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Tadalafil (Cialis) Can Significantly Improve Erections for Up to 36 Hours

TORONTO, ON -- June 23, 2004 -- A new analysis of data published in the June issue of British Journal of Urology shows that tadalafil (Cialis^®), a PDE5 inhibitor developed by Lilly ICOS for the treatment of erectile dysfunction (ED), improved erections and rates of successful intercourse attempts for up to 36 hours after taking the pill.

The authors of this manuscript, which contained a combined analysis of 11 separate tadalafil clinical trials involving more than 2,000 men, concluded that tadalafil is an effective and well-tolerated treatment option for many men with ED.

The British Journal of Urology is a peer-reviewed medical journal published monthly. It is the official journal of the British Association of Urological Surgeons, the Société Internationale d'Urologie and the European Society of Paediatric Urology.

The report includes data from 2102 men with mild-to-severe ED who participated in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. Participants were randomized to receive placebo or tadalafil taken as needed with or without food at doses of 10 mg or 20 mg.
· About 30% of men in each tadalafil group attempted intercourse between 24 and 36 hours after taking the tablet.
· On average, 73% of intercourse attempts by men in the 20 mg tadalafil group were successful from 24 to 36 hours after taking the tablet.
· Of patients who received 10 mg and 20 mg tadalafil, 71% and 84%, respectively, reported improved erections, compared with 33% in the placebo group (P <.001).

The most common side effects in these trials were headache, upset stomach and back pain. Most side effects were mild or moderate and generally decreased in frequency during treatment. The number of patients leaving the study due to side effects was low among patients taking each of the tadalafil doses (10 mg, 1.6%; 20 mg, 3.2%), though the discontinuation rate was slightly higher than among those in the placebo group (1.3%, P =.026). The men in the study were of the mean age of 56 years. In the study, 29% of the men with ED had hypertension, and 20% had diabetes.

About Cialis
Cialis, approved by Health Canada in September 2003, and available for the first time in Canadian pharmacies November 2003, is the first oral ED treatment shown to be effective for up to 36 hours after taking the drug. Cialis will not cause an erection without sexual stimulation. Cialis can be taken without regard to food¹.

Since its introduction into the Canadian market, Cialis has captured a significant share of new prescriptions. By the end of March 2004, Cialis captured 54.2% of new prescriptions written by Canadian urologists.² There are currently three medications approved for erectile dysfunction in the PDE5 inhibitor market in Canada.

Cialis is currently available in more than 60 countries, including Canada, Australia, Brazil, Mexico, the United States and countries throughout Europe. More than two million patients worldwide have been treated with Cialis since its first introduction in February 2003.

The most commonly reported side effects with Cialis are headache, upset stomach, nasal congestion, delayed backache, muscle ache, dizziness and flushing. The side effects 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.

References:
¹. Cialis® (tadalafil) Product Monograph. Toronto, ON: Eli Lilly Canada Inc.; September 2003.
2. IMS Health Canada, CompuScript Data, March 2004. Based on a selected market: Cialis, Viagra and Levitra.
3. Aytac 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.
4. Impotency Information from NIH. NIH Publication No. 03-3923, November 2002.


SOURCE: Lilly ICOS LLC.

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