Every drug from the moment of its invention to the wide usage by lots of patients goes a long and rough way through the clinical tests and studies. Cialis (tadalafil) is not an exception. It was adopted by a joint venture Lilly ICOS LLC as a prescription pill for treatment of erectile dysfunction (ED) in men. In November 2003 it was approved by FDA. Nowadays it is used worldwide.
The very first study funded by Lilly ICOS itself was aimed in revealing the main benefits of the pill. The results were more than satisfactory. 348 men with mild to severe ED were given Cialis over eight weeks and asked to attempt an intercourse with a partner on two occasions 24 hours and 36 hours after taking a 20-miligram dose. About 59% of patients reported successful attempts to have sex even after 36 hours passed. Furthermore, the duration of effectiveness did not influence the severity of the side effects, which were mainly headaches and upset stomach. Nevertheless, only about 2% of subjects had to drop out of the study because of them.
This study was followed by two American and five international primary efficacy and safety studies of 12-weeks duration. They involved 4000 patients of different races and nationalities with different degree and etiology of ED, complicated with various conditions (diabetes, cardiovascular diseases, etc.). The age of the subjects ranged from 27 to 87. The dose of the pill varied from 2.5 to 20mg. Men took the pill when needed; they were not restricted in food or alcohol.
During the trials every patient had to fulfill Sexual Encounter Profile (SEP) with a number of questions a diary which reflected each sexual attempt. In all the cases the results showed a significant improvement of sexual activity.
Among the main side effects were: headache, dyspepsia, back and limb pain, nasal congestion, and flushing. Nevertheless, theses conditions did not need medical treatment and stopped in some time.
Taking into account these studies, FDA approved Cialis as an effective medication for ED treatment.
One more group of studies was conducted to determine the optimal use of Cialis. In one of them 223 patients were randomized to placebo, Cialis 10 or 20mg. Using a stopwatch, they recorded the time (after taking a pill) when an erection for a successful sexual intercourse was obtained. The results showed that sexual activity was successful in or prior to 30 minutes following the dose.
The results of the above mentioned studies inspired the patients so much that a great number of them within a year switched from other ED medications to Cialis. The main benefit, as independent studies report, is a chance to feel free in choosing the time for sexual activity, because the "weekend pill" works up to 36 hours.
What can we say? Well done! I believe many men now wait for the next breakthrough in the world of pharmacy. Maybe it will be a pill, which will help win the ED not for 36 hours but for good. Who knows
Ivanna
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