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Stalevo May Increase Risk of Cardiovascular Events (Heart Attack, Stroke, and Death)

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Wouldn’t it be wonderful if we could talk about heart disease in a vacuum - isolated from all other factors or influences? It would be wonderful, but the hard reality is that nothing about our health is isolated. Our bodies are a magnificent mesh of interconnecting systems, neurons, muscles, bone, organs, and so very much more.

Often what affects one part of the body - or more specifically, the “cure” for what affects one part of the body - has the potential to have very unhealthy (and generally unwelcome) side effect on another part. One only has to watch television to verify this truth. The airways are full of advertisements for pharmaceutical cures - try product X (the newest, latest, greatest on the market, guaranteed to help and endorsed by patients and physicians alike) but side effects include nausea, vomiting, diarrhea, sterility, mood swings, depression, muscle cramps, changes in vision, hair loss, and so on ad infinitum! I’ve yet to see a single drug where known side effects were listed as “none.” (Maybe they do exist, but I’ve never personally come across such a novelty.)

If you are concerned about heart disease, then you also need to be aware that some drugs, or combination of drugs, just may take a toll on your heart health. While they may cure the ailment they’re designed to target, you may be left with new health concerns. One such new red-treatment-flag was just raised by the U.S. Food and Drug Administration (FDA) on August 20, 2010 regarding the use of Stalevo (entacapone or C/LE).

Stalevo is a drug that is commonly used to treat Parkinson’s disease (PD). As a part of the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) clinical trials, researchers have been evaluating the effectiveness of taking combined carbidopa/levodopa and Stalevo for the treatment of PD. While carbidopa/levodopa are used to treat PD, the real improvement for those suffering from PD comes when Stalevo is added to the cocktail. Stalevo is currently available as a stand-alone drug but is generally prescribed for use in combination with carbibopa/levodopa.

The STRIDE-PD study findings appeared to indicate that the addition of Stalevo leads to an increased risk of all types of “cardiovascular events” such as stroke and heart attack. In this study, the control group taking cardibopa/levodopa and Stalevo combination suffered a total of seven heart attacks and one death (heart related) compared no heart events or deaths in the group which took only cardibopa/levodopa. The STRIDE-PD study lasted for almost three years.

The disparity in the cardiovascular events between the two groups was significant enough for the FDA to examine the results from 15 other similar clinical trials. When the STRIDE-PD data was combined with date from the other studies, the results were similarly lopsided against Stalevo. A total of 27 “cardiovascular events” (stroke, heart attack or death from heart attack) were reported in groups taking Stalevo compared to only 10 such events in groups taking only cardibopa/levodopa. The FDA noted that most of the participants who had a cardiovascular event, already had some risk factors for heart disease. While the FDA is not yet saying conclusive that adding Stalevo increases your risk of heart disease, it does bear watching particularly if you are already at risk for heart disease.

Most of us know someone whose life has been touched by PD in some way. I myself have a family member and a friend living with PD. It’s a horrible, terrible debilitating disease I’d be hard pressed to tell someone who may be considerably better because they’re taking Stalevo to stop. Despite this, as with any drug, it’s prudent to know what the side effects are and what else may be in store as a result - health care is all about empowerment and making informed decisions. If you or someone you know has PD and as taking Stalevo, then discuss with your doctor if this is the right choice for you given your personal full health (including your personal risk factors for heart disease) picture.

Source:
Robert Lowes, Parkinson’s Drug Under FDA Review: Stalevo Suspected of Upping Cardiovascular Risk, 20 Aug 2010, Medscape, http://www.medscape.com/viewarticle/727266

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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