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Tadalifil Appears Safe in Patients Taking One or More Antihypertensive Drugs

The phosphodiesterase 5 (PDE5) inhibitor tadalafil appears to be safe in patients who take 1 or more antihypertensive agents, conclude the authors of a new review article.

About 30% of men with erectile dysfunction (ED) have a history of hypertension, note Robert A. Kloner MD, PhD, Keck School of Medicine, University of Southern California, Los Angeles, United States and colleagues.

In their report, the authors summarise the haemodynamic effects of tadalafil when administered with commonly used antihypertensive therapies.

The studies reviewed included tadalafil administration during treatment with enalapril (angiotensin-converting enzyme inhibitor), metoprolol (beta-adrenergic antagonist), bendrofluazide (thiazide diuretic), amlodipine (calcium antagonist), and angiotensin II receptor blockers (ARBs).

In the studies with enalapril, metoprolol, and bendrofluazide, there were "no serious adverse events related to tadalafil administration," the authors note. "In addition, these studies demonstrate that, although blood pressure measurements were marginally lower when tadalafil was administered to subjects whose mild-to-moderate hypertension was controlled with enalapril, metoprolol, or bendrofluazide, these effects were minor and unlikely to be of clinical concern."

Likewise, in studies with tadalafil and amlodipine, a similar number of tadalafil-treated and placebo-treated subjects had reductions in ambulatory systolic and diastolic blood pressure during treatment with amlodipine, and none of these episodes was associated with cardiovascular adverse events.

With ARBs and tadalafil, mean ambulatory systolic and diastolic blood pressure measures were generally lower at all time points after administration of tadalafil compared with placebo. "Nonetheless, tadalafil was well tolerated when administered during treatment with an ARB, and there were no serious or severe adverse events related to reductions in blood pressure," they report.

Furthermore, their analysis of results from 6 placebo-controlled phase 3 studies suggests that tadalafil administered with 2 or more antihypertensive agents does not increase the occurrence of potentially clinically significant changes in blood pressure. In addition, cardiovascular events were reported in less than 1% of patients.

"Tadalafil, as with other PDE5 inhibitors, is a vasodilator that may augment the blood pressure-lowering effects of antihypertensive agents," Dr. Kloner and colleagues note. However, studies suggest that the blood pressure reduction observed is generally mild and does not increase hypotensive symptoms, they add.


Am J Cardiol 2003;92:47M-57M. "Cardiovascular effects of tadalafil in patients on common antihypertensive therapies"

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