{1} Release: 87% Of Patients Not Responding To Herbal Treatments for Urinary Symptoms Satisfied Following Treatment With FLOMAX

SAN FRANCISCO, May 11 /PRNewswire/ -- Results of a European post-marketing study of 3,322 men suffering from the signs and symptoms of benign prostatic hyperplasia (BPH), who switched from phytotherapy to FLOMAX(R) (tamsulosin hydrochloride), found that patients experienced considerable improvement in bothersome lower urinary tract symptoms (LUTS) and quality of life. This German study evaluated the switch to 0.4 mg of FLOMAX in BPH patients with poor response to at least four weeks of phytotherapy. Almost 94% of urologists indicated that FLOMAX was more effective than phytotherapy in these patients. Results were presented today at the annual meeting of the American Urological Association (AUA). FLOMAX is a selective alpha (1a)-blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

This study was funded by Boehringer Ingelheim Pharma GmbH & Co. KG.

"This study further supports alpha-blockers such as tamsulosin, as an effective first line treatment option for the relief of lower urinary tract symptoms associated with BPH," said Prof. Andreas Gross, a urologist with Marien Krankenhaus in Bergisch-Gladbach, Germany, and the senior consultant for the study. "However, the efficacy of herbal treatments for LUTS/BPH require further investigation."

Results

After switching from phytotherapy to FLOMAX, BPH patients with lower urinary tract symptoms saw a 41% improvement in their total International Prostate Symptom Scores (I-PSS) and a 46% improvement in their quality of life scores (I-PSS-QoL). The mean I-PSS total for patients after phytotherapy was 16.7 compared with a mean of 9.8 after treatment with FLOMAX. 31.2% of patients had an I-PSS < 8 after treatment with FLOMAX compared with 0% prior to treatment. The mean I-PSS-QoL was 3.5 prior to switching to FLOMAX, compared with 1.9 after treatment. Maximum flow rate and post-void residual were determined to have improved significantly. Among patients and urologists, satisfaction treatment effectiveness increased considerably after FLOMAX treatment, with a total of 87.1% of patients (compared with 4.2% satisfied prior to treatment) and 93.9% (compared with 10.4% satisfaction with phytotherapy) of urologists indicating FLOMAX was superior in effectiveness to herbal treatment.

Study Methods

The German study evaluated 3,332 men (mean age of 65.9 years) with lower urinary tract symptoms associated with BPH who had a poor response to phytotherapy. The effect of switching to >/= 2 months of treatment with FLOMAX 0.4 mg once daily in patients with a total I-PSS >/= 8 after >/= 4 weeks of herbal treatment was assessed by means of total I-PSS, I-PSS quality of life (QoL) and urologists' and patients' global ratings. The Guidelines of the German Urologic Association indicate that patients with a total International Prostate Symptom Score (I-PSS) >/= 8 should receive effective therapy for lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

About BPH

BPH is a common condition in aging men, which is 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 symptoms of the condition. 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 Abbott Laboratories, FLOMAX 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 Corporation is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information please visit http://www.boehringer-ingelheim.com/.

Boehringer Ingelheim Pharmaceuticals, Inc.