New Analysis Shows Men Treated With Cialis(R) for ED Report Significant Satisfaction With Quality of Erection and Overall Sexual Experience

    London (ots/PRNewswire) -

    - Spontaneity and Self-Confidence Cited as Reasons Why Men Preferred Cialis In Second Study

    A recent analysis demonstrated that 80 percent of men who took 20 mg Cialis(R)(1) (tadalafil) for the treatment of erectile dysfunction (ED) and had successful intercourse reported satisfaction with the hardness of their erection, and 76 percent indicated satisfaction with their overall sexual experience with the drug. The data were released here today at the 7th Annual Congress of the European Society for Sexual Medicine (ESSM).

    "As we see from this data, men who use Cialis to treat their ED continue to be satisfied with the way the product works and the results it provides them," said Professor Hartmut Porst, lead investigator, private urological/andrological physician in Hamburg, Germany, and associate professor of urology at the University of Bonn. "Specifically, that men report such satisfaction with the quality of their erections and their overall sexual experience when using Cialis continues to be encouraging."

    Analysis Design and Results

    The data are from an integrated analysis of 11 double-blind, placebo-controlled, randomized ED clinical trials that included 2,102 men receiving either 10 mg Cialis, 20 mg Cialis or placebo. After each time a trial participant engaged in sexual activity, he filled out a Sexual Encounter Profile (SEP)(2) diary, which included questions about achievement of successful sexual intercourse (SEP 3), satisfaction with the hardness of his erection (SEP 4), and satisfaction with the overall sexual experience (SEP 5). Data were only analysed on SEP 4 and SEP 5 when the response to SEP 3 was positive.

    Following positive responses to SEP 3, 80 percent of men who took 20 mg Cialis (N=1,006) and 66 percent of men who took 10 mg Cialis (N=266) responded that they were satisfied with the hardness of their erection compared with 52 percent taking placebo (N=399, p<.001). Further, 76 percent of men taking 20 mg Cialis and 63 percent of men taking 10 mg Cialis indicated satisfaction with their overall sexual experience compared with only 48 percent taking placebo (p<.001). The most common side effects were headache, upset stomach and back pain.

    Patient satisfaction is supported by another study in which 544 patients of Eastern European and Mediterranean descent who had been taking Viagra(R) (sildenafil citrate) for six weeks or more continued on Viagra for another four weeks and then switched to Cialis for an eight-week treatment period. During the final four weeks of each treatment arm, sexual attempt patterns were assessed from patient diaries, specifically looking at the areas of preference between the two products, time concerns, spontaneity, and sexual self-confidence. These last three concepts were measured using the validated questionnaire, Psychological and Interpersonal Relationship Scales (PAIRS, scale range 1-4).(3) Men then continued on their treatment of choice during an extension phase.

    In the study, 83.5 percent of men preferred Cialis to Viagra. Investigators noted that once men began to take Cialis, they also began to take advantage of the up-to-36-hour extended time period Cialis offers. The median time between when men took their medication until they attempted intercourse changed 1.92 hours (1.08 hours when men took Viagra compared with 3.00 hours when men took Cialis). There was also a 40.2 percent increase in the number of men who attempted intercourse at a time point beyond four hours between the two groups (79 percent of men taking Cialis attempted intercourse beyond four hours compared with 38.8 percent of men taking Viagra). Further, once men began to use Cialis, there was a 24 percent increase in the number of men who attempted intercourse beyond 12 hours (50.6 percent of men taking Cialis compared with 26.6 percent of men taking Viagra).

    Results from the PAIRS evaluations were equally illuminating. On a scale of one to four, time concern scores significantly decreased from 2.55 when subjects took Viagra to 2.33 when they took Cialis. Also, sexual spontaneity scores rose (2.94 on Viagra compared with 3.03 on Cialis) as did sexual self-confidence scores (2.61 on Viagra compared with 2.80 on Cialis, all p<0.0005). All changes in scores were statistically significant, an important distinction when measuring scores of such low proportion, and all indicate that men responded better when taking Cialis. The proportion of patients reporting one or more treatment-related side effects during Viagra and Cialis assessment periods were 8.9 percent and 5.7 percent, respectively.

    About Cialis

    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.

    About ED

    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.(4) Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are due to psychological causes.(5,6) In many cases, however, both psychological and physical factors contribute to the condition.(7)

    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.

    ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is marketing its first product, Cialis (tadalafil), through Lilly ICOS LLC. ICOS is working to develop treatments for serious unmet medical conditions such as chronic obstructive pulmonary disease, benign prostatic hyperplasia, 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.

@@start.t1@@      (1) Cialis(R) is a registered trademark of Lilly ICOS LLC. All other
            trademarks are the property of their respective owners.
      (2) Sexual Encounter Profile - SEP is a self-administered patient diary
            completed by clinical trial participants after each sexual encounter.
      (3) PAIRS is an internationally validated patient questionnaire used to
            measure behavioural, psychological and relationship outcomes
            associated with ED and its treatment.
      (4) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou
            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.
      (5) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
            Intimacy. New York: Kensington.
      (6) Diseases and Conditions: Impotence,
   . Data accessed 11.20.03.
      (7) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.@@end@@

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