The effect of tadalafil on the time to exercise-induced myocardial ischaemia in subjects with coronary artery disease.
OBJECTIVE
To investigate the effect of tadalafil on the time to exercise-induced myocardial ischaemia in subjects with coronary artery disease (CAD). Background CAD and erectile dysfunction (ED) share similar risk factors. It is important to know the cardiovascular effects of tadalafil in patients with CAD during physical exertion that is comparable with sexual activity.


METHODS
A randomized, placebo-controlled, double-blind, two-period, crossover study comparing the effects of tadalafil 10 mg and placebo on the time to exercise treadmill test (ETT)-induced myocardial ischaemia in subjects with stable CAD (n = 23; age range: 53-75 years, all exhibited ST-segment depression >1.5 mm at screening ETT at > 5METS). Haemodynamic responses to sublingual nitroglycerin (NTG) were assessed before and after ETT.


RESULTS
Compared with placebo, tadalafil did not significantly affect the time to ETT-induced ischaemia (13 min/31 s vs. 13 min/36 s, respectively). Before exercise, NTG evoked decreases in sitting systolic blood pressure (SBP) that were significantly greater when subjects received tadalafil compared with placebo, and after exercise, more subjects experienced a decrease in SBP <85 mmHg in response to NTG after taking tadalafil vs. placebo. When subjects received tadalafil compared with placebo, SBP was lower at rest (-7 mmHg; -12,-2), during ETT (-10 mmHg; -16, -3), and after ETT (-13 mmHg; -19, -7).


CONCLUSIONS
Tadalafil did not significantly alter the time to ETT-induced ischaemia compared with placebo in subjects with CAD. Tadalafil reduced resting and exercise SBP. Due to the potential for hypotension, the concomitant use of nitrates and tadalafil is contraindicated.
Patterson
Dean
D
Hypertension Research Centre, Department of Medicine and Therapeutics, Ninewells Hospital and Medical School, Dundee University, Dundee DD1 9SY, Scotland, UK. d.patterson@dundee.ac.uk
Kloner
Robert
R
Effron
Mark
M
Emmick
Jeffrey
J
Bedding
Alun
A
Warner
Margaret
M
Mitchell
Malcolm
M
Braat
Simon
S
MacDonald
Thomas
T
D000368:Aged; D000704:Analysis of Variance; D001794:Blood Pressure / Q000187:drug effects; D002243:Carbolines / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000150:complications* / Q000503:physiopathology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D005996:Nitroglycerin / Q000627:therapeutic use; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D000068581:Tadalafil; D014665:Vasodilator Agents / Q000627:therapeutic use
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D014665:Vasodilator Agents; D000068581:Tadalafil; D005996:Nitroglycerin