Columbia Presbyterian Center Researchers Determine VIAGRA(R) Offers Women Little Benefit
First Study to Focus on Drug's Effectiveness and Safety in Women
PR Wire
March 5, 1999, 12:03 p.m. ET
NEW YORK, March 5 /PRNewswire/ -- In the first evaluation of the effects
of Viagra(R) (sildenafil) on women, investigators at Columbia Presbyterian
Center of New York Presbyterian Hospital found that, unlike in men, the drug
offers little relief of sexual dysfunction.
The results of the nonrandomized study, published in the March 1999 issue
of "Urology," examined the safety and efficacy of Viagra(R) in 33
postmenopausal women with self-described sexual dysfunction of at least six
months' duration. Each of the study participants took 50 mg of Viagra(R) (the
same dose prescribed for men) approximately 1 hour prior to planned sexual
activity, but not more than once daily. All of the women were in stable,
monogamous relationships with male partners that had begun at least six months
earlier. Thirty women completed the study; the mean use of Viagra(R) was
about three times per week for the duration of the study.
The most common symptoms of sexual dysfunction reported by the study
participants included decreased arousal, decreased lubrication, diminished
orgasm, and inability to achieve orgasm.
Therapy effectiveness was evaluated at four, eight, and 12 weeks using a
newly developed nine-item self-administered Index of Female Sexual Function
(IFSF). The IFSF uses a numbered scale (1 = almost never; 5 = almost always
or always) to measure overall satisfaction with sexual function, orgasm,
lubrication, and clitoral sensation, as well as degree of lubrication and
clitoral sensation, and ability to achieve orgasm. In addition, women were
asked to assess whether treatment improved overall sexual function. Blood
pressure also was measured at each assessment visit, and patients were
questioned about any adverse reactions to Viagra(R).
The IFSF is patterned after the International Index of Erectile Function
(IIEF), a 15-question, validated, multidimensional, self-administered
questionnaire that is used for assessing erectile dysfunction in men.
Currently, there is no validated, widely accepted assessment tool for
sexual function in women.
"We found that there was no significant change either in intercourse
satisfaction or in the degree of sexual desire after the patients had taken
Viagra(R) for 12 weeks," says Steven A. Kaplan, M.D., who is the Given
Foundation Professor of Urology at the Columbia University College of
Physicians & Surgeons and the Director of the Prostate Center at the Squier
Urologic Clinic at the Columbia Presbyterian Center. Dr. Kaplan is also Vice
Chairman and Administrator of the Department of Urology and Director of
Neurourology at the Columbia Presbyterian Center.
"Even though about 25 percent of the patients had some improvement in
overall sexual function, that's equal to the placebo response in men receiving
Viagra(R). So that response might be a placebo effect rather than a true
improvement in sexual function due to the drug, although that remains to be
determined," notes Dr. Kaplan. "Men and women have fairly equivalent placebo
responses to other medications, so there is little reason to think that the
placebo response rate would be different for Viagra(R)."
Overall, only 21 percent of patients had a significant (greater than
60 percent improvement in IFSF) response. Although the mean scores for the
questions dealing with lubrication and clitoral sensation improved by 23 and
31 percent, respectively, those changes were not statistically significant.
The mean score for the question regarding orgasm improved by only 7 percent.
Furthermore, the changes in overall scores for lubrication, clitoral
sensation, and orgasm were not significantly different for women who were on
hormone replacement therapy versus those who were not. And only 20 percent of
patients wished to continue drug therapy after 12 weeks. While the
neurovascular events that accompany and result in erectile dysfunction in men
have been well described, the corollary mechanisms in women have not.
Unpublished preliminary data suggest that changes in both clitoral and vaginal
blood flow are related to aging and may be involved with sexual dysfunction in
women.
"Viagra(R) did appear to increase blood flow to the clitoris," says Dr.
Kaplan, "but this didn't seem to translate to increased sexual satisfaction.
Neither increased clitoral sensation or lubrication would be expected to be of
benefit to women with diminished desire to either initiate or respond to
sexual activity." In fact, clitoral discomfort and hypersensitivity occurred
in 7 of the patients, 3 of whom withdrew from the study. Other side effects
were minor (dizziness and headache) and did not cause withdrawal from the
study.
Dr. Kaplan cautions that while the Columbia Presbyterian Center study
shows little to support the use of Viagra(R) for postmenopausal women with
sexual dysfunction, it must be noted that only a small number of women were
evaluated and the follow-up was relatively short. In addition, the entry
criteria were completely subjective. "Our study does, however, point out the
need for a validated instrument to assess efficacy and sexual function in
women, as there is for men. Larger, long-term studies in both post- and
premenopausal women that look at different dosages and combinations with other
drugs are necessary to fully assess Viagra(R)'s safety and efficacy regarding
female sexual dysfunction," concludes Dr. Kaplan.
SOURCE Columbia Presbyterian Center
-0- 03/05/99
/CONTACT: Karin Eskenazi of Columbia Presbyterian Center, 212-305-5587/
/Web site: 1st; Largest; NYC; Hospital/
CO: Columbia Presbyterian Center
ST: New York
IN: HEA MTC
SU: PDT
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