Is tadalafil safe in men with cardiovascular disease?

Tadalafil has an established safety profile  including its cardiovascular safety profile. In  the more than 12,000 patients who have been  exposed to tadalafil in clinical trials, the cardiovascular-  related adverse events have been  low and comparable to placebo-treated  patients [54].  In tadalafil studies, about 15% of patients  had hyperlipidemia, 20% had diabetes, and  about 30% had hypertension [54]. Extensive  evaluation of cardiac parameters did not  demonstrate any clinically relevant cardiac  events attributable to tadalafil. The incidence  of adverse events associated with cardiovascular  function (such as dizziness, syncope, or  chest pain) was low, and tadalafil was not  associated with an increased incidence of these  events.

Also, the incidence of myocardial  infarction in tadalafil clinical trials was 0.33  per 100 patient years, which is no higher than  that observed in the placebo-treated patients  in the same set of trials (0.41 per 100 patient  years) or in age-standardized male population  (0.6 per 100 patient years) [55–57].  For tadalafil, the following groups of  patients have not been studied: patients with  a myocardial infarction within the last 90  days, patients with unstable angina, or angina  occurring during sexual intercourse, patients  with New York Heart Association Class 2 or  greater heart failure in the last 6 months,  patients with uncontrolled arrhythmias, hypotension  (<90/50 mm Hg), or uncontrolled  hypertension (>170/100 mm Hg), and patients  with a stroke within the last 6 months. Thus,  tadalafil should not be prescribed to this  patient population.  Tadalafil has minimal effects on blood pressure  and heart rate in healthy subjects [58]. At a  dose of 100 mg, 5 times higher than the highest  recommended dose, there were no clinically  relevant effects of tadalafil on ventricular  repolarization as assessed by QTc interval measurement  [21,58]. Further, no adverse effects  on myocardial blood flow or time to ischemia  have been demonstrated in patients with coronary  artery disease taking tadalafil.