In the last post, I discussed a clinical research study designed to increase sales of expensive new drugs like Jardiance for type 2 diabetes. The patients in these research studies are not on best practice treatment or optimal medical therapy for type 2 diabetes. They are on usual care which is dramatically inferior.
Let’s look at the research related to Jardiance, a drug for type 2 diabetes, that slows the progression of chronic kidney disease. This study lasted 2 years, and progression of kidney disease or death from heart disease occurred in 432 of 3304 patients (13.1%) in the empagliflozin (Jardiance) group and in 558 of 3305 patients (16.9%) in the placebo (fake pill) group. 13.1% vs 16.9% is a 28% reduction in relative risk. This benefit from Jardiance, a medication that was developed for patients with diabetes, occurred in patients with or without diabetes. So, it has nothing to do with sugar control. If you look at the real benefit to the entire population of patients with chronic kidney disease, the real difference is 16.9% minus 13.1% or 3.8%.
Let’s compare that with best practice medical treatment or optimal medical therapy (OMT) patients with diabetes and chronic kidney disease. Our current research studies examine the effect of a single drug compared with usual care. OMT combines the medications and lifestyle interventions that produce the greatest protection for cells and organs. OMT provides the most powerful protection against the dreaded complications of type 2 diabetes. The end result is dramatically better results than usual care. Jardiance reduces relative risk by 28%. Patients with type 2 diabetes and chronic kidney disease on usual care are 6 times more likely to go on to dialysis compared with patients on OMT. That is an order of magnitude better than the effect of Jardiance. It is highly probable that Jardiance tested against a background of OMT would provide even less advantage. It would be easy to correct our clinical research for cardiovascular disease and related conditions like diabetes. Prior to beginning the study, patients should be placed on optimal medical therapy and then the study should begin.
There is another level of support for this approach. Most clinicians think of Jardiance as a drug for type 2 diabetes. That is not why it reduces chronic kidney disease progression and hospitalizations for heart failure by one third. It cannot be about sugar because Jardiance provides those benefits whether the individual is diabetic or not. Jardiance produces these benefits compared with other diabetic drugs because it activates the master metabolic genetic survival switch AMPK. Switching on AMPK protects every cell and organ in the body from the complications of diabetes.
If you look at the diagram above, you can easily see that the interventions that are part of the optimal medical therapy protocol also produce their superior benefits by switching on AMPK. That included caloric restriction, intermittent fasting, exercise, ACE inhibitors like lisinopril, ARBs like losartan, statins, spironolactone, metformin, and SGLT2 inhibitors like Jardiance. All those other drugs are generic, and you can get all for about $40 a month. Since Jardiance and the other medications all produce their benefit by switching on AMPK, adding Jardiance to these other medications will have limited benefit at a much higher price. We can have better health at lower cost now, but we must all push for it.
Great in-depth article. So many studies behave as if they exist in a pristine lab with perfect lab rats giving us perfect data in isolation.