What are Cardiovascular Outcome Trials?
Pharmaceutical companies are continuously working on developing new drugs to relieve the burden of chronic illness such as diabetes, hypertension, high cholesterol, and obesity. These types of chronic illnesses are significant risk factors for the development of cardiovascular disease. Cardiovascular diseases include a wide range of conditions that affect the circulatory system, i.e., blood vessels in the body. Given that cardiovascular diseases are the leading cause of death worldwide, drug developers are now often asking the question “Can this new drug also reduce the risk of developing cardiovascular disease in the population?” Therefore, clinical trials are being developed to answer that exact question.
These trials are called cardiovascular outcome clinical trials or CVOT. CVOT trials help to investigate whether a new drug has a positive or negative impact on cardiovascular events. This can establish a secondary benefit for newer medications aside from the drugs primary purpose. For example, if a new drug is being developed to help improve glucose control in diabetes but it can also be proven to reduce risk of heart attack or stroke then the new drugs benefit has a wider indication of use for the general population.
How Long are CVOT Trials?
CVOT trials do tend to last longer than a typical clinical trial. Typically, they are 2-5 years in length as they are evaluating patient outcomes over a longer period. Some of the major adverse cardiovascular events that are monitored are nonfatal heart attack, nonfatal stroke, heart failure, ischemic related revascularization (such as cardiac stent placement) and/or cardiovascular related deaths. Data is collected over time to determine if the risk of cardiovascular events in the study participant group differs from the risk in the trial population.
Are There Medications That Help Reduce the Risk of Developing Cardiovascular Disease?
There are many drugs currently on the market that have been proven to have this dual benefit. One example is GLP-1 medications initially being developed for diabetes to improve glucose control. It was also found that it can be an effective medication in non-diabetics for weight loss. Diabetic patients and non-diabetic patients who lose weight and can maintain a healthy body composition should then have lower cardiovascular risk factors, ultimately lowering their risk of developing cardiovascular disease. This lowered cardiovascular risk could be a secondary benefit for weight loss medication.
In addition to weight loss, improved glucose control and potentially lowered cardiovascular risk, GLP-1s and other diabetic medications such as SGLT-2s have been shown to reduce the risk of kidney disease in certain patient populations. SGLT-2s (examples: Jardiance, Farxiga) are often prescribed for non-diabetic congestive heart failure patients and/or for patients with chronic kidney disease. SGLT-2s aid in removing extra fluid buildup which is a common problem in people with heart failure. These medications also protect the kidneys by reducing pressure within the glomeruli, which are small filters in the kidneys. This reduced pressure helps to reduce stress on the kidneys and slows the progression of kidney disease. For more information about kidney (renal) disease, keep an eye on our website as new blogs will be coming shortly on this topic.
Clinical Trials
Cardiovascular outcome trials are a type of clinical research trial that switches the focus from treatment to prevention. Focusing on treating the risk factors of cardiovascular events, i.e., high blood pressure, obesity, and diabetes in hopes to help prevent cardiovascular outcomes such as heart attack and stroke. Learning about secondary benefits through conducting outcome driven clinical trials such as CVOTs can expand the impact that a new drug can have on a wider range of patients. If you are interested in learning more about cardiovascular outcome clinical trials or if you are interested in participating in a clinical trial, please contact us at (203) 419-4404 for more information.
