Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.
Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly). For other men, Cialis taken as needed - the previously approved dosing regimen - may be most appropriate.
In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy.
"ED can be a chronic condition like diabetes or high blood pressure," said Ridwan Shabsigh, M.D., Director of the Division of Urology at Maimonides Medical Center in New York. "As a urologist, I know couples like to have choices and will appreciate the availability of Cialis for once daily use."
Cialis for use as needed transformed the U.S. ED market when it was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use provides a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them.
"We strive to provide patients with solutions that fit their needs and Cialis for once daily use delivers on this promise," said Shawn Heffern, Cialis U.S. Director of Brand Marketing at Lilly. "Now, patients have two options - some may prefer the up to 36 hours of efficacy provided by Cialis for use as needed while others may want the unique benefit provided by this daily dosing option."
Additionally, Lilly's wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed should not experience higher treatment costs with Cialis for once daily use.
The FDA's approval of Cialis for once daily use was based upon the evaluation of the comprehensive data package for the daily dosing option. The data include results from three phase III randomized, double-blind, placebo- controlled studies. Men with ED who participated in these clinical studies and who took tadalafil 2.5 mg and 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function compared with those taking placebo.(2) Cialis 5 mg, 10 mg and 20 mg have been approved in the United States for as-needed treatment of ED since November 2003.
The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse events reported with tadalafil were transient and generally mild or moderate.
Monday, January 28, 2008
Wednesday, January 23, 2008
ED drugs prove effective, safe for men with diabetes. Part 2.
Taken an hour before sexual activity, PDE-5 inhibitors work by enhancing the effects of nitric oxide, a chemical that relaxes smooth muscles in the penis during sexual stimulation and allows increased blood flow.
"PDE-5 inhibitors have been considered the mainstay of treatment for erectile dysfunction in the general population for many years," said Vardi. "Diabetics are prone to this complication, and the etiology of their erectile dysfunction is multifactorial, thus making their treatment a special challenge for physicians and other health care professionals."
No deaths were reported in any of the included trials; the most common side effects for men in the treatment groups were headache, flushing and upper respiratory tract complaints and flu-like symptoms. The overall risk for developing any adverse reaction was 4.8 times higher in the PDE-5 group than in the control group.
As with any drug therapy, the Cochrane reviewers caution that men should use PDE-5 inhibitors only as directed by their physicians.
"These drugs can be taken on an 'as needed' basis, as their half-life spans from several hours to 48 hours at most," said Vardi. "Patients should also consult their physicians for drug-drug interactions and specific contraindications."
While this review supports the short-term safety of these medications for men with diabetes, experts say as yet there is no concrete evidence whether these medications are safe for the long term.
"I prescribe PDE-5 inhibitors every day to people with diabetes," said John Buse, M.D., director of the Diabetes Care Center at the University of North Carolina School of Medicine. "But whether they are safe [in the long term] is the essential quandary of all medical care. We make our best guesses based on imperfect information, hopes and fears. And then we monitor progress. I am impressed that patients with diabetes in my practice in 2006 are living much better lives and perhaps longer lives than they did 10 years ago."
"PDE-5 inhibitors have been considered the mainstay of treatment for erectile dysfunction in the general population for many years," said Vardi. "Diabetics are prone to this complication, and the etiology of their erectile dysfunction is multifactorial, thus making their treatment a special challenge for physicians and other health care professionals."
No deaths were reported in any of the included trials; the most common side effects for men in the treatment groups were headache, flushing and upper respiratory tract complaints and flu-like symptoms. The overall risk for developing any adverse reaction was 4.8 times higher in the PDE-5 group than in the control group.
As with any drug therapy, the Cochrane reviewers caution that men should use PDE-5 inhibitors only as directed by their physicians.
"These drugs can be taken on an 'as needed' basis, as their half-life spans from several hours to 48 hours at most," said Vardi. "Patients should also consult their physicians for drug-drug interactions and specific contraindications."
While this review supports the short-term safety of these medications for men with diabetes, experts say as yet there is no concrete evidence whether these medications are safe for the long term.
