Study Evaluates Onset of Symptom Improvement for Avodart (Dutasteride) and Proscar(reg) (Finasteride)

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology
Article Date: 12 May 2004 - 0:00 PDT

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New data, presented today at the annual meeting of the American Urological Association, suggest that treatment with Avodart, the dual 5 alpha-reductase inhibitor (5ARI), may provide faster onset of symptom improvement for patients with benign prostatic hyperplasia (BPH)--or enlarged prostate--than treatment with Proscar.

The data showed that after three months of treatment, significantly more patients receiving Avodart experienced an improvement in American Urological Association Symptom Index (AUA-SI) score than those receiving Proscar1.

"As a clinician, I know that symptom improvement has always been important to my patients," said Richard Harkaway, MD, Co-Director Residency Education, Einstein Medical Center, Philadelphia, Pennsylvania. "The differences in DHT suppression and half-life between Avodart and Proscar are well documented, and now clinical observations suggest that there may be another important difference with regard to onset of symptom improvement."

Onset of symptom results were obtained from a prospective, observational study conducted at the Albert Einstein Medical Center in Philadelphia, Pennsylvania. Men with benign prostatic enlargement and symptomatic BPH were assigned to receive either Avodart (0.5 mg) or Proscar(5 mg), daily. Of the 240 patients enrolled, the first 120 were prescribed Proscar and the subsequent 120 were prescribed Avodart. There were no significant differences in baseline demographics between treatment groups.

Patients were evaluated using the AUA-SI prior to the start of treatment and following three months of treatment. Following three months of treatment, significantly more patients receiving Avodart experienced a one to three point improvement in AUA-SI score than those receiving Proscar (44 percent vs. 23 percent; p< 0.0016).1

About Avodart

Avodart, the first and only dual 5ARI for the treatment of BPH, inhibits both the type I and type II isoenzymes responsible for the conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. Avodart provides the power to suppress DHT by 93 percent, reduces prostate volume, improves symptoms, and arrests the BPH disease process.

Avodart is indicated for the treatment of symptomatic BPH in men with an enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of BPH-related surgery. While some men have fewer problems and symptoms after three months of treatment with Avodart, a treatment period of at least six months is usually necessary to see if Avodart will improve symptoms.

Only a doctor can tell if symptoms are from an enlarged prostate and not a more serious condition such as prostate cancer. Women and children should not take Avodart. Women who are, or could become, pregnant should not handle Avodart due to the possibility of a specific birth defect. Men treated with Avodart should not donate blood until at least six months after their final dose. Caution should be used in patients with liver disease. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently.

For full prescribing information, see www.Avodart.com.

About BPH

Benign prostatic hyperplasia (BPH) is a prevalent and progressive condition in aging men, affecting greater than 50 percent of men by the time they are 60 years of age and 90 percent of men by age 85.2 The progressive nature of the disease is associated with an increased risk of AUR (a sudden inability to urinate) and BPH-related surgery. The 2003 AUA guidelines recommend the use of a 5ARI as an appropriate and effective option for the treatment of men with symptomatic BPH and an enlarged prostate. 2

About AUA-SI

The AUA-SI is a tool used in evaluating the severity of BPH symptoms, including frequent or urgent urination, weak or intermittent urine stream, sensation of incomplete emptying, the need to strain and frequent urination during bedtime hours. Patients with AUA-SI scores of seven or less are considered to have mild symptoms. Patients with AUA-SI scores between eight and 19 are considered to have moderate symptoms and those with scores of 20 to 35 are classified as having severe symptoms.2,3 An improvement in AUA-SI score of three points or greater is considered meaningful to the patient.3

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References

1. Hagerty J, Ginsberg P, Harkaway R. A prospective, comparative study of the onset of symptomatic benefit of dutasteride versus finasteride in men with benign prostatic hyperplasia in everyday clinical practice. Annual meeting of American Urological Association 2004. Abstract #1353.

2. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: diagnosis and treatment recommendations. J Urol. 2003: 170: 530-547.

3. Barry M, Williford W, Chang Y, et al. Benign Prostatic Hyperplasia specific health status measures in clinical research: How much change in the American Urological Association symptom index and the Benign Prostatic Hyperplasia Impact Index is perceptible to patients? Urology. 1995; 154: 1770-1774.

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