|San Antonio, TX|
|May 25, 2005|
|Men also showed improvement of sexual function when taking Uroxatral to treat lower urinary tract symptoms|
The sanofi-aventis Group announced today the interim results of a large ongoing, open-label study demonstrating that men treated with UroxatralÒ (alfuzosin HCl), a clinically uroselective alpha1-blocker for the treatment of the signs and symptoms of enlarged prostate, or benign prostatic hyperplasia (BPH), reported sustained benefit over two years in reducing lower urinary tract symptoms (LUTS) and sexual function. Further, a second analysis from the trial demonstrated the relationship between LUTS severity and sexual function and showed that improvement in men with LUTS taking Uroxatral corresponded to similar improvements in sexual function such as stiffness of erection, volume of ejaculate, and degree of pain upon ejaculation. Both of the above analyses were presented at the 100th Annual Meeting of the American Urological Association (AUA).
“These results are important because they demonstrate consistent efficacy with Uroxatral for treatment of the signs and symptoms of enlarged prostate,” said Mostafa Elhilali, MD, Professor and Chair, Department of Surgery at McGill University, Montreal, QC. “These studies reaffirm that Uroxatral provides efficacy over the long-term.”
In a separate analysis of Alfone, also presented at the AUA meeting, investigators looked at improvement of the IPSS and sexual function categories after one year of UroxatralÒ (alfuzosin HCl) treatment. In the analysis, men reported a reduction in Bother Score by 33.2 percent, and a reduction in IPSS domains by 32.1 percent compared to baseline. However, in men with sexual dysfunction, the reported clinical improvements in such categories as stiffness of erection, ejaculation in general and pain or discomfort upon ejaculation all showed more marked improvements in those patients who began the study with more severe LUTS.
Study Design and Safety
In the first analysis, 839 men (mean age 67.3 years) complaining of LUTS suggestive of BPH were assessed after two years. Investigators analyzed results from the IPSS and the BSFI. Efficacy results were provided in the intent-to-treat population.
In this analysis, Uroxatral was well tolerated, and there were no clinically relevant changes in blood pressure, including in elderly and hypertensive patients. The most common side effect was dizziness (3.0 percent). Adverse events related to sexual function were uncommon.
In the second subset analysis, 3,076 men, (mean age 65.9 years) were analyzed after one-year in the Alfone study. Sexual function was assessed by the DAN-PSSsex. Analysis was performed in the intent-to-treat population.
Important Information About Uroxatral
Uroxatral is contraindicated in patients with moderate or severe hepatic insufficiency and therefore should not be used in these patients. Uroxatral should not be administered with potent CYP3A4 inhibitors and therefore should not be used in combination with drugs such as ketoconazole, itraconazole, or ritonavir.
Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of Uroxatral. As with all alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur.
Uroxatral should be used with caution in patients with severe renal insufficiency, and should not be prescribed to patients with a known history of QT prolongation or to patients who are taking medication known to prolong QT.
The most common side effects are dizziness, upper respiratory tract infection, headache, and fatigue. For full prescribing information, call 1-800-633-1610 or visit www.uroxatral.com.
Sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
Sanofi-aventis, manufacturers of Uroxatral, sponsored the Alfone study.
Forward Looking Statements
Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.