研究對象是1,519名男性，來自參與「ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET)」研究以及「Telmisartan Randomized AssessmeNt Study in ACE [angiotensin-converting enzyme] INtolerant subjects with cardiovascular Disease (TRANSCEND)」試驗之「ED次研究」的13個國家，兩項研究的多數研究對象都有心血管疾病，在ONTARGET研究中，這些男性病患被隨機指派接受ACE抑制劑ramipril、telmisartan或併用這兩種藥物，在TRANSCEND試驗中，對於ACE抑制劑無法耐受者被隨機指派接受telmisartan或安慰劑。
紐約大學醫學院心臟科教授Richard A. Stein醫師受邀發表獨立評論時向Medscape Cardiology表示，我們早就已經知道控制動脈粥狀硬化的主要細胞是位於血管內層的內皮細胞，陰莖海綿組織上也有這種細胞，因此我們知道勃起障礙和心臟病之間有某種關聯，本研究追蹤一群已經知道有心血管疾病的男性達將近5年，提出令人印象深刻的結果：勃起功能障礙是實際風險增加的一種標記。
Erectile Dysfunction a Red Flag for Mortality, Cardiovascular Events
By Norra MacReady
Medscape Medical News
March 19, 2010 — Erectile dysfunction (ED) is a robust predictor of all-cause mortality and cardiovascular events in men with cardiovascular disease or those with risk factors, new data show.
ED and cardiovascular disease both are associated with endothelial dysfunction, "so it was reasonable to assume that ED was related to cardiovascular outcomes and possibly both cardiovascular-related and all-cause death." These findings, published online March 15 in Circulation, support that assumption, write the investigators, led by Michael Bohm, MD, of the University of the Saarland, Saarbrucken, Germany.
The study subjects were 1519 men from 13 countries participating in an ED substudy of the ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET) and the Telmisartan Randomized AssessmeNt Study in ACE [angiotensin-converting enzyme] INtolerant subjects with cardiovascular Disease (TRANSCEND) trial. Most of the subjects in both trials had cardiovascular disease. In ONTARGET, the men had been randomly assigned to receive the ACE inhibitor ramipril, telmisartan, or a combination of the 2 agents. In TRANSCEND, people intolerant to ACE inhibitors were randomly assigned to treatment with telmisartan or a placebo.
For the ED substudy, each man answered the 5-item International Index of Erectile Function (IIEF) and the 6-item Kolner Evaluation of Erectile Dysfunction questionnaires. Worsening ED is indicated by higher scores on the Kolner scale and lower scores on the IIEF. The questionnaires were administered at baseline; 2 years later; and on the penultimate follow-up visit, which occurred at a median of 48 months later.
The overall prevalence of ED was 55% — approximately twice as high as in the general population — with no difference between the ONTARGET or TRANSCEND groups. The median age of the men with ED was 66 years vs a median age of 63 years for the men with no or mild ED (P < .0001). All-cause mortality occurred in 11.3% of the men with ED at baseline vs 5.6% of the men with no or mild ED at baseline, for a hazard ratio of 2.04 (95% confidence interval, 1.40 - 2.97; P = .0002). The composite primary outcome of cardiovascular death, myocardial infarction, stroke, and hospitalization for heart failure occurred in 16.2% of the men with ED vs 10.3% of the men with no or mild ED, for a hazard ratio of 1.62 (95% confidence interval, 1.22 - 2.17; P = .0001).
"Patients with ED at baseline also were more likely to die of cardiovascular causes (P=0.0009) or myocardial infarction (P=0.04)," the investigators write. They observed a stepwise increase in risk depending on the severity of the ED. A tendency toward a higher risk for heart failure and stroke was observed in the men with ED but did not attain statistical significance.
Scores on the IIEF and Kolner scales did not change appreciably during the course of the study, suggesting that none of the treatments had any effect on ED among the participants.
"We've known for many years that the major cell that controls the development of atherosclerosis is the endothelial cell, which lines the blood vessels" as well as the spongy tissue of the penis," Richard A. Stein, MD, professor of cardiology at New York University School of Medicine in New York, NY, told Medscape Cardiology when asked for independent comment. "So we've known there should be a relationship between erectile dysfunction and heart disease. This study, which followed a group of men with known cardiovascular disease for nearly five years, showed in an impressive way that erectile dysfunction is a marker of substantial increased risk."
Treatment of these patients should be the same as for any patient with heart disease: weight control, exercise, smoking cessation, and improving the serum lipid profile, says Dr. Stein, who was not involved in the study. It still is not known conclusively if these measures can resolve ED. Still, he says, "there’s a reasonable basis to think that this patient has increased cardiac risk factors and would benefit from reducing them. Hopefully, that might reduce the erectile dysfunction, but more clearly, it will reduce the patient's risk of having a downstream cardiac event."
These findings suggest that ED is a manifestation of cardiovascular risk, the study authors believe. They conclude: "ED is a powerful predictor of cardiovascular death and of major cardiovascular events in high-risk patients and represents a symptom of more advanced atherosclerosis and endothelial dysfunction."
The ONTARGET/TRANSCEND ED Substudy was supported by Boehringer-Ingelheim, Germany. All of the study authors have received grants or funds from Boehringer-Ingelheim for the conduct of these trials. Dr. Stein has disclosed no relevant financial relationships.
