Item #7
Tadalafil
Safe and Effective in Impotent Diabetic Men
64%
of men reported improved erections.
The
phosphodiesterase type 5 (PDE5) inhibitor tadalafil is effective in
the treatment of erectile dysfunction in men with diabetes, according
to researchers in North America and Spain.
Dr.
Inigo Saenz de Tejada of Fundacion para la Investigacion y el
Desarrollo en Andrologia, Madrid, and colleagues note that as many as
75% of diabetic men may experience such dysfunction at some point. The
risk has been estimated to be almost twice that of the general
population.
Tadalafil,
they also observe, is a potent selective inhibitor of PDE5 in
development for oral treatment of mild-to-severe erectile dysfunction
of psychogenic, organic or mixed etiology. Blockade of PDE5
potentiates the nitric oxide-mediated erectile response.
To
determine the drug's safety and efficacy in men with type 1 or type 2
diabetes, the researchers enrolled 216 such subjects with erectile
dysfunction for at least 3 months. They were randomized in a
double-blind fashion to tadalafil 10 mg or 20 mg taken as needed no
more than once daily, or to placebo.
Among
the 191 men who completed the study, there was a significant
improvement over baseline as measured by responses to questionnaire on
erectile function and in entries in a sexual encounter diary. The
results were not associated with the baseline level of dysfunction.
In
all, 64% of men in the 20-mg group reported improved erections, as did
56% of those in the 10-mg group. Both of these improvements were
significantly greater (p < 0.001) than that experienced by men in
the placebo group (25%).
The
researchers observe that tadalafil was well tolerated, did not alter
mean hemoglobin A1c levels and significantly enhanced erectile
function. This was the case, they point out, "when taken as
needed with no restrictions on either food or alcohol intake or the
timing of dose administration."
Diabetes
Care 2002;25:2159-2164
================================
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