It’s Indisputable: Heart Failure is a Too Little Too Late Disease

Look at the graph above. This represents 21 years of follow-up in patients with type 2 diabetes and chronic kidney disease identified by a small amount of protein in the urine. This study compared usual care— the care that almost everyone receives— with optimal medical therapy (OMT) (protocol-driven, advanced primary care best practice treatment.) OMT dramatically reduced all complications of diabetes eight years into the study. The difference in outcomes was so impressive, the researcher rightly concluded it would be unethical to continue to expose people to usual care and everyone went on OMT. Therefore, from the eight-year mark onward, we would expect these two lines to come together. We would expect the dashed line to come down towards the solid line since the treatments are the same. But they don’t. In fact, they continue to pull apart. The people originally in usual care continue develop heart failure and die of heart-related causes in ever greater numbers. By 20 years, at an average age of 75, only one in four of the usual care people was still alive, compared with half of the OMT group. There was a 70% reduction in the number of patients who developed heart failure in this study. Ten patients in the OMT group developed heart failure vs twenty-four in the usual care group over the 21 years of follow-up.

It is the same with all complications of diabetes in this study. OMT impressively reduced heart attack, stroke, dialysis, amputations, the need for stents, eye damage and so forth, and even when the usual care group used OMT, the original OMT patients continued to do better, and the two lines continued to diverge. See the graph on page 588 in this link. OMT fails to rescue these people for a very clear reason. Their disease has advanced beyond the point of no return. There is so much scar tissue, inflammation, and loss of the critical functional cells in their organs that these individuals can no longer be rescued, especially if they have the type of heart failure with stiffness of the heart muscle caused by scar tissue.

That type of heart failure is strongly associated with obesity and related high blood pressure. Most type 2 diabetics are obese and even more have extra abdominal fat. That is where it all begins. Genes in increased stores of abdominal fat make hormones, enzymes, inflammatory mediators, and excess oxidants that lead to high blood pressure, insulin resistance, high cholesterol, high triglycerides, prediabetes, and ultimately diabetes. There is a much higher risk of chronic kidney disease in people with diabetes and high blood pressure. At the beginning of the study, these individuals had been exposed to damage from hormones, inflammatory mediators, and excess oxidants for decades. This study involved individuals who were late in the disease process. After eight years, those in usual care had so much damage OMT could not protect them as much.

OMT is a combination of best practice lifestyle changes and medications. OMT patients received recommendations for diet, exercise, and stopping smoking cigarettes. Patients also got lisinopril or losartan for high blood pressure, atorvastatin for high cholesterol, and metformin for high sugar. They also got low-dose aspirin to prevent clots. All these interventions block the root cause of congestive heart failure and other diabetic complications. They interfere with oxidant production from the hormones and enzymes produced from abdominal fat. They interfere with the production of inflammatory mediators. Now we know that spironolactone and eplerenone also interfere with oxidant production. Jardiance produces similar effects by activating the master metabolic genetic switch (AMPK) By starting these medications when high blood pressure, high cholesterol, and diabetes first begin, chronic kidney disease and congestive heart failure occurrence can be even more dramatically reduced. The key is blocking the metabolic root cause early. We do too little too late. Once the organ damage is advanced, even these precision treatments have limited effects.

This is very important information. If anyone lives to be 80, there is about a 40% chance they will have congestive heart failure.  Individuals with type 2 diabetes mellitus have a risk of developing heart failure at least twice as high as individuals without diabetes. This risk is even higher when there is protein leaking into the urine. Patients with diabetes and heart failure have an average survival from the time of their heart failure diagnosis of three and a half years and a 5-year mortality rate of 75%. The outlook for individuals with type 2 diabetes and heart failure is worse than that of heart failure patients without diabetes mellitus. There is nothing as effective as OMT and the earlier you start the more effective it is. I agree with the investigators in this study. We have an ethical obligation as clinicians to develop the systems to assure patients receive OMT consistently.