RIDGEFIELD, Conn., July 12 /PRNewswire/ — Findings from a newly published study showed that patients who received Flomax(R) (tamsulosin hydrochloride) experienced significantly greater improvement in symptoms associated with benign prostatic hyperplasia (enlarged prostate) than patients who received terazosin hydrochloride, after four days of treatment. The study also showed that treatment with terazosin was associated with significantly more side effects, including dizziness and sleepiness. The study, “Early Efficacy of Tamsulosin Versus Terazosin in the Treatment of Men With Benign Prostatic Hyperplasia: A Randomized, Open-Label Trial,” was published in the summer issue of The Journal of Applied Research In Clinical and Experimental Therapeutics. FLOMAX is a sub-type selective alpha blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). This study was funded by Boehringer Ingelheim Pharmaceuticals Inc.
“Unlike terazosin, tamsulosin does not have to be titrated and patients receive a therapeutically effective dose on day one. This study shows that tamsulosin works faster than terazosin in treating the symptoms associated with an enlarged prostate,” said Perinchery Narayan, M.D., director of the North Florida Urology Association and principal author of the study. “Because side effects, including dizziness and reduced blood pressure, were more common in men treated with terazosin, these findings also indicate that tamsulosin may be a more appropriate treatment option for men with BPH who might also be taking medications for hypertension.”
Study Design
In the study, 1,993 patients with BPH were randomized to receive tamsulosin (0.4 mg/day) or terazosin (5 mg/day, following titration). The primary efficacy endpoint was a comparison of total American Urological Association Symptom Index (AUA-SI) score after four days of treatment. Secondary endpoints — the mean change in total AUA-SI score at Day 5, AUA Bother Score Index and BPH Impact Index from baseline, and Investigator’s Global Assessment — were completed at days 5, 8, 15, 19, 22 and 57.
Key Findings
Patients taking tamsulosin (n=905) experienced a statistically and clinically significant improvement (25.3%) in BPH symptoms (mean total AUA-SI score) after four days of treatment, which was not seen in patients who received terazosin (n=884, improvement: 18.1%). The adjusted mean change in total AUA-SI score after 4 days was -4.8 for tamsulosin and -3.4 for terazosin (P
About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a common condition in aging men caused by the non-cancerous enlargement of the prostate gland. According to the American Urological Association (AUA), 50 percent of men older than 50 and 80 percent of men older than 80 experience BPH symptoms. As the prostate enlarges, it compresses the urethra. This obstruction of the urethra can lead to a gradual impairment of normal bladder function. Over time, the bladder may not empty properly due to prostatic obstruction. BPH symptoms include the frequent need to urinate, particularly at night; feeling that the bladder has not emptied completely after urination; hesitant, interrupted, or weak urine stream caused by decreased force; pushing or straining to begin urination; the leakage of urine (i.e., overflow incontinence); and dribbling at the end of voiding.
About FLOMAX
Co-marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Astellas Pharma Inc., Flomax(R) (tamsulosin hydrochloride) is the most widely prescribed alpha-blocker indicated for the treatment of the signs and symptoms of BPH in the United States. FLOMAX is generally well tolerated, has minimal effect on blood pressure and can be started at a therapeutically effective dose, which does not require titration.
The most common side effects in men with BPH, taking FLOMAX, were stuffy nose, abnormal ejaculation and dizziness. As with all alpha-blockers, there is a risk of syncope (fainting). Therefore, men beginning FLOMAX treatment should avoid situations where injury could result should this occur.
For more information about Flomax(R) (tamsulosin hydrochloride) capsules please visit http://www.flomax-bph.com/.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com/ .
Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Katherine O’Connor, Manager, Communications & Public Relationsof Boehringer Ingelheim Pharmaceuticals, Inc., +1-203-791-6250,[email protected]; Nicole Cheeks of GCI Healthcare,+1-212-537-8170, Fax: +1-212-537-8250, [email protected]
Web site: http://us.boehringer-ingelheim.com/http://www.flomax-bph.com/
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