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Clinical trials conducted with tadalafil show it to be safe and generally
well tolerated. The most common treatment-emergent adverse events
reported in men receiving 20 mg of tadalafil are headache and dyspepsia,
which are mild or moderate in severity and transient in nature (18). Flushing
and myalgia have also been reported to occur with somewhat greater
frequency among men taking tadalafil than among those receiving placebo, but the incidence of flushing and myalgia among 804 men
taking up to 20 mg of tadalafil was 5% or less (Table 2). A similar profile of adverse events was observed in men with comorbid
diabetes. In these men, only dyspepsia occurred with significantly greater
frequency in men taking tadalafil (11%) than in men taking placebo (0%)
(p < 0.005). No clinically significant changes in the electrocardiogram,
vital signs, or blood chemistry have been observed with tadalafil.
Notably, there has been only one report of visual disturbance, consisting of
abnormal color vision, among men receiving tadalafil. As discussed
earlier, tadalafil lacks selectivity for the PDE6 isoenzyme, which may
explain the low incidence of visual disturbances. For this reason, tadalafil
as a therapy for ED has been suggested as an option in patients with retinopathy. In addition, no visual disturbances were reported among men
with comorbid diabetes, including those with diabetic retinopathy.

The recommended starting dose of tadalafil in most patients is 10 mg,
taken before anticipated sexual activity. The dose may be increased to
20 mg or decreased to 5 mg once per day, based on individual efficacy
and tolerability. No dose adjustment of tadalafil is required in patients
older than 65 yr age, in patients with diabetes, or in patients with mild
renal insufficiency.

Diabetes is a common comorbidity in men with ED. Several studies
have explored the effectiveness of tadalafil in this patient population. One study investigated men (n = 216) with type 1 or type 2 diabetes. Most men
in this study had moderate to severe ED (72%) and a diagnosis of type 2
diabetes (>90%), with more than 80% having only fair (HbA1C > 7.0–9.5%)
to poor (HbA1C > 9.5%) diabetes control. Nearly 40% of the patients also
had hypertension; 22% had microvascular complications, including retinopathy
or neuropathy; and 18% had hypercholesterolemia. Patients were
eligible whether or not they had responded to previous ED therapy, including
sildenafil.
As in studies of the general population of men with ED, studies of men
with comorbid diabetes (n = 216) benefited from using tadalafil. The erectile
function in most men improved significantly, with more than a six-point
(with 10 mg) or seven-point (with 20 mg) increase in scores for the EF
domain of the IIEF (compared with a 0.1 increase for placebo [p < 0.001])
at end point. Both doses of tadalafil, 10 and 20 mg, were superior to placebo
in improving successful vaginal penetration (SEP Q2). The end points
(change from baseline) were 30% (–4%), 57% (22%), and 54% (23%) for
placebo, 10 mg of tadalafil, and 20 mg of tadalafil, respectively.
Similarly, end-point scores for successful intercourse attempts (SEP
Q3) were more pronounced in patients receiving 20 mg of tadalafil, (51%)
or 10 mg (44%), vs 16% for those taking placebo (p < 0.001).
By the end of the 12-wk treatment period, 56% and 64% of men taking
10 and 20 mg, respectively, of tadalafil, compared with 25% receiving placebo, responded positively to the GAQ (p < 0.001). These benefits were
observed irrespective of the level of diabetes control. Many of the
patients in this study had long-standing, fairly advanced diabetes, and,
given the level of morbidity of the patient population, the effects of tadalafil
were clinically noteworthy.