It has long been known that erectile dysfunction (ED) often occurs in men with hypertension and receiving antihypertensive drugs. And, of course, the question immediately arises about the safety of the simultaneous use of Viagra (sildenafil citrate) and several antihypertensive drugs of different classes. In 1999, the American College of Cardiology and the American Heart Association’s Expert Consensus Document on the Use of Sildenafil in Patients with Cardiovascular Disease raised concerns for the first time. Since then, there have been several studies that have shown that the safety and efficacy profiles of Viagra are similar in patients not taking and taking antihypertensive drugs.
Additionally, the safety of sildenafil in the latter group of patients has been studied in a large clinical trial.
The objectives of the study were to assess the safety of sildenafil in men with ED and hypertension receiving multiple antihypertensive drugs of different classes, and to describe the potential differences between patients receiving two, three, or more than three different classes of antihypertensive drugs.
This prospective, double-blind, placebo-controlled, multicenter study featured flexible dosage of the test drugs. Its duration was 14 weeks: a two-week screening period, a six-week double-blind therapy phase, and a six-week open therapy phase with sildenafil. During the entire study, patients underwent 7 clinical visits: screening, baseline, two visits during the double-blind phase, and three during the open phase. The initial dose of the test drug was 50 mg, which could be reduced to 25 mg or increased to 100 mg depending on efficacy and tolerability. During the study, all objective and subjective side effects were recorded and their association with the test drug was assessed.
The study involved men with a stable sexual partner over the age of 18 years with diagnosed ED, that is, “inability to achieve and maintain an erection sufficient for satisfactory sexual intercourse.” Moreover, ED should be <21 points on the Sexual Health Inventory for Men (SHIM) scale. And to participate, men had to take two or more classes of antihypertensive drugs at stable doses for> 4 weeks to treat hypertension.
Men with arterial hypotension (<90/50 mm Hg) or arterial hypertension (> 170/110 mm Hg), with severe cardiovascular disease (heart failure, myocardial infarction, unstable angina pectoris, stroke) were excluded from the study. , symptomatic or clinically significant cardiac arrhythmias) in the previous 6 months. Also, no history of retinitis pigmentosa or recent prescription and / or intake of nitrates or nitric oxide donors on a regular or intermittent basis, or ritonavir were allowed.
Of the 670 men screened in the study, 559 (279 in the sildenafil group and 283 in the placebo group) were included in the safety analysis of double-blind therapy, and 529 patients (of whom, during the double-blind phase, 259 received sildenafil and 270 received placebo) ) – in the analysis of the safety of open therapy. The dose of sildenafil at the end of the double-blind phase in 60% of patients was 100 mg. More than 90% of patients completed the double-blind and open treatment phases, with the majority of dropouts not attributable to study drug use (less than 1.5%).
The demographic characteristics of the patients who took part in the study are presented in Table 1.
We will now study in more detail the safety of using sildenafil separately during the first and second phases of treatment.
The first phase – a course of 6-week double-blind therapy was completed by 95% of patients, and in each treatment group, the frequency of side effects was similar among patients receiving two or more three classes of antihypertensive drugs. One or more side effects occurred in 39.8% of patients in the sildenafil group and 25.1% of patients in the placebo group. And in 4 patients (1.4%) in each group, the drug was discontinued due to side effects, but most side effects were transient, and their intensity varied from mild to moderate. Serious side effects occurred in only 2 patients in each group (0.7%), and none of them, according to the researchers, was associated with the tested drug. The most common side effects were headache (10% in the sildenafil group versus 3.5% in the placebo group), hot flashes (6.1% versus 0.4%), dyspepsia (5.4% versus 1.1%), dizziness (3.9% versus 0.4%), nasal congestion (2.5% versus 0.4%) and visual impairment (2.5% versus 0%).
In the second phase – a course of 6-week open therapy – the percentage of patients with side effects in the groups receiving two, three or more classes of antihypertensive drugs was also similar. In total, side effects were recorded in 38.7% and 40.1% of patients (who took sildenafil or placebo during the double-blind phase, respectively), as a result of which 2 people (1.5%) who received placebo in the first phase were excluded from the study. … Side effects associated with the treatment of hypertension (in the sildenafil group versus placebo group) were as follows: hypotension (0.7% versus 0%), postural hypotension (0.4% versus 0.4%), and dizziness (2% versus 2%). %). Serious side effects occurred in less than 2% of all patients, and none of these effects were associated with therapy. Sildenafil oral was temporarily discontinued or dose reduced in less than 2% of all patients, and only one of these patients made these changes due to a therapy-related side effect.
The most common side effects were headache (7.6% in the sildenafil group versus 9.8% in the placebo group), hot flashes (5.7% versus 6%), dyspepsia (1.8% versus 2.7%), dizziness (1.6% versus 2.1%), nasal congestion (1.3% versus 2%) and visual impairment (1.3% versus 2.6%).
Consequently, men who received multiple antihypertensive drugs of different classes did not have an increased risk of more frequent or severe side effects with sildenafil treatment for ED.
The results of this study indicate that sildenafil is well tolerated in ED patients receiving several classes of antihypertensive drugs. In addition, the safety profile of sildenafil noted in the present study is similar to the safety profiles observed in all previous trials of sildenafil therapy for ED of varying severity and etiology.
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