Healthcare Industry News:  erectile dysfunction 

Biopharmaceuticals

 News Release - March 22, 2006

Study Shows LEVITRA(R) Treats Erectile Dysfunction Effectively in Men Taking Medications to Lower High Blood Pressure

Clinical trial data showed improvement in erectile function with LEVITRA was unaffected by different classes of anti-hypertensive medication

KENILWORTH, N.J. and PHILADELPHIA, March 22 (HSMN NewsFeed) -- LEVITRAŽ (vardenafil HCl), a PDE5 inhibitor, is effective in treating erectile dysfunction (ED) in men receiving one or more medications for the treatment of hypertension (high blood pressure),(1) according to data published in a recent issue of The Journal of Sexual Medicine. In this double-blind, placebo-controlled clinical trial, patients treated with LEVITRA experienced an 83% overall success rate in erectile function while also receiving one or more anti-hypertensive medications.

"This study demonstrated that LEVITRA was well-tolerated when used concomitantly with anti-hypertensive medications in patients not previously treated with PDE5 inhibitors," said study author Dr. Hermann van Ahlen, University of Muenster, Germany.

Hypertension, a major risk factor for ED, affects 29.4 million men in the United States(2). It is one of the most common medical conditions, along with diabetes and high cholesterol, associated with ED. In addition many blood-pressure-lowering medications, particularly beta-blockers and diuretics, may adversely affect erectile function.

"As a primary care physician, I know that my male patients are often concerned about taking anti-hypertensive drugs for fear of the potential sexual side effects," said Dr. Matthew Rosenberg, medical director at Mid-Michigan Health Centers in Jackson, MI. "This study gives me support to tell patients that I can treat hypertension and also prescribe an effective medication to treat ED. The fact that LEVITRA improved erectile function in patients taking multiple anti-hypertensive medications is a testimony to its efficacy."

About the study

Study investigators carried out a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of flexible-dose LEVITRA in men with treated hypertension and ED who had not previously used LEVITRA or other PDE5 inhibitors. In this study, use of alpha blockers was not permitted. The study, conducted at 98 primary care sites in Germany, involved 354 patients over age 18 who had experienced ED for more than 6 months. Participants received either placebo or LEVITRA, in a dose ranging from 5 mg to 20 mg, for 12 weeks. To measure the drug's efficacy, the patients kept diaries of their responses to standardized questions regarding their erectile function.

LEVITRA was well-tolerated and effective at improving all ED efficacy parameters. There was no significant difference in the frequency of adverse events when patients were grouped according to the type of anti-hypertensive medications being received. Compared with placebo, LEVITRA significantly improved patients' ability to successfully have intercourse. The success rate was 83% for men treated with LEVITRA vs 58% for placebo (P < 0.0001). Success rates for LEVITRA were unaffected by the concomitant use of one or more antihypertensive medications including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. When compared to baseline or placebo, there were no clinically significant differences in ECG findings, supine (or at rest) systolic and diastolic blood pressure readings, or heart rate in LEVITRA-treated patients during clinic visits. The most common reported adverse events were headache and flushing.

Background: erectile dysfunction

erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. ED can be a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. It is estimated that some degree of ED affects up to 30 million men in the United States.

Some of the most common treatments for ED include adjustments to lifestyle and better control of concomitant medical conditions as well as the use of oral medications or other forms of therapy. Treating related health conditions or reducing stress may help maintain erectile function. LEVITRA belongs to a class of medications called oral phosphodiesterase type 5 (PDE5) inhibitors, which are among the most successful treatments for ED. There are currently three FDA-approved oral PDE5 inhibitors available.

About LEVITRA

LEVITRA is an FDA-approved oral prescription medication for the treatment of erectile dysfunction (ED) in men. It belongs to a class of medications commonly referred to as oral phosphodiesterase type 5 (PDE5) inhibitors, the most commonly prescribed treatments for men with ED. LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.

LEVITRA, developed by Bayer Healthcare and GlaxoSmithKline (GSK), is jointly promoted in the U.S. by GSK and Schering-Plough Corporation.

Important Safety and Dosing Information

LEVITRA is a prescription medicine that is used to treat erectile dysfunction (ED). Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take LEVITRA. Such combinations could cause blood pressure to drop to an unsafe level.

As with all ED drugs, there is a rare risk of an erection lasting longer than four hours. To avoid long-term injury, seek immediate medical attention. LEVITRA does not protect against sexually transmitted diseases. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicine, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away.

Discuss your medical conditions, including heart problems, and medications, including alpha blockers prescribed for prostate problems or high blood pressure, with your doctor to ensure LEVITRA is right for you and that you are healthy enough for sexual activity.

The starting dose of LEVITRA is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking alpha blockers, your doctor may start you on a lower dose of LEVITRA. In patients taking certain medications such as ritonavir, indinavir, ketoconazole, itraconazole, and erythromycin, lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended.

In clinical trials, the most commonly reported side effects were headache, flushing, and stuffy or runny nose. LEVITRA is available in 2.5-mg, 5-mg, 10-mg, and 20-mg tablets.

For Prescribing Information please visit http://www.LEVITRA.com.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

About Schering-Plough

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the potential market for LEVITRA. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the Company's 2005 10-K.

(1) van Ahlen H, Wahle K, Kupper W, Yassin A, Reblin T, Neureither M. Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with multiple antihypertensives. J Sex Med. 2005;2:856-864.

(2) American Heart Association. At-a-glance summary tables: men and cardiovascular diseases. Available at:

http://www.americanheart.org/downloadable/heart/1109000828619FS07MN05.REV.DOC.


Source: Schering-Plough

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