Study Shows Use of Tamsulosin or Nifedipine Helps Patients to Clear Ureteral Stone Fragments Faster and Reduces Rate of Recurrence

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

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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