"I prescribe PDE-5 inhibitors every day to people with diabetes," said John Buse, M.D., director of the Diabetes Care Center at the University of North Carolina School of Medicine. "But whether they are safe [in the long term] is the essential quandary of all medical care. We make our best guesses based on imperfect information, hopes and fears. And then we monitor progress. I am impressed that patients with diabetes in my practice in 2006 are living much better lives and perhaps longer lives than they did 10 years ago."
Friday, January 18, 2008
ED drugs prove effective, safe for men with diabetes. Part 1.
Popular drugs used to treat erectile dysfunction -- Viagra, Levitra and Cialis -- are safe and effective for men with diabetes, a new review has found.
The introduction of the medications known as phosphodiesterase type 5 (PDE-5) inhibitors to the market has changed the way physicians manage their patients with erectile dysfunction. The drugs have been shown to be quite effective in treating the condition in the general population and the number of men requesting them has soared in recent years.
The aim of the systematic review, however, was to determine whether PDE-5 inhibitors such as sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) are also a safe and effective option for men with diabetes. Although diabetes can causes a variety of other chronic complications, such as heart disease and high blood pressure, PDE-5 inhibitors were shown not to cause many
adverse reactions in this group.
At the end of the studies, men who took PDE-5 inhibitors showed improvements on all measures of erectile function, with an average difference of 26.7 percent more "successful intercourse attempts" compared to placebo groups.
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.
"The results of our meta-analysis are not surprising, but give strength to the general notion that this class of drugs is efficient and safe for this specific wide population," said lead author Moshe Vardi, M.D., with the internal medicine division at Lady Davis Carmel Medical Center in Israel.
The Cochrane reviewers analyzed eight studies that compared the effectiveness of the three PDE-5 medications to placebo. A total of 1,759 men were recruited -- with roughly half randomized to receive PDE-5 inhibitor therapy and the rest to the placebo group.
Overall, 80 percent of the participants had type 2 diabetes and the others had type 1 diabetes.
Most of the studies lasted for 12 weeks, with no significant differences among treatment groups with regard to age, medical history, other prescribed medications or severity or duration of diabetes or erectile dysfunction.
Erectile dysfunction is defined as the repeated inability to get or maintain an erection firm enough for sexual intercourse. According to the National Institute of Diabetes and Digestive and Kidney Diseases, men who have diabetes are three times more likely to have erectile dysfunction than men who do not have diabetes.
The introduction of the medications known as phosphodiesterase type 5 (PDE-5) inhibitors to the market has changed the way physicians manage their patients with erectile dysfunction. The drugs have been shown to be quite effective in treating the condition in the general population and the number of men requesting them has soared in recent years.
The aim of the systematic review, however, was to determine whether PDE-5 inhibitors such as sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) are also a safe and effective option for men with diabetes. Although diabetes can causes a variety of other chronic complications, such as heart disease and high blood pressure, PDE-5 inhibitors were shown not to cause many
adverse reactions in this group.
At the end of the studies, men who took PDE-5 inhibitors showed improvements on all measures of erectile function, with an average difference of 26.7 percent more "successful intercourse attempts" compared to placebo groups.
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.
"The results of our meta-analysis are not surprising, but give strength to the general notion that this class of drugs is efficient and safe for this specific wide population," said lead author Moshe Vardi, M.D., with the internal medicine division at Lady Davis Carmel Medical Center in Israel.
The Cochrane reviewers analyzed eight studies that compared the effectiveness of the three PDE-5 medications to placebo. A total of 1,759 men were recruited -- with roughly half randomized to receive PDE-5 inhibitor therapy and the rest to the placebo group.
Overall, 80 percent of the participants had type 2 diabetes and the others had type 1 diabetes.
Most of the studies lasted for 12 weeks, with no significant differences among treatment groups with regard to age, medical history, other prescribed medications or severity or duration of diabetes or erectile dysfunction.
Erectile dysfunction is defined as the repeated inability to get or maintain an erection firm enough for sexual intercourse. According to the National Institute of Diabetes and Digestive and Kidney Diseases, men who have diabetes are three times more likely to have erectile dysfunction than men who do not have diabetes.
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