Lilly ICOS' Cialis (tadalafil) Improves Erectile Function in ED Patients

Erectile Dysfunction Treatment

Lilly ICOS LLC announced data today from an open-label clinical trial showing Cialis (tadalafil)(1) improved erections in more than three- quarters of men who were suffering from erectile dysfunction (ED) and one or more comorbid conditions. These comorbidities include cardiovascular disease (including hypertension), diabetes, depression, hyperlipidemia, and prostate disease (including those who had undergone prostatectomy). On average, nearly 50 percent of all attempts resulted in an erection that lasted long enough to have successful sexual intercourse when patients were treated with Cialis 20 mg. This is compared to approximately 17 percent of attempts at baseline for this patient group. These data will be presented today at the 100th Annual Meeting of the American Urological Association (AUA).
"Treatment of erectile dysfunction in men with comorbid conditions is a challenge. It is exciting to see such positive results in this group of patients, who had a relatively high degree of severe erectile dysfunction and many of whom had multiple comorbidities," said Irwin Goldstein, M.D., Professor of Urology and Gynecology at the Boston University School of Medicine. "The findings confirm that Cialis improved erectile function in men with erectile dysfunction even when associated with significant comorbid conditions. Also, these patients tolerated treatment with Cialis very well."

Study Design and Key Findings on Erectile Dysfunction

The MOMENTUS study (Multiple Observations in Men with erectile dysfunction in National Tadalafil Study in the United States) is a multi-center, open-label study that evaluated the efficacy and safety of Cialis 20 mg in 1,911 American men with ED who were enrolled into eight predefined groups. In this study, after a four-week treatment-free period to determine baseline erectile dysfunction, patients were instructed to take Cialis 20 mg as needed prior to sexual activity (not more than one dose a day) for a period of 12 weeks. The subgroup discussed here included 155 patients, mean age 65, who had significant comorbid conditions; many of these patients also had severe erectile dysfunction at baseline (51.9 percent). This subgroup comprised patients who met the enrollment criteria for the MOMENTUS trial but who could not be included in any other predefined group.
In the subgroup, 77.4 percent of patients reported an improvement in their erections after taking Cialis 20 mg based on the Global Assessment Questions (GAQ)(2), question one (Has the treatment you've been taking during this study improved your erections?). They also showed a 7.6 point improvement from the baseline score of 11.48 in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)(3). It is generally considered that an improvement of four points or more in the EF domain score reflects a clinically meaningful change(4).
After taking Cialis 20 mg, patients reported an increase from baseline in erections that resulted in "successful sexual intercourse" based on positive per patient response to Sexual Encounter Profile (SEP)(5) question three (Did your erection last long enough for you to have successful sexual intercourse?). On average, nearly half (49.4 percent) of the attempts resulted in an erection that lasted long enough for successful sexual intercourse, compared to the percentage at baseline of 16.9.
"Cialis provides a meaningful therapeutic benefit with regards to erectile function in men suffering fromerectile dysfunction and significant comorbid conditions," said Sanjeev Ahuja, M.D., Associate Medical Director, Eli Lilly and Company. "Men who have ED should visit their doctor to discuss their sexual health and their overall health. This will give their doctor the opportunity to do a complete exam, during which significant health problems may be detected and addressed, and treatment options for erectile dysfunction can be discussed."
The most commonly reported side effects in the patients in this group were headache, flushing, nasal congestion, back pain, and upset stomach. Discontinuations due to adverse events in this group were three percent and similar to previously reported discontinuation rates in Cialis clinical trials. Not included in this clinical trial were patients with certain serious underlying cardiovascular conditions, including recent myocardial infarction, uncontrolled arrhythmias, hypotension (<90/50 mm Hg), uncontrolled hypertension (>170/100 mm Hg), unstable angina or angina occurring during sexual intercourse, or those who recently suffered a stroke or had severe heart failure.