One of the reasons that I enjoy attending the annual American College of Cardiology conference is the air of excitement among the attendees, as this is where the latest research is released to the world. One of the most important studies presented, on Friday in Washington, has to do with cholesterol-lowering medications. The results of this trial, called FOURIER, will affect all of us — even those who do not need medications to lower cholesterol.
A new drug, called Repatha, has been shown, for the first time, to decrease the chance of someone dying from a heart attack, stroke, or needing bypass surgery. The study looked at 27,500 patients who had a history of heart attack, stroke or had peripheral arterial disease, and already had good cholesterol levels on optimal statin therapy. They received 140 mg Repatha injections every two weeks, 420 mg injections every month, or a placebo injection. The drug made an impressive difference.
When added to a statin, Repatha lowered LDL cholesterol 59% from baseline, from a mean value of 92 mg/dl decreased to a mean of 30 mgdl. More importantly, there was a 15% reduction in the main study endpoint, which was a combination of death from a heart problem, having a heart attack, stroke, or need for a bypass or stent
Why is this so important? Up until now, only statins, like Crestor and Lipitor, have been proven to prevent these life -threatening problems.
I remember attending the ACC conference in 1994, soon after I started in practice, and hearing the results of the first study (called the Scandinavian Simvastatin Survival Study) to show that a statin could decrease the chance of having a cardiac event. I remember thinking how the field of cardiology was about to change. In an admittedly nerdy way, I actually had chills of excitement. My world as a cardiologist had changed. Heart disease could now be reversed by a medication, without the need for open heart surgery. Flash forward 23 years, and a new medication has again been proven to do the same thing.
But we live in more complicated medical times. The new drugs are potentially life-saving, but come at a high price. Like many newly developed medications, they are incredibly expensive, costing as much as $16,000 per year, and they require receiving an injection every two to four weeks for the rest of your life. Insurance companies are reluctant to pay for such a medication. They require extensive pre-authorization paperwork, and often high co-pays.
To help ease the way for acceptance of these and other expensive medications, pharmaceutical companies have taken to the airwaves. Advertising of prescription meds has become a daily event. While I was watching the news the other night, almost every commercial was about medications, urging me to contact my doctor to get a prescription for treatment for diabetes, depression, opiate induced constipation and, of course, erectile dysfunction. Within the next few weeks, we will likely be inundated with ads for Repatha and its close cousin, Praluent, adding to the pressure on doctors to prescribe them.
But there is controversy about just who should be taking them. With this news comes a push to bring cholesterol levels lower than ever before, with LDL cholesterol levels often brought below 30 mg/dl. They are touted as having almost no side-effects; the worst thing noticed so far has been a higher risk of developing cataracts. As more people use these drugs, more side-effects may be seen, however.
What is not talked about as much is that almost all of the statins are now generic and cheap. The latest to become generic, Crestor (rosuvastatin calcium), the most powerful statin, is available for under $20 per month. A second medication called Zetia (ezetimibe), which often is combined with a statin to further lower cholesterol, recently became generic as well. It will be tough to justify a medication that costs $1,500 per month when the results may be almost as good for generics that can be found for 1 percent of that.
Although I hope to experience another breakthrough moment like I felt so many years ago with the introduction of statins, I have become more cynical over the years about the motivations of pharma companies to aggressively market their products, and how side-effects often do not turn up until a medication has been on the market for years. Time will tell if this cynicism is justified, or if the new drugs are worth the price. In the meanwhile, watch for clever ads urging you to speak to your doctor about new ways to lower your cholesterol.
Dr. David Becker is a board certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown, Pa. and has been in practice for 25 years. In 1993, after extensive research, Dr. Becker launched Healthy Change of Heart™, an innovative 10-week program designed to reverse heart disease and improve quality of life through diet, exercise, and stress management. Since then, thousands of patients have participated in the program, achieving significant results in improving cardiac wellness.
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