Column #388     February 3, 2023

Maybe there’s more to better health than just nutrition. Could it be possible that taking Viagra will stave off heart disease? A recent study published in “The Journal of Sexual Medicine” implies that it does.¹

Prior to that study the word was that Viagra, and other drugs belonging to a class of medications called phosphodiesterase type 5 inhibitors (PDE5 inhibitors or PDE5i), may not be safe for people with certain types of heart disease. The two main reasons given were the way those drugs affected blood pressure and their potential for interaction with nitrates, a drug sometimes prescribed to treat angina. There are four major types of PDE5 inhibitors available: sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra or Staxyn), and avanafil (Stendra).²

People who have erectile dysfunction (ED) are already at risk of having heart disease and vice-versa. This is because both can be associated with vascular disease, conditions that affect blood vessels and blood flow. In fact, vascular conditions account for 70% of erectile dysfunction. For years the medical community has said vascular conditions include atherosclerosis (hardening of the arteries), hypertension (high blood pressure), and high cholesterol.

According to the Food and Drug Administration (FDA) there have been reports of myocardial infarction (heart attack), stroke, irregular heartbeat (arrhythmias), and even death in people taking Viagra. But most of the reports were of men who had been diagnosed with heart problems before taking the drug. Consequently, the FDA does note that it hasn’t determined whether those events were directly related to the PDE5i-type drugs.³

But concerns for PDE5i-type drugs may be about to change! A study indicating that PDE5i may have a positive impact on heart disease was released January 13, 2023, and it has become an overnight sensation—to say the least.

The data was derived from patient records of more than 50 million members of medical and pharmacy commercial health plans in the United States that identified male patients with ED between January 1, 2006, and October 31, 2020. The researchers broke them down into two groups. One group was individuals who filled one or more prescriptions for an approved PDE-5i  (n = 23,816). From the same large population they identified a group of patients (controls) without any claims for PDE-5i during the study period (n = 48,682).

PDE-5i–exposed men were matched to controls on the basis of age; index dates; diagnoses of coronary artery disease, type 2 diabetes mellitus, hypertension, cholesterol levels, and antiplatelet, statin, and blood pressure therapy.

The study’s conclusion found that the men with ED and exposure to PDE-5i were associated with a 13% lower rate of major adverse cardiovascular (CV) events (MACE), 25% lower rate of mortality, and 39% lower rate of CV mortality than nonexposure. The highest exposure levels were associated with the greatest reductions in MACE and death and were also associated with significant reductions in myocardial infarction and stroke. Based on that they concluded that this study shows the potential for PDE-5i to provide CV protection and that there are good reasons for future randomized, controlled trials.

The authors did point out some limitations in their study since it was a retrospective observational study with the potential for “residual confounding by unaccounted-for variables.” For instance, there’s the absence of an independent measure of sexual activity in these men. So it wasn’t clear whether increased sexual activity may have contributed to the benefits. The data relied on health plan prescription claims, and how many of the PDE-5i pills men took was not recorded.^{4 5}

Another drawback in the study is that erectile dysfunction medications are usually taken as needed rather than daily. So just filling a prescription does not necessarily translate into taking the medication. Men, in either group, could have also obtained PDE-5i pills from other sources, such as the internet or a friend.

Consequently the study was not designed to show whether PDE-5i medications are the cause of the observed heart-related benefits. It only shows that there is an association between taking PDE-5 inhibitors and cardiovascular outcomes.

Although he wasn’t paid directly to write this report, in terms of conflicts of interest the head author, Dr. Kloner, is a paid consultant for Sanofi—a French multinational pharmaceutical and healthcare company. The study was supported by a grant from Sanofi to Huntington Medical Research Institutes (HMRI)—a California-based, biomedical research lab. Sanofi was not involved with data collection or data analysis or in drafting of the manuscript. But Sanofi is working on obtaining regulatory approval for an over-the-counter version of Cialis.^{6 7 8}

Independent cardiologists do point out that PDE-5i medications work by opening (dilating) blood vessels. That’s how they improve symptoms of erectile dysfunction, by increasing blood flow in the penis. Therefore they believe it’s possible that PDE-5i drugs might improve cardiovascular outcomes because they improve overall blood vessel health.⁹

Needless to say, this new report, regardless of the validity of its conclusions, is being well received by millions of men all over the world. Will there be a run on PDE-5i drugs? If so, will the rate of heart disease in men be impacted? It will be exciting to find out.¹⁰

To your health.

Ted Slanker

Ted Slanker has been reporting on the fundamentals of nutritional research in publications, television and radio appearances, and at conferences since 1999. He condenses complex studies into the basics required for health and well-being. His eBook, The Real Diet of Man, is available online.

For additional reading:

1. Effect of Phosphodiesterase Type 5 Inhibitors on Major Adverse Cardiovascular Events and Overall Mortality by Robert A. Kloner, MD, PhD, et al. from The Journal of Sexual Medicine

2. What Are the Most Common PDE5 Inhibitors? by Daniel Yetman from Healthline

3. Is Viagra (Sildenafil) Safe for Men With Heart Disease? by Richard N. Fogoros, MD from Very Well Health Updated on September 08, 2022

4. Viagra and Heart Health: Why Taking ED Drugs May Help Extend Your Life Too by Shawn Radcliffe from Healthline

5. Healthy Males Have High Sex Drives—But Today’s Men Don’t by Tristan Justice from The Federalist

6. Sanofi S.A. A French multinational pharmaceutical and healthcare company headquartered in Paris, France.

7. Sanofi S.A. Website

8. Huntington Medical Research Institutes (HMRI)—a California-based, biomedical research lab

9. Why Viagra May Help You Live Longer by Paul Schrodt from Honehealth

10. Ten Oldest Fathers in the World from Oldest.org