Clinical data demonstrated continued efficacy and tolerability of LEVITRA in men with ED and high blood pressure, diabetes and/or dyslipidemia, including high cholesterol. LEVITRA(R) (vardenafil HCl), is effective at first dose with continued success in treating erectile dysfunction (ED) in men with associated medical conditions that affect the cardiovascular system. These conditions included high blood pressure, diabetes and/or dyslipidemia, which includes high cholesterol and other lipid abnormalities. These data were presented today at the Sexual Medicine Society of North America (SMSNA) Fall meeting and published in the November issue of the International Journal of Clinical Practice.
This randomized, placebo-controlled study involved 600 patients with diagnosed ED who received a single open-label challenge dose of LEVITRA 10 mg. Overall first dose success rates for SEP-2 (penetration) and SEP-3 (erection maintenance until completion of intercourse) during the one-week challenge period were 87 percent and 74 percent, respectively. SEP-2 first dose success was demonstrated in 84 percent of men with high blood pressure, 84 percent of men with dyslipidemia, and 75 percent of men with diabetes. Patients who achieved SEP-2 success were randomized to LEVITRA or placebo for 12 weeks. At the end of 12 weeks of treatment, study participants receiving LEVITRA 10 mg had a SEP-2 success rate of 83 percent versus 56 percent for patients receiving placebo.
“These study results demonstrate the efficacy of LEVITRA at first dose and after continued treatment in men whether or not they have associated medical conditions,” said study author Luc Valiquette, MD, University of Montreal Hospital Center, Montreal, Quebec. “First-dose success and long-term reliability are important criteria for patients.”
“These study results are particularly important to the nearly 30 million American men who currently suffer from ED, including the millions of men with high blood pressure, high cholesterol, and diabetes. These men are at an increased risk of developing ED,” said Andrew Axilrod, MD, Director of Male Sexual Health at the University of Pennsylvania, Philadelphia.
It is estimated that more than half of all men over 40 years of age are affected by ED, to some degree. Vascular diseases, including high blood pressure, high cholesterol and diabetes may have a role in up to 80 percent of ED cases. In the United States, an estimated 10.9 million men have diabetes, 29.4 million have high blood pressure and 50.4 million have high cholesterol. Even when controlled by medication, these conditions may still cause changes in blood flow, a critical component of healthy erectile function.
About the study
The study included a one-week open-label challenge phase, followed by a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment phase. The primary objective of the study was to demonstrate that patients who responded the first time to LEVITRA 10 mg in the open label challenge phase will continue to respond to the same dose over a 12-week period. The secondary objective was to evaluate the safety and tolerability of LEVITRA 10 mg compared with placebo. The study, conducted at 42 centers in Europe, North America, South America, and Asia Pacific, involved 600 patients over age 18 who had experienced ED for more than six months. The majority of participants were diagnosed with at least one associated medical condition [hypertension – 32 percent (n=191); diabetes – 16 percent (n=95); dyslipidemia – 19 percent (n=116); diabetes and hypertension – 8 percent (n=48); all three conditions – 4 percent (n=24)]. To measure the efficacy of LEVITRA, the patients kept diaries of their responses to standardized questions regarding their erectile function during attempts made at sexual intercourse.
LEVITRA was effective at improving all ED efficacy parameters measured in this study at first dose and for up to 12 weeks and was generally well tolerated. Compared with placebo, men treated with LEVITRA had a statistically and clinically significant superiority in International Index of Erectile Function-Erectile Function (IIEF-EF) domain score (P < 0.0001). First-dose success rates in penetration (SEP 2) and ability to maintain an erection to successfully complete intercourse (SEP 3) in patients with co- morbid conditions were as follows: 84 percent and 66 percent in men with hypertension; 84 percent and 72 percent in men with high cholesterol; and 75 percent and 58 percent in men with diabetes. At the end of 12 weeks of treatment, patients receiving LEVITRA had a greater reliability of penetration (SEP-2) compared to placebo (83 percent vs. 56 percent respectively, p<0.001). The majority of adverse events were mild to moderate in intensity. The most common adverse events reported in approximately 5 percent of patients treated with LEVITRA were headache and flushing.Background: Erectile dysfunctionErectile 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.About LEVITRALEVITRA is an FDA-approved oral prescription medication for the treatment of erectile dysfunction (ED) in men. LEVITRA belongs to a class of medications called 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. There are currently three FDA-approved oral PDE5 inhibitors available.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 InformationLEVITRA 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.About Schering-PloughSchering-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.About GSKGlaxoSmithKline, 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.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 Item 1A. Risk Factors in the Company’s second quarter 2006 10-Q.GlaxoSmithKline’s Cautionary Statement Regarding Forward Looking StatementsUnder the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GlaxoSmithKline cautions investors that any forward- looking statements or projections made by GlaxoSmithKline, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in GlaxoSmithKline’s Annual Report 2005.