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Boehringer Ingelheim Pharmaceuticals, Inc. Release: Study Shows Use Of Tamsulosin Or Nifedipine Helps Patients To Clear Ureteral Stone Fragments Faster And Reduces Rate Of Recurrence


10/19/2005 5:09:48 PM

SAN ANTONIO, May 25 /PRNewswire/ -- Findings from a new study show that patients with ureteral stones who received either tamsulosin, sold in the U.S. as Flomax(R) (tamsulosin hydrochloride), or nifedipine were able to clear stone fragments faster than patients who did not receive either drug following shock wave therapy. The study, "Efficacy of expulsive medical therapy using nifedipine or tamsulosin after shock wave lithotripsy of ureteral stones," also showed that use of tamsulosin or nifedipine reduced the need for re-treatment, as well as the recurrence rate of ureteral stones. The data were presented today at the 100th annual meeting of the American Urological Association (AUA). FLOMAX is not FDA approved for indication of post lithotripsy management of ureteral stones.

"This study suggests that tamsulosin and nifedipine can help patients to expel ureteral stone fragments faster and decrease the need for further treatment of one of the most common and painful urologic conditions," said Salvatore Micali, M.D., Department of Urology, University of Modena (Italy), principal author of the study.

Key Findings

In patients treated with either tamsulosin or nifedipine following extracorporeal shock wave lithotripsy (ESWL), a non-invasive treatment method in which high intensity shock waves are generated outside of the patient and focused on the stone within the ureter to break it into fragments, 50 and 81 percent were stone free at one and three months, respectively, compared to 26.5 and 55 percent of patients who did not receive either drug following the ESWL (p = 0.04; p = 0.00). In addition, only 31 percent of patients receiving tamsulosin or nifedipine needed ESWL retreatment compared to 50 percent of patients who did not receive expulsive medical therapy (p=0.00). The average number of days to achieve a stone-free condition was 49.9 (range: 5-150) days among patients receiving tamsulosin or nifedipine and 82.9 days (range: 5-180) in patients who did not receive either drug (p = 0.048).

Study Design

In the study, 81 patients with ureteral stones were divided into two groups after receiving ESWL. Thirty-two patients received expulsive medical therapy for two weeks (nifedipine 30 mg/day for upper and middle ureteral stones, tamsulosin 0.4 mg/day for lower ureteral stones), while 49 patients received only pain relievers. Both ultrasound and x-ray were used for stone scanning. Stone clearance was assessed 30 and 90 days after ESWL. Stone-free condition was defined as the complete stone clearance or the presence of residual fragments less than 3 mm.

Flomax(R) (tamsulosin hydrochloride) is the most widely prescribed alpha-blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Nifedipine is a calcium channel blocker indicated for hypertension and other cardiovascular conditions.

About Ureteral Stones

A ureteral stone is a kidney stone that has traveled down from the kidney into the ureter, a tube that carries urine to the bladder(1). Kidney stones occur in approximately 5.2 percent of the U.S. population, resulting in approximately 2 million doctor visits per year(2). Kidney stones disproportionately affect men, who represent four out of five cases(3). A kidney stone forms when waste products that are normally excreted as urine build up as crystals in the kidney, forming hard masses or stones. Symptoms of a kidney stone include extreme pain in the back and side in the area of the kidney or in the lower abdomen, nausea and vomiting, and pain in the groin. Serious complications from kidney stones can include infection, blockage, or kidney damage(4). Most smaller kidney stones can be passed by drinking fluids and taking pain relievers as needed. Occasionally, stones may cause persistent symptoms or complications that require medical intervention(5).

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/

1. National Institute of Diabetes and Digestive and Kidney Diseases. Kidney Stones in Adults. http://kidney.niddk.nih.gov/kudiseases/pubs/stonesadults/index.htm#howa. Accessed April 2005

2. National Institute of Diabetes and Digestive and Kidney Diseases. Kidney and Urologic Diseases Statistics for the United States. http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm. Accessed April 2005.

3. National Kidney Foundation Guide to Kidney Stones. http://www.kidney.org/atoz/atozItem.aspx?id=84. Accessed April 2005

4. National Kidney Foundation Guide to Kidney Stones. http://www.kidney.org/atoz/atozItem.aspx?id=84. Accessed April 2005

5. National Institute of Diabetes and Digestive and Kidney Diseases. Kidney Stones in Adults. http://kidney.niddk.nih.gov/kudiseases/pubs/stonesadults/index.htm#howa. Accessed April 2005

Boehringer Ingelheim Pharmaceuticals, Inc.

CONTACT: Marybeth McGuire, Manager, Communications & Public Relations ofBoehringer Ingelheim Pharmaceuticals, Inc., +1-203-798-4801,mmcguire@rdg.boehringer-ingelheim.com; or Nicole Cheeks (on-site),+1-917-674-7623, Fax: +1-212-537-8250, ncheeks@gcigroup.com, or Jim Wetmore(on-site), +1-646-537-5463, Fax: +1-212-537-8250, jwetmore@gcigroup.com, bothof GCI Healthcare, both for Boehringer Ingelheim Pharmaceuticals, Inc.



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