New Guidelines on Men with Erectile Dysfunction and Cardiac Health Published in the Journal of Sexual Medicine Concludes PDE-5 Inhibitors are Still Safe for the Cardiovascular System

PASADENA, Calif.--(BUSINESS WIRE)--25 years after Viagra hit the market, a group of experts from across the country examined the link between erectile dysfunction (ED) and heart health. Their summary and guidelines have now been published in the Journal of Sexual Medicine. They determined that PDE-5 inhibitors are still safe for the cardiovascular system.

In March of 2023, a group of 17 interdisciplinary scientists and practitioners convened “The Princeton IV: PDE-5 Inhibitors and Cardiac Health Symposium” held at Huntington Medical Research Institutes (HMRI) in Pasadena, California. Principal Investigator Robert A. Kloner, MD, PhD, Chief Science Officer and Scientific Director of Cardiovascular Research at HMRI, and Professor of Medicine at the Keck School of Medicine of the University of Southern California, led the group with co-chair Raymond Rosen, PhD of the University of California San Francisco, steering committee members Arthur L. Burnett, MD, MBA of Johns Hopkins, and Martin M. Miner, MD of Brown University. The conference was funded by an unrestricted grant from Sanofi to readdress the cardiovascular workup of men presenting with ED and the cardiovascular safety of the phosphodiesterase-5 (PDE-5) inhibitors for treating ED.

Princeton IV expanded on the findings of Princeton III, held over a decade ago. These findings include:

1. ED is a risk-marker and risk-enhancer for atherosclerotic cardiovascular disease (CVD), and men who present with ED, especially vasculogenic ED, should have an assessment of their atherosclerotic cardiovascular risk as outlined by the American College of Cardiology/American Heart Association algorithms.

2. Those patients at the borderline to intermediate risk for cardiovascular events should undergo coronary artery calcium (CAC) scoring by computerized tomography scanning. The CAC score will aid in determining therapy and the need to refer to a cardiologist.

3. Patients with ED should be characterized as low-risk, intermediate (or indeterminable), or high-risk of developing a cardiac event with sexual activity. Risk is largely assessed by the patient’s exercise ability for age and may require a stress test.

4. If the patient has good exercise tolerance without symptoms or signs of ischemia (lack of oxygen) and is classified as low-risk, then ED can be treated.

5. If a patient is on nitrates or riociguat then PDE-5 inhibitors are contraindicated. However, in some cases, if nitrates are not necessary, then consideration should be given to stopping them and trying PDE5 inhibitors to treat ED.

6. New observational data show an association between the use of PDE-5 inhibitors in men with ED and lower rates of major adverse cardiovascular events and overall mortality. Prospective trials are needed.

7. Recent studies show that dietary supplements for treating ED may be adulterated with PDE-5 inhibitors such as Viagra. The problem is that some men on nitrates may inadvertently receive PDE-5 inhibitors (a current contra-indication due to hypotension [low blood pressure] when both drugs are taken together).

8. Some countries are now making PDE-5 inhibitors available over the counter with input from pharmacists. There is growing interest in similar possibilities in the U.S., but this remains under study.

9. PDE-5 inhibitors also appear to have cardiovascular safety in women. They are used for treating pulmonary hypertension in women. Subgroups of women with female sexual dysfunction may benefit from PDE-5 inhibitors, but more research is required. New therapies have been developed to treat female sexual dysfunction.

“Cardiovascular disease (CVD) remains a leading cause of death in the world. The development of ED is often a precursor to the development of atherosclerotic coronary artery disease,” said Kloner. “When a man presents with ED, leading to a CVD workup, there is an opportunity for earlier identification and treatment of risk factors for CVD, which may ultimately save lives.”

The most important future studies include prospective, randomized, placebo-controlled studies to see if drugs like tadalafil and sildenafil reduce major adverse cardiovascular events. There are ongoing studies of regenerative medicine to study their effects on ED. While still considered investigational, shock wave therapy, stem cells and platelet-rich plasma may hold promise.

The full manuscript can be read here.

About HMRI

Huntington Medical Research Institutes (HMRI) is a pioneer in scientific research with a 70-year track record of groundbreaking discoveries that have changed our world. Today, our work is laser-focused on innovative biomedical research that investigates diseases of the heart and brain, and we are committed to inspiring and educating the next generation of scientists. Our scientists work on solving Alzheimer’s disease, mental illnesses like schizophrenia, and cardiovascular disease. At HMRI, we serve society by fearlessly pursuing science and contributing to a future free from diseases that today affect millions of people around the world. For more information about HMRI, visit https://www.hmri.org.

About the International Society for Sexual Medicine (ISSM)

The International Society for Sexual Medicine was established in 1978. The goals of the ISSM are to encourage the highest standards of practice, education, and research in the field of human sexuality; to develop and assist in developing scientific methods for the diagnosis, prevention, and treatment of conditions affecting human sexual function; and to promote the publication and encourage contributions to the medical and scientific literature in the field of sexual function. The ISSM has over 3,000 members from all five continents and from 100+ nations. For more information about the ISSM, visit https://www.issm.info.