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…