New Treatment For ED Effective
for Up to 36 Hours in Patients
It lasts up to 36 hours: take a pill on
a Friday evening and have intercourse on Saturday
night or Sunday morning, Tadalafil allows more
freedom in the timing of sexual activity.
Tadalafil was effective for up to 36 hours in
more than half of patients with erectile dysfunction
(ED), which was about twice the effect of placebo,
according to the results of a double-blind, randomized
trial published in the July issue of Urology.
The editorialists comment favorably on the role
of tadalafil in the therapeutic armamentarium
for ED.
"Tadalafil (Cialis, Lilly ICOS LLC...) is
a potent, reversible, and selective PDE5 inhibitor
for the treatment of ED. Compared with sildenafil
(Viagra, Pfizer), tadalafil has an extended terminal
half-life, 17.5 hours versus 3.7 hours, suggesting
a lengthened period of responsiveness," write
Hartmut Porst, a urologist in Hamburg, Germany,
and colleagues. "This was not a study of
efficacy per se or the time of maximum efficacy;
rather, it was designed to determine whether tadalafil
was associated with a treatment effect that could
be discriminated from the effect of placebo for
at least 24 and 36 hours."
In this European and U.S. multicenter, parallel-group
study of 348 men with ED, patients were stratified
by baseline severity of ED and then randomized
to receive tadalafil 20 mg or placebo. Subjects
were then randomized to two 4-week treatment intervals,
during which they were requested to attempt sexual
intercourse approximately 24 or 36 hours after
tadalafil or placebo dosing.
Of the 348 patients, 327 (94%) completed the trial,
including 163 of 175 in the tadalafil group and
164 of 173 in the placebo group. At 36 hours after
dosing, 59.2% of intercourse attempts were successful
(completed to ejaculation) in the tadalafil group
compared with 28.3% in the placebo group (P <
.001). At 24 hours, 52.9% of intercourse attempts
were successful in men receiving tadalafil compared
with 29.1% in men receiving placebo (P < .001).
"The advent of a pharmacologic agent such
as tadalafil, with a period of responsiveness
that begins soon after dosing and lasts up to
36 hours, may allow men and their partners more
freedom in the timing of their sexual activity,"
the authors write. "Unlike currently available
treatments, tadalafil may, for example, enable
a patient to take a pill on a Friday evening and
have intercourse with his partner on Saturday
night or Sunday morning. The broad therapeutic
coverage conferred by tadalafil, which can be
taken without restrictions on alcohol or food
intake, might translate to enhanced convenience
and simplicity of administration, traits that
are valued by men with ED."
Tadalafil was well tolerated, although treatment-emergent
headache, flushing, dyspepsia, and myalgia were
more common than in the placebo group (P <
.05 for all). There were no reported cardiovascular
events, or any clinically significant effects
of tadalafil on electrocardiographic findings,
heart rate, or blood pressure.
"Just how tadalafil will fit into our therapeutic
armamentarium vis-à-vis other PDE5 inhibitors
(and future remedies unknown) will not become
clear until the widespread use expected after
Food and Drug Administration approval," Leonard
S. Marks, MD, from Urological Sciences Research
Foundation in Culver City, California, writes
in an accompanying editorial. "[Its] convenience
must be weighed against the possibility of a lingering
undesirable effect in some men."
Dr. Marks notes that in Europe, where the drug
was approved in November 2002, the package leaflet
warns that men using organic nitrates and nitric
oxide donors, and men with serious heart disease,
recent stroke or myocardial infarction, and uncontrolled
blood pressure should not take tadalafil.
"It is noteworthy that the side-effect and
discontinuation profiles were modest and no greater
than those reported elsewhere with other PDE5
inhibitors with substantially shorter half-lives
of elimination," Arthur L. Burnett II, MD,
from Johns Hopkins Hospital in Baltimore, Maryland,
writes in an accompanying editorial. "Why
the medication affords a prolonged efficacy without
yielding greater severity or prolongation of adverse
effects is puzzling and remains unexplained....
Continued scientific investigation in the field
is absolutely necessary to understand the pathophysiologic
conditions associated with ED and to develop specific
therapies that are truly corrective." Urology.
2003;62:121-125, 125-126
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