Objectives: To determine the occurrence of clinically significant decreases in blood pressure (BP) with sildenafil use in normotensive and hypertensive men by means of ambulatory BP monitoring.
Methods: On 2 nights, 49 men (22 hypertensive, 27 normotensive) had their ambulatory systolic BP (SBP), diastolic BP (DBP), and heart rate monitored during the first 3 hours (waking period) and every 30 minutes after midnight for 3 additional hours (sleeping period). No medication was taken on one night; sildenafil 100 mg was taken on the other.
Results: Sildenafil decreased SBP (-6.0 mm Hg; P = 0.0003), DBP (-4.5 mm Hg; P = 0.001), and mean arterial pressure (-5.3 mm Hg; P = 0.00008). The BP-lowering effects of sildenafil did not differ significantly in the normotensive and hypertensive men. Age significantly affected the BP reductions; decreases in SBP, DBP, and mean arterial pressure were greater in men 49 years old and older than in those younger than 49 years old. According to readings averaged over the entire control and treatment periods, 22.7% of hypertensive men and 3.7% of normotensive men experienced SBP reductions of 20 mm Hg or greater (P = 0.08 for comparison of the two groups); the respective values for DBP were 9.1% and 3.7% (P not significant). These reductions were not associated with any hypotensive symptoms. All participants tolerated sildenafil well.
Conclusions: Sildenafil caused small, clinically insignificant reductions in ambulatory BP in active and resting normotensive and hypertensive men. The results of this study suggest that, when used in accordance with the prescribing information and current treatment guidelines, sildenafil should be safe in younger and older men with or without hypertension.