Healthcare Industry News: GSK
News Release - December 10, 2007
New Study Shows LEVITRA Successfully Treats Erectile Dysfunction (ED) in Men with Dyslipidemia, Including High CholesterolThe first prospective trial specifically designed to evaluate erectile function in ED patients with dyslipidemia
CHICAGO, Dec. 10 (HSMN NewsFeed) -- Results of the first prospective trial specifically designed to evaluate erectile function in erectile dysfunction (ED) patients with dyslipidemia show that LEVITRAŽ (vardenafil HCl), used in treating ED, significantly improves the ability of men with ED and dyslipidemia to achieve and maintain an erection for successful sexual intercourse. These data were presented at the Sexual Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).
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 (vardenafil HCl) is a prescription medicine that is indicated to treat erectile dysfunction (ED). Consistent with the effects of PDE5 inhibition, administration of LEVITRA with nitrates and nitric oxide donors is contraindicated.
Caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with stable alpha-blocker therapy, because of the potential for lowering blood pressure.
LEVITRA is not recommended for patients with uncontrolled hypertension (>170/110 mmHg).
In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.
In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and clarithromycin), lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended. See prescribing information for LEVITRA for dosing guidance.
In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis. Adverse events were generally transient.
Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden loss of vision or hearing.
The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg or down to 5 mg based on efficacy and side effects.
The maximum recommended dosing frequency is once daily.
LEVITRA is available in 2.5-mg, 5-mg, 10-mg and 20-mg tablets.
For Prescribing Information please visit http://www.levitra.com.
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. For company information, visit GlaxoSmithKline at www.GSK.com.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "To Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related 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 Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
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