Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples
May 06 2009 - 7:00AM
PR Newswire (US)
Data Published in May Issue of Journal of Sexual Medicine
INDIANAPOLIS, May 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) today announced results from a double-blind,
placebo-controlled study which showed that tadalafil 5 mg dose
taken once daily was generally well-tolerated, improved erectile
function for men with erectile dysfunction (ED) and reported
improvement in the sexual quality of life scores for men and their
female partners. The 12-week study monitored 342 men and their
partners, using several scientific questionnaires to assess changes
in erectile function and sexual quality of life before and after
treatment with a tadalafil once daily dose. The study appears in
the May issue of the peer-reviewed Journal of Sexual Medicine.
"This is the first study of tadalafil 5 mg once daily dose in the
treatment of men with ED in which the female partner reported
improvement in sexual quality of life scores," said lead
investigator Eusebio Rubio-Aurioles M.D., Ph.D. "The sexual quality
of life scores also improved among males being treated. In
addition, this study showed that daily dose of tadalafil is
effective and generally well tolerated in the treatment of erectile
dysfunction." Study Findings The 16-week double-blind, multicenter,
randomized study followed 342 men with a minimum three-month
history of ED, as well as their female partners who had adequate
sexual function as measured by the Female Sexual Function Index
(FSFI). Male candidates were excluded from the study if they: 1)
had previously used tadalafil; 2) experienced ED as a result of
other primary sexual disorders or related surgeries; 3) had a
history of other medical conditions or treatments that could
negatively impact erectile or cardiovascular function; or 4) had
found other phosphodiesterase-5 (PDE5) inhibitor treatments to be
ineffective in treating ED. The 26 investigation sites were located
in Austria, France, Germany, Mexico and the United States. In the
first, four-week run-in phase of the study, men remained ED
treatment-free and were asked to make a minimum of four sexual
attempts with their partners. In the second, 12-week treatment
phase of the study, men were randomized to receive either a placebo
(N=78) or tadalafil 5 mg (N=264) taken once daily and were asked to
make at least one sexual attempt with their partner per week.
Subjects were evaluated throughout the study using the
International Index of Erectile Function (IIEF) Erectile Function
(EF) Domain,(1) Sexual Encounter Profile (SEP) diary(2) and the
Sexual Quality of Life (SQoL) domain of the Sexual Life Quality
Questionnaire (SLQQ).(3) Each couple's responses were captured at
entry, the end of each phase and following each sexual attempt.
Changes in vital signs were also monitored to evaluate safety.
Results showed that tadalafil 5 mg taken daily significantly
improved erectile function according to changes from baseline
measured by the IIEF and SEP. The average increase from baseline to
endpoint in the IIEF-EF domain was 7.9 points in the tadalafil
group, compared with 0.7 points in the placebo group. Men in the
tadalafil group reported a 28.6 percent increase on average
(compared with 2.7 percent in the placebo group) in the ability to
achieve an erection sufficient for vaginal penetration. When asked
if their erections lasted long enough for successful intercourse,
men in the tadalafil group reported a 46 percent increase on
average in positive responses from baseline to endpoint, compared
with 10.8 percent in the placebo group. The study also reported a
significant improvement in the sexual quality of life scores for
men taking tadalafil once daily and their partners. The average
increase in SQoL scores from baseline to endpoint for men in the
tadalafil group was 39.5 points, compared with 12.5 point increase
in the placebo group. The average increase in SQoL scores for women
whose partners were in the tadalafil group was 32.4 points,
compared with 5 points in the placebo group. Tadalafil 5 mg was
generally well-tolerated, and the most frequently reported adverse
events were headache, dyspepsia and nasal congestion. Three
subjects in the tadalafil group discontinued their participation in
the study due to adverse events. About Cialis Cialis(R) (tadalafil)
is approved for the treatment of erectile dysfunction on an
as-needed basis or in a daily regimen. The recommended starting
dose of Cialis for use as needed in most patients is 10 mg, taken
prior to anticipated sexual activity. The dose may be increased to
20 mg or decreased to 5 mg, based on individual efficacy and
tolerability. As part of a daily regimen, Cialis may be taken as
2.5 mg or increased to 5 mg, based on individual efficacy and
tolerability. Important Safety Information for Cialis Cialis is
available by prescription only and is not for everyone. Men should
discuss their medical conditions and all medications with their
doctors to ensure Cialis is right for them and that they are
healthy enough for sexual activity. Men taking nitrates, often used
for chest pain, should not take Cialis. Such a combination could
cause a sudden, unsafe drop in blood pressure. Cialis for once
daily use provides continuous plasma tadalafil levels which should
be considered when evaluating the potential for interactions with
certain medications (e.g., nitrates, alpha-blockers,
anti-hypertensives and potent inhibitors of CYP3A4) and with
substantial amounts of alcohol. Cialis does not protect a man or
his partner from sexually transmitted diseases, including HIV. Men
should not drink alcohol in excess with Cialis. The most common
side effects with Cialis were headache, upset stomach, backache or
muscle ache. As with any ED tablet, in the rare event of priapism
(an erection lasting more than four hours), men should seek
immediate medical attention to avoid long-term injury. In rare
instances, men taking prescription ED tablets (including Cialis)
reported a sudden decrease or loss of vision, or a sudden decrease
or loss of hearing (sometimes with ringing in the ears and
dizziness). It's not possible to determine if these events are
related directly to the ED tablets or to other factors. If a man
has a sudden decrease or loss of vision or hearing, he should stop
taking any ED tablet including Cialis and seek medical attention
right away. For full patient information and/or full prescribing
information, visit http://www.cialis.com/ or call 1-877-4-CIALIS
About Erectile Dysfunction (ED) ED is defined as the consistent
inability to attain and maintain an erection sufficient for sexual
intercourse. As of 2004, it is estimated that approximately 189
million men worldwide will have ED.(4) Experts believe that 80 to
90 percent of ED cases are related to a physical or medical
condition, such as diabetes, cardiovascular diseases, and prostate
cancer treatment, while 10 to 20 percent are predominantly due to
psychological causes.(5, 6) In many cases, however, both
psychological and physical factors contribute to the condition.(7)
About Lilly Lilly, a leading innovation-driven corporation is
developing a growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers - through medicines and information - for
some of the world's most urgent medical needs. P-LLY (1) The IIEF
is a validated scale that assesses erectile function by measuring
treatment-related responses in patients. (2) The SEP diaries
contain five patient diary questions that allow patients to record
responses following sexual events. (3) The SQoL domain contains 10
questions that compare the current sexual experience with the
subject's experience prior to the onset of ED. (4) Data were
extrapolated from Feldman HA, Goldstein I, Hatzichristou DG, Krane
RJ. Impotence and its Medical and Psychosocial Correlates: Results
of the Massachusetts Male Aging Study, Journal of Urology. Vol.
151, 54-61, January 1994 and World Population Projection Program Of
United Nations (2002 Revision) with indirect standardization. (5)
Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim
Lost Intimacy. New York: Kensington. (6) Erectile Dysfunction,
http://kidney.niddk.nih.gov/kudiseases/pubs/impotence/. Data
accessed 09/28/07. (7) Lue, Tom F. Erectile Dysfunction. N Engl J
Med 2000; 342: 1802-1813. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGODATASOURCE: Eli
Lilly and Company CONTACT: Keri McGrath, Eli Lilly and Company,
+1-317-651-6001(office), +1-317-554-7928 (cell),
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