODART® as monotherapy or in combination with tamsulosin:
- The most common adverse reactions reported in subjects receiving AVODART® were
- decreased libido
- breast disorders (including breast enlargement and tenderness)
- and ejaculation disorders.
- The most common adverse reactions reported in subjects receiving combination therapy (AVODART® plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving AVODART® (2%) or tamsulosin (4%) as monotherapy.
- Trial withdrawal due to adverse reactions occurred in 4% of subjects receiving AVODART®, and 3% of subjects receiving placebo in placebo-controlled trials with AVODART®. The most common adverse reaction leading to trial withdrawal was impotence (1%).
- In the clinical trial evaluating the combination therapy, trial withdrawal due to adverse reactions occurred in 6% of subjects receiving combination therapy (AVODART® plus tamsulosin) and 4% of subjects receiving AVODART® or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).
Long-term Treatment (Up to 4 Years):
High-grade Prostate Cancer: The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Subjects were randomized to receive placebo (n = 4,126) or 0.5-mg daily doses of AVODART® (n = 4,105) for up to 4 years. The mean age was 63 years and 91% were white. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. There was a higher incidence of Gleason score 8-10 prostate cancer in men receiving AVODART® (1.0%) compared with men on placebo (0.5%) [see Indications and Usage (1.3), Warnings and Precautions (5.2)]. In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).
No clinical benefit has been demonstrated in patients with prostate cancer treated with AVODART®.