February marks American Heart Month and the opportunity to participate in a new study designed to prevent heart attacks, strokes and the onset of diabetes.
The U.S. National Heart, Lung and Blood Institute and Dr. Paul Ridker of Harvard Medical School are beginning a study to target inflammation in the blood vessels. Their thought is that inflammation causes blockage of the blood vessels, which leads to heart attacks and strokes and contributes to high blood pressure and the onset of diabetes. This study represents the first new class of anti-artery clogging drugs since 1987, when statins — drugs used to lower cholesterol — were introduced.
Previously, doctors have treated patients with heart attacks, strokes, diabetes, high blood pressure and high cholesterol as if these diseases were not connected. New research by Ridker suggests that inflammation of the blood vessels could connect these separate processes. If so, an anti-inflammatory medication could treat and hopefully prevent the worsening of these different diseases.
A previous study by Ridker in 1997 showed that healthy men taking aspirin (which reduces blood clots and is anti-inflammatory) avoided heart attacks. In 2008, Ridker showed that taking a statin to reduce cholesterol reduced heart attacks and strokes by 50 percent and deaths by 20 percent. The important question is whether the benefits to the patients come from reducing cholesterol or inflammation or the anti-clotting effects of aspirin. This information will further patient-centered treatment, as not every patient will need all three treatment plans.
The medication Ridker plans to use in the study is a low dose of methotrexate. This medication has been used in the treatment of rheumatoid arthritis to reduce the inflammation that causes this disease. These patients have a 40 percent lower rate of heart attacks than untreated patients. Low doses have been safely used for the past 40 years, with 5 million patients currently receiving this treatment on a regular basis.
The doctor regularly measures the patient’s liver function tests and blood counts to insure no side effects develop. If side effects develop, the medication is stopped until the patient’s blood tests return to normal. Ridker, rheumatologists and the NHLBI consider low-dose methotrexate a safe and cheap generic treatment to prevent inflammation thought to cause heart attacks, strokes and aggravate diabetes and high blood pressure.
Our site was selected by Ridker to conduct this exciting study. We are looking for 20 patients who have had a heart attack in the past five years. They must also have other signs of inflammation, such as type 2 diabetes or a combination of overweight, high-blood pressure (or treatment of high-blood pressure), elevated cholesterol (or treatment of high cholesterol) or elevated fasting blood sugar (or treatment for it) or low levels of good cholesterol. These processes correlate with inflammation and make theses patients a good target for this treatment. The results of this study will show the way to improved personalized medical care with better targeted medicines.