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ADVERSE EFFECTS OF ALFUSIN-D
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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The incidence of treatment-emergent adverse events has been ascertained from three placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin hydrochloride were evaluated. In these 3 trials, 473 men received alfuzosin Hydrochloride 10 mg extended-release tablets. In these trials, 4% of patients taking Alfuzosin HCl 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group.
The other adverse reactions, reported by between 1% and 2% of patients receiving alfuzosin hydrochloride and occurring more frequently than with placebo are listed alphabetically by body system and by decreasing frequency within body system:
Body as a whole: pain
Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea
Reproductive system: impotence
Respiratory system: bronchitis, sinusitis, pharyngitis
Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (<= 90 mmHg, with a decrease >= 20 mmHg from baseline) was observed in none of the 674 placebo patients and in 1 (0.2%) of the 469 alfuzosin hydrochloride patients. Decreased diastolic blood pressure (<= 50 mmHg, with a decrease >= 15 mmHg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the alfuzosin hydrochloride patients. A positive orthostatic test (decrease in systolic blood pressure of >= 20 mmHg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the alfuzosin hydrochloride patients.
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.
The most common adverse reactions reported in subjects receiving dutasteride were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders.
Study withdrawal due to adverse reactions occurred in 4% of subjects receiving dutasteride, and 3% of subjects receiving placebo in placebo-controlled trials with dutasteride. The most common adverse reaction leading to study withdrawal was impotence (1%).
Over 4300 male subjects with BPH were randomly assigned to receive placebo or 0.5 mg daily doses of dutasteride in three identical 2-year, placebo-controlled, double-blind, Phase 3 treatment trials, each followed by a 2-year, open-label extension. During the double-blind treatment period, 2167 male subjects were exposed to dutasteride, including 1772 exposed for 1 year and 1510 exposed for 2 years. When including the open-label extensions, 1009 male subjects were exposed to dutasteride 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 dutasteride (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 receiving dutasteride (1%) compared with men on placebo (0.5%). In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (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 dutasteride.
Reproductive and Breast Disorders
In the three pivotal placebo-controlled BPH trials with dutasteride, each of 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 three trials, there was one case of breast cancer in the dutasteride group and one 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 the long-term use of dutasteride and male breast neoplasia is currently unknown.
Combination with Alpha-Blocker Therapy
Over 4800 male subjects with BPH were randomly assigned to receive 0.5-mg dutasteride, 0.4-mg tamsulosin, or combination therapy (0.5-mg dutasteride plus 0.4-mg tamsulosin) administered once daily in a 4-year double-blind trial. Overall, 1623 subjects received monotherapy with dutasteride; 1611 subjects received monotherapy with tamsulosin; and 1610 subjects received combination therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were Caucasian.
The most common adverse reactions reported in subjects receiving combination therapy (dutasteride 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 dutasteride (2%) or tamsulosin (4%) as monotherapy.
Trial withdrawal due to adverse reactions occurred in 6% of subjects receiving combination therapy (dutasteride plus tamsulosin) and 4% of subjects receiving dutasteride or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).
Cardiac Failure: In a trial with combination therapy with dutasteride and alpha-blocker, 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: dutasteride, 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 dutasteride in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking dutasteride was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had comorbidities 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 trial.
The following adverse reactions have been identified during post-approval use of alfuzosin hydrochloride. 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.
General disorders: Oedema.
Cardiac disorders: Tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation.
Gastrointestinal disorders: Diarrhoea.
Hepatobiliary disorders: Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation).
Respiratory system disorders: Rhinitis.
Reproductive system disorders: Priapism.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, angioedema.
Vascular disorders: Flushing.
Blood and lymphatic system disorders: thrombocytopenia
The following adverse reactions have been identified during post-approval use of dutasteride. 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 dutasteride.
Immune system disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized oedema, serious skin reactions, and angioedema.
Neoplasms: Male breast cancer.
Psychiatric disorders: Depressed mood.
Reproductive System and Breast disorders: Testicular pain and testicular swelling.
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