Originally published in MedPage Today
by Joyce Frieden, MedPage Today News Editor
Patients with erectile dysfunction (ED) who were treated with telmisartan, ramipril, or both were at greater risk for cardiovascular events than other patients on the same medications, researchers found.
In men who reported ED at baseline, all-cause mortality during a median follow-up of four years was double that seen in men who had mild ED or no erectile dysfunction, according to a study published online in Circulation.
“The present data clearly show that ED is closely associated with an increased risk for all-cause deaths, as well as the primary composite outcome of cardiovascular death, myocardial infarction, stroke, and hospitalization for heart failure,” wrote Michael Böhm, MD, of the University of the Saarland, Saarbrücken, Germany, and colleagues.
“The evaluation of ED in the medical history as an early symptom of endothelial dysfunction and atherosclerosis and as a predictor of death and future cardiovascular events might be relevant to identify patients at particularly high risk of experiencing a cardiovascular event.”
For this study, the researchers looked at a subgroup of 1,549 men who had participated in either the ONTARGET study — which looked at the effectiveness of a ramipril/telmisartan combination in patients with cardiovascular disease — or the TRANSCEND study, which examined the effects of telmisartan in patients who were intolerant of ACE inhibitors.
Of those enrolled in the ONTARGET study, 400 had been randomly assigned to ramipril, 395 to telmisartan, and 381 to combination therapy. Among those in the TRANSCEND study, 202 patients had been randomized to placebo and 171 to telmisartan.
The researchers developed an ED questionnaire using the five-item short form of the International Index of Erectile Function (IIEF) and the Kölner (Cologne) Evaluation of Erectile Dysfunction scores. Questionnaires were obtained from all patients at baseline, at year two, and at the next-to-last follow-up visit.
Of the 1,519 men included in the final analysis, 842 had moderate to severe ED at baseline and 677 had mild ED or functioned normally.
Patients with ED at baseline were older and had a higher prevalence of hypertension, stroke or transient ischemic attack, diabetes, and lower urinary tract surgery than those without ED, the researchers noted.
There were no significant differences in the prevalence of ED among the different treatment groups.
The majority of substudy patients were found to have cardiovascular disease, a finding similar to that of the main trials. Large percentages of patients had had a previous myocardial infarction or stroke, and 34% had a history of diabetes.
Adherence to study medications was high in all groups, with most patients continuing to take their full doses, the researchers said.
In the ONTARGET study, blood-pressure-lowering effects were greatest in the combination arm (average reduction 8.5 mm/Hg) compared with the telmisartan-only arm (7.6 mm/Hg) and the ramipril-only arm (5.4 mm/Hg).
All-cause deaths during the study period occurred in 11.3% of the patients who reported ED at baseline compared with 5.6% of patients with no or mild ED at baseline, the researchers said (HR 2.04, 95% CI 1.40 to 2.97, P=0.0002).
The composite primary endpoint of cardiovascular death, myocardial infarction, stroke, and hospitalization for heart failure occurred in 16.2% of patients with ED (HR 1.62, 95% CI 1.22 to 2.17, P=0.001) compared with 10.3% of patients with mild ED at baseline or none at all.
Patients with ED at baseline also were more likely to die of cardiovascular causes or MI and tended to have higher risks for heart failure and stroke, “but the observed trends toward increased risk were not significantly different,” the authors noted.
The researchers also looked at the effects of the study drugs on ED.
“There were no significant differences in IIEF scores or the changes in scores at the run-in, two-year, and penultimate visits among the treatment groups in either ONTARGET or TRANSCEND,” they said. In addition, “over time, there were also no differences in onset of new ED due to either treatment.”
The authors concluded that “it is likely that the presence of ED identifies individuals whose cardiovascular disease might be far more advanced than evaluated by other clinic parameters alone.”
They added that the association was particularly close with regard to all-cause and cardiovascular death: “According to the IIEF scores in the present study, there was an increased risk in patients with mild to severe ED, and we observed a stepwise increase in risk depending on the severity of ED.”
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