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This study was designed to obtain data in a ‘real world’ clinical setting about treatment preference and satisfaction of both men and their partners when they switched from one treatment to another.

The study was conducted at 266 research sites across Canada and involved >2,600 patients who signed up and >2,400 patients and >320 partners who completed both visits. Patients who planned to change treatment from either sildenafil or Cialis to the other drug were invited to participate. Their level of satisfaction with their existing treatment was measured using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire, both patient and partner versions, at their first physician visit.

Treatment preference by patients and their partners was measured at the second visit together with physician-rated patient preference. More than 98% of the patients completed the study.

While overall treatment satisfaction scores were higher for Cialis than sildenafil, the level of satisfaction was pronounced amongst partners, suggesting that the benefits of Cialis are particularly appealing to this group.

“In treatment of men with erectile dysfunction, the goal is to find a treatment that works well and, more importantly, satisfies both patients and their partners,” said Dr. Carrier, Urologist, CUSM-Royal Victoria Hospital. “This study may provide Canadian physicians with a stronger understanding of patient and partner preference and satisfaction levels. The information gained by these findings may assist physicians to help men and their partners find the treatment option that works best for them.”

Recent guidelines by the American Association for Clinical Endocrinologists recommend that partners be involved in treatment decisions and early on in the process[1] Guay et al. Endrocin Pract, 2003.[1]. In this study, it was found that almost three quarters of men informed their partner of their use of an ED treatment but only 12% of partners actually participated in the consultation process with the physician.

The first presentation of large-scale integrated analysis of Phase III data on CialisÔ (tadalafil), a new oral treatment for erectile dysfunction (ED) being developed by Lilly ICOS LLC, shows a consistent response to the investigational treatment.
Eighty-one percent of patients treated with 20 mg Cialis (n=165) reported improved erections (1). This analysis, taken from studies of 972 men with ED (711 Cialis, 261 placebo), and other new research - including a study that shows Cialis’s absorption was not decreased by food intake (2) - were presented today at the 4th Congress of the European Society for Sexual and Impotence Research (ESSIR) in Rome.

“With each new data analysis, we continue to see consistent and robust scientific evidence that Cialis has an attractive profile,” said Charles Beasley, M.D., medical director, Eli Lilly and Company. “The many findings from these Phase III analyses suggest Cialis has the potential to be a valuable treatment for a large number of men who have ED, regardless of severity. Cialis has other attributes that may also be clinically important.”

Several studies were conducted to evaluate Cialis absorption by the body. Pharmacokinetic studies are important because they can identify differences in drug absorption and elimination in the body between various patient populations. These studies investigated, among other characteristics, the impact of age, diabetes, renal function, and liver function on the pharmacokinetics of Cialis. There were no clinically significant differences in extent of drug exposure among these diverse groups. In addition, Cialis’s absorption was not decreased by food intake (3).

“These findings suggest that dosing for Cialis should be simple and uncomplicated, which is important from a health care professional standpoint,” said Hartmut Porst, associate professor of the urological department of the medical university in Bonn, Germany, and secretary general of the ESSIR. “From a patient’s point of view, it is the absence of food effect that I find most interesting. These data suggest that a man can have a normal, romantic dinner with his partner without diminishing the effect of Cialis.”

The integrated Phase III analysis included randomised, placebo-controlled studies involving

972 men with ED of various causes and severity. Men were treated with Cialis (ranging up to

20 mg) or placebo for 12 weeks. Improved erections, as assessed by the Global Assessment Questionnaire (GAQ), were reported by 81 percent of patients taking 20 mg Cialis (35 percent placebo) (4).

The Phase III integrated analysis showed Cialis improved erections in 76 percent of the subset of men with diabetes taking a 20 mg dose (5). Diabetes-related ED is often more difficult to treat than ED caused by other factors. Erectile dysfunction is a common complication of diabetes, affecting between 27 and 75 percent of men with the disease (6). The World Health Organization estimates 151 million people worldwide have diabetes (7).

In the Phase III studies, participants were instructed to take study medication at the time of their choosing prior to sexual activity, with no more than one dose daily. No instructions were given with regard to food or alcohol consumption and time of dosing.

More than 4,000 men have participated in more than 60 studies that characterized the safety and efficacy profile of Cialis. In primary efficacy studies involving 1,112 men (804 Cialis, 308 placebo) with mild to severe ED, up to 81 percent of those treated with Cialis reported improved erections compared with 35 percent of those taking placebo1.

The most commonly reported adverse events were 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. It should not be taken by patients with certain heart diseases for whom sexual activity itself is not advisable.

Cialis is not approved for sale in the United States. Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002.