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Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy.

Kloner, Morris Brown, L.Michael sildenafil teva 5343 Prisant, Mike Collins, for the Sildenafil Study Group, Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy, American Journal of Hypertension , Volume 14, Issue 1, January 2001, Pages 70–73, https://doi.org/10.1016/S0895-7061(00)01177-8.

Oral sildenafil is an effective treatment for erectile dysfunction (ED), which is a common complaint for patients with hypertension and those taking antihypertensive agents. This post hoc subanalysis assessed the efficacy and safety of sildenafil in men with ED who were receiving concomitant antihypertensive medication. Efficacy was assessed in 3414 men (1218 of whom were taking antihypertensive medication) who received sildenafil (5 to 200 mg) or placebo for 6 weeks to 6 months in 10 double-blind, placebo-controlled studies.

The significant improvements in erectile function demonstrated by sildenafil-treated patients were comparable in patients taking and those not taking antihypertensive medication.

Safety was assessed in 3975 men (1094 of whom were taking one or more antihypertensive agent, classified as a diuretic, ?-blocker, ? 1 -blocker, angiotensin converting enzyme inhibitor, or calcium channel blocker), who received sildenafil or placebo in 18 double-blind, placebo-controlled studies. For patients taking sildenafil and antihypertensive medication, the incidence of treatment-related adverse events (34%) was similar to that for sildenafil-treated patients not taking any antihypertensive agent (38%).

The incidences of the most common adverse events and of adverse events potentially related to blood pressure decreases (eg, hypotension, dizziness, and syncope) were similar in both sildenafil groups. The number of antihypertensive medications taken from among the five classes had no effect on the adverse event profile of sildenafil.

Sildenafil is an effective and well-tolerated

treatment

Am J Hypertens 2001;14:70–73 © 2001 American Journal of Hypertension, Ltd.

Erectile dysfunction (ED), the inability to achieve or maintain an erection sufficient for satisfactory sexual activity, 1 is a common problem in patients with hypertension and in those being treated with antihypertensive agents.

2, 3 In the Massachusetts Male Aging Study, a random sample survey of 1290 men aged 40 to 70 years, the age-adjusted prevalence of complete ED (no erections) was 15% in those with treated hypertension and 14% in those taking antihypertensive agents compared with a prevalence of 9.6% in the entire sample. Sildenafil, an orally active sildenafil teva 50 mg uses and selective inhibitor of cGMP-specific phosphodiesterase type 5, is an effective and well-tolerated treatment for ED of various causes.

4 By inhibiting the degradation of cGMP in the corpus cavernosum of the penis, sildenafil enables smooth muscle relaxation and penile erection in patients with ED.

The most common adverse events associated with sildenafil treatment are headache and flushing, 5 which reflect its modest vasodilating properties. 6 Oral sildenafil (100 mg) produces transient decreases in systolic (8 to 10 mm Hg) and diastolic (3 to 6 mm Hg) blood pressure in healthy male volunteers.

5 Peak decreases are observed 1 h after dosing and coincide with peak plasma concentrations of drug.

These changes in blood pressure generally return to pretreatment values by 4 to 8 h after dosing in healthy men.

6 This post hoc analysis assessed the efficacy and safety of sildenafil in men with ED who were receiving concomitant treatment with antihypertensive agents. Efficacy data were analyzed post hoc for groups of patients enrolled in 10 of 18 randomized, double-blind, placebo-controlled studies of sildenafil in the treatment of ED of various causes.

In these 10 studies that assessed efficacy with the same outcome measure, a total of 3414 patients, 1218 (36%) of whom were taking concomitant antihypertensive medication, were randomized to sildenafil (5 to 200 mg) or placebo for 6 weeks to 6 months. The patients enrolled were 18 years of age or older with a clinical diagnosis of ED of at least 6 months’ duration and in a stable relationship with a female partner for at least 6 months.

Patients were excluded if they had penile anatomic defects, a recent (within the previous 6 months) history of stroke, myocardial infarction, or life-threatening arrhythmia, a resting blood pressure 170/110 mm Hg, a known history of retinitis pigmentosa, any significant concomitant medical condition that would impair participation in the study, or were receiving regular treatment with nitrates or anticoagulants.

All patients provided written informed consent before enrollment.

The patients were instructed to take study medication approximately 1 h before sexual activity but not more than one dose daily. Safety data were analyzed for 3975 patients from 18 randomized, double-blind, placebo-controlled studies lasting from 6 weeks to 6 months, which included the 10 studies analyzed for efficacy data. In the 18 studies, of the 4274 patients randomized to sildenafil (5 to 200 mg) or placebo, 2881 ( n = 1837 sildenafil, n = 1044 placebo) were not taking any antihypertensive medication, 1094 ( n = 704 sildenafil, n = 390 placebo) were taking concomitant antihypertensive medication classified as a diuretic, ?-blocker, ? 1 -blocker, angiotensin converting enzyme inhibitor, or calcium channel blocker, and 346 ( n = 217 sildenafil, n = 129 placebo) were taking two or more of these classes of antihypertensive agent

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