Levitra® (vardenafil HCl) Demonstrates Normal Erectile Function in 53% of Men with Spinal Cord Injury (SCI)
Changes to the European label for Levitra shows that it is effective for men with erectile dysfunction (ED) due to SCI
Results from RESPITE (REsults in SPinal Cord Injury PaTiEnts: Vardenafil for Erectile Dysfunction) study1 showed that 53% of patients treated with Levitra reported that their erectile function returned to normal (an IIEF-EF domain score of >26 is considered to be clinically normal level of sexual function2) compared to 9% who took placebo (p<0.001). Success rate for penetration (SEP2) and maintenance of erection (SEP3) was also significantly higher than placebo in men with SCI (both p<0.001). These statistically and clinically significant results in subjects with ED following traumatic spinal cord injury has led to an update in the European label for Levitra (Summary of Product Characteristics [SmPC]).
“The label change and study results are very encouraging for the many men who suffer from spinal cord injury. The recorded levels of improvement in erectile function and ejaculation rates during the study period were impressive. This is great news for men suffering with ED resulting from spinal cord injury who wish to father children.” Lead author of the study, François Giuliano, MD, PhD, a professor at the department of urology, CHU de Bicetre, in Paris
About the study
The RESPITE study is a 12-week randomised, double blind, parallel group, multicentre trial, which studied men with ED (mean baseline IIEF-EF score of around12.0 [moderate severity], ITT population) in an at-home setting. Dosage could be titrated as necessary at week four and eight, subjects were closely monitored including a follow up phone call after the week 12 visit.
The men recruited to the RESPITE study suffered with varying degree of severity of spinal cord injury as measured by American Spinal Injury Association (ASIA) Impairment scale. The scale measures the level of impairment and categorises from A to E – where “A” is complete impairment with no Motor function or sensation preserved in Sacral segments S4 – S5 and category “E” is normal motor and sensory function. In the study, approximately half of the subjects were categorised as “A” and half were categorised “B-D”.
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33.800 people worldwide in 2005.
The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.
Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
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1. Giuliano F et al, Efficacy & safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006;66:210-216.
2. Rosen R C et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49(6):822-830
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