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AVODART: ADVERSE REACTIONS
Clinical trials experience
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 (Dutasteride) as monotherapy or in combination with tamsulosin:
The most common adverse reactions reported in subjects receiving Avodart were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (dutasteride with 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.
Study withdrawal due to adverse reactions occurred in 4% of subjects receiving Avodart, and 3% of subjects receiving placebo in placebo-controlled trials with this drug. The most common adverse reaction leading to study withdrawal was impotence (1%).
In the clinical trial evaluating the combination therapy, study withdrawal due to adverse reactions occurred in 6% of subjects receiving combination therapy (dutasteride with tamsulosin) and 4% of subjects receiving Avodart or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to study withdrawal was erectile dysfunction (1% to 1.5%).
Monotherapy: Over 4,300 male subjects with BPH were randomly assigned to receive 121 placebo or 0.5-mg daily doses of Avodart in three identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each followed by a 2-year open-label extension. During the double-blind treatment period, 2,167 male subjects were exposed to this mdeicine, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. When including the open-label extensions, 1,009 male subjects were exposed to Avodart for 3 years and 812 were exposed for 4 years. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90% were caucasian.
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 caucasian. 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 the medication (1.0%) compared with men on placebo (0.5%. In a 7-year placebo-controlled clinical trial with another 5-alpha-reductase inhibitor (Proscar, Finasteride 5 mg), 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.
Reproductive and breast disorders: In the 3 pivotal placebo-controlled BPH trials with Avodart (Dutasteride), each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.
The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.
Combination with alpha-blocker therapy (CombAT): Over 4,800 male subjects with BPH were randomly assigned to receive 0.5 mg Avodart, 0.4 mg tamsulosin, or combination therapy (0.5 mg Avodart (Dutasteride) with 0.4 mg tamsulosin) administered once daily in a 4-year double-blind study. Overall, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were caucasian.
Cardiac failure: In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: Avodart, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating the drug in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking Avodart was 0.6% (26/4,105) compared with 0.4% 187 (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both studies had co-morbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between dutasteride, alone or in combination with tamsulosin, and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either study.
The following adverse reactions have been identified during post-approval use of Avodart. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to the medicine.
Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema.
Neoplasms: Male breast cancer.
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