To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Investigational Drug, Cialis (IC351), May Improve Mild-To-Severe Erectile Dysfunction URL: http://www.pslgroup.com/dg/1F5656.htm Doctor's Guide March 19, 2001
TORONTO, ON -- March 19, 2001 -- Men with mild-to-severe erectile dysfunction (ED) may benefit from IC351 (Cialis™), an investigational oral treatment for ED, according to a study published in the latest issue of International Journal of Impotence Research. This first-time publication of detailed Phase II data in a peer-reviewed journal shows that on-demand treatment with IC351, an advanced phosphodiesterase type 5 (PDE5) inhibitor, improved erections in 81 percent of men (relative to placebo - 17 percent), regardless of severity. IC351 is currently in global Phase III studies. "IC351 is a potent and highly selective treatment that both increased sexual function and was well-tolerated in a broad range of men with ED," said Dr. Luc Valiquette, Urologist, Centre hospitalier de l'Université de Montréal. "Based on these data, IC351 may have the potential to become a new treatment alternative for ED." In the trial, up to 80 percent of patients with severe ED and up to 90 percent of patients with moderate ED reported significant improvement in their ability to attain and maintain an erection. Additionally, IC351 increased the percentage of successful and satisfying intercourse attempts for both men and their partners. In this study, 179 men (mean age: 56 years) with mild-to-severe ED were randomized to receive placebo or IC351, at doses up to 25 mg, taken on-demand over a three-week period. The men in the trial agreed to attempt at least four sexual encounters during the treatment period. Several measures were used to assess IC351 in a natural setting. Researchers compared baseline scores from the International Index of Erectile Function (IIEF) questionnaire (an important outcome measure reflecting overall erectile function), sexual encounter profile diaries of ED sufferers and their partners, and a global assessment question of treatment effect on erections. The data showed that both the men in the IC351 group and their partners reported a significant increase in the number of satisfying intercourse attempts, compared with the placebo group. In addition, a significant number of men taking IC351 reported an increase in the number of successful intercourse attempts compared to pre-treatment. Men treated with IC351 were also able to achieve penetration and maintain erections significantly more often than those on placebo. IC351 also significantly increased the IIEF erectile function domain score compared with placebo. "One of the most encouraging signs was that, as evidenced by the IIEF score, a substantial number of men who took IC351 were returned to normal sexual function," said Dr. Valiquette. In this trial, the only three treatment-related adverse events reported by greater than three percent of men were headache, back pain and dyspepsia (stomach upset following meals). These effects were generally mild to moderate and tended to decrease with time. Only two men discontinued due to adverse events. No alterations of color vision were reported. Additionally, no clinically significant changes were observed in clinical laboratory values, ECGs (electrocardiogram), or blood pressure at any of the doses studied in this trial. Other clinical trials are underway to determine the overall safety profile of IC351. Erectile dysfunction is defined as the persistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. According to a recently published study in the British Journal of Urology, it is a highly prevalent condition that affects an estimated 152 million men worldwide.(1) The condition is associated with a range of behavioural risk factors, such as cigarette smoking and excessive alcohol consumption, as well as numerous other medical conditions, notably diabetes and cardiovascular disease. As a result of these often age-related co-morbidities, there is a higher prevalence of ED in older men. Between the ages of 40 and 70 years, for example, the incidence of severe ED triples from 5 percent to 15 percent, while moderate ED doubles from 17 percent to 34 percent. References: 1. Ayta IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84: 50-56. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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