Newly-Published Data Showed LEVITRA(R) Treated Erectile Dysfunction Effectively At First Dose In Men With Certain Associated Cardiovascular Conditions
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
Noile date publicate-a arãtat LEVITRA (R) disfuncþie erectilã tratate în mod eficient de la prima dozã în oameni cu anumite condiþii asociate cardiovasculare - Newly-Published Data Showed LEVITRA(R) Treated Erectile Dysfunction Effectively At First Dose In Men With Certain Associated Cardiovascular Conditions - articole medicale engleza - startsanatate