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Buenos Aires, Argentina (ots/PRNewswire) -
-- Additional Analysis Shows Couples Agree Cialis Improves Erectile Function in Men with ED and Increases Satisfaction with Sexual Experience --
An international study conducted in 21 countries showed that 82 percent of men with ED who were treated with 20 mg Cialis(R) (tadalafil)(1) preferred the medication to 18 percent of those receiving their currently prescribed dosage of Viagra(R) (sildenafil citrate)(2), citing a reduction in the time pressure to perform and in increase in sexual self-confidence as important benefits of Cialis. In a separate analysis of four studies of men with erectile dysfunction (ED) and their female partners, couples reported increased overall satisfaction with their sexual experience after 20 mg CCialis dosing
These data will be presented here today at the 11th World Congress of the International Society for Sexual and Impotence Research (ISSIR).
"Erectile dysfunction can put a serious strain upon the emotional and physical well being of a man and his partner," said Stanley E. Althof, Ph.D., Professor, Department of Urology, University Hospitals of Cleveland, Cleveland, OH, USA and lead author. "Cialis offers a couple up to 36 hours to choose the moment for intimacy that is right for them, and can help reduce that strain."
Predictors for Preference Study Design and Results
Patient preferences for Cialis and Viagra were measured among 2,762 men in 21 countries who had a history of ED for three months or longer. The open-label trial showed that men suffering from ED who attempted sex beyond a 4-hour period preferred Cialis because of its long duration. The study enrolled men who were taking Viagra for six weeks or more prior to entering the trial. At study initiation, patients continued taking Viagra (at current dosage: 60% of patients took 50 mg Viagra, 34% of patients took 100 mg Viagra) an additional four weeks followed by a one-week wash out period. Patients were then given 20 mg Cialis for eight weeks. Participating men were instructed to take the medications on an as-needed basis, but no more than once a day, prior to sexual activity.
This study showed that 82 percent of the men preferred Cialis to Viagra (18 percent). Patients who experienced a reduction in the pressure on timing of sexual intercourse and increased sexual self-confidence were more likely to prefer Cialis over Viagra. These findings were based on the PAIRS assessment, which was administered at baseline, and at the end of Viagra and Cialis treatment phases. PAIRS is an internationally validated patient questionnaire used to measure behavioural, psychological and relationship outcomes associated with ED and its treatment.
"The study was designed to identify potential predictors of treatment preference for Cialis and Viagra among men with ED," said Chris McMahon, MD, Director of the Australian Centre for Sexual Health, St Luke's Hospital Complex, Sydney, Australia and lead author. "What we found is that men with a reduction in time pressure to perform and enhanced sexual self-confidence had a greater preference for Cialis."
Partner Satisfaction Data
In a separate analysis, data from men with ED (assigned to 10 or 20 mg Cialis or placebo for 12 weeks) and their female partners were analyzed from four double-blind, placebo-controlled trials involving more than 700 couples. Effectiveness and satisfaction were evaluated by the average percentage of "yes" responses to the Sexual Encounter Profile (SEP) diary questions for the patient (SEP Q1, Q2, Q5 dealing with erection achievement, penetration ability and overall satisfaction with the sexual experience, respectively) and the corresponding questions for his partner (SEP Q1, Q2, Q3) dealing with erection achievement, penetration ability and overall satisfaction with sexual experience, respectively). Patients also were asked to indicate whether their erection lasted long enough to have sexual intercourse (SEP Q3). For each couple, the number of attempts in which the couple agreed on an outcome (positive or negative) was tabulated and divided by the total number of attempts; the average percentage of agreement for all couples was then calculated. The SEP is a patient self-administered diary that is completed after each sexual encounter.
According to the analysis, there was a significant increase in "overall satisfaction" among couples who had successful intercourse (positive patient response to SEP Q3) after taking 20 mg Cialis. Eighty-two percent of women and 72 percent of men reported overall satisfaction with their sexual experience based upon positive responses to patient SEP Q5 and partner SEP Q3 (were you satisfied overall with this sexual experience). Among couples in the placebo group who had successful intercourse, 66.1 percent of women and 43.7 percent of men reported increased overall satisfaction with their sexual experience.
In the analysis of all patients entered into the study, for patients on 20 mg Cialis, positive responses to (SEP Q5 - overall satisfaction with sexual experience) increased from 5 percent to about 43 percent versus from 7 percent to about 14 percent for placebo. For the partners of patients on 20 mg Cialis, the positive responses to the corresponding question (SEP Q3) increased from 21 percent to about 53 percent versus from 19 percent to about 24 percent for placebo. About 68 percent of intercourse attempts, with the patient on 20 mg Cialis, resulted in successful penetration, as confirmed by both the patients and their partners, versus approximately 45 percent for placebo. There was a very high degree (more than 85 percent) of agreement in the responses (positive or negative) of the couple with regard to all of the questions analyzed.
Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than 3 million patients worldwide have been treated with Cialis since its first introduction in February 2003. Cialis is available by prescription only.
The most commonly reported adverse events with Cialis are headache, upset stomach, nasal congestion, backache, muscle ache, dizziness and flushing. The adverse events reported with Cialis were transient and generally mild or moderate. As with other PDE5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates or for those who have cardiac disease and for whom sexual activity is not advisable.
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. As of 2004, it is estimated that approximately 189 million men worldwide will report having ED(3). Experts believe that 80 to 90 percent of ED cases are related to a physical or medical condition, like diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 to 20 percent are due to psychological causes(4,5). In many cases, however, both psychological and physical factors contribute to the condition(6).
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq: ICOS) and Eli Lilly and Company (NYSE: LLY), developed tadalafil for the treatment of erectile dysfunction.
Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is marketing its product, Cialis (tadalafil), through Lilly ICOS LLC. ICOS is working to develop treatments for serious unmet medical conditions such as chronic obstructive pulmonary disease, cancer and inflammatory diseases.
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by the management of ICOS and Lilly. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological, legal and other factors discussed in the two companies' respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies and Lilly ICOS. Results and the timing and outcome of events may differ materially from those expressed or implied by the forward-looking statements in this press release. More specifically, there can be no assurance that Cialis will achieve commercial success or that competing products will not pre-empt market opportunities that might exist for the product.
(1) Cialis(R) is a registered trademark of Lilly ICOS LLC. All other trademarks are the property of their respective owners.
(2) Viagra is a registered trademark of Pfizer. All other trademarks are the property of their respective owners.
(3) Data were extrapolated from Feldman HA, Goldstein I, Hatzicheristou DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study, Journal of Urology. Vol. 151, 54-61, January 1994 and World Population Projection Program Of United Nations (2002 Revision) with indirect standardization.
(4) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington.
(5) Diseases and Conditions: Impotence, http://www.impotence.org/FAQ/index.asp. Data accessed 11.20.03
(6) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813
ots Originaltext: Lilly ICOS LLC
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Jane Calloway of Lilly, +1-317-651-5870; or Lacy Fitzpatrick of ICOS,
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