A New Drug To Lower Lipid Levels was Just Approved by the FDA

So a new drug to lower lipid levels was just approved by the FDA, good news? IF you have ever attended my heart health class I hope you answer no or at least maybe to that question. I don’t think like our typical medical establishment thinks, that lipids are the “bad guy” in our heart health. Well at least not in the way that they think. If you have never attended my heart health talk let me share a few things with you.

So I am not a Cardiologist, duh, but I have read several books written by cardiologists and read cardiology research. What I have read and understand is that the issue with heart health isn’t cholesterol, it is actually sugar. I won’t get too deep into the topic but several sources I read make the case that is insulin, which gets released due to the presence of sugar in our blood stream, that triggers the inflammation in our arteries. That inflammation causes our arteries to be less permeable to lipid molecules causing them to stick in our arteries. While cardiologists are treating the lipids that are accumulating by putting people on lipid lowering drugs, they aren’t treating the reason they are accumulating.

Satin’s, the drugs that lower lipids, do their job very well. Meaning, they work great at lowering cholesterol. The real question I have is does lowering cholesterol really mean lowering a risk for cardiovascular disease and stroke. I have had a difficult time finding a good graphic to illustrate my point but here you go. The two of following graphs are from the American Heart Association.0824 news mortality_graphic In the first graph you can see the rate of heart disease and cancer deaths from 1950-2014. Check out how the rate of heart disease started to decline in the mid 1980’s. The first stating approved by the FDA occurred in 1987. Prescription rates didn’t start to jump up until the mid 90’s. While the largest decline has occurred since the introduction of statins our awareness of heart health also increased. Educating the public on exercise and nutrition has also been a huge thing since the 1980’s for sure. Check out these two graphs from data regarding British citizens. Comparing these two it appears that the climb in lipid lower prescriptions did not add to the gradual decline in cardiovascular deaths which appears to have been going on since 1969. So if statins were an important part of a reduction in CVD as statin use took off in the graph on the left, there should be a dramatic drop in the graph on the right at the same point. cvd-death-rates

British Statin Stat 1








Going back to the first AHA graph check out that there was an increase in cardiovascular deaths noted between 2011-2014. Now look at this graph, from the AHA, that shows the increase in US Adults taking statins or eligible for taking statins between 2011-2014. Looking at this shows me that despite an increase in statin use there was actually an increase in cardiovascular death over the same time frame.Number of People I believe that what goes on in America to make these stats on cardiovascular deaths is due to complex issues beyond one type of drug. Things that we did in the last two decades of the 20th century include awareness of the health complications from smoking. In the 90’s we started talking about the problem with processed foods on our health as well.  I also can’t help but think if statins, which do lower cholesterol, actually lowered our risk for death from cardiovascular disease; as the number of prescriptions rise the rate of death should decline.

OK back to the topic of the article, this new drug approved by the FDA to lower lipid level. The safety and efficacy was studied over 52 weeks in two trials. A question, do patients take statins for only 52 weeks? What is the safety and efficacy over 3 years? Besides the side effects which include gout and tendon rupture the most interesting part to me is that the label on the drug says that the drug’s effect on reducing cardiovascular death has not been determined. What does this mean, again this drug will lower your lipid levels but it may not reduce your risk of death or disability due to cardiovascular disease. The measure should be reducing risk for death or disability due to cardiovascular disease not how well it lowers cholesterol. These drugs should be studied for 3-5 years before being approved by the FDA as well, not just 52 weeks – ish.

So why am I writing this today. To get you to think differently about what you are being told to do. Not to stop taking your drugs but instead look into the why. To understand better that the FDA is approving drugs they barely test, 52-ish weeks? Really? For a drug your doctor will put you on for how many years? Think about this, every drug the FDA has pulled off the market for safety reasons, they once approved because of studies like this. It does appear that post stroke or heart attack there is strong evidence for protection from further events in taking these medications.

How about while you take the drugs change your lifestyle, diet and nutrition. Work to reduce your risk for heart disease and stroke then talk to your doctor about changing what medications he or she has you on. If you need help, let us be a resource for you.

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Posted in Exercise and Fitness, Healthcare Policy and Politics, Nutrition, Wellness

